Brazilian Journal of Cardiovascular Surgery 28.2 - 2013

28.2 APRIL/JUNE 2013

BRAZILIAN JOURNAL OF CARDIOVASCULAR SURGERY | REVISTA BRASILEIRA DE CIRURGIA CARDIOVASCULAR

VOL. 28 Nยบ 2 APRIL/JUNE 2013

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RBCCV REVISTA BRASILEIRA DE CIRURGIA CARDIOVASCULAR

EDITOR/EDITOR Prof. Dr. Domingo M. Braile - PhD São José do Rio Preto - SP - Brasil domingo@braile.com.br

BRAZILIAN JOURNAL OF CARDIOVASCULAR SURGERY

EDITORES ANTERIORES/FORMER EDITORS • Prof. Dr. Adib D. Jatene PhD - São Paulo (BRA) [1986-1996] • Prof. Dr. Fábio B. Jatene PhD - São Paulo (BRA) [1996-2002]

EDITOR EXECUTIVO EXECUTIVE EDITOR Ricardo Brandau Pós-graduado em Jornalismo Científico - São José do Rio Preto (BRA) brandau@sbccv.org.br

ASSESSORA EDITORIAL/EDITORIAL ASSISTANT Rosangela Monteiro Camila Safadi PhD - São Paulo (BRA) São José do Rio Preto (BRA) rosangela.monteiro@incor.usp.br camila@sbccv.org.br

EDITORES ASSOCIADOS/ASSOCIATE EDITORS • Antônio Sérgio Martins • Gilberto Venossi Barbosa • José Dario Frota Filho • José Teles de Mendonça • Luciano Cabral Albuquerque • Luis Alberto Oliveira Dallan • Luiz Felipe Pinho Moreira

Botucatu (BRA) Porto Alegre (BRA) Porto Alegre (BRA) Aracaju (BRA) Porto Alegre (BRA) São Paulo (BRA) São Paulo (BRA)

• Manuel Antunes • Mario Osvaldo P. Vrandecic • Michel Pompeu B. Oliveira Sá • Paulo Roberto Slud Brofman • Ricardo C. Lima • Ulisses A. Croti • Walter José Gomes

Coimbra (POR) Belo Horizonte (BRA) Recife (BRA) Curitiba (BRA) Recife (BRA) S.J. Rio Preto (BRA) São Paulo (BRA)

EDITOR DE ESTATÍSTICA/STATISTICS EDITOR • Orlando Petrucci Jr.

Campinas (BRA)

CONSELHO EDITORIAL/EDITORIAL BOARD • Adib D. Jatene • Adolfo Leirner • Adolfo Saadia • Alan Menkis • Alexandre V. Brick • Antônio Carlos G. Penna Jr. • Bayard Gontijo Filho • Borut Gersak • Carlos Roberto Moraes • Christian Schreiber • Cláudio Azevedo Salles • Djair Brindeiro Filho • Eduardo Keller Saadi • Eduardo Sérgio Bastos • Enio Buffolo • Fábio B. Jatene • Fernando Antônio Lucchese • Gianni D. Angelini • Gilles D. Dreyfus • Ivo A. Nesralla • Jarbas J. Dinkhuysen • José Antônio F. Ramires • José Ernesto Succi • José Pedro da Silva • Joseph A. Dearani

São Paulo (BRA) São Paulo (BRA) Buenos Aires (ARG) Winnipeg (CAN) Brasília (BRA) Marília (BRA) Belo Horizonte (BRA) Ljubljana (SLO) Recife (BRA) Munique (GER) Belo Horizonte (BRA) Recife (BRA) Porto Alegre (BRA) Rio de Janeiro (BRA) São Paulo (BRA) São Paulo (BRA) Porto Alegre (BRA) Bristol (UK) Harefield (UK) Porto Alegre (BRA) São Paulo (BRA) São Paulo (BRA) São Paulo (BRA) São Paulo (BRA) Rochester (USA)

VERSÃO PARA O INGLÊS/ENGLISH VERSION • Carolina Zuppardo • Fernando Pires Buosi • Marcelo Almeida

• Joseph S. Coselli • Luiz Carlos Bento de Souza • Luiz Fernando Kubrusly • Mauro Paes Leme de Sá • Miguel Barbero Marcial • Milton Ary Meier • Nilzo A. Mendes Ribeiro • Noedir A. G. Stolf • Olivio Souza Neto • Otoni Moreira Gomes • Pablo M. A. Pomerantzeff • Paulo Manuel Pêgo Fernandes • Paulo P. Paulista • Paulo Roberto B. Évora • Pirooz Eghtesady • Protásio Lemos da Luz • Reinaldo Wilson Vieira • Renato Abdala Karam Kalil • Renato Samy Assad • Roberto Costa • Rodolfo Neirotti • Rui M. S. Almeida • Sérgio Almeida de Oliveira • Tomas A. Salerno

Houston (USA) São Paulo (BRA) Curitiba (BRA) Rio de Janeiro (BRA) São Paulo (BRA) Rio de Janeiro (BRA) Salvador (BRA) São Paulo (BRA) Rio de Janeiro (BRA) Belo Horizonte (BRA) São Paulo (BRA) São Paulo (BRA) São Paulo (BRA) Ribeirão Preto (BRA) Cincinatti (USA) São Paulo (BRA) Campinas (BRA) Porto Alegre (BRA) São Paulo (BRA) São Paulo (BRA) Cambridge (USA) Cascavel (BRA) São Paulo (BRA) Miami (USA)

ÓRGÃO OFICIAL DA SOCIEDADE BRASILEIRA DE CIRURGIA CARDIOVASCULAR DESDE 1986 OFFICIAL ORGAN OF THE BRAZILIAN SOCIETY OF CARDIOVASCULAR SURGERY SINCE 1986

ENDEREÇO/ADDRESS

Sociedade Brasileira de Cirurgia Cardiovascular

Rua Beira Rio, 45 • 7º andar - Cj. 72 • Vila Olímpia • Fone: 11 3849-0341. Fax: 11 5096-0079. Cep: 04548-050 • São Paulo, SP, Brasil E-mail RBCCV: revista@sbccv.org.br • E-mail SBCCV: sbccv@sbccv.org.br • Site SBCCV: www.sbccv.org.br • Sites RBCCV: www.scielo.br/rbccv / www.rbccv.org.br (também para submissão de artigos)

Publicação trimestral/Quarterly publication Edição Impressa - Tiragem: 250 exemplares (*)

REVISTA BRASILEIRA DE CIRURGIA CARDIOVASCULAR (Sociedade Brasileira de Cirurgia Cardiovascular) São Paulo, SP - Brasil. v. 119861986, 1: 1,2 1987, 2: 1,2,3 1988, 3: 1,2,3 1989, 4: 1,2,3 1990, 5: 1,2,3 1991, 6: 1,2,3 1992, 7: 1,2,3,4 1993, 8: 1,2,3,4 1994, 9: 1,2,3,4

1995, 10: 1,2,3,4 1996, 11: 1,2,3,4 1997, 12: 1,2,3,4 1998, 13: 1,2,3,4 1999, 14: 1,2,3,4 2000, 15: 1,2,3,4 2001, 16: 1,2,3,4 2002, 17: 1,2,3,4 2003, 18: 1,2,3,4

2004, 19: 1,2,3,4 2005, 20: 1,2,3,4 2006, 21: 1 [supl] 2006, 21: 1,2,3,4 2007, 22: 1 [supl] 2007, 22: 1,2,3,4 2008, 23: 1 [supl] 2008, 23: 1,2,3,4 2009, 24: 1 [supl]

2009, 24: 1,2,3,4 2009, 24: 2 [supl] 2010, 25: 1,2,3,4 2010, 25: 1 [supl] 2011, 26: 1,2,3,4 2011, 26: 1 [supl] 2012, 27: 1,2,3,4 2012, 27: 1 [supl] 2013, 28: 1,2

ISSN 1678-9741 - Publicação online ISSN 0102-7638 - Publicação impressa RBCCV 44205

CDD 617.4105 NLM18 WG 168

(*) ASSOCIAÇÃO PAULISTA DE BIBLIOTECÁRIOS. Grupo de Bibliotecários Biomédicos. Normas para catalogação de publicações seriadas nas bibliotecas especializadas. São Paulo, Ed. Polígono, 1972

INDEXADA EM • Thomson Scientific (ISI) http://science.thomsonreuters.com • PubMed/Medline www.ncbi.nlm.nih.gov/sites/entrez • SciELO - Scientific Library Online www.scielo.br • Scopus www.info.scopus.com • LILACS - Literatura Latino-Americana e do Caribe em Ciências da Saúde. www.bireme.org

• ADSAUDE - Sistema Especializado de Informação em Administração de Saúde www.bibcir.fsp.usp.br/html/p/pesquisa_em_ bases_de_dados/programa_rede_adsaude • Index Copernicus www.indexcopernicus.com • Google scholar http://scholar.google.com.br/scholar • EBSCO www2.ebsco.com/pt-br

• LATINDEX -Sistema Regional de Información en Línea para Revistas Cientificas de America Latina, el Caribe, España y Portugal www.latindex.uam.mx

Distribuída gratuitamente aos sócios da Sociedade Brasileira de Cirurgia Cardiovascular

SOCIEDADE BRASILEIRA DE CIRURGIA CARDIOVASCULAR

BRAZILIAN SOCIETY OF CARDIOVASCULAR SURGERY DEPARTAMENTO DE CIRURGIA DA SOCIEDADE BRASILEIRA DE CARDIOLOGIA DEPARTMENT OF SURGERY OF THE BRAZILIAN SOCIETY OF CARDIOLOGY

“Valorizando o profissional em prol do paciente” DIRETORIA 2011 - 2013 Presidente: Vice-Presidente: Secretário Geral: Tesoureiro: Diretor Científico:

Walter José Gomes (SP) João Alberto Roso (RS) Marcelo Matos Cascudo (RN) Eduardo Augusto Victor Rocha (MG) Fábio Biscegli Jatene (SP)

Conselho Deliberativo:

Bruno Botelho Pinheiro (GO) Henrique Barsanulfo Furtado (TO) José Glauco Lobo Filho (CE) Rui M.S. Almeida (PR) Henrique Murad (RJ)

Editor da Revista: Editor do Site: Editores do Jornal:

Domingo Marcolino Braile (SP) Vinicius José da Silva Nina (MA) Walter José Gomes (SP) Fabricio Gaburro Teixeira (ES) Josalmir José Melo do Amaral (RN) Luciana da Fonseca (SP)

Presidentes das Regionais Afiliadas Norte-nordeste: Rio de Janeiro: São Paulo: Minas Gerais: Centro-Oeste: Rio Grande do Sul: Paraná: Santa Catarina:

Maurílio Onofre Deininger (PB) Marcelo Sávio da Silva Martins Carlos Manuel de Almeida Brandão Antonio Augusto Miana Luiz Carlos Schimin (DF) Marcela da Cunha Sales Rodrigo Mussi Milani Lourival Bonatelli Filho

Departamentos DCCVPED: DECAM: DECA: DECEN: DEPEX: DECARDIO: DBLACCV:

Marcelo B. Jatene (SP) Alfredo Inácio Fiorelli (SP) Luiz Paulo Rangel Gomes da Silva (PA) Rui M. S. Almeida (PR) Melchior Luiz Lima (ES) Miguel Angel Maluf (SP) Gabriel R. Liguori (SP)

SOCIEDADE BRASILEIRA DE CIRURGIA CARDIOVASCULAR BRAZILIAN SOCIETY OF CARDIOVASCULAR SURGERY E-mail: revista@sbccv.org.br Sites: www.scielo.br/rbccv www.rbccv.org.br

REVISTA BRASILEIRA DE CIRURGIA CARDIOVASCULAR

ISSN 1678-9741 - Publicação online ISSN 0102-7638 - Publicação impressa RBCCV 44205

Fator de Impacto: 0,809

BRAZILIAN JOURNAL OF CARDIOVASCULAR SURGERY Rev Bras Cir Cardiovasc, (São José do Rio Preto, SP - Brasil) abr/jun - 2013;28(2) 167-314

CONTENTS/SUMÁRIO

EDITORIAIS/EDITORIALS Authorship in the scientific paper: defining the role of each one Domingo M. Braile.................................................................................................................................................................................. I SYNTAX From the Evidence to the Disobedience Enio Buffolo, Alberto Juffe Steinb.........................................................................................................................................................III A debt with our nation’s health: the case of congenital heart diseases Walter José Gomes................................................................................................................................................................................ VI ORIGINAL ARTICLES/ARTIGOS ORIGINAIS 1454 Doppler echocardiographic criteria in patency assessment of composite grafts from left internal thoracic artery Parâmetros Dopplerfluxométricos de perviedade do enxerto composto de artéria torácica interna esquerda Maria Claudia A. Leitão, José Glauco Lobo Filho, Tiago Magalhães Freire, Marília Leitão Montenegro, Francisco Vagnaldo Fechine Jamacuru, Eduardo Rebouças de Carvalho, Amanda Ximenes Couto Bem, Heraldo Guedis Lobo Filho, Manuel Odorico de Moraes Filho..............167 1455 Results of Castro Bernardes intraluminal ring in surgery for ascending aortic aneurysms and dissections Resultados do anel intraluminal de Castro Bernardes nas cirurgias de aneurismas e dissecções da aorta ascendente Fernando Rotatori Novaes, Tulio Pinho Navarro, Rodrigo de Castro Bernardes, Fernando Antonio Roquete Reis Pinto, Luiz Cláudio Moreira Lima, Ernesto Lentz da Silveira Monteiro, Carla Patrícia Perpétua Medeiros......................................................................176 1456 Impact of autologous blood transfusion on the use of pack of red blood cells in coronary artery bypass grafting surgery Impacto da transfusão autóloga no uso de concentrado de hemácias em cirurgias de revascularização do miocárdio Leonardo Leiria de Moura da Silva, Anna Júlia de Borba Andres, Roberta Senger, Ralf Stuermer, Maria Celoni de Mello de Godoy, Eduardo Francisco Mafassioli Correa, Virgínia Maria Cóser..............................................................................................................183 1457 Reinforced aortic root reconstruction for acute type A aortic dissection involving the aortic root Reconstrução da raiz da aorta reforçada para dissecção aguda da aorta tipo A envolvendo a raiz da aórtica Qing-qi Han, Zhi-gang Song, Liang-jian Zou, Lin Han, Fang-lin Lu, Xi-long Lang, Zhi-yun Xu.....................................................190 1458 Mediastinitis: mortality rate comparing single-stage surgical approach and preconditioning of wound Mediastinite: mortalidade comparando abordagem cirúrgica em tempo único e o pré-condicionamento da ferida operatória Marcelo Curcio Gib, Juglans Souto Alvarez, Orlando Carlos Belmonte Wender................................................................................200 1459 Initial and pioneer experience of transcatheter aortic valve implantation (Inovare) through femoral or iliac artery Experiência inicial e pioneira do implante de valva aórtica transcateter (Inovare) por via femoral ou ilíaca José Carlos Dorsa Vieira Pontes, João Jackson Duarte, Augusto Daige da Silva, Neimar Gardenal, Amaury Mont’Serrat Ávila Souza Dias, Ricardo Adala Benfatti, Guilherme Viotto Rodrigues da Silva, Amanda Ferreira Carli Benfatti..............................................208 1460 Pulsatile stent graft: a new alternative in chronic ventricular assistance Stent aórtico pulsátil: uma nova alternativa na assistência ventricular crônica José Honório Palma, Diego Felipe Gaia, Guido Caputi, Guilherme Agreli, João Roberto Breda, Domingo M. Braile, Enio Buffolo.........217

1461 Comparison between the doppler flowmetry and the free flow of dog's internal toracic artery with and without use of norepinephrine Comparação entre a dopplermetria e o fluxo livre da artéria torácica interna de cães com e sem o uso de noradrenalina Alessandro Bordinhão..........................................................................................................................................................................224 1462 Acute kidney injury after coronary artery bypass grafting: assessment using RIFLE and AKIN criteria Lesão renal aguda no pós-operatório de revascularização do miocárdio: avaliação pelos critérios RIFLE e AKIN Vinicius José da Silva Nina, Maryanne Miranda Matias, Dyego José de Araújo Brito, José Albuquerque de Figueiredo Neto, Léa Barroso Coutinho, Rayssa Fiterman Rodrigues, Vinícius Giuliano Gonçalves Mendes, Shirlyne Fabianni Dias Gaspar..................231 1463 Cardiovascular prevention in coronary heart disease patients: guidelines implementation in clinical practice Prevenção cardiovascular abrangente em pacientes com doença arterial coronária: implementação das diretrizes na prática clínica Clarisse Kaoru Ogawa Indio do Brasil, Álvaro Avezum Junior, Luciana Uint, Maria Isabel Del Monaco, Valéria Mozetic de Barros, Soraia Youssef Rachid Campos, Amanda M. R. Sousa........................................................................................................................238 SPECIAL ARTICLES/ARTIGOS ESPECIAIS 1464 Cardiac Surgery: the infinite quest - Part III Cirurgia cardíaca: a busca infinita Rodolfo A. Neirotti...............................................................................................................................................................................248 1465 Regionalization of Brazilian pediatric cardiovascular surgery Regionalização da cirurgia cardiovascular pediátrica brasileira Valdester Cavalcante Pinto Júnior, Maria de Nazaré de Oliveira Fraga, Sílvia Maria de Freitas, Ulisses Alexandre Croti................256 1466 Heart surgery programs innovation using surgical risk stratification at the São Paulo State Public Healthcare System: SPSCORE-SUS STUDY Estratificação de risco cirúrgico como instrumento de inovação em programas de cirurgia cardíaca no Sistema Único de Saúde do Estado de São Paulo: ESTUDO SP-SCORE-SUS Omar Asdrúbal Vilca Mejía, Luiz Augusto Ferreira Lisboa, Luis Alberto Oliveira Dallan, Pablo Maria Alberto Pomerantzeff, Evelinda Marramon Trindade, Fabio Biscegli Jatene, Roberto Kalil Filho........................................................................................................263 EXPERIMENTAL STUDIES/TRABALHOS EXPERIMENTAIS 1467 Clinical and ultramicroscopic myocardial randomized study of beating versus arrested heart for mitral surgery Estudo randomizado clínico e ultramicroscópico na cirurgia valvar mitral com o coração com atividade elétrica versus sem atividade elétrica Clotario Neptali Carrasco Cueva, Maiara dos Santos Rocha, Carlos Maurício Cardeal Mendes, Luiz Antonio Rodrigues de Freitas, José Augusto Baucia, Roberto Badaró.................................................................................................................................................270 1468 The use of the virtual reality as intervention tool in the postoperative of cardiac surgery O uso da realidade virtual como ferramenta complementar no pós-operatório de cirurgia cardíaca Lucas de Assis Pereira Cacau, Géssica Uruga Oliveira, Luana Godinho Maynard, Amaro Afrânio de Araújo Filho, Walderi Monteiro da Silva Junior, Manoel Luiz Cerqueria Neto, Angelo Roberto Antoniolli, Valter J. Santana-Filho...................................................281 SHORT COMMUNICATIONS/COMUNICAÇÕES BREVES 1469 Cardiogenic shock due to coronary artery disease associated with interrupted aortic arch Choque cardiogênico decorrente de cardiomiopatia isquêmica associada à interrupção do arco aórtico Luís Alberto Oliveira Dallan, Adriano Milanez, Luiz Augusto F. Lisboa, Fabio B. Jatene.................................................................290 1470 Extracorporeal membrane oxygenation as a support for TGA/IVS with low cardiac output syndrome and pulmonary hemorrhage Oxigenação extracorpórea por membrana como suporte para TGA /IVS com síndrome de baixo débito e hemorragia pulmonar Xiaoyang Hong, Zhichun Feng, Gengxu Zhou, Xuan Xu...................................................................................................................292 CASE REPORT/RELATO DE CASO 1471 Use of autologous pericardium for mitral leaflet reconstruction in a child with endocarditis Uso de pericárdio autólogo para reconstrução de folheto mitral em criança com endocardite Olcay Murat Disli, Cemsit Karakurt, Nevzat Erdil, Bektas Battaloglu...............................................................................................296

MEMORY/MEMÓRIA 1472 Extracorporeal Circulation System Sistema de Circulação Extracorpórea Paulo Prates..........................................................................................................................................................................................299 SCIENTIFIC DISSEMINATION/DIVULGAÇÃO CIENTÍFICA 1473 “Scientists can tell a story without losing accuracy” "Cientistas podem contar uma história sem perder a acurácia" Frances Jones/Agência Fapesp.............................................................................................................................................................300 LETTERS/CARTAS 1474 Letter to the Editor Cartas ao Editor ...................................................................................................................................................................................302

Reviewers BJCVS/RBCCV 28.2.........................................................................................................................................................308

Impresso no Brasil Printed in Brazil

Grafic Designer: Heber Janes Ferreira

SOCIEDADE BRASILEIRA DE CIRURGIA CARDIOVASCULAR BRAZILIAN SOCIETY OF CARDIOVASCULAR SURGERY E-mail: revista@sbccv.org.br Sites: www.scielo.br/rbccv www.rbccv.org.br

Editorial

Authorship in the scientific paper: defining the role of each one Domingo M. Braile* DOI: 10.5935/1678-9741.20130022

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he Brazilian Journal of Cardiovascular Surgery (BJCVS) has been putting emphasis all over the years on the aspects concerned with not only content but also the form and the ethical issues surrounding the paper preparation and publication. I believe that is a way to inform readers, all potential authors or reviewers, about what has been discussed in the area of scientific dissemination. One issue that arouses most interest is that concerning the authorship of the articles. The subject was featured in an article in BJCVS in 2004 [1]. A definition that takes a scientist to be included as co-author of a paper is tenuous and varies by area, but there is no escape from the premise that the contribution must have been significant. This could be a starting point, in order to avoid excessive number of collaborators. People whose role was very limited and whose name should be placed in the “Acknowledgements section” are wrongly included as co-authors. There are worse cases, which are characterized as unethical behavior, such as placing the name of people who did not even participate in the study. BJCVS has sought to limit possible abuses with some simple, but effective measures. There is a limit of the number of authors per article category. For example, the original article can not have more than eight authors. Another step is that during the submission process by the website www. rbccv.org.br, all authors must sign the Copyright and the Conflict of Interests and send a copy of the authorization form of the Intitution Ethics Committee in which it was carried out authorizing the research study. If it is verified the absence of one or more subscriptions, the paper is returned until the appropriate steps are taken. Since last year, we have also asked to be defined in writing, during the submission process, the role of each author in the preparation of the paper. By the end of 2012, we accepted generic definitions, but since the beginning of 2013 we are requiring an accurate description. Papers that come with terms like "co-authoring" are returned with the request that you specify the type of collaboration. This is a way to enhance the role of each co-author in the article, preventing them from being included in the shares that may be mentioned in the acknowledgments, as cited above. So, I count on the understanding and cooperation of all, since this is a trend of major international publications.

Another important point that greatly facilitates the reading of the articles is a list of all abbreviations and symbols we have placed in bold type in the beginning of the publication. We have received many papers that have dozens of abbreviations and / or symbols in which the authors cite only one or two. This causes a great job for our tiny staff, leading to delay in the journal publication. I also take this opportunity to make one more request. Try not to use abbreviations in the Abstracts, therefore, except for the Title, this Chapter is the first article to be read by readers interested in the subject. We have received many Abstracts with several abbreviations, so we have to return them because they were unintelligible. Along the same line, remember that the Abstracts must be written in perfect english, so they can be internationationally understood and eventually cited, increasing our impact factor. We are translating all articles into English, but everyone's cooperation is crucial, as we will see below. Articles in English In order to streamline the publication of the BJCVS in various databases, we have emphasized that authors have to send us their papers in English or that provide the translation as soon as it is approved. Thus, we will save valuable time, with potential benefits for Impact Factor, because the sooner BJCVS is available, the greater the chances are of more recent articles to be cited. English is currently the world’s lingua franca and it is fundamental that the authors know this language to express themselves properly. Editorials We published two important Editorials in this issue. In (p. III), the Professor Enio Bufollo, a member of the Editorial Board of the BJCVS, and Dr. Alberto Juffe Stein, Chief of Cardiac Surgery at Hospital Modelo in La Coruña, Spain, comment the results of the SYNTAX trial and the need for implementation of guidelines that demonstrate superiority of CABG surgery over percutaneous techniques. The editorial will also be published by "Cardiovascular Surgical", a Journal of the Spanish Society of Thoracic and Cardiovascular Surgery.

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Rev Bras Cir Cardiovasc | Braz J Cardiovasc Surg

In “The debt with our nation's health: the case of congenital heart diseases" (p. VI), the President of the Brazilian Society of Cardiovascular Surgery (BSCVS), Prof. Dr. Walter Gomes, from the data of the article "Regionalization of Brazilian pediatric cardiovascular surgery" (p. 256), assesses the prospects in Brazil, this important specialty of cardiovascular surgery.

Paulo) and colleagues; 2nd place (a tie): "The CABG benefits equally both genders?", by José Carlos Rossini Iglezias (São Paulo) and colleagues; "Comparative study of the route of administration of cardioplegia in heart transplantation", by Dr. Orlando Petrucci (São Paulo) and colleagues; and "Coronary artery bypass grafting in patients with severe atherosclerotic disease of the ascending aorta: number of cases", by Dr. Rodrigo Coelho Segalote (Rio de Janeiro) and colleagues. The Award of BSCVS Professional of the Year went to Dr. João Alberto Roso (Rio Grande do Sul), vice president of the BSCVS for his tireless work on the Board of our organization. My congratulations to him! We published the last part of the essay "Cardiac Surgery: the infinite quest," by Dr. Rodolfo Neirotti in this issue. The topic emphasizes the particularities of pediatric cardiac surgery. I hope that the series of texts may have caused reflection on how we deal with various aspects of our specialty and can serve as a boost in the adoption of new measures in order to raise the level of excellence in cardiovascular surgery promoting the patients well-being, which is our ultimate goal. Items available for testing by the Continuing Medical Education (CME) are the following: “Impact of autologous blood transfusion on the use of pack of red blood cells in coronary artery bypass grafting surgery” (p. 183); “Mediastinitis: mortality rate comparing singlestage surgical approach and preconditioning of wound” (p. 200); “Comparison between the Doppler flowmetry and the free flow of dog's internal thoracic artery with and without use norepinephrine”, p. 224); e “Heart surgery programs innovation using surgical risk stratification at the São Paulo State Public Healthcare System: SP-SCORE-SUS STUDY” (p. 263).

Specialist Title We also published the Internal Rules for obtaining Specialist title of the BSCVS (p. 306). The goal is to make candidates aware of the rules governing the process, so that they can prepare themselves properly. Updated Standards After a long research paper, we published the BJCVS updated standards in this issue (p. 309), according to the requirements of PubMed Central that the authors should follow when submitting papers. Examples of how references should be written were also renovated. Please read it carefully, and we are open to criticism and suggestions. 40th BSCVS Congress Unfortunately, due to health reasons, I could not be present at the 40th BSCVS Congress held from April 18th to 20th in Florianópolis (SC), but, as always, the event was really successful. Again, I congratulate the Board of BSCVS and the Organizing Committee. This congress has been gaining more and more content with its numerous scientific activities, such as the section called "Hands-On". The presence of international guests and the participation of professionals from related activities, such as perfusionists, nurses and physical therapists, in addition to academics, ensures the opportunity for socializing and learning with colleagues who have decades of experience. The awarded works in the area of Cardiovascular Surgery, were as follows: Free Themes - 1st place: "Control of graft vascular disease with intravenous infusion of artificial nanoemulsion carrying methotrexate. Experimental study", by Dr. Alfredo Fiorelli (São Paulo) and colleagues; 2nd place:" Comparative analysis of patency of right and left internal thoracic arteries in the anterior interventricular branch revascularization. Evaluation by angiography after 6 months in the postoperative period", by Dr. Maurílio Onofre Deininger (Paraíba) and colleagues; 3rd place: "Myocardial regeneration after implantation of porcine submucosa in left ventriculotomy", by Dr. Luiz César Guarita Souza (Paraná) and colleagues. Posters - 1st place: "Thrombocytopenia after transpical implantation of aortic valve", by Dr. João Roberto Breda (São

My warmest regards and have a good read.

1 – Editor-in-Chief - BJCVS

REFERENCES 1. Monteiro R, Jatene FB, Goldenberg S, Población DA, Pellizzon RF. Critérios de autoria em trabalhos científicos: um assunto polêmico e delicado. Rev Bras Cir Cardiovasc. 2004;19(4):III-VIII.

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Rev Bras Cir Cardiovasc | Braz J Cardiovasc Surg

Editorial

SYNTAX From the Evidence to the Disobedience Enio Buffolo1, Alberto Juffe Stein2 DOI: 10.5935/1678-9741.20130023

The results between coronary artery bypass grafting and myocardial coronary angioplasty has been the subject of controversy since the year 1979, when percutaneous technique was intriduced by Andreas Grüntzig [1]. Since then, numerous randomized and multicenter studies were performed including: ERACI, EAST, GABI, CABRI, MASS, BARI, SIMA, LAUSANNE, RITA, TOULOUSE [2]. All studies have shown superiority of surgical revascularization versus percutaneous treatment, which consisted of substrate for abandoning balloon angioplasty and the emergence of a new era with stents. In this second phase, the results of angioplasty and stenting procedures are again compared, new studies were undertaken including: AWESOME, ARTS, SOS, ERACI, MASS, among others. Overall, the results in the first year were similar in both groups, but in 5 years, the reoperations in the stent group were higher due to multiple restenosis, which reaffirmed the surgical revascularization was the best option for this group of patients.

The aim of this study was to demonstrate the non-inferiority of surgical versus percutaneous treatment, outcomes of interest to all participants of this scientific study. 85 sites were selected, with 62 European and 23 from U.S. Patients with arteries smaller than 1.5 mm or obstructions below 50% were not included in the study [3]. It was established that the sponsors would collect data and perform biostatistics assessment, and the writing and publication of the results would be provided by the researchers. The study was approved by the Research Ethics Committees of all participating hospitals. The study sponsor was Boston Scientific Corp., with a cost of $ 50 million. The patients who were initially considered for the study were 3,075 cases, 1,275 were rejected for entry in the register of randomization by the complexity of the lesions. Of these, 1077 were directly surgically treated and only 198 were selected for stent procedure. The inclusion of this large number of patients was due to the rejection of interventional hemodynamicists to treat these patients with stents. Of the patients accepted for randomization, 897 underwent surgery and 903 underwent angioplasty with TAXUS stent. We assessed 29 clinical variables with homogeneous groups differed only on 5 parameters: hypertriglyceridemia, duration of hospital stay, duration of the procedure and the waiting time, which was higher for the surgical group. Complete myocardial revascularization was higher for the surgery group. Of the randomized patients, 25.6% had diabetes in the stent group versus 24.6% in the surgery group. The average score of the SYNTAX score, which assesses the complexity of coronary artery disease, was 28.4% for the stent group versus 19.1% for the surgical group, without statistical significance. The SYNTAX score assessed calcified lesions, total occlusions, arterial tortuosity and vessels smaller than 2.5 mm, etc.. In patients undergoing CABG, there were 3.2 anastomoses per patient, and complete revascularization with arterial grafts was achieved in 18.9% of the cases. An arterial graft in 97.3% of the cases and double mammary was used in 27.6%. Isolated vein graft was used only in 2.6% of patients (Table 1). In the percutaneous treatment group, the mean was 4.2 stents per patient. Annualy, the results of 1,275 patients were assessed demonstrating a significant difference in both groups, with an incidence of stroke (4.2% (stent) versus 2.5% (surgery), increased mortality (7.3 and 2.5%, respectively), higher need for percutaneous treatment in stent group compared with the surgical group (12 and 3%, respectively). It was proved that the surgical

With the emergence of drugs stents, new studies comparing surgery and the new generation of stents became necessary, now using chemicals to prevent restenosis. All prospective randomized studies were criticized, because they included only 5% of randomized susceptible patients. Research had serious distortions to include few patients with 3-vessel injury and critical injury of anterior proximal descending artery. These studies also excluded patients with left main coronary artery lesion [2]. The results presented in the short- and medium-term have brought a lot of confusion because they were from a sample of only 5% of the cases, by assuming that in the real world results would be similar to clinical trials. The Synergy Between PCI with Taxus and cardiac surgery (SYNTAX) study, when looking more realistic approach proposed to compare surgical outcomes with new-generation percutaneous techniques including patients with 3-vessel lesions, trunk lesions or both. The study was designed as a prospective randomized controlled trial of more complex cases in which surgical or percutaneous treatment would be accepted by surgeons and hemodynamicists.

1. Titular professor of cardiovascular surgery, São Paulo Medical School, Federal University of São Paulo, Brazil. 2. Head of the cardiac surgery at Hospital Modelo. A Coruña. España.

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revascularization had better results in at least one third of the initial population of SYNTAX. The resolutions of the SYNTAX study was first published in 2009 [4], (Table 2) and showed the following conclusions: “The SYNTAX trial was designed to compare surgical or percutaneous revascularization in patients with 3-vessel lesions, trunk lesions or both. For the first objective of death or serious adverse events, the non-inferiority was not demonstrated by the results of percutaneous treatment. Surgical treatment proved superior and should remain the treatment of choice for these patients”. In the following years, data at 2, 3 and 4 years were assessed, showing that the differences observed initially at the end of the first year, were heightened in the following years (Table 3), for the first time has shown a reduction in mortality and myocardial infarction for the surgical group. At 4 years, significant differences disappear with respect to stroke among both study groups [5,6]. However, in patients with SYNTAX score <22, the stent is as safe as surgical revascularization [7]. Surprisingly, the SYNTAX study in patients with isolated left main coronary artery disease showed no significant differences between surgery and angioplasty [8].

This observation led to the study Evolution of Xience Prime versus coronary artery surgery in left main revascularization (EXCEL), which has already begun with the planned inclusion of 2,500 patients. The design of this study is very unfavorable for surgery because patients with complex coronary artery disease and previous surgical revascularization were included. The differences between the two alternative revascularization will be difficult to prove in 3 years. In February 2013, the 5-year results of the SYNTAX study have been published in Lancet [9] showing significant differences in favor of surgery when patients present intermediate to high SYNTAX score (Tables 4 and 5). In all published studies of SYNTAX, comparing percutaneous coronary intervention with surgery, some thoughts have been extracted: 1. The need to classify each patient with the SYNTAX score, prior to making the decision of which therapy is the most recommended for that patient. 2. The treatment of choice for patients with medium and high SYNTAX score should be surgical, reserving for low-risk patients the stent treatment, which remains a safe alternative. 3. In 65% of all patients with left main coronary artery disease (SYNTAX> 32) and in 79% of patients with 3 vessel disease (SYNTAX> 22), coronary artery bypass surgery has advantages for three years, which is maintained at 5 years.

Table 1. Characteristcs of the surgical group on SYNTAX group Revascularization using arterial grafts At least one internal mammary Double internal mammary Mammary + saphenous Use of radial artery Only venous grafts Grafts per patient Distal anastomoses per patient

18.90% 97.30% 27.60% 78.10% 14.10% 2.60% 2.8 +/‑ 0.7% 3.2 +/‑ 0.9%

Table 4. 5-years results of SYNTAX trial on three-vessels disease Surgery(%) Stent(%) P Number of patients 549 546 Death 9.2 (–5.4%) 14.6 0.006 Cardiac death 4 (–5.2%) 9.2 0.001 AMI 3.3 (–7.3%) 10.6 0.001 ACVA 3.4 (+0.6%) 3 0.66 Death + cardiac death + myocardial infarction 14 (–8%) 22 0.001 New coronary revascularization 12.6 (–12,8%) 25.4 0.001

15.0 of surgeries were performed without cardiopulmonary bypass Table 2. Results on te follow-up year of the SYNTAX trial Stent TAXUS Total mortality 4.30% Acute myocardial infarction 4.80% Stent occlusion/thrombosis 3.30% ACVA 0.60% Death by ACVA or myocardial infarction 10.10% New revascularization 16.10%

coronary artery bypass grafting 3.50% 3.20% 3.40% 2.20% 10.30% 3.90%

ACVA: acute cerebrovascular accident, AMI: infardo infarction. If we assess the SYNTAX score, there was no significant differences between both groups of patients at low risk score (<23), but significant differences was fount on the intermediate risk (23-32)

P 0.37 0.11 0.89 0.003 0.96 0.0025

Table 5. 5-years results of SYNTAX trial on left trunk disease

ACVA: acute cerebrovascular accident

Number of patients Death Cardiac death AMI ACVA Death + cardiac death + myocardial infarction New coronary revascularization

Table 3. 4-years clinical results of the SYNTAX trial Major events Death/MI/ACVA All cause mortality Death from cardiac causes ACVA Infarction New revascularization

Surgery (%) 2.3 14.6 8.8 4.3 3.7 3.8 11.9

Stent (%) 33.5 18 11.7 7.6 2.3 8.3 23

P < 0.001 0.07 0.048 0.04 0.06 < 0.001 < 0.001

Surgery(%) Stent(%) P 348 357 14.6 (+1.8%) 12.8 0.53 7.2 (–1.4%) 8.6 0.46 4.8 (–3.4%) 8.2 0.1 4.3 (+2.8%) 1.5 0.03 20.8 (+1.8%) 19 0.57 15.5 (–11.2%) 26.7 0.001

ACVA: acute cerebrovascular accident, AMI: acute myocardial infarction. If we assess the SYNTAX score, there was no significant differences between both groups of patients at low and medium risk, but significant differences was fount on the high score (<32), where the surgery has better results than the stent

ACVA: acute cerebrovascular accident

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4. Developing the concept of “core-team”, multidisciplinary group comprising clinical cardiologist, hemodynamicist, the surgeon and the patient, which ultimately will make the best decision for him. 5. The examination of the coronary anatomy must be assessed by the team in all patients, to decide in daily practice what is the best therapeutic option for him and not just discuss in conferences and different publications which ideal behavior for each subgroup of patients. The new clinical practice guidelines for myocardial revascularization show philosophical and ethical change in the treatment of coronary artery disease and recommend the surgical treatment as the best choice for left main coronary artery disease and 3-vessel involvement with anterior proximal descending artery. The ad hoc coronary angiography is indicated only in patients with unstable angina, in other cases, the patient must have enough time to choose his treatment of choice, advised by team work [10,11]. Current scientific evidence, the publications of the new guidelines of the European Society of Cardiology, Hemodynamics and Surgery, and the various prospective randomized multicenter studies indicate that surgical revascularization is the preferred option for patients with complex coronary lesions, diabetics, trunk lesions and multivessel ostial lesions of the left anterior descending [12-15]. In day to day, however, it is remommended to avoid sternotomy and subject the patient to percutaneous treatment, often leaving scientific evidence-based medicine, perhaps we are faced with an extra ethical issue [16]. Despite scientific evidence available in randomized trials, meta-analyzes and guidelines that confirm that coronary artery bypass surgery is better, patients are still undergoing percutaneous treatment. We wonder what is the ethical and economic cost of not indicating the right therapy for each patient. Cardiovascular surgeons and scientific societies must enforce and defend the implementation of the new guidelines for coronary revascularization and the evidence in favor of surgery at 5 years demonstrated in the SYNTAX study [17]. Professionals must persuade hospital management bodies and insurers, that patients requiring coronary revascularization should be assessed, discussed between cardiologists and surgeons, indicating the more correct therapy for each patient.

artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360(10):961-72. 5. Kappetein AP, Feldman TE, Mack MJ, Morice MC, Holmes DR, Ståhle E, et al. Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year followup of the SYNTAX trial. Eur Heart J. 2011;32(17):2125-34. 6. Rastan AJ, Mohr FW. Three years after SYNTAX trial: change in practice? Eur J Cardiothorac Surg. 2011;40(6):1279-81. 7. Mohr FW, Rastan AJ, Serruys PW, Kappetein AP, Holmes DR, Pomar JL, et al. Complex coronary anatomy in coronary artery bypass graft surgery: impact of complex coronary anatomy in modern bypass surgery? Lessons learned from the SYNTAX trial after two years. J Thorac Cardiovasc Surg. 2011;141(1):130-40. 8. Morice MC, Serruys PW, Kappetein AP, Feldman TE, Ståhle E, Colombo A, et al. Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2010;121(24):2645-53. 9. Mohr FW, Morice MC, Kappetein AP, Feldman TE, Stahle E, Colombo A, et al. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet. 2013;381(9867):629-38. 10. Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI), Kolh P, Wijns W, Danchin N, Di Mario C, Falk V, Folliguet T, et al. Guidelines on myocardial revascularization. Eur J Cardiothoracic Surg. 2010;38(Suppl):S1-S52. 11. Juffe A. Nuevas guías de revascularización miocárdica. Punto de vista del cirujano. Cir Cardiov. 2011;18(4):263-7. 12. Hannan EL, Racz MJ, Walford G, Jones RH, Ryan TJ, Bennett E, et al. Long-term outcomes of coronary-artery bypass grafting versus stent implantation. N Engl J Med. 2005;352(21):2174-83. 13. Yang JH, Gwon HC, Cho SJ, Hahn JY, Choi JH, Choi SH, et al. Comparison of coronary bypass grafting with drug-eluting stent implantation for the treatment of multivessel coronary artery disease. Ann Thorac Surg. 2008;85(1):65-70.

*Editorial also published in Cirugía Cardiovascular 20(2):49-51.

14. Hueb W, Lopes NH, Gersh BJ, Soares P, Machado LA, Jatene FB, et al. Five-year follow-up of the Medicine, Angioplasty, or Surgery Study (MASS II): a randomized controlled clinical trial of 3 therapeutic strategies for multivessel coronary artery disease. Circulation. 2007;115(9):1082-9.

REFERENCES 1. Grüntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979;301(2):61-8.

15. Juffe A. Superioridad de la cirugía coronaria versus intervencionismo coronario en el paciente diabético. Cir Cardiov. 2013;20(1):3-7.

2. Soran O, Manchanda A, Schueler S. Percutaneous coronary intervention versus coronary artery bypass surgery in multivessel disease: a current perspective. Interact Cardiovasc Thorac Surg. 2009;8(6):666-71.

16. Hlatky MA, Boothroyd DB, Baker L, Kazi DS, Solomon MD, Chang TI, et al. Comparative effectiveness of multivessel coronary bypass surgery and multivessel percutaneous coronary intervention: a cohort study. Ann Intern Med. 2013;158(10):727-34.

3. Jatene FB. A visão de um cirurgião sobre o estudo SYNTAX. Rev Bras Cardiol Invas. 2008;16(3):265-7.

17. Taggart D. Surgery is best for most patient, final SYNTAX data confirm. Heart wire. International surgery. Disponível em: http://www.theheart. org/article/1466345.do

4. Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, et al. Percutaneous coronary intervention versus coronary-

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Editorial

A debt with our nation’s health: the case of congenital heart diseases Walter J. Gomes1 and Working Group of BSCVS on National Programme for the Full Treatment of Children Diagnosed With Congenital Heart Disease: Aldemir José da Silva Nogueira, Fabio Biscegli Jatene, José Teles de Mendonça, José Wanderley Neto, Leonardo Andrade Mulinari, Luiz Fernando Caneo, Marcelo Biscegli Jatene, Marcelo Matos Cascudo, Valdester Cavalcante Pinto Junior.

DOI: 10.5935/1678-9741.20130024

Accepting the quality of healthcare provided to Brazilians has become untenable, not only to the population as a whole, but especially to patients and their loved ones as well as doctors and other related professionals. The situation becomes worse when it compromises children with congenital heart diseases, stripping them of their basic rights to proper care and the chance of remaining alive. The article by Pinto Jr. about the difficulties of caring for children with congenital heart diseases, published in this issue of the Brazilian Journal of Cardiovascular Surgery, is particularly timely as it does a great job of showcasing part of the reality faced by all of us in our daily routine [1]. Epidemiological data show a painful reality, in which 65% of the 23000 children diagnosed with congenital heart disease needing surgical treatment born annually in Brazil do not have access to the procedures requested. The largest discrepancies are found in the North and Northeast of the country (93.5% and 77.4%, respectively); the smallest, in the South and MidWest (46.4% and 57.4%, respectively). These children grow up with the natural progression of the disease. Consequently, they face high mortality rates and restrictions in their quality of life, both preventable considering more than 70% of them could be cured if treated appropriately. Resources dedicated to the treatment of congenital heart diseases are insufficient and, most of the time, are re-allocated to other departments whose productivity results are more visible thereby impressing authorities [2,3]. With a growing concern about this omission, the Brazilian Society of Cardiovascular Surgery (BSCVS) has made every effort to find solutions for this deficit. A group of specialists was gathered to tackle the problem by formulating several

proposals for a definitive solution, which were then referred to the Brazilian Society of Cardiology (BSC) to be discussed. READ THE ARTICLE ON PAGES 256-262 The joint efforts of the BSCVS, supported by the vigor and enthusiasm of the BSC, represented by its president, Dr. Jadelson Pinheiro de Andrade, along with the Brazilian Society of Hemodynamics and Interventional Cardiology (BSHIC) and the Brazilian Society of Pediatrics (BSP) and its departments, resulted in the creation of a committee formed by specialists from those Societies. The committee developed the National Program for the Full Treatment of Children Diagnosed with Congenital Heart Disease. The goal of the program is to develop an instrument, backed by the Health Ministry as well as other social segments and governmental agencies, to solve once and for all the grim picture of the treatment of children with congenital heart disease in Brazil [4]. Among the proposals presented, the creation of a specialized Secretariat, the Special Secretariat for the Treatment of Children with Congenital Heart Disease (SETRACCC), under the Health Ministry is particularly noteworthy. By receiving resources for managing and fully treating children with congenital heart diseases, the Secretariat administration would make it possible to both channel these resources specifically to these patients and create the Centers for Full Treatment of Children with Congenital Heart Disease (CETICCCs), thus avoiding scattering in the use of these resources. The proposal establishes the allocation of financial resources intended solely for the full treatment of children with congenital heart disease; the expansion of the capability to assist patients as well as improvements to existing centers; the opening of new centers in deprived areas; and training of teams specialized in this type of treatment, to be allocated evenly throughout the country, thereby ensuring patients in need have universal access to this type of treatment. According to the guidelines set out in the proposal,

1. President of the Brazilian Society of Cardiovascular Surgery, São Paulo, SP, Brazil.

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financing will come from specific funding allocation, with funds being released through the special Secretariat, regardless of ordinary funding from the Public Healthcare System. The Program reiterates and calls for compliance with Article 11 of Statute of the Child and Adolescent: “Child’s and adolescent’s access to healthcare is guaranteed through the Public Healthcare System, ensuring universal and egalitarian access to actions and services for the promotion, protection, and recovery of health”. The proposal has been delivered and is currently being analyzed by the Health Ministry. Thus, there is an urgent need to raise awareness of the gravity of the problem so that positive and concrete actions can be taken; enabling assistance to these children and reversing the picture of oblivion toward them. The proposal should also be used to set an example to correct the healthcare system in Brazil, making it more fair and efficient.

REFERENCES 1. Pinto Júnior VC, Fraga MNO, Freitas SM, Croti UA. Regionalização da cirurgia cardiovascular pediátrica brasileira. Rev Bras Cir Cardiovasc. 2023;28(2):256-262. 2. Pinto Jr VC, Fraga MNO, Freitas SM. Análise das portarias que regulamentam a Política Nacional de Atenção Cardiovascular de Alta Complexidade. Rev Bras Cir Cardiovasc. 2012;27(3):463-8. 3. Caneo LF, Jatene MB, Yatsuda N, Gomes WJ. Uma reflexão sobre o desempenho da cirurgia cardíaca pediátrica no Estado de São Paulo. Rev Bras Cir Cardiovasc. 2012;27(3):457-62. 4. Pinheiro JA, et al. Programa Nacional para o Tratamento Integral de Crianças com Diagnóstico de Cardiopatia Congênita.

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SOCIEDADE BRASILEIRA DE CIRURGIA CARDIOVASCULAR BRAZILIAN SOCIETY OF CARDIOVASCULAR SURGERY E-mail: revista@sbccv.org.br Sites: www.scielo.br/rbccv www.rbccv.org.br

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Leitão MCA, et al. - DopplerARTICLE echocardiographic criteria in patency assessment ORIGINAL of composite grafts from left internal thoracic artery

Doppler echocardiographic criteria in patency assessment of composite grafts from left internal thoracic artery Parâmetros Dopplerfluxométricos de perviedade do enxerto composto de artéria torácica interna esquerda

Maria Claudia A. Leitão1, José Glauco Lobo Filho2, Tiago Magalhães Freire3, Marília Leitão Montenegro4, Francisco Vagnaldo Fechine Jamacuru5, Eduardo Rebouças de Carvalho6, Amanda Ximenes Couto Bem7, Heraldo Guedis Lobo Filho8, Manuel Odorico de Moraes Filho9

DOI: 10.5935/1678-9741.20130025

RBCCV 44205-1454

Abstract Objectives The purpose of our study was to establish, with an entirely noninvasive method, transthoracic Doppler echocardiography, criteria for patency of composite left internal thoracic artery grafts when placed on the left anterior descending artery and other branches of the left coronary system. Methods: The control group comprised 20 patients with single graft and 20 patients with composite graft; all forty having their patency confirmed by coronary angiogram (CA). In this control group, two Doppler echocardiographic variables, diastolic mean velocity-time and integral diastolic peak velocity to systolic peak velocity ratio were recorded. For each variable, established cut-off points were established, using the ROC (Receiver Operator Characteristic) curves, to identify criteria which could differentiate the composite grafts. Only patients

with composite grafts were included in the 159-patients study group. The criteria established by the cut-off points in the control group were then applied to detect patency using a diastolic fraction of ≥ 0.5 as the gold standard. The sensitivity, specificity, and positive and negative predictive values of these two criteria were determined. Results: In the control group, cut-off points of 0.71 and 0.09m were established for the diastolic peak velocity/systolic peak velocity ratio and for diastolic mean velocity-time integral, respectively. In the study group phase, the sensitivity and negative predictive value of the diastolic peak velocity/systolic peak velocity ≥ 0.71 criterion were 36% and 11%, respectively. Diastolic mean velocity-time integral ≥ 0.09m criterion, were 40% and 10.48%. The specificities and positive predictive values of each criterion were 100%.

1. Cardiologist echocardiographer, master’s degree from the Department of Physiology and Pharmacology, School of Medicine, Federal University of Ceará, Professor of Medicine at Christus University, Fortaleza, CE, Brazil. Author of the master's thesis that gave rise to this paper. Echocardiographer of this study. 2. Professor of Cardiovascular Surgery, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil. Head of the surgical team of this study. 3. Medical student, Federal University of Ceará, Fortaleza, CE, Brazil. Assistance in data collection, literature review and drafting work. 4. Medical student, Christus University, Fortaleza, CE, Brazil. Responsible for data collection, assistance in literature review and drafting work. 5. Research doctor and statistician, Clinical Pharmacology Unit, Federal University of Ceará, Fortaleza, CE, Brazil. Responsible for coordinating the statistical analysis. 6. Medical doctor graduated from Federal University of Ceará, Fortaleza, CE, Brazil. Responsible for the statistical analysis. 7. Medical student, Federal University of Ceará, Fortaleza, CE, Brazil.

Assistance in data collection, literature review. 8. Cardiovascular Surgeon - Specialist Member of Brazilian Society of Cariovascular Surgery. MS at the Federal University of Ceará, Fortaleza, CE, Brazil. Research. 9. PhD in Oncology from the University of Oxford, UK, Professor of the Federal University of Ceará, Fortaleza, CE, Brazil. Master’s thesis supervisor. Work carried out at Federal University of Ceará, Fortaleza, CE, Brazil. Correspondence address: Maria Claudia de Azevedo Leitão Rua Canuto de Aguiar, 500 – ap. 1600 – Fortaleza, Ceará, Brazil Zip code 60160-120 E-mail: mariaclaudialeitao@uol.com.br / mariaclaudialeitao@gmail.com Article received on November 9th, 2012 Article accepted on April 10th, 2013

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Leitão MCA, et al. - Doppler echocardiographic criteria in patency assessment of composite grafts from left internal thoracic artery

revasculariza a artéria interventricular anterior e outro ramo do sistema esquerdo. Métodos: O grupo controle foi formado por 20 pacientes com enxerto simples e 20 pacientes com enxerto, composto cuja perviedade foi confirmada por cineangiocoronariografia. No grupo controle, as variáveis de fluxo relação velocidade pico diastólico/velocidade pico sistólico e integral da velocidade média/tempo na diástole foram registradas. Para cada variável, estabeleceram-se pontos de corte para identificar enxertos compostos, usando-se curvas ROC (receiver operator characteristic). No grupo estudo, foram avaliados 159 pacientes com enxerto composto, determinando-se os dois parâmetros de fluxo. Pontos de cortes estabelecidos no grupo controle foram usados para determinar sensibilidade, especificidade, valores preditivos positivo e negativo de cada variável relacionada à perviedade dos enxertos, tomando-se como referência a fração diastólica ≥ 0,5. Resultados: No grupo controle, os pontos de corte estabelecidos para as variáveis velocidade pico diastólico/ velocidade pico sistólico e integral velocidade média/tempo na diástole foram, respectivamente, 0,71 e 0,09m. No grupo estudo, a sensibilidade para a velocidade pico diastólico/velocidade pico sistólico e integral da velocidade média/tempo na diástole, considerando seus pontos de corte, foi de 36,4% e 40%, respectivamente. Os respectivos valores preditivos negativos foram 11% e 10.48%, enquanto especificidade e valor preditivo positivo foram de 100% para os dois parâmetros. Conclusão: Valores maiores ou iguais aos estabelecidos para cada variável indicam alta probabilidade de perviedade do enxerto composto. Valores inferiores apresentam grande proporção de falsos negativos, não sendo conclusivos quanto à perviedade.

Abbreviations, Acronyms & Symbols CA CABG CPB DPV DVTI FN FP LAD LCS LITA NPV PPV ROC SMV SPV SVTI TDE TN TP VTI

Coronary angiography Coronary artery bypass graft surgery Cardiopulmonary bypass Diastole peak velocity Diastole velocity-time integral False-negative False-positive Left anterior descending coronary artery Left coronary system Left internal thoracic artery Negative predictive value Positive predictive value Receiver Operator Characteristic Saphenous magna vein Systole peak velocity Systole velocity-time integral Transthoracic Doppler echocardiography True-negative True-positive Velocity/time integral

Conclusion: Values reaching the criteria established for each variable indicate high probability of composite graft patency. Lower values have a large proportion of false negatives and are not conclusive as patency criteria. Keywords: Coronary artery bypass. Doppler echocardiography. Mammary arteries. Myocardial ischemia. Myocardial revascularization. Resumo Objetivo: O objetivo deste estudo é estabelecer parâmetros preditores de perviedade, avaliados por Dopplerfluxometria, do enxerto composto de artéria torácica interna esquerda, quando

Descritores: Ponte de artéria coronária. Ecocardiografia Doppler. Isquemia miocárdica. Artéria torácica interna. Revascularização miocárdica.

INTRODUCTION

al. [7], in 1993. It is a noninvasive and low cost method, and of quick completion even at bedside setting. It can identify left internal thoracic artery (LITA) graft, measure its blood flow [8], and it can be carried out in every routine echocardiogram requested in the follow up appointments. Furthermore, it can be used to provide information on a patient’s physiological response to increased myocardial oxygen demand, the coronary reserve flow [9,10]. The flow of the in situ LITA has systolic predominance. When anastomosed to a coronary artery, the flow begins to show an increment of the diastolic component. This is justified because the coronary arteries inflow occurs primarily during diastole [11]. Thus, the LITA starts to assume the pattern of the coronary flow, including varying its diastolic component according to demand [12]. Several measurements can be recorded by Doppler spectral imaging such as: peak velocities during systole and dias-

Anatomic confirmation of patency and functional evaluation of the coronary grafts is crucial in the coronary artery bypass graft surgery (CABG). The most commonly used method for assessing bypass patency in CABG is coronary angiography (CA). The routine tests for myocardial ischemia are often difficult to interpret in patients who underwent CABG. Therefore, a method that directly analyzes the graft and is less invasive than CA is needed [1]. In recent years, coronary angiography by multidetector computed tomography has been used with good sensitivity and specificity [2], but these two methods are expensive, and the patients are exposed to radiation [3-5]. The transthoracic Doppler echocardiography (TDE) is a particularly interesting tool. The first descriptions of using Doppler applications in CABG were reported by Fusejima [6], in 1987, and Takagi et

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tole (SPV and DPV), mean velocities, mean velocity-time integrals during systole (SVTI) and diastole (DVTI), diastolic fraction, cross-sectional vessel area, and blood flow at rest and under stress. Using these recorded measurements, the flow reserve can also be measured by comparing flow under stress to flow at rest [13]. When LITA revascularizes the left anterior descending coronary artery (LAD), the presence of a diastolic component is a promising sign of graft patency. In a composite graft, when two coronary arteries are revascularized by LITA, determining their patency is a challenge. TDE has a high sensitivity and specificity when performed on left internal thoracic arteries (LITA) grafted to the LAD. It is known that the flow is greater in composite grafts than in single grafts since there is a naturally increased demand at rest. This observation throught 10 years of experience was the motivation for our research. This difference has not yet been quantified [14,15]. How much flow increment would it be necessary to suggest that both grafts in configuration of the composite graft were patent? The purpose of this study is to contribute to the field of physiology and cardiology. The clinical relevance of this paper is to find out if transthoracic Doppler echocardiographic criteria could estimate the patency of the composite LITA graft when it revascularizes LAD and another branch of the left coronary system (LCS). The overall objective of this study was to establish at rest, Doppler echocardiographic criteria for assessing the patency of a LITA composite graft, when it is revascularizing LAD and another LCS branch. The specific objective was to identify the sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively) of the DPV/SPV and DVTI variables for determining composite graft patency, using a diastolic fraction (DF) ≥ 0.5 as the reference value.

identify composite grafts by analyzing the Receiver Operator Characteristic (ROC) curves. Patients whose LITA was not adequately seen due to technical limitations were excluded. Study Group In the study group, 159 examinations were evaluated, corresponding to 159 subjects, 27% of which were female patients. The mean age was 63.4 years, ranging from 36 to 82 years. All patients had undergone CABG with a composite graft in which the LITA was grafted to the LAD and to another LCS artery by a saphenous vein segment in “Y” anastomosis without cardiopulmonary bypass (CPB). All Doppler studies were performed by one echocardiographer (MCAL). The average time interval between surgery and examination was approximately 12.9 months, ranging from 2 to 96 months. The examinations were done and collected for the last 10 years and the preparation of the database occurred between December 2010 and January 2011. Patients were excluded from the study group because of the following reasons: a LITA that could not be visualized, when LITA provided blood flow to more than two vessels of the LCS; and patients who were submitted to the Vineberg procedure, LITA single grafts, LITA sequential grafts, and onpump operations. Tests performed during the first two months after CABG were also excluded because as outpatients it’s easier to avoid unstable conditions that could be presented during hospitalization period. The concern was to get an uniform group. In this phase, the Doppler criteria obtained from the cutoff points in the control group were applied to these 159 patients. They were tested in the real world. The rate of truepositives, false-positives, false-negatives and true-negatives were calculated. Sensitivity, specificity, PPV and NPV, were determined with their respective confidence intervals of 95%. The reference pattern for patency was the diastolic fraction of ≥ 0.5 which is considered by meta-analysis the Doppler gold standard for assessment of single graft patency with LITA. There is no one criterion yet for patency of composite grafts with LITA. The fact that all patients in the control group had FD ≥ 0.5 supports its use. The Doppler examinations were conducted at the Unimed Regional Hospital (Hospital Regional da Unimed). The operations were performed at these four hospitals: Unimed Regional Hospital (Hospital Regional da Unimed), Monte Klinikum Hospital (Hospital Monte Klinikum), São Raimundo Hospital (Hospital São Raimundo), and the Walter Cantídio Hospital at the Federal University of Ceará (Hospital Walter Cantídio da Universidade Federal do Ceará). This study was approved by the Research Ethics Committee of Federal University of Ceará (CONEP - Comitê de Ética em Pesquisa) on October 12, 2010, protocol no. 315/10 and letter no. 349/10.

METHODS This study was carried out in two groups: control and study group. None of the patients included or excluded from the study group were part of the control group. Control Group In the control group, 40 bypass patients were studied; 20 had single grafts, and 20 had composite grafts. A single graft is when LITA is anastomosed to LAD only and a composite graft is when a segment of the valveless saphenous magna vein (SMV) is anastomosed in “Y” shape in a single graft with a distal anastomosis to another branch of the LCS. Patients with simple and composite grafts, who had their graft patency confirmed by angiography, underwent TDE in order to record two flow variables: the DVTI, and the ratio of diastolic peak velocity to systolic peak velocity (DPV/SPV). For each flow variable, cutt-off points were established to

Description of technique The equipment used was the Toshiba and GE Vivid7. The

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transducer was a nonlinear 5 MHz frequency. The patient was placed in the dorsal decubitus position and the transducer placed on the left supraclavicular region. Using color Doppler, the LITA leaving the subclavian artery was visualized. Subsequently, a pulsed Doppler was applied to obtain the spectral curve and measurement of the variables. Angle adjustment was not necessary for aligning the Doppler cursor with LITA flow [8].

RESULTS Control Group The cutoff points obtained from the ROC curves for identifying composite grafts were 0.71 for DPV/SPV (Figure 1) and 0.09m for DVTI (Figure 2). The median values and the respective interquartile ranges for DPV/SPV and DVTI were also calculated. In the control group, the patients with composite grafts had significantly higher values (P< 0.0001) than those with single grafts (Table 1). All patients of the control group with composite graft showed FD>0.5.

Statistical analysis The data were analyzed using the Statistical Package for the Social Sciences® for Windows (v.16, SPSS Inc. Chicago, IL) statistical package. None of the quantitative variables had normal distributions according to the KolmogorovSmirnov test. As a result, parametric tests could not be used and the variables were described by medians and interquartile ranges. The nonparametric Mann-Whitney test was used to compare the medians in relation to the type of graft configuration (single or composite) in the control group phase. The cutoff points for the DPV/SPV and DVTI variables during the standardization phase were defined using the ROC curve. In the study group phase, TDE criteria for composite graft patency determined by the cutoff points were put in a 2x2 contingency table, designed using the DF as the reference for graft patency. Subsequently, sensitivity, specificity, PPV, and NPV were calculated, with 95% confidence intervals. The results were expressed in tables. A probability of type I error of 5% was established 5% for every analysis, being considered statistically significant the value of P<0.05.

Study Group Table 1 shows the median values and interquartile range of the variables in the control group and study group considering the type of graft performed. Table 2 shows the performance of our criterion DSV/SPV ≥0.71 in the assessment of patency of LITA composite grafts. Because DF is the most accurate criterion according to the literature of LITA graft, it was our reference standard for validation of our two patency criteria for composite grafts. This table displays the rates of true-positive (TP), false-positive (FP), false-negative (FN), and true-negative (TN) findings for the criterion DPV/SPV ≥ 0.71. Among the 159 patients of the study group, 59 were TP: they had DSV/SPV ≥ 0.71 and patency was confirmed by DF ≥ 0.05. Eleven were TN, they neither reached the patency criterion for LITA composite graft we were testing nor achieved the reference pattern. 89 were FN: our criterion had detected as non-patent or non-composite graft but they had DF ≥ 0.05.

Fig. 1 – ROC curve in the control group to determine the best cutoff point for the variable VPD/VPS in evaluating the patency of composite graft

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Fig. 2 – ROC curve in the control group to determine the best cutoff point for the variable VTId in evaluating the patency of composite graft

Table 1. The medians and interquartile ranges (lower and upper quartiles) of the variables analyzed during the standardization and validation phases by type of graft used. Control Group Composite graft (n=20)

Simple graft (n=20) Variables

Median

Interquartile range

Median

Interquartile range

Statistical significance

DPV/SPV DVTI (m)

0.64 0.06

0.45 – 0.69 0.04 – 0.08

0.87 0.12

0.69 – 1.05 0.09 – 0.16

P<0.0001*** P<0.0001***

Study Group Variables DPV/SPV DVTI (m)

Composite graft (n=159) Median

Interquartile range

0.64 0.08

0.45 – 0.69 0.06 – 0.10

DPV/SPV = Peak diastolic velocity/peak systolic velocity; DVTI = Diastolic velocity integral

Table 2. Detecting composite graft patency (present or absent) using DPV/SPV, with DF as the gold standard. Data obtained from 38 patients. Patency – DF (gold standard) Patency – DPV/SPV DPV/SPV ≥ 0.71 (present) DPV/SPV< 0.71 (absent) Total

DF ≥ 0.5 (present)

DF < 0.5 (absent)

True-positives 59 False-negatives 89 148

False-positives –– True-negatives 11 11

DPV/SPV = Peak diastolic velocity/peak systolic velocity; DF = Diastolic fraction

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Table 3 shows the same for the criterion DVTI ≥ 0.09m. The number of TP was 54: they had DVTI ≥ 0.09m and patency was confirmed. There were also eleven TN. 94 patients, out of a total of 159, were FN, meaning our criterion had detected as non-patent or non-composite graft but they had DF ≥ 0.05. There was no FP with our two criteria: no graft detected as patent composite graft had DF lower than 0.05. In Table 4, we can see the percentages of sensitivity, specificity, positive and negative predictive values calculated for our patency criteria of the composite grafts, all of them with confidence interval of 95%. For both criteria, DPV/SPV ≥ 0.71 and DVTI ≥ 0.09m, the specificity and positive predictive value were 100%.

the first contributions to finding criteria to establish patency of composite graft of LITA and SMV revascularizing LAD and another branch of the LCS, using TDE at rest; a totally noninvasive diagnostic method which is part of the routine clinical practice [17]. It is important to mention that all patients in the control group had their graft patency confirmed by CA. This is meaningful because it corroborates the efficiency of the criteria we applied in the study group. In the study group phase, an actual practical application of these criteria occurred in a considerable sample of 159 patients with composite graft. This sample is consistent with the reality of the routine follow-up of CABG patients. This evaluation is not easy because these patients can present atypical symptoms and nonspecific, or even inconclusive, changes in some exams, such as exercise stress test for example. There are controversies regarding some variables measured by Doppler, but the integral of the mean velocity/time (VTI) is well accepted as an indicator of patency [6-13].

DISCUSSION The prognosis of the CABG patients depends on demonstration of an efficient by pass function. This study is one of

Table 3. Detecting composite graft patency (present or absent) using DVTI, with DF as the gold standard. Data obtained from 38 patients. Patency – DF (gold standard) Patency – DVTI DVTI ≥ 0.09 m (present) DVTI< 0.09 m (absent) Total

DF ≥ 0.5 (present)

DF < 0.5 (absent)

True-positives 54 False-negatives 94 148

False-positives –– True-negatives 11 11

Total 54 105 159

DVTI = Diastolic average velocity-time integral; DF = Diastolic velocity integral

Table 4. Validation criteria for using DPV/SPV to detect composite graft patency, with DF as the gold standard. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and the associated 95% confidence intervals were calculated. DPV/SPV Parameter Sensitivity Specificity PPV NPV

Value 0.3986 (39.86%) 1.0000 (100.00%) 1.0000 (100.00%) 0.1100 (11.00%)

95% confidence interval 0.3192 to 0.4823 0.7151 to 1.0000 0.9394 to 1.0000 0.0562 to 0.1883

Significance

95% confidence interval 0.2874 to 0.4479 0.7151 to 1.0000 0.9340 to 1.0000 0.0535 to 0.1797

Significance

DVTI Parameter Sensitivity Specificity PPV NPV

Value 0.3649 (36.49%) 1.0000 (100.00%) 1.0000 (100.00%) 0.1048 (10.48%)

DPV/SPV = Peak diastolic velocity/peak systolic velocity; DVTI = Diastolic velocity integral; PPV = Positive Predictive Value; NPV = Negative Predictive Value

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The VTI is calculated by using the mean velocity, mapping the Doppler spectral curve point to point rather than at punctual time. That’s why it quantifies the flow with more reliability than the peak velocity. It’s simple and reproducible. Peak velocity is affected by the intravascular resistance and pressure and is a measure of the maximum velocity at one moment during systole or diastole. Even so, Shimizu et al. [18] and Dubey et al. [19] have shown that the graft diameter, its degree of obstruction, and its flow, are proportional to DPV [20]. A DPV/SPV ratio greater than 1 [21] is associated with good angiographic findings and can provide sensitivity up to 100% and a specificity of 58% for detecting graft patency [12]. The DF expresses how much the diastolic flow represents in relation to the total (systolic plus diastolic) flow and it can be calculated using VTI (m) or the blood flow (ml/min). When VTI is used, the diastolic VTI fraction is obtained by dividing the DVTI by the sum of the VTI in systole plus VTI in diastole. When blood flow is used, the diastolic fraction is the diastolic blood flow divided by the sum of diastolic and systolic blood flow. Blood flow is obtained from the product of three variables: VTI, cross-sectional vessel area, and heart rate. For this reason, blood flow is more susceptible to interoperator variations and to the status of the patient at the time of the exam. The diastolic fraction calculated using the velocity integral has shown a good correlation with cardiac catheterization results. A DF value lower than 0.5 is predictive of graft stenosis [16,22]. The specificity of the two criteria evaluated in this study was 100%, meaning that all of the composite grafts that were not patent were correctly classified by the cutoff points. Thus, DPV/SPV and DVTI values greater than or equal to the cutoffs were a strong indicators of composite graft patency. Despite the 100% specificity, the possibility of false-positives cannot be ruled out. During the surgical report collection phase, it was observed that some single grafts had a surprisingly high diastolic flow to LAD at rest. In these cases, patients even with obstruction of the SMV graft to the other LCS branch would meet the patency criteria for patent composite grafts established in this study. A large number of patients did not meet our criteria for patency of the composite graft, but they had DF ≥ 0.5; the FN. LITA flow was suggestive of obstruction at rest. Several factors can affect the LITA graft flow and may explain these data. One of the grafts in the configuration of the composite graft could be obstructed; however, what we could observe more frequently was the latent flow. The latency of the flow when there is no obstruction in the graft but rather a reduced demand is described in the literature. Understanding flow competition is extremely important to grasp the complex anatomy and pathophysiology of coronary flow. LAD flow competition is associated with a reduction in LITA diastolic velocity. Invasive studies have shown that residual flow in

the recipient artery, when the obstruction is not severe, can compete with the flow of the patent LITA, thereby reducing blood flow in the graft. In addition, collateral circulation resulting from the total obstruction of a vessel, also called a physiological bridge, can lead to flow competition within the LITA bypass [18]. As the coronary disease progress es in the native or collaterals, the flow of the graft increases considerably. It is described in the literature and we can notice it in everyday practice. LITA has the ability to restore its patency after apparent occlusion in the progression of the coronary disease. Other conditions can influence LITA flow, including severe dysfunction of the left ventricle [6], coronary microcirculation disease, hypertrophy, fibrosis and myocardial viability [24,25]. TDE at stress can be very helpful in these situations and it can avoid a more invasive test [23]. The increased demand will enhance the velocity of the graft flow and confirm that it was a false negative and the graft is patent. The realization that there is graft malfunction with TDE can’t be done unless the graft flow has been previously registered and its patency established. There was a sensitivity of 39.86% for DPV/SPV and 36.49% for DVTI. One may think that the detection rate is low, yet as sensitivity represents the ability to identify patent composite grafts among those that are truly patent, it is not a low rate. It is even audacious if in 40% of CABG patients with composite grafts coming for an echocardiogram with three more minutes we are able to affirm that their grafts are patent. Moreover, TDE is not expensive and totally noninvasive. It can be repeated frequently in routine or forward to a change in clinical status, providing the possibility of comparison of data during follow ups. Actually, it is much more important to compare previous Doppler measurements in a given patient than isolated ones. Final considerations Studying resting coronary graft flow with Doppler echocardiography in a completely noninvasive manner is challenging. The coronary vessel pattern is similar to a fingerprint and then, there are unlimited normal anatomical variations. Coronary heart disease involves a large number of other pathophysiological conditions that can affect the flow through the coronary arteries and their grafts. Similar to other exams, Transthoracic Doppler echocardiography requires accurate interpretation, and the multifactorial context must be considered. It is significant that Transthoracic Doppler echocardiography at rest can be performed at any time deemed necessary to evaluate bypass patients because of its noninvasive nature. Additionally, this technique compares the current and previous values rather than obtaining an absolute value from a single observation [16]. When reduction in these patency criteria is observed, it is possible that part of the composite graft is obstructed. A stress TDE is suggested to measure the coronary

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flow reserve and notice its potential increase. Values equal or greater than the cutoffs are probably indicators of composite graft patency. These cases do not require additional testing beyond the resting TDE, although the medical decision making always depends on the clinical setting. One of the mains contributions of this study is briefly illustrated in Figure 3.

REFERENCES 1. Cerqueira Neto FM, Guedes MA, Soares LE, Almeida GS, Guimarães AR, Barreto MA, et al. Flowmetry of left internal thoracic artery graft to left anterior descending artery: comparison between on-pump and off-pump surgery. Rev Bras Cir Cardiovasc. 2012;27(2):283-9. 2. Nieman K, Pattynama PM, Rensing BJ, Van Geuns RJ, De Feyter PJ. Evaluation of patients after coronary artery bypass surgery: CT angiographic assessment of grafts and coronary arteries. Radiology. 2003;229(3):749-56. 3. Tello R, Hartnell GG, Costello P, Ecker CP. Coronary artery bypass graft flow: qualitative evaluation with cine single-detector row CT and comparison with findings at angiography. Radiology. 2002;224(3):913-8. 4. Rozen WM, Alonso-Burgos A, Murray AC, Whitaker IS. Is there a need for preoperative imaging of the internal mammary recipient site for autologous breast reconstruction? Ann Plast Surg. 2013;70(1):111-5. 5. Brenner DJ, Hall EJ. Computed tomography: an increasing source of radiation exposure. N Engl J Med. 2007;357(22):2277-84.

Fig. 3 – Follow-up algorithm for bypass patients with composite LITA grafts that are grafted to the LAD and another LCS branch (1100% specificity for both, 39.86% sensitivity for DPV/SPV, 36.49% sensitivity for DVTI, 100% PPV for both, 11% NPV for DPV/SPV, and 10.48% NPV for DVTI)

6. Fusejima K. Noninvasive measurement of coronary artery blood flow using combined two-dimensional and Doppler echocardiography. J Am Coll Cardiol. 1987;10(5):1024-31. 7. Takagi T, Yohikawa J, Yoshida K, Akasaka T. Noninvasive assessment of left internal mammary artery graft patency using duplex Doppler echocardiography from supraclavicular fossa. J Am Coll Cardiol. 1993;22(6):1647-52.

Study and technique limitations The Doppler imaging may not have visualized the LITA for anatomical or operator-dependent reasons. The anatomical reasons include unfavorable configurations of the rib cage, the position and diameters of the LITA graft, and the mobility of the heart [6-22]. The overlap of vessels in the supraclavicular block may also have impaired the visualization of LITA. In the quantitative evaluation of the graft flow, the LITA diameter was considered to be equal during systole and diastole because of the technical difficulty in measuring this difference. This study did not obtain data on comorbidities, the medications used by the patients, previous coronary anatomy, or the segmental and overall myocardial contractility, all of which are factors that can affect LITA flow.

8. Crowley JJ, Shapiro LM. Noninvasive assessment of left internal mammary artery graft patency using transthoracic echocardiography. Circulation. 1995;92(9 Suppl):II25-30. 9. Gaudino M, Serricchio M, Tondi P, Glieca F, Giordano A, Trani C, et al. Non-invasive evaluation of mammary artery flow reserve and adequacy to increased myocardial oxygen demand. Eur J Cardiothorac Surg. 1998;13(4):404-9. 10. Chirillo F, Bruni A, Balestra G, Cavallini C, Olivari Z, Thomas JD, et al. Assessment internal mammary artery and saphenous vein graft patency and flow reserve using transthoracic Doppler echocardiography. Heart. 2001;86(4):424-31. 11. Arruda A, Campos Filho O, Ribeiro E, Petrizzo A, Andrade JL, Carvalho AC, et al. Assessment of left internal thoracic artery anastomosis with left anterior descending coronary artery by Doppler echocardiography. Arq Bras Cardiol. 1997;69(6):413-9.

CONCLUSION Values equal or greater than those established by the criteria DPV/SPV ≥ 0.71 and DVTI ≥ 0.09m suggest high probability of patency of the composite graft. Lowers values present a large number of false negatives, not being conclusive to patency and needing further evaluation.

12. De Simone L, Caso P, Severino S, Scherillo M, D’Andrea A, Varricchio A, et al. Noninvasive assessment of left and right internal mammary artery graft patency with high-frequency transthoracic echocardiography. J Am Soc Echocardiogr. 1999;12(10):841-9.

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13. Pezzano A, Fusco R, Child M, Riccobono S, Milazzo A, Recalcati F, et al. Assessment of left internal mammary artery grafts using dipyridamole Doppler echocardiography. Am J Cardiol. 1997;80(12):1603-6.

angiography or Doppler? Asian Cardiovasc Thorac Ann. 2000;8(4):325-9. 20. Cagli K, Emir M, Kunt A, Ergun K, Muharrem T, Murat T, et al. Evaluation of flow characteristics of the left internal thoracic artery graft: perioperative color Doppler ultrasonography versus intraoperative free-bleeding technique. Tex Heart Inst J. 2004;31(4):376-81.

14. Lobo Filho JG, Leitão MCA, Lobo Filho HG, Silva AA, Machado JJA, Forte AJV, et al. Revascularização miocárdica com enxerto composto de artéria torácica interna esquerda em Y: análise de fluxo sanguíneo. Rev Bras Cir Cardiovasc. 2004;19(1):1-8. 15. Lobo Filho JG, Leitão MCA, Forte AJV, Lobo Filho HG, Silva AA, Bastos ES, et al. Flow analysis of left internal thoracic artery in myocardial revascularization surgery using Y graft. Tex Heart Inst J. 2006;33(4):430-6.

21. Hata M, Raman JS, Shiono M, Sezai A, Negishi N, Sezai Y, et al. What can Doppler wave forms of the left internal thoracic artery teach us? The efficacy of apical transthoracic approach of Doppler echocardiography. Ann Thorac Cardiovasc Surg. 2002;8(2):92-6.

16. Jones CM, Athanasiou T, Tekkis PP, Malinovski V, Purkayastha S, Haq A, et al. Does Doppler echography have a diagnostic role in patency assessment of internal thoracic artery grafts? Eur J Cardiothorac Surg. 2005;28(5):692-700.

22. El-Masry MM, Salama MM, Darwish AZ, El-Aziz OA. Assessment of left internal mammary artery graft patency by transthoracic Doppler echocardiography. Clin Cardiol. 2002;25(11):511-6.

17. Lobo Filho JG, Leitão MCA, Lobo Filho HG, Soares JPH, Magalhaes GA, Leão Filho CSC, et al. Cirurgia de revascularização coronariana esquerda sem CEC e sem manuseio da aorta em pacientes acima de 75 anos: análise das mortalidades imediata e a médio prazo e das complicações neurológicas no pós-operatório imediato. Rev Bras Cir Cardiovasc. 2002;17(3):208-14.

23. Kitamura S, Kawachi K, Seki T, Sawabata N, Morita R, Kawata T. Angiographic demonstration of no-flow anatomical patency of internal thoracic-coronary artery bypass grafts. Ann Thorac Surg. 1992;53(1):156-9. 24. Krams R, Sipkema P, Zegers J, Westerhof N. Contractility is the main determinant of coronary systolic flow impediment. Am J Physiol. 1989;257(6 Pt 2):H1936-44.

18. Shimizu T, Hirayama T, Suesada H, Ikeda K, Ito S, Ishimaru S. Effect of flow competition on internal thoracic artery graft: postoperative velocimetric and angiographic study. J Thorac Cardiovasc Surg. 2000;120(3):459-65.

25. Maudière A, Lacroix P, Cornu E, Aboyans V, Laskar M, Bensaid J, et al. Etude en echo-doppler transparietal postoperatoire du flux du greffon mammaire interne en fonction de la qualite du myocarde sous-jacent. Arch Mal Coeur Vaiss. 1996;89(11):1343-8.

19. Dubey B, Bhan A, Choudhary SK, Sharma S, Sharma R, Airan B, et al. Assessment of internal mammary artery graft patency:

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Novaes FR, etORIGINAL al. - Results of Castro Bernardes intraluminal ring in surgery ARTICLE for ascending aortic aneurysms and dissections

Results of Castro Bernardes intraluminal ring in surgery for ascending aortic aneurysms and dissections Resultados do anel intraluminal de Castro Bernardes nas cirurgias de aneurismas e dissecções da aorta ascendente

Fernando Rotatori Novaes1, Tulio Pinho Navarro2, Rodrigo de Castro Bernardes3, Fernando Antonio Roquete Reis Pinto4, Luiz Cláudio Moreira Lima4, Ernesto Lentz da Silveira Monteiro4, Carla Patrícia Perpétua Medeiros5

DOI: 10.5935/1678-9741.20130026

RBCCV 44205-1458

Abstract Objective: To demonstrate surgical results using Castro Bernardes intraluminal ring in ascending aorta surgery, instead of conventional suture. Methods: 95 patients underwent ascending aorta surgery from December 2008 to April 2011 at Madre Tereza Hospital (Belo Horizonte, MG, Brazil), using Castro Bernardes intraluminal ring instead of conventional suture of the aorta. Results: Ninety five patients underwent ascending aorta surgery with Castro-Bernardes intraluminal ring. Thirty patients presented acute dissection and 65 aneurism. Overall postoperative mortality was 15.78% (15/95). Nine patients in 15 (60%) died due to acute type A dissection. For acute type A dissection, mortality was 30% and for aneurism mortality was 9.23%. The intraluminal ring was inserted in distal position in 89 patients and in proximal and distal position in 6 patients. Mortality was related to Bentall & De Bono or Cabrol associated

techniques. Average extracorporeal circulation time was 57.4 minutes and average aortic cross-clamping time was 37 minutes. Conclusion: The use of Castro Bernardes intraluminal ring in ascending aortic surgery avoiding conventional suture reduces extracorporeal circulation time and aortic cross-clamping time, improving surgical results. This approach simplifies ascending aortic surgery whether the disease is type A dissection or aneurysm, and may be considered a good alternative technique.

1. Head of the Cardiac Surgery Unit of the Montes Claros/MG public hospital (Santa Casa), Montes Claros, MG, Brazil. 2. Medical Doctor. Coordinator, Unit of Vascular and Endovascular Surgery, Hospital das Clínicas, Federal University of Minas Gerais, Belo Horizonte, MG, Brazil. 3. Head of the Cardiovascular Unit of the Instituto do Coração (Heart Institute) of the Madre Teresa Hospital, Belo Horizonte, MG, Brazil. 4. Member of the cardiovascular surgery team of the Madre Tereza Hospital, Belo Horizonte, MG, Brazil. 5. Undergraduate student of Medical School at the State University of Montes Claros (UNIMONTES), Belo Horizonte, MG, Brazil.

MG, Brazil in a partnership between the State University of Montes Claros (UNIMONTES) and Madre Tereza Hospital, Belo Horizonte, MG, Brazil.

Descriptors: Aneurysm, dissecting. Aortic aneurysm. Blood vessel prosthesis. Resumo Objetivo: Demonstrar os resultados do uso do anel intraluminal de Castro Bernardes no tratamento cirúrgico dos aneurismas e dissecções da aorta ascendente. Métodos: Foram avaliados 95 pacientes submetidos a

Correspondence address: Fernando Rotatori Novaes Cardiovascular Surgeon of the Montes Claros/MG Public Hospital – Santa Casa Rua Londres, 211 – Ibituruna District – Montes Claros, MG, Brazil Zip code: 39408-111 E-mail: fernandorotatori@yahoo.com.br Article received on August 8th, 2012 Article accepted on March 7th, 2013

Work carried out in the Public Hospital – Santa Casa – in Montes Claros,

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e distal, em seis A mortalidade foi maior no grupo de pacientes submetidos a técnica cirúrgica de Bentall & De Bono ou Cabrol, quando comparados àqueles submetidos ao uso de prótese de Dacron, associada ou não à plastia ou troca valvar aórtica. O tempo médio de circulação extracorpórea (CEC) foi de 57,4 minutos e o tempo médio de pinçamento de aorta, 37 minutos. Conclusão: A utilização do anel intraluminal de Castro Bernardes, que evita sutura convencional, foi eficaz em reduzir o tempo de CEC e de pinçamento de aorta e, por conseguinte, de melhorar os resultados pós-operatórios. Essa opção contribuiu para simplificar o tratamento cirúrgico dos aneurismas e dissecções da aorta ascendente e constitui boa alternativa técnica.

Abbreviations, Acronyms & Symbols CABG ECC

Coronary artery bypass grafting Extracorporeal circulation

cirurgia de aorta ascendente, no período de dezembro de 2008 a abril de 2011, no Hospital Madre Teresa (Belo Horizonte, MG, Brasil), nos quais foi utilizado anel intraluminal de Castro Bernardes, ao invés de sutura convencional na aorta. Resultados: A mortalidade pós-operatória geral foi de 15,78% (15 pacientes em 95). Dos óbitos, 60% (nove pacientes) foram por dissecção aguda tipo A. Do total de 95 pacientes operados, 30 apresentavam dissecção aguda tipo A, com mortalidade de 30% e 65 pacientes apresentavam aneurismas de aorta ascendente, com mortalidade de 9,23%. Utilizou-se o anel em posição distal em 89 pacientes e, em posições proximal

Descritores: Aneurisma dissecante. Aneurisma aórtico. Prótese vascular.

INTRODUCTION

implant of a valved tube with reimplantation of coronaries. Since then some contributions have been made to its improvement, such as the technique described by Cabrol et al. [1]. The operation requires sutures in friable tissues. This is due to that fact that there may be the need to reinforce the line of suture to prevent bleeding. Frequently, pericardial patches are used as reinforcement, or polytetrafluoroethylene (Teflon) plate and/or biological adhesives such as GRF-gelatin - resorcinol-formaldehyde or Cryolife Bioglue®. This however, implies an increase in the surgical times, in the ECC and the aortic cross-clamping. The intraluminal prosthesis for the confection of anastomosis without conventional suture in aortic surgeries was proposed in 1978 by Dureau et al. [8] and Ablaza et al. [9] and subsequently, by Lemole et al. [10]. Initially the ring was associated with complications such as: migration, formation of pseudo aneurysms and bleeding. In 1988, Bernardes et al. [11,12] developed an intraluminal ring with a wider and deeper groove, which facilitated its fixing in the aorta, and avoided the complications described above. Their works demonstrated the effectiveness of the use of this ring in the surgical treatment of the aorta at all its levels: ascending, arch, descending, thoracoabdominal and infrarenal, as it allowed rapid and safe anastomosis. The objective of this study is to demonstrate the results of the use of the Castro Bernardes intraluminal ring in the surgical treatment of the ascending aorta diseases in relation to postoperative mortality, ECC time, aortic cross-clamping time, associated surgical technique and patients' demographic and intraoperative variables of the patients.

The most common diseases of the ascending aorta that require intervention are aneurysms and dissections, associated or not with valve and coronary insufficiency [1]. Aneurysms can involve the aortic root and the sinuses of Valsalva (annuloaortic ectasia) or the ascending aorta above the coronary ostia (supra-coronary aneurysm) [1]. Chronic dissections present behaviour similar to that of aneurysms [2]. Acute dissections of the ascending aorta can extend to the aortic arch and supra-aortic branches, and/or to the descending aorta and intercostal, visceral and iliac branches. The incidence of aneurysms of the thoracic aorta is estimated at 10.4 cases per 100,000 people/year [3] and for acute dissections it is 10 to 20 per 1,000,000 people/year [4]. The average age in the diagnosis ranges from 59 to 69 years old, with a predominance of men at a frequency two to four times greater than in women. Around 50% to 60% of aneurysms of the thoracic aorta compromise the ascending aorta, 30% to 40% the descending aorta, 10% the aortic arch and 10% the thoracoabdominal portion [5]. In acute dissections that involve the ascending aorta, surgical intervention should be immediate and has the aims of preventing rupture and death by cardiac tamponade, correcting aortic regurgitation when present, preventing myocardial ischemia, excluding the torn part from the intima and redirecting the flow by the true lumen to the supra-aortic branches and descending aorta [6]. Ascending aorta surgeries can be lengthy with long times of extracorporeal circulation (ECC) and of aortic crossclamping due to the anatomical complexity of the aortic root, the presence of friable structures of difficult hemostasis, the necessity of approaching the aortic valve by means of plasty or substitution and of reimplantation of the coronary ostia. Bentall & De Bono [7] described the technique for the correction of the diseases that involve the aortic root, through

METHODS A transverse and descriptive study was carried out, obtaining secondary data of patient medical records from Madre Teresa Hospital database (Belo Horizonte, MG, Brazil).

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During the period from December 2008 to April 2011, 114 patients with aneurysms and/or dissections of the ascending aorta were operated. The patients that did not use the ring and/or that were submitted to associated surgeries, such as coronary artery bypass grafting (CABG) and aneurysmectomy of the left ventricle were excluded. Ninety-five patients were studied in which the Castro Bernardes intraluminal ring was used without suture. The variables investigated were: 1) gender; 2) age; 3) postoperative mortality; 4) ECC time; 5) aortic cross-clamping time; 6) associated surgical techniques: isolated use of Dacron

prosthesis, use of Dacron prosthesis with plasty of the aortic valve, use of Dacron prosthesis with substitution of the aortic valve, Bentall & De Bono or Cabrol techniques; 7) complications: migration, formation of pseudo aneurysms and bleeding. A descriptive analysis was carried out of the clinical characteristics using frequency distributions, measures of centre and spread (average and standard deviation). Femoral cannulation was used in the majority of patients (88.4%), axillary (12.6%) and aortic (5.2%), in some cases two cannulation sites were associated depending on the surgical time and the anatomy of the lesions (Table 1). This research was approved by the Research Ethics Committee (CEP) of the State University of Montes Claros – UNIMONTES (Montes Claros, MG, Brazil).

Table 1. Preoperative variables. Variable Cardioplegia Femoral cannulation Axillary cannulation Femoral and axillary cannulation

n 95 85 2 8

RESULTS

% 100 89.4 2.1 8.4

Ninety-five patients submitted to ascending aorta surgery were studied, 33 of them (34.37%) were female, average age was 57.5 years-old and the average hospitalization time was 16.6 days (Table 2).

Table 2. Demographic, clinical and surgical variables of the 95 patients submitted to surgery of the ascending aorta at Madre Tereza Hospital (Belo Horizonte, MG, Brazil), from 2008 to 2011. Variable Sex Female Male Age bracket ≤40 41 to 50 51 to 60 61 to 70 71 to 80 Mortality Survived Died Type of condition Aneurysm of the ascending aorta Acute dissection Chronic dissection Aneurysm of the ascending aorta and bicuspid valve Aneurysm of the ascending aorta and chronic dissection Aneurysm of the ascending aorta and acute dissection Use of the ring Distal ring Proximal and distal ring Surgical technique Isolated Dacron prosthesis Dacron prosthesis and aortic valve plasty Dacron prosthesis and aortic valve substitution Bentall & De Bono Cabrol

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n

%

33 62

34.7 65.3

7 19 23 34 12

7.3 20.0 24.2 35.7 12.6

80 15

84.2 15.7

42 29 5 14 4 1

44.2 30.5 5.2 14.7 4.2 1.0

89 6

93.6 6.31

14 27 15 31 8

14.7 28.4 15.7 32.6 8.4

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Table 3. Types of surgical techniques of the 95 patients related to ECC and aortic cross-clamping times and mortality. Variables

Extracorporeal circulation time Aortic cross-clamping time Deaths, n (%) Survival, n (%)

Use of Dacron prosthesis + aortic valve substitution n: 15 Average

Use of Bentall & De Bono technique

Use of Cabrol technique

n:14 Average

Use of Dacron prosthesis + aortic valve plasty n:27 Average

n: 31 Average

n: 8 Average

34.9 18.2 __ 14 (100%)

65.0 55.0 2 (7.4%) 25 (92.2%)

67.7 50.2 2 (13.3%) 13 (86.6%)

69.9 50.0 6 (19.3%) 25 (80.6%)

86.7 63.3 5 (62.5%) 3 (37.5%)

Use of isolated Dacron prosthesis

Eight patients were submitted to the Cabrol technique, 31 to the Bentall & De Bono and the remaining 56 to the use of the isolated Dacron either associated with plasty or aortic valve replacement. The mortality rate was 15.78% (15/95 patients), for the patients with acute dissection the mortality was 30%, and in patients with aneurysm the mortality was 9.23%. The technique used also influenced mortality since it was greater in the cases submitted to the techniques of Cabrol (62.5%), and Bentall & De Bono (19.35%) and only 7.1% when the Dacron was used associated or not with plasty or the substitution of the aortic valve. The ECC and aortic cross-clamping times were lower when the isolated Dacron was used and longer with the more complex techniques such as Cabrol and Bentall & De Bono (Table 3). Complications such as migration, formation of pseudo aneurysms and bleeding were not reported.

of the ascending aorta occurred nine times more in patients with bicuspid aortic valve than in patients with tricuspid valve. Schmid et al. [16] reported the association of aneurysm of the ascending aorta with bicuspid aortic valve in 35% to 80% of the cases. In the present study, the association of bicuspid aortic valve and ascending aorta diseases was found in 14 of the 95 (14.7%) patients (Table 2). Studies have demonstrated that the ECC time, the aortic cross-clamping time and age are identified as strong predictors of worst forecast [17], which justifies the concern in reducing these times, through use of the intraluminal ring that allows us to bypass conventional suture. Prifti et al. [18], on the other hand, reported that the mortality is directly related to the type of condition, being greater in acute dissections than in aneurysms and chronic dissections, to the preoperative clinical conditions such as cardiogenic shock, cerebrovascular accident and kidney failure and to surgical findings, such as cardiac tamponade, aortic arch defficiency, coagulation disorders and friableness of the aortic wall [19]. Dissections of the ascending aorta and aneurysms that need surgical treatment remain as challenges to cardiovascular surgeons, due to the anatomy of this region, frequently with involvement of the aortic valve, of the Valsalva sinuses, of the coronary ostia, of the straight tubular portion of the aorta, perhaps extending up to the aortic arch and its branches. The coagulation disorders which are common in these patients, added to the technical difficulties commonly found in carrying out sutures in friable structures and of difficult access, result in increased bleeding, which is a difficult problem to be solved, extension of surgical times, of ECC and cross-clamping of the aorta, with possible catastrophic consequences for these patients. Trimarchi et al. [19] demonstrated that in patients with type A acute dissection of the aorta, the mortality is higher in the patients that were unstable in the preoperative period (31.4%), if compared with the stable patients (16.7%), defining as unstable the presence of cardiac tamponade, cardiogenic shock, acute kidney failure, cerebrovascular accident, mesenteric ischemia and/or acute myocardial infarction. The

DISCUSSION Since DeBakey and Cooley described the first successful surgery for aneurysm of the descending thoracic aorta utilizing prosthesis in 1953, several techniques have arisen with different applications depending on the structures affected [13]. The same author, DeBakey, in 1955, described the first case of dissection of the descending thoracic aorta operated successfully [13]. The complications observed by Dureau et al. [8] and Ablaza et al. [9] with the use of the ring, such as migration, bleeding and formation of pseudo aneurysms were due to the difficulty in fixing the ring to the friable tissues and to the characteristics of the ring they used. The development of the Castro Bernardes ring with a wider and deeper groove, added to the greater experience of the surgical team, practically abolished these complications, which were not observed in any patient of this series [12]. The bicuspid aortic valve is a risk factor for the development of aneurysms and dissections of the ascending aorta [14]. Larson & Edwards [15] observed that dissection

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difficulty access of the patients to the reference centres should be remembered, which can increase the interval between diagnosis and surgery, which is crucial, especially in the cases of acute dissections and ruptured aneurysms [20]. The general postoperative mortality in this study was 15.7%, that is, 15 of the 95 patients. In the patients with a diagnosis of aneurysm, the mortality was 9.23% (6 in 65 patients). In the patients with acute dissection, the mortality was 30% (9 in 30 patients). Of the 15 deaths of this series, nine (60%) patients were diagnosed as acute dissection and the remaining six (40%) as aneurysm (Table 4). The techniques of Bentall & De Bono and Cabrol were associated with greater mortality due to the greater gravity of these patients, to disorders of the aortic root and the need to manipulate the aortic valve and coronary sinuses, which is also found in other studies [21]. Of the 15 patients that died, six were operated by the technique of Bentall & De Bono, five by the Cabrol technique, four by the use of a Dacron tubular prosthesis associated or not with aortic valve plasty, which resulted in a mortality of 19.35% (6 in 31 patients) for the Bentall & De Bono technique, 62.5% (5 in 8 patients) for the Cabrol technique and 7.1% (4 in 56 patients) when the Dacron tube was used (Table 4). In the present study the diagnosis of acute dissection led to a tendency to greater mortality in relation to patients with aneurysm. Perhaps with a larger sample this tendency could prove to be statistically significant (chance of error less than 5%). In the majority of patient femoral cannulation was used due to its practicality, however it was used in conjunction with aortic and axillary cannulation in some cases, depending on the anatomy of the lesions and the necessity of flow in a

determined moment of the surgery. Studies show benefits with the use of axillary cannulation with a reduction of the rate of cerebrovascular accidents in comparison to the retrograde flow that we observe in femoral cannulation that increases the shift of plates at the level of the descending aorta and aortic arch. The cardiovascular surgeon should familiarize him or herself with the use of axillary cannulation, in spite of its technical difficulties. In this study, the Castro Bernardes intraluminal ring was used in 95 patients out of the total of 114, 89 being in the distal position and 6 in distal and proximal positions. The use of the ring in the proximal position is more difficult in the ascending aorta, due to the anatomical characteristics of the aortic root with the presence of the coronary ostia and the pillars of the aortic valve, its use was reserved for cases in which there is a condition of the aorta above the sinotubular junction. The use of the ring in the distal position is easily handled and of rapid execution (Figures 1 and 2). Of the six patients where the Castro Bernardes ring in the proximal and distal position was used, none died, probably as they are less complex cases, with no condition of the aortic root, treating only the tubular portion of the ascending aorta, by means of substitution by Dacron straight tubular prosthesis, associated with aortic valve plasty in two cases. It was chosen to employ the Castro Bernardes intraluminal ring without suture whenever possible, because its use is associated with less surgical time, of ECC and of aortic cross-clamping. The ring was not used in 14 patients, because of the impossibility of proper accommodation in the distal portion of the ascending aorta next to the aortic arch, which would result in an unsafe anastomosis, with the risk of the ring working loose.

Table 4. Distribution of patients who died and their demographic, diagnostic characteristics and surgical techniques used. n 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Sex* M M F M M M M F M M M M M M M

Age 60 49 35 57 53 63 61 62 64 70 71 46 42 57 40

Type of condition** ADAA ADAA ADAA ADAA ADAA ADAA ADAA ADAA ADAA AAA AAA AAA AAA AAA AAA

Surgical technique Dacron prosthesis + aortic valve plasty Dacron prosthesis + aortic valve plasty Dacron prosthesis + aortic valve plasty Bentall & De Bono Cabrol Cabrol Cabrol Cabrol Dacron prosthesis + aortic valve plasty Bentall & De Bono Bentall & De Bono Bentall & De Bono Bentall & De Bono Bentall & De Bono Cabrol

*F = Female; M = Male. **ADAA = Acute dissection of the ascending aorta. AAA = Aneurysm of the ascending aorta.

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Position of the ring Distal Distal Distal Distal Distal Distal Distal Distal Distal Distal Distal Distal Distal Distal Distal

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Fig. 1 – Surgical treatment of type A acute dissection of the aorta. Preparation of the intraluminal prosthesis with two rings

Fig. 2 – Surgical aspect of anastomosed proximal intraluminal ring above the coronary ostia. Distal ring prepared for implant

Studies carried out on patients submitted to surgeries with the employment of the conventional suture technique demonstrated results with ECC and aortic cross-clamping times longer than that observed in the patients of this work, submitted to the use of the intraluminal ring. Hagl et al. [22] in a work analysing the employment of the Bentall & De Bono technique with conventional suture in 142 patients, reported average ECC time of 209 minutes and aortic cross-clamping time of 142 minutes, while in this work an average ECC time of 69.9 minutes and an aortic cross-clamping time of 50 minutes were found, in 31 patients submitted to the same technique with the use of the intraluminal ring in distal anastomosis. A study performed by Gelsomino et al. [21] demonstrated an average ECC time of 198 minutes and an aortic cross-clamping time of 135 minutes, obtained by the analysis of 45 patients submitted to the Cabrol technique with conventional suture. In the present study an average ECC time of 86.7 minutes was observed and of aortic cross-clamping of 63.3 minutes, in eight patients submitted to the same technique with the use of the distal intraluminal ring. These data confirm the reduction of the ECC and aortic cross-clamping times with the use of the ring. The use of Castro Bernardes intraluminal ring without suture is contributing to simplifying the operation reducing the ECC and cross-clamping time, avoiding sutures in friable tissues, bleeding controlled with difficultly and excessive use of blood products. The results with the use of the ring have already been demonstrated in previous studies. Wei et al. [23] reported the use of the intraluminal ring without suture in 19 patients, with anastomosis times from 1 to 2 minutes, without bleeding or other complications. Bernardes et al. [11,12] demonstrated in various papers that the intraluminal ring can be used in substitution of conventional suture in all the segments of the aorta with good results, as it is an easy and rapid execution technique with low cost.

CONCLUSION It has been demonstrated that the use of Castro Bernardes intraluminal ring without suture in surgeries on the ascending aorta led to a reduction of the ECC and aortic cross-clamping times with consequent improvement in the results of the surgery. It, therefore, constitutes a safe alternative technique which produces good results and it is easy and low costly, which can be performed in centres with few resources.

REFERENCES 1. Cabrol C, Gandjbakhc I, Pavie A. Surgical treatment of ascending aortic pathology. J Cardiac Surg. 1988;3(3):167-80. 2. Coady MA, Rizzo JA, Goldstein LJ, Elefteriades JA. História Natural, patogênese e etiologia dos aneurismas e dissecções da aorta torácica. Clin Cardiol Am N. 1999;17(4):836-9. 3. Clouse WD, Hallet JW Jr, Schaff HV, Gayari MM, Ilstrup DM, Melton LJ 3rd. Improved prognosis of thoracic aortic aneurysms: a population-based study. JAMA. 1998;280(22):1926-9. 4. Sorensen HR, Olsen H. Ruptured and dissenting aneurysms of the aorta. Incidence and prospects of surgery. Acta Chir Scand. 1964;128:644-50. 5. Schmid FX, Bielenberg K, Scheneider A, Haussler A, Keyser A, Birnbaum D. Ascending aortic aneurysm associated with bicuspid and tricuspid aortic valve: involvement and clinical relevance

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of smooth muscle cell apoptosis and expression of cell deathinitiating proteins. Eur J Cardiothorac Surg. 2003;23(4):537-43.

16. Schmid FX, Bielenberg K, Schneider A, Haussler A, Keyser A, Birnbaum D. Ascending aortic aneurysm associated with bicuspid and tricuspid aortic valve: involvement and clinical relevance of smooth muscle cell apoptosis and expression of cell death-initiating proteins. Eur J Cardiothoracic Surg. 2003;23(4):537-43.

6. Albuquerque LC, Braile DM, Palma JH, Saadi EK, Almeida RMS, Gomes WJ, et.al. Diretrizes para o tratamento cirúrgico das doenças da aorta da Sociedade Brasileira de Cirurgia Cardiovascular. Rev Bras Cir Cardiovasc. 2009;24(2 suppl):7-33s. 7. Bentall H, De Bono A. A technique for complete replacement of the ascending aorta. Thorax. 1968:23(4):338-9.

17. David TE, Maganti M, Armstrong S. Aortic root aneurysm: principles of repair and long-term follow-up. J Thorac Cardiovasc Surg. 2010;140(6 Suppl):S14-9.

8. Dureau G, Villard J, George M, Deliry P, Froment JC, Clermont A. New surgical technique for the operative management of acute dissections of the ascending aorta. Report of two cases. J Thorac Cardiovasc Surg. 1978;76(3):385-9.

18. Prifti E, Bonacchi M, Frati G, Proietti P, Giunti G, Babatasi G, et al. Early and long-term outcome in patients undergoing aortic root replamecent with composite graft according to the Bentall’s technique. Eur J Cardiothoracic Surg. 2002;21(1):15-21.

9. Ablaza SG, Ghosh SC, Grana VP. Use of a ringed intraluminal graft in the surgical treatment of dissecting aneurysms of the aorta. A new technique. J Thorac Cardiovasc Surg. 1978;76(3):390-6.

19. Trimarch S, Nienaber CA, Rampoldi V, Myrmel T, Suzuki T, Mehta RH, et al; International Registry of Acute Aortic Dissection Investigators. Contemporary results of surgery in acute type A aortic dissection: The International Registry of Acute Aortic Dissection experience. J Thorac Cardiovasc Surg. 2005;129(1):112-22.

10. Lemole GM, Strong MD, Spagna PM, Karmilowicz NP. Improved results for dissecting aneurysms. Intraluminal sutureless prosthesis. J Thorac Cardiovasc Surg. 1982;83(2):249-55.

20. Oliveira JF, Reis Filho FAR, Lima LCM, Monteiro ELS, Martins SA, Faria PEA, et al. Resultados a médio prazo do tratamento cirúrgico da dissecção aguda de aorta tipo A com o emprego de prótese intraluminal. Rev Bras Cir Cardiovasc. 2001;16(2):136-40.

11. Bernardes RC. Dissecção aguda de aorta. Tratamento cirúrgico precoce com menor agressividade: maior chance de sobrevivência. Rev Bras Ter Intensiva. 1996;8(2):68-74. 12. Bernardes RC, Rabelo RC, Reis Filho FAR, Rabelo W, Marino MA, Marino RL. Tratamento cirúrgico das dissecções agudas de aorta tipo B. Técnica da “tromba de elefante” modificada pelo emprego de prótese intraluminal sem sutura. Rev Bras Cir Cardiovasc. 1996;11(1):12-7.

21. Gelsomino S, Frassani R, Da Col P, Morocutti G, Masullo G, Spedicato L, et al. A long-term experience with the Cabrol root replacement technique for the management of ascending aortic aneurysms and dissections. Ann Thorac Surg. 2003;75(1):126-31.

13. Kouchoukos NT, Blackstone EH, Doty DB, Hanley FL, Karp RB. Cardiac surgery. 3rd ed. Philadelphia: Churchill Livingstone; 2003.

22. Hagl C, Strauch JT, Spielvogel D, Galla JD, Lansman SL, Squitieri R, et al. Is the Bentall procedure for ascending aorta or aortic valve replacement the best approach for long-term event-free survival? Ann Thorac Surg. 2003;76(3):698-703.

14. Edwards WD, Leaf DS, Edwards JE. Dissecting aortic aneurysm with congenital bicuspid aortic valve. Circulation.1978;57(5):1022-5.

23. Wei J, Chang CY, Chuang YC, Sue SH, Lee KC, Tung D. A new vascular ring connector in surgery for aortic dissection. J Thorac Cardiovasc Surg. 2009;138(3):674-7.

15. Larson EW, Edwards WD. Risk factors for aortic dissection: a necropsy study of 161 cases. Am J Cardiol. 1984;53(6):849-55.

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Silva LLM, etORIGINAL al. - Impact ofARTICLE autologous blood transfusion on the use of pack of red blood cells in coronary artery bypass grafting surgery

Impact of autologous blood transfusion on the use of pack of red blood cells in coronary artery bypass grafting surgery Impacto da transfusão autóloga no uso de concentrado de hemácias em cirurgias de revascularização do miocárdio

Leonardo Leiria de Moura da Silva1, Anna Júlia de Borba Andres2, Roberta Senger3, Ralf Stuermer4, Maria Celoni de Mello de Godoy5, Eduardo Francisco Mafassioli Correa6, Virgínia Maria Cóser7

DOI: 10.5935/1678-9741.20130027

RBCCV 44205-1456

Abstract Objective: To evaluate the impact of Cell Saver autologous blood transfusion system (CS) on the use of packed red blood cells (pRBC) in coronary artery bypass grafting (CABG) surgery. Methods: We carried out a retrospective cross-sectional study in 87 patients undergoing primary elective CABG with miniaturized cardiopulmonary bypass (miniCPB), divided in two groups: 44 without-CS and 43 with-CS. We investigated the necessity of absolute use and the volume of packed red blood cells (pRBC) in each group, as well as cardiovascular risk factors, presurgical variables and intraoperative surgical parameters. All data were collected from medical records and there was no randomization or intervention on group selection. Statistical analysis was performed with Student t-test, Mann-Whitney Utest and χ2 test, with a 5% significance level. Results: There were no significant differences between the two groups in terms of cardiovascular risk factors and pre and

intraoperative variables. Evaluating the absolute use of pRBC during surgery, there was a statistically significant difference (P=0.00008) between the groups without-CS (21/44 cases; 47.7%) and with-CS (4/43 cases; 9.3%). There was also a statistically significant difference (P=0.000117) in the volumes of pRBC between the groups without-CS (198.65±258.65ml) and with-CS (35.06±125.67ml). On the other hand, in the early postoperative period (up to 24h) there was no difference regarding either the absolute use or the volumes of pRBC between both studied groups. Conclusion: Autologous erythrocyte transfusion with CS use reduces the use of intraoperative homologous pRBC in coronary artery bypass grafting surgeries associated with miniCPB.

1. Anesthesiologist, MD, MSc. University Hospital of Santa Maria (HUSM). Post-Graduate Program on Health Sciences - Federal University of Santa Maria (UFSM), Santa Maria, RS, Brazil. Study design, data collection, anesthesia of the patients, writing, and review. 2. Medical Student. Federal University of Santa Maria (UFSM), Santa Maria, RS, Brazil. Data collection, structuring of the database, and review. 3. Perfusionist Nurse. University Hospital of Santa Maria (HUSM), Santa Maria, RS, Brazil. Data collection, management of perfusion of patients, and review. 4. Cardiovascular Surgeon, MD. University Hospital of Santa Maria (HUSM), Santa Maria, RS, Brazil. Surgeon who operated on patients, structuring of the database, review. 5. Anesthesiologist, MD, PhD. Associate Professor of Anesthesiology. Federal University of Santa Maria (UFSM), Santa Maria, RS, Brazil. Coorientation of the study, review. 6. Anesthesiologist, MD, TSA. Chief, Division of Anesthesiology. University Hospital of Santa Maria (HUSM), Santa Maria, RS, Brazil. Study design, coorientation to the study, anesthesia of the patients and review.

7. MD, PhD. Attending Physician, Division of Hematology-Oncology. University Hospital of Santa Maria (HUSM). Supervisor Professor at Post-Graduate Program on Health Sciences - Federal University of Santa Maria (UFSM), Santa Maria, RS, Brazil. Orientation of the study, review of data collected, review.

Descriptors: Blood transfusion, autologous. Myocardial revascularization. Erythrocyte transfusion.

Work carried out at Post-Graduate Program on Health Sciences (UFSM) and University Hospital of Santa Maria (HUSM), Santa Maria, RS, Brazil. Correspondence adress: Leonardo L M Silva Hospital Universitário de Santa Maria (HUSM) – Anesthesia Services. Av. Roraima, s/n – Prédio 22 – Campus da UFSM – Camobi – Santa Maria, RS, Brazil – Zip code: 97105-900. E-mail: leonardolms@gmail.com Article received on November 19th, 2012 Article accepted on May 17th, 2013

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intervenção na seleção dos grupos. Na análise estatística foram utilizados os testes t de Student, teste U de Mann-Whitney, teste do qui-quadrado, com um nível de significância de 5%. Resultados: Em relação a fatores de risco cardiovascular e variáveis pré e transoperatórias, não houve diferença estatística significativa entre os dois grupos. Quando se avaliou o uso absoluto de CH no transoperatório, houve diferença estatística significativa (P=0,00008) entre os grupos sem-SAH (21/44 casos; 47,7%) e com-SAH (4/43 casos; 9,3%). Na análise dos volumes de CH utilizado no transoperatório, também houve diferença significativa (P=0,000117) entre os volumes utilizados no grupo sem-SAH (198,65±258,65 ml) e com-SAH (35,06±125,67 ml). Já no pós-operatório imediato (até 24 horas), não houve diferença tanto no uso absoluto como nos volumes de CH entre os grupos que usaram ou não o SAH. Conclusão: A autotransfusão de hemácias possibilitada pelo uso do SAH determina menor uso de CH homólogo no transoperatório de CRM com uso de miniCEC.

Abbreviations, Acronyms & Symbols AMI ASA CABG CPB CS HUSM miniCPB pRBC

Acute myocardial infarction American Society of Anesthesiologists Coronary artery bypass grafting surgery Cardiopulmonary bypass Cell Saver autologous blood transfusion system Hospital Universitário de Santa Maria Miniaturized cardiopulmonary bypass Packed red blood cells

Resumo Objetivo: Avaliar o impacto do sistema de autotransfusão com hemoconcentração (SAH) no uso de concentrado de hemácias (CH) em cirurgias de revascularização do miocárdio (CRM). Métodos: Foi desenvolvido um estudo transversal, que incluiu 87 pacientes submetidos a CRM eletiva primária com miniCEC, sendo 44 sem uso do SAH e 43 pacientes com uso do SAH. Foi investigada a necessidade de uso e o volume de CH em cada grupo, bem como fatores de risco cardiovascular, variáveis préoperatórias e parâmetros cirúrgicos transoperatórios por meio de coleta de dados em prontuários. Não houve randomização ou

Descritores: Transfusão de sangue autóloga. Revascularização miocárdica. Transfusão de eritrócitos.

INTRODUCTION

homologous pRBC transfusion, we find the so-called Cell Saver (CS). It is a specialists’ consensual opinion (level C of evidence and class IIb recommendation) that the use of autologous blood transfusion through mechanisms such as Cell Saver is reasonable, during surgeries with cardiopulmonary bypass [8]. However, there are few studies related to the impact of this practice on the real necessity of pRBC transfusion in cardiac surgeries with CPB, especially in coronary artery bypass grafting surgeries. The present study aims to evaluate the impact of Cell Saver on the necessity of pRBC use in coronary artery bypass grafting surgeries associated with miniCPB which were carried out at the University Hospital of Santa Maria (HUSM).

Cardiovascular diseases are the leading causes of mortality not only in Brazil but also throughout the world [1,2], with acute myocardial infarction (AMI) being the main cause of death. The AMI surgical treatment through coronary artery bypass grafting surgery is an usual procedure, which is frequently associated with cardiopulmonary bypass (CPB) and high rates of homologous blood transfusion, varying from 40 to 90% in most publications [3-5]. Transfusion therapy is associated with several unfavorable outcomes, such as renal dysfunction, cardiac, neurological and immunological complications, among others [6]. There is no consensus regarding an ideal value of hemoglobin or hematocrit which suggests transfusion in cardiac surgeries. The American Society of Anesthesiologists (ASA) recommends that pRBC transfusion in patients with serum level of hemoglobin between 6 and 10 g/dL be based on the risk of developing complications or organic lesion by inappropriate oxygenation [7]. The latest consensus concerning perioperative transfusion in cardiac surgery identified six variables as being important risk indicators of pRBC transfusion: old age, small total amount of red blood cells (anemia or small body size), use of antiplatelet or antithrombotic drugs, reoperation or complex procedures, emergency procedures and non-cardiac comorbidity. This same study stated, with a level A of evidence (class I), that all measures of pre and perioperative blood conservation must be taken into this group of patients, since they correspond to the greatest part of hemocomponent transfusions [8]. Among mechanical strategies to reduce the necessity of

METHODS We carried out a retrospective cross-sectional study in patients who had their health care provided by the Division of Cardiac Surgery of HUSM, undergoing CABG surgery from January 2011 to October 2012. All patients were operated by the same surgical team, with right atrial and aortic cannulation, mild hypothermia and blood cardioplegia, and perfusion managed by only one professional. The same group of anesthesiologists was in charge of all patients’ anesthesia care, following the indicative criteria of pRBC transfusion: metabolic acidosis, bad peripheral perfusion, cerebrovascular disease, peripheral vascular disease, hemodynamic instability and mixed venous saturation (SvO2) <75%. Patients with ischaemic heart disease undergoing CABG associated with miniCPB, either using hemocomponents or

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not in the intra or postoperative periods were included in the study. The exclusion criteria were: combined cardiac surgery, previous cardiac surgery, emergency surgery, surgery indication for non-ischaemic heart disease and the use of hemocomponents in priming constitution in the circuit in miniCPB. To determine the minimum sample size, we collected a pilot sample of 10 cases from the group without CS use (without-CS) and 14 cases in the group with CS use (with-CS), considering a 5% significance level, a power of 80% and a sample error (e0) of 0,5 pRBC bags, with standard deviations estimates of 1.287 and 0.938, respectively, totalizing 44 patients in each group. Upon determining the necessary minimum sample size, we selected the last 44 patients who underwent coronary artery bypass grafting surgery with miniCPB and did not make use of CS, as well as the first 43 that used it. As randomized selection of patients was not used in the study, the occurrence of sample selection bias is possible. However, we intended to minimize it through a linear selection of patients, in which the first half did not use CS and the second half did. There was no change in the anesthetic-surgical technique in both groups of patients. The Cell Saver System (autoLog® Autotransfusion System, Medtronic) is composed of a console which is responsible for its operation and programming, as well as a disposable set which includes a vaccum, cardiotomy reservoir, centrifugation reservoir, waste bag, blood collection reservoir bag, which is assembled in each surgery. The CS operation was managed by the same perfusionist who was responsible for performing the cardiopulmonary bypass. This system has been used as a routine in cardiac surgeries which are carried out at HUSM since the end of the year 2011. We investigated cardiovascular surgical risk factors such as hypertension, smoking, diabetes mellitus, COPD, renal dysfunction and previous AMI through an instrument for collecting data, developed for this specific purpose. We also collected information related to the surgical procedure (CPB time and aortic clamp, the amount of grafted blood vessels) and the anesthetic procedure (ASA classification, blood typing and Rh factor, left ventricular ejection fraction and previous and postoperative hematocrit and hemoglobin), as well as the use or not of hemocomponents in the intra and immediate postoperative periods (up to 24h). To evaluate whether there was some difference in the use of pRBC, the c2 test was applied in the groups, using the program called Statistica v. 9.1 (Statsoft Inc., Tulsa, OK, USA). The present study was approved by the UFSM Research Ethics Committee (No. 36,523, June 13th 2012) in compliance with 196/96 National Health Council Resolution (Conselho Nacional de Saúde).

factor and ASA classification may be seen in Table 1. The data are not only frequency-based, but also expressed through mean, standard deviation and significance level. Table 1. Patients’ profile stratified by group without-CS n = 44

Gender male 29 (65.9%) female 15 (34.1%) Age (years-old) 62.25 ± 7.85 Weight (kg) 75.34 ± 14.68 BSA (m2) 1.83 ± 0.18 SAH yes 37 (84.1%) no 7 (15.9%) Smoking yes 34 (77.3%) no 10 (22.7%) DM yes 25 (56.8%) no 19 (43.2%) COPD yes 9 (20.4%) no 35 (79.6%) Renal disease yes 6 (13.6%) no 38 (86.4%) Previous AMI yes 29 (65.9%) no 15 (34.1%) LVEF normal (≥55%) 35 (79.6%) abnormal (<55%) 9 (20.4%) ASA III 37 (84.1%) IV 7 (15.9%) BT A 14 (31.8%) B 18 (40.9%) AB 3 (6.8%) O 9 (20.5%) Rh positive 36 (81.8%) negative 8 (18.2%) Number of grafts 3.00 ± 0.71 Initial Ht (g/dL) 40.27 ± 4.54 Initial Hb (g/dL) 13.45 ± 1.72 Clamp T. (min) 72.02 ± 20.91 CPB T. (min) 89.52 ± 20.23

with-CS n = 43 33 (76.7%) 10 (23.3%) 62.53 ± 11.94 80,37 ± 14.64 1.90 ± 0.17 37 (86.0%) 6 (14.0%) 29 (67.4%) 14 (32.6%) 22 (51.2%) 21 (48.8%) 4 (9.3%) 39 (90.7%) 7 (16.3%) 36 (83.7%) 30 (69.8%) 13 (30.2%) 32 (74.4%) 11 (25.6%) 39 (90.7%) 4 (9.3%) 22 (51.2%) 17 (39.5%) 0 (0.0%) 4 (9.3%) 34 (79.1%) 9 (20.9%) 2.81 ± 0.85 39.43 ± 4.71 13.22 ± 1.63 67.37 ± 21.21 86.58 ± 24.90

P value 0.264 0.895 0.112 0.072 0.798 0.305 0.596 0.144 0.729 0.700 0.569 0.353 0.081

0.746 0.272 0.399 0.535 0.306 0.546

BSA: body surface area; SAH: systemic arterial hypertension; DM: diabetes mellitus; COPD: chronic obstructive pulmonary disease; AMI: acute myocardial infarction; LVEF: left ventricular ejection fraction; ASA: clinical classification of American Society of Anesthesiologists; BT: blood type; Rh: Rh factor; Ht: hematocrit; Hb: hemoglobin; Clamp T.: aortic clamp time; CPB T.: cardiopulmonary bypass time

RESULTS Patients’ profile in both groups related to cardiovascular surgical risk factors, previous AMI, value of LV ejection fraction, as well as frequencies referred to blood typing, Rh

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There was no statistically significant difference between the two groups in relation to researched cardiovascular surgical risk factors. The values of hematocrit and early hemoglobin (presurgical) are also found in Table 1. The groups without-CS and with-CS showed, respectively, mean values of 89.52±20.23min and 86.58±24.90min of CPB time and 72.02±20.91min and 67.37±21.21min aortic clamp time. The mean number of grafted blood vessels (distal anastomosis) was 3.00±0.71 in the group without-CS and 2.81±0.85 blood vessels in the group with-CS. There was not also a statistically significant difference between the groups for these variables, confirming the global sample homogeneity. When we evaluated the use of intraoperative pRBC or not, there was a statistically significant difference between the two groups (P=0.00008). In the group without-CS, 21 patients (47.7%) received intraoperative pRBC, whereas in the group with-CS, only four patients (9.3%) received homologous pRBC besides the one processed by Cell Saver. Such results show that the pRBC volume processed by CS significantly decreased the necessity of homologous pRBC use in the group that made use of this system (Table 2). The pRBC mean volume processed by Cell Saver in the patients that used it was 503.34±148.90ml, ranging from 183ml to 872ml. Considering that the mean pRBC volume which is processed by each unit and recommended by the Brazilian Ministry of Health is 220-280ml, it is possible to infer that CS

was able to avoid, on average, the transfusion of approximately two homologous pRBC units in each patient. When homologous pRBC volumes used in the intraoperative period were evaluated, the patients from the group without-CS showed significantly higher volumes (198.65±258.65ml) than the homologous pRBC ones used in the patients from the group with-CS (35.06±125.67ml) (P=0.000117). The mean values of postoperative hematocrit and hemoglobin of both groups may be seen in Table 3. In relation to the hemoglobin variable, there was positive correlation between the groups of a 5% significance level (P=0.016), showing that the patients from the group that used the blood volume processed by CS had superior mean values of hemoglobin compared to the mean values of patients from the group without-CS. The postoperative mean values of hematocrit were also superior in the group with-CS, but not reaching statistical significance (P=0.057). Upon analyzing the postoperative data, there was no statistically significant difference in the absolute use of pRBC in the immediate postoperative period (up to 24h) (P=0.739), not even in the pRBC volumes used (P=0.642401) between the two groups. Such results show that Cell Saver is efficient in the reduction of absolute use and in the reduction of pRBC mean volume used in intraoperative coronary artery bypass grafting surgery, when associated with miniCPB.

Table 2. Necessity of intra and postoperative packed red blood cells in both groups

Use of intraoperative pRBC yes no pRBC volume (ml)

without-CS n = 44

with-CS n = 43

21 (47.7%) 23 (52.3%) 198.65±258.65

4 (9.3%) 39 (90.7%) 35.06±125.67

Use of postoperative pRBC yes no pRBC volume (ml)

7 (15.9%) 37 (84.1%) 56.36±139.13

8 (18.6%) 35 (81.4%) 99.76±240.82

P value 0.00008 0.000117 0.739 0.642

pRBC: pack of red blood cells

Table 3. Postoperative mean values of hematocrit and hemoglobin in both groups

PO Ht (g/dL) PO Hb (g/dL)

without-CS n = 44 32.37 ± 4.77 10.66 ± 1.62

with-CS n = 43 34.51 ± 5.55 11.63 ± 2.08

PO: postoperative; Ht: hematocrit; Hb: hemoglobin

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P value 0.057 0.016

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groups of patients, one using the hemoconcentrator and the other not using it, investigating the quantity of blood used during CPB and in the immediate postoperative period. The group that used the hemoconcentrator showed a lower necessity of blood transfusions during CPB, as well as lower mean volumes of used blood in the intraoperative period. In 2009, an important meta-analysis evaluated the efficiency of CS use in cardiac surgeries, showing that it reduces the necessity of exposure to hemocomponents and pRBC in this population when compared to the non-use of CS, indicating the benefit of applying this system in bleeding throughout the intraoperative period [19]. Another study comparing the use of CS in immediate postoperative outcomes of 288 patients who underwent cardiac surgeries with CPB showed advantages in the use of CS, especially in an increase of postoperative hemoglobin levels and no hospitalization time in ICU [20]. The same study also evaluated the blood volume which was reinfused in each patient by CS, resulting in a mean of 426ml pRBC, a slightly inferior value in relation to the one found in our study (mean of 503.34ml). However, the former study evaluated cardiac surgeries with conventional CPB, not with miniCPB as in our study. The use of miniCPB may have highly contributed to obtain more significant results, showing that it may provide more favorable outcomes. On the other hand, other authors reported that the use of CS may not have clinical benefits in certain groups of patients. They state that with the proper control of intraoperative hemostasis in patients with low risk of bleeding during cardiac surgeries, the use of CS may not have a reasonable cost-benefit [8], not reducing the use of homologous transfusion [21]. Nevertheless, the technical complexity, which is inherent in cardiac surgeries, associated with a higher morbidity of patients undergoing such procedure per se would be potential indicators of the necessity of pRBC homologous transfusion. Our study showed an important reduction in the use of pRBC in the intraoperative period of coronary artery bypass grafting surgery with miniCPB associated with CS. With the reinfusion of autologous pRBC processed by the system during the intraoperative period, there was a lower necessity of homologous pRBC in these patients. The mean volume of pRBC processed by CS was 503.34Âą148.90ml, corresponding approximately to two homologous pRBC units. This pRBC volume, which was reinfused, avoided the use and, consequently, specific risks related to homologous hemotransfusion, which have already been previously discussed. The analysis of such risks was not the objective of the present study, but they are important variables which deserve attention and must be evaluated in further studies. The postoperative values of hemoglobin and hematocrit in the patients who used CS were also higher in relation to the other group. In addition, the population of patients

DISCUSSION The use of hemotransfusions in patients undergoing cardiac surgeries is frequent, due to higher morbidity of this population and the complexity of the procedure itself. It is estimated that 20% of all blood transfusions in the United States are linked to cardiac surgeries [3]. For this reason, there is great interest in developing mechanisms and techniques which are able to reduce this great necessity. CPB has a considerable impact on the systemic inflammatory response and on the induction of circulatory diseases [9], which may be attenuatted through miniaturization of its circuit (miniCPB). With miniCPB, it was possible to diminish the patient’s hemodilution, as well as reducing the blood contact surface with non-endothelial structures, resulting in a lower necessity of hemocomponents transfusion compared to the conventional use of CPB, with significant impact on cardiac surgeries outcome [10]. Autotransfusion through devices which can process intraoperative bleeding and promotes hemoconcentration, with posterior reinfusion to the patient, has been the most used method currently in elective cardiac surgeries [11,12]. The benefits in using this kind of system are considerable, as they diffuse in different steps of the global process of hemotransfusion. Perhaps the best characteristic of this system is the elimination of all steps of processing, storage and later distribution of pRBC in blood banks, since the final pRBC volume is processed and reinfused in the patient inside the surgical environment. Thus, it is possible to avoid a bag switch, contamination in processing, and other potential errors while managing the product. Another benefit is a better proven viability of processed red blood cells due to the absence of the storage process, which causes a decrease in 2.3-DPG levels, besides morphological alterations in the erythrocyte cytoskeleton [13,14]. CS is also safer in terms of transmission of external infectious agents [15], besides significantly diminishing all the other risks and immunological complications or not related to blood transfusion therapy [16]. Since the 1970s, studies have been carried out to evaluate the CS performance related to the necessity of blood transfusion, especially in surgeries with a high risk of bleeding, for instance, cardiac surgeries. The use of CS in cardiac surgeries has already been compared to the use of associated cardiopulmonary bypass or not, showing that, regardless of CPB use, there was a lower necessity of homologous blood transfusion in relation to the group who did not use it [17]. In our study, we chose to include only patients who underwent CABG with miniCPB because of advantages previously discussed. Another study evaluated the new hemoconcentration technique, which is used in CS, in the necessity of hemocomponents transfusion in patients undergoing coronary artery bypass grafting surgery [18]. This study evaluated two

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who received autotransfusion benefited from a pRBC with superior viability in relation to the stored homologous pRBC. Taking in consideration that it was a cross-sectional study, our research shows a range of methodological limitations, which were, to some extent, minimized throughout its development. However, we were able to show that the use of CS led to an important impact in terms of reducing homologous pRBC use in CABG with miniCPB, possibly being as basis for new investigations related to cost-effectiveness, cost-benefit, mortality, long-term risks and complications by using this system in such surgical procedures.

7. American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Practice guidelines for perioperative blood transfusion and adjuvant therapies: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Anesthesiology. 2006;105(1):198-208. 8. Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Ferraris VA, Ferraris SP, Saha SP, Hessel EA 2nd, Haan CK, Royston BD, et al; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg. 2007;83(5 Suppl):S27-86.

CONCLUSION

9. Mulholland JW, Anderson JR, Yarham GJ, Tuladhur S, Saed I, Oliver MD. Miniature cardiopulmonary bypass: the Hammersmith experience. Perfusion. 2007;22(3):161-6.

The use of Cell Saver was efficient in reducing the necessity of intraoperative use of homologous packed red blood cells in patients undergoing coronary artery bypass grafting surgery associated with miniCPB. When it was necessary, the homologous pRBC volume used was significantly greater than the group of patients who did not use CS, showing that the autologous pRBC volume processed by CS and reinfused in the patient was also efficient in reducing this necessity.

10. Gunaydin S, Sari T, McCusker K, Schonrock U, Zorlutuna Y. Clinical evaluation of minimized extracorporeal circulation in high-risk coronary revascularization: impact on air handling, inflammation, hemodilution and myocardial function. Perfusion. 2009;24(3):153-62. 11. Henry DA, Henderson KM, Fryer JL, Treloar CJ, McGrath KM, Deveridge SF. Use of interventions to minimise perioperative allogeneic blood transfusion in Australia. A survey by the International Study of Perioperative Transfusion (ISPOT) Study Group. Med J Aust. 2000;172(8):365-9.

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12. McGill N, O’Shaughnessy D, Pickering R, Herbertson M, Gill R. Mechanical methods of reducing blood transfusion in cardiac surgery: randomized controlled trial. BMJ. 2002;324(7349):1299.

2. Chor D, Fonseca MJ, de Andrade CR. Cardiovascular diseases. Comments on early mortality in Brazil. Arq Bras Cardiol. 1995;64(1):15-9.

13. Simchon S, Jan KM, Chien S. Influence of reduced red cell deformability on regional blood flow. Am J Physiol. 1987;253(4 Pt 2): H898-903.

3. Stover EP, Siegel LC, Parks R, Levin J, Body SC, Maddi R, et al. Variability in transfusion practice for coronary artery bypass surgery persists despite national consensus guidelines: a 24-institution study. Institutions of the Multicenter Study of Perioperative Ischemia Research Group. Anesthesiology. 1998;88(2):327-33.

14. Surgenor SD, DeFoe GR, Fillinger MP, Likosky DS, Groom RC, Clark C, et al. Intraoperative red blood cell transfusion during coronary artery bypass graft surgery increases the risk of postoperative low-output heart failure. Circulation. 2006;114(1 Suppl):I43-8. 15. Carless PA, Henry DA, Moxey AJ, O’Connell DL, Fergusson DA. Cell salvage for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2003;(4):CD001888.

4. Arora RC, Légaré JF, Buth KJ, Sullivan JA, Hirsch GM. Identifying patients at risk of intraoperative and postoperative transfusion in isolated CABG: toward selective conservation strategies. Ann Thorac Surg. 2004;78(5):1547-54.

16. Klein HG, Spahn DR, Carson JL. Red blood cell transfusion in clinical practice. Lancet. 2007;370(9585):415-26.

5. Snyder-Ramos SA, Möhnle P, Weng YS, Böttiger BW, Kulier A, Levin J, et al. The ongoing variability in blood transfusion practices in cardiac surgery. Transfusion. 2008;48(7):1284-99.

17. Niranjan G, Asimakopoulos G, Karagounis A, Cockerill G, Thompson M, Chandrasekaran V. Effects of cell saver autologous blood transfusion on blood loss and homologous blood transfusion requirements in patients undergoing cardiac surgery on- versus off-cardiopulmonary bypass: a randomised trial. Eur J Cardiothorac Surg. 2006;30(2):271-7.

6. Engoren MC, Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002;74(4):1180-6.

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18. Souza DD, Braile DM. Avaliação de nova técnica de hemoconcentração e da necessidade de transfusão de hemoderivados em pacientes submetidos à cirurgia cardíaca com circulação extracorpórea. Rev Bras Cir Cardiovasc. 2004;19(3):287-94.

20. Marcoux J, Rosin M, McNair E, Smith G, Lim H, Mycyk T. A comparison of intra-operative cell-saving strategies upon immediate post-operative outcomes after CPB-assisted cardiac procedures. Perfusion. 2008;23(3):157-64.

19. Wang G, Bainbridge D, Martin J, Cheng D. The efficacy of an intraoperative cell saver during cardiac surgery: a meta-analysis of randomized trials. Anesth Analg. 2009;109(2):320-30.

21. Klein AA, Nashef SA, Sharples L, Bottrill F, Dyer M, Armstrong J, et al. A randomized controlled trial of cell salvage in routine cardiac surgery. Anesth Analg. 2008;107(5):1487-95.

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Han Q, et al. ORIGINAL - Reinforced aortic root reconstruction for acute type A aortic ARTICLE dissection involving the aortic root

Reinforced aortic root reconstruction for acute type A aortic dissection involving the aortic root Reconstrução da raiz da aorta reforçada para dissecção aguda da aorta tipo A envolvendo a raiz da aórtica

Qing-qi Han1, Zhi-gang Song2, Liang-jian Zou2, Lin Han2, Fang-lin Lu2, Xi-long Lang2, Zhi-yun Xu3

DOI: 10.5935/1678-9741.20130028

RBCCV 44205-1457

Abstract Objective: There are debates regarding the optimal approach for AAAD involving the aortic root. We described a modified reinforced aortic root reconstruction approach for treating AAAD involving the aortic root. Methods: A total of 161 patients with AAAD involving the aortic root were treated by our modified reinforced aortic root reconstruction approach from January 1998 to December 2008. Key features of our modified approach were placement of an autologous pericardial patch in the false lumen, lining of the sinotubular junction lumen with a polyester vascular ring, and wrapping of the vessel with Teflon strips. Outcome measures included post-operative mortality, survival, complications, and level of aortic regurgitation. Results: A total of 161 patients were included in the study (mean age: 43.3 ± 15.5 years). The mean duration of follow-up was 5.1 ± 2.96 years (2-12 years). A total of 10 (6.2%) and 11 (6.8%) patients died during hospitalization and during followup, respectively. Thirty-one (19.3%) patients experienced postoperative complications. The 1-, 3-, 5-, and 10-year survival rates were 99.3%, 98%, 93.8%, and 75.5%, respectively. There were no instances of recurrent aortic dissection, aortic aneurysm, or pseudoaneurysm during the entire study period.

The severity of aortic regurgitation dramatically decreased immediately after surgery (from 28.6% to 0% grade 3-4) and thereafter slightly increased (from 0% to 7.2% at 5 years and 9.1% at 10 years). Conclusion: This modified reinforced aortic root reconstruction was feasible, safe and durable/effective, as indicated by its low mortality, low postoperative complications and high survival rate.

1. MD, Shanghai Hospital, Second Military Medical University, Shanghai, People’s Republic of China. Conception and design; analysis and interpretation of data; drafting the manuscript; acquisition of data; critical revision of the manuscript for important intellectual content.

Correspondence address: Zhi-yun Xu Director of the Department of Cardiothoracic Surgery, Shanghai Hospital 168# Shanghai Rd, Shanghai (200433), People’s Republic of China E-mail: zhiyunx@hotmail.com

Descriptors: Aneurysm, dissecting. Aortic diseases/surgery. Aorta/surgery. Resumo Objetivo: Há um debate sobre a melhor abordagem para dissecção aguda da aorta tipo A (DAAA) envolvendo a raiz da aorta. Nós descrevemos abordagem aórtica reforçada modificada de reconstrução de raiz para o tratamento DAAA envolvendo a raiz da aorta. Métodos: Um total de 161 pacientes com DAAA envolvendo a raiz da aorta foram tratados pelo nosso abordagem reforçada modificada da reconstrução da raiz da aorta de janeiro de 1998 a dezembro de 2008. As características-chave da nossa

2. Shanghai Hospital, Second Military Medical University, Shanghai, People’s Republic of China. Analysis and interpretation of data; critical revision of the manuscript for important intellectual content.

This study was carried out at Shanghai Hospital, Second Military Medical University, Shanghai, People’s Republic of China.

3. Doctor, Department of Cardiothoracic Surgery, Shanghai Hospital, Shanghai, People’s Republic of China. Conception and design; analysis and interpretation of data; critical revision of the manuscript for important intellectual content; supervision.

Article received on October 12th, 2012 Article accepted on January 14th, 2013

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acompanhamento foi de 5,1 ± 2,96 anos (2-12 anos). Um total de 10 (6,2%) e 11 (6,8%) pacientes morreram durante a internação e durante o acompanhamento, respectivamente. Trinta e um (19,3%) pacientes apresentaram complicações pós-operatórias. A 1 -, 3 -, 5 -, e as taxas de sobrevivência de 10 anos foram 99,3%, 98%, 93,8% e 75,5%, respectivamente. Não houve casos de dissecção aórtica recorrente, aneurisma ou pseudoaneurisma da aorta durante o período de estudo. A gravidade da regurgitação aórtica diminuiu drasticamente logo após a cirurgia (de 28,6% para grau 0 de 3-4%) e, posteriormente, teve ligeiro aumento (de 0% a 7,2% em 5 anos e de 9,1% aos 10 anos). Conclusão: A reconstrução da raiz da aorta reforçada modificada é viável, segura e durável/eficaz, como indicado pelas baixas mortalidade e complicações pós-operatórias e taxa de sobrevivência elevada.

Abbreviations, Acronyms & Symbols AAAD BP CIs CT HR OR PASW SOV STJ

Acute type A aortic dissection Blood pressure Confidence intervals Computed tomographic scan Hazard ratios Odds ratios Predictive Analytics SoftWare Sinus of Valsalva Sinotubular junction

abordagem modificada foram a colocação de um remendo de pericárdio autólogo na falsa luz, forro do lúmen supravalvar com um anel vascular, poliéster e envolvimento dos vasos com tiras de teflon. A avaliação pós-operatória incluiu mortalidade, sobrevivência, complicações, e grau de insuficiência aórtica. Resultados: Um total de 161 pacientes foram incluídos no estudo (média de idade: 43,3 ± 15,5 anos). A duração média de

Descritores: Aneurisma dissecante. Doenças da aorta/ cirurgia. Aorta/cirurgia.

INTRODUCTION

and recurrent aortic dissection, development of aortic aneurysm or pseudoaneurysm, aortic insufficiency, and increased morbidity because of failure at the proximal aorta with the supracomissural replacement [1,16]. Based on the available evidence, none of these approaches appear to be associated with consistently better outcomes than the others [1]. Unsurprisingly, there is a lack of consensus as to the optimal surgical approach for the treatment of AAAD involving the aortic root. Herein, we describe a modified reinforced aortic root reconstruction approach for treating acute AAAD involving the aortic root and analyzed effects of various perioperative factors on survival, postoperative mortality and complications. The aim of this study is to investigate the feasibility, effectiveness and safety of this modified approach.

Acute type A aortic dissection (AAAD) is associated with a very high mortality rate (1%-2% per hour after the onset of symptoms) if left untreated, and up to 20% of patients die before receiving medical attention [1-3]. The current standard of care in the treatment of AAAD is emergency surgery, which is associated with an approximately 70% chance of survival, and high postoperative mortality and morbidity [1,2,4]. The primary aim of surgery in the treatment of AAAD is to prevent rupture of the dissection and subsequent hemorrhage. For patients with involvement of the aortic root, there are two conventional methods of surgical management. First, if the aortic root has evidence of aortic valve or aortic ring pathologies, or there is an existing aortic aneurysm, a valve sparing [5] or Bentall approach [6] may be used. Second, if the aforementioned pathologies are not apparent, ascending aortic replacement with traditional aortic root reconstruction (supracomissural replacement) may be performed [7,8]. Various modifications of aortic valve sparing approaches have also been described, including remodeling [9], Teflon remodeling [10], gluing dissected layers [11], and supracoronary replacement of the ascending aorta with root reconstruction [12]. Aortic valve-sparing can reduce short- and long-term complications associated with mechanical and biological replacement valves [13,14]. However, the conventional methods of management have limitations, including a long duration of surgery for both the valve sparing and Bentall approaches (a particular concern for patients requiring emergency surgery), the need for long term anticoagulation with the Bentall approach [15],

METHODS Patients All patients were treated from January 1998 to December 2008 at Shanghai Hospital, Second Military Medical University, P. R. China. Patients with AAAD affecting the aortic root (between the sinotubular junction and the aortic annulus) were eligible for the surgery, and thus inclusion in the study. Exclusion criteria were pathologies not suitable for aortic root reconstruction including aortic sinus aneurysm or aortic annulus dilatation; tears at the aortic root or in the coronary artery; coronary artery avulsion; moderate or severe aortic regurgitation caused by disorders other than dissection; and obvious aortic valve lesions. A total of 161 patients were included in the study and their demographic and clinical characteristics are summarized in Table 1.

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Table 1. Patient demographic and clinical characteristics (N = 161).

above the sinotubular junction (STJ), and thrombi and debris in the false lumen were removed. A valve gauge was used to measure the STJ endoluminal diameter, and an 8 mm polyester vascular ring (with an inner diameter 1 to 2 mm smaller than that of the STJ) was used to line the STJ lumen (i.e., the inner surface of the intima). The lower edge of the vascular ring was approximately 1 mm above the STJ plane. The vessel was wrapped (outside the adventitia) in Teflon felt strips for reinforcement. An autologous pericardial patch, which had already been trimmed to match the affected area, was then placed in the false lumen. Care was taken to avoid the coronary artery to ameliorate the risk of myocardial ischemia caused by coronary artery compression. Root reconstruction was completed by performing over-and-over suturing using 4-0 propylene. The stitch emerging from the aortic intima was in the same plane as that 2 mm above the STJ plane. A prosthetic Dacron graft was used to replace the ascending aorta. The Dacron graft within the lumen was not everted. After aortic root reconstruction, the reconstructed stump was anastomosed with the artificial vessel directly. There was rarely any difficult-to-control bleeding after the reconstruction; the fragile dissected vascular wall became very robust with firm suturing. If there was bleeding, U-shaped suturing using propylene with a patch was performed and satisfactory hemostasis was obtained. In the meantime, the systemic temperature was continuously being reduced until the rectal temperature measured approximately 22°C. Then the systemic circulation was stopped and antegrade brain perfusion was initiated after the following conditions were met: if the right subclavian artery was already cannulated, then the origin of the innominate artery would be clamped. At the same time, origin of the left common carotid artery would be cannulated with a 14F perfusion tube and origin of the left subclavian artery would be clamped. Subsequently, antegrade brain perfusion with 25°C perfusion fluid would be initiated at 10 ml/kg/min, and radial artery pressure would be maintained at approximately 50 mmHg; if the right subclavian artery was not cannulated (as described previously), the origin of the innominate artery would be cannulated with an 18F perfusion tube. At the same time, the origin of the left common carotid artery would be cannulated with a 14F perfusion tube and origin of the left subclavian artery was clamped. Subsequently, antegrade brain perfusion would be initiated with the parameters as described earlier. The distal procedure was completed under deep hypothermic circulatory arrest and antegrade cerebral perfusion. A different technique was used for the distal portion of the anastomosis. If the dissection was DeBakey type I, a stented elephant trunk implantation to the proximal end of descending aorta was performed and the distal reconstruction was completed using the suturing ring of the stented

Age, years Sex Male Female Smoking Hypertension Pericardial effusion Diabetes mellitus Cardiogenic shock Visceral malperfusion Neurological symptoms Creatinine > 2 mg/dL DeBakey type Type I Type II Time from symptom onset to surgery (days)

43.3 ± 15.5 (16-71) 131 (81.4) 30 (18.6) 40 (24.8) 106 (65.8) 20 (12.4) 16 (9.9) 14 (8.7) 10 (6.2) 8 (5.0) 5 (3.1) 142 (88.2) 19 (11.8) 3.5 ± 2.9 (1-14)

Data are summarized as mean ± standard deviation (range: minimum to maximum) for continuous variables or number (percentage) for categorical variables

The study was approved by the Ethics Committee of Shanghai Hospital, Second Military Medical University. Patients’ informed consent was waived due to the retrospective nature of the study. Surgical Technique The surgical technique was adapted from a previously described method [17]. A midline incision was performed to open the chest cavity, and catheters were placed to monitor central venous and pulmonary artery pressure. Invasive arterial blood pressure (BP) monitoring in the upper bilateral and lower limbs was also initiated via the subclavian and femoral arteries. Normally, the right subclavian artery was cannulated for arterial inflow. If the subclavian artery was too thin and unable to satisfy the inflow requirement, the femoral artery would be cannulated. If the subclavian artery had plaque or dissection, the femoral artery would be cannulated initially. The aorta was never directly cannulated. After the right atrium was cannulated, cardiopulmonary bypass was initiated with lowered systemic temperature (nasopharyngeal temperature of 30oC). The aortic arch and its branches were fully exposed during this period. The distal ascending aorta was clamped and the proximal aorta was incised. Subsequently, a cardioplegic solution was directly infused. After cardiac arrest, aortic root reconstruction was performed while systemic temperature continued to be lowered. Then, the aortic root was carefully explored to ensure that the criteria for aortic root reconstruction were met. The tissue surrounding the aortic root was carefully dissected to ensure that the integrity of the intima and the adventitia was maintained. The ascending aorta was transected 5 mm

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Han Q, et al. - Reinforced aortic root reconstruction for acute type A aortic dissection involving the aortic root

elephant trunk with the Teflon felts of the outermost layer (without placing an autologous pericardial patch in the false lumen). Then anastomosis with artificial vessels was then performed. If the dissection was DeBakey type II, Teflon felts were used on the inner and outer layers (again without placing autologous pericardial patch in the false lumen) to complete distal reconstruction before anastomosis with the artificial vessels. Representative intraoperative and postoperative followup images are shown in Figures 1 to 3.

Fig. 2 – A, B) The vascular lumen was lined with an artificial polyester vascular ring, and the false lumen was lined with an autologous pericardial patch, and a Teflon felt strip was wrapped around the vessel. Finally, 4-0 propylene suture was used to complete reconstruction. C) Reconstructed aortic root was anastomosed with the artificial vessel

Fig. 1 – A) Dissection involved posterior, right, and left coronary cusps of the aortic valve. Partial thrombus formation can be seen within the false lumen. B) Thrombus removed. No formation of aortic root aneurysm and expansion of aortic valvular ring were visualized. No dissection tear was seen at the aortic root, and the coronary arteries were uninvolved with good aortic valvular function

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Han Q, et al. - Reinforced aortic root reconstruction for acute type A aortic dissection involving the aortic root

with mortality and complications. These data are presented as odds ratios (OR) with 95% confidence intervals (95% CIs). Variables with P<0.2 in the univariate logistic regression analysis were entered into multivariate logistic regression analysis using backward selection. Cox regression analysis was performed to determine the relationship between survival time and demographic and clinical variables. These data are presented as hazard ratios (HR) with 95% CIs. All statistical assessments were two-tailed and the level of statistical significance was determined at P<0.05. Statistical analyses were performed using Predictive Analytics SoftWare (PASW) 18.0, a statistics software (SPSS Inc, Chicago, IL). RESULTS Patients were followed up with a mean time of 5.1 Âą 2.96 years (2-12 years). Details of surgical methods and perioperative data are presented in Table 2. A total of 21 patients died during hospitalization (n=10, 6.2%) or followup (n=11, 6.8%). Causes of death during hospitalization were gastrointestinal tract necrosis (n=3), gastrointestinal hemorrhage (n=2), sepsis (n=2), acute renal failure (n=1), pulmonary failure (n=1), and stroke (n=1). Causes of death during follow-up were stroke (n=2), ruptured abdominal aortic aneurysm (n=1), pneumonia (n=1), lung cancer (n=1), acute myocardial infarction (n=1), chronic renal failure (n=1), undefined accident (n=1), surgical repair of acute aortic dissection (n=1), car accident (n=1), and pancreatic cancer (n=1). Approximately 20% of patients (n=31) experienced postoperative complications, including acute renal failure (requiring bedside hemodialysis), stroke, poor pulmonary function requiring prolonged ventilatory support (> 72h), transient neurological deficits, mild paraplegia, and local infection. All patients recovered from these complications. Univariate regression analysis revealed that visceral malperfusion, creatinine concentration > 2 mg/dL, operation time, cardiopulmonary bypass time, aortic occlusion time, and deep hypothermic circulatory arrest time were associated with postoperative complications (all, P<0.05, Table 3). Subsequent multivariate regression analysis revealed that visceral malperfusion, operation time, and cardiopulmonary bypass time were associated with postoperative complications (all, P<0.05, Table 3). Univariate logistic regression analysis also revealed that age, visceral malperfusion, creatinine concentration > 2 mg/dL, operation time, cardiopulmonary bypass time, aortic occlusion time, and deep hypothermic circulatory arrest time were associated with mortality during hospitalization (all, P<0.05, Table 4). However, multivariate regression analysis did not reveal any association between the demographic and clinical variables with mortality during hospital stay.

Fig. 3 – CT angiography 1 year post-operatively showed that the morphology of the reconstructed aortic root appeared normal without sign of aneurysm or dissection recurrence

Follow-up All patients were followed up after discharge. Patients were contacted by a combination of outpatient and phone interviews. Physical examinations were performed to check for the development of heart murmurs. Echocardiography and contrast-enhanced computed tomographic (CT) scans were performed before discharge, 3 and 6 months after surgery, and annually thereafter to evaluate the degree of aortic valve function and cardiac function, observe whether any recurrent dissection, aneurysm, or pseudoaneurysm had developed, and measure the annulus, sinus of Valsalva (SOV), and STJ lumen diameter. Aortic regurgitation was classified as follows: 0 = none; 1 = trivial; 2 = mild; 3 = moderate; 4 = severe [12]. Outcomes Our measured outcomes included postoperative mortality, survival, complications, and the extent of aortic regurgitation after surgery. Statistical Analysis Demographic and clinical characteristics are presented as mean Âą standard deviation (range) for continuous variables and number (percentage) for categorical variables. Kaplan-Meier curves summarizing survival over time were constructed. Univariate and subsequent multivariate binary logistic regression analyses were performed to identify demographic and clinical variables associated

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Table 2. Surgical methods and perioperative details (N=161). Surgical methods Modified ARR + ascending aorta replacement 14 (8.7) 12 (7.4) Modified ARR + ascending aorta and semi-arch replacement 25 (15.5) Modified ARR + ascending aorta and total arch replacement Modified ARR + ascending aorta and total arch replacement + elephant trunk implantation 45 (28.0) Modified ARR + ascending aorta and total arch replacement + stented elephant trunk implantation 65 (40.3) Degree of aortic valve implication 161 (100.0) Posterior cusp 106 (65.8) Right cusp Left cusp 9 (5.6) Operation time, minutes 463.4 ± 129.5 (226-822) Cardiopulmonary bypass time, minutes 239.0 ± 63.0 (122-463) 149.4 ± 48.1 (56-287) Aortic occlusion time, minutes 49.3 ± 22.3 (17-118) Deep hypothermic circulatory arrest time, minutes 10 (6.2) Death during hospitalization 11 (6.8) Death during follow-up 31 (19.3) Complications 5.1 ± 2.9 (0-10) Survival, years ARR = aortic root reconstruction. Data are summarized as mean ± standard deviation (range: minimum to maximum) for continuous variables or number (percentage) for categorical variables Table 3. Associations between demographic and clinical variables and postoperative complications (N=161). Variable Age, years Gender (male vs. female) Smoking Hypertension Pericardial effusion Diabetes mellitus Cardiogenic shock Visceral malperfusion Neurological symptoms Creatinine > 2 mg/dL DeBakey type (type II vs. type I) Time from symptom onset to surgery, days Operation time, minutes Cardiopulmonary bypass time, minutes Aortic occlusion time, minutes Deep hypothermic circulatory arrest time, minutes

Univariate OR (95% CI) 1.01 (0.99-1.04) 3.98 (0.80-17.71) 1.31 (0.55-3.13) 1.11 (0.48-2.56) 1.47 (0.49-4.42) 0.96 (0.26-3.62) 1.16 (0.30-4.43) 22.26 (4.44-111.57) 0.59 (0.07-4.94) 19.11 (2.06-177.77) NA 1.04 (0.92-1.19) 1.01 (1.01-1.02) 1.03 (1.01-1.04) 1.03 (1.02-1.05) 1.03 (1.02-1.05)

P value 0.283 0.070 0.549 0.804 0.488 0.957 0.829 <0.001* 0.623 0.010* 0.513 <0.001* <0.001* <0.001* <0.001*

Multivariate OR (95% CI) P value

21.97 (2.31-208.66)

0.007*

1.008 (1.001-1.014) 1.020 (1.005-1.035)

0.028* 0.010*

Data are presented as odds ratios (OR) with 95% confidence intervals (95% CI). NA = not applicable because of limited numbers. Variables with P<0.05 as determined by univariate logistic regression analysis were entered into multivariate logistic regression analysis using a backward conditional method.* Indicates a significant association between the variable and mortality (P<0.05)

The mean duration of survival after surgery was 5.1 years (Table 2). A Kaplan-Meier curve showing cumulative survival during the study period is presented in Figure 4. Cox regression analysis revealed that none of the demographic or clinical variables were associated with survival (Table 4). Of note, the 10 patients who died during hospitalization were not included in this analysis. The 1-, 3-, 5-, and 10-year survival rates were 99.3%, 98.0%, 93.8%, and 75.5%, respectively. The severity of aortic regurgitation was dramatically de-

creased immediately after surgery, and thereafter increased only slightly (Figure 5). Preoperatively, 47.8% of patients had trivial to mild (grade 0 to 1) and 28.6% of patients had moderate to severe (grade 3 to 4) aortic regurgitation. At postoperative discharge, 89.4% patients (135 of 151) had no aortic regurgitation, and only 10.6% of patients (16 of 151) had trivial and mild aortic regurgitation. At 5 years after surgery, 29.9% of patients (29 of 97) had trivial to mild, and 7.2% of patients (7 of 97) had moderate to severe aortic re-

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gurgitation. At 10 years after surgery, 45.4% of patients (10 of 22) had trivial to mild, and 9.1% of patients (2 of 22) had moderate to severe aortic regurgitation.

Aortic annulus, sinus of Valsalva, and STJ size increased slightly over the 10 year follow-up period (Table 5). The mean aortic annulus size was 20.5 ± 1.2 mm at discharge, 21.3 ± 1.3 mm at 5 years, and 21.8 ± 1.3 mm at 10 years. The mean sinus of valsalva size was 30.9 ± 1.5 mm at discharge, 31.1 ± 1.6 mm at 5 years, and 32.1 ± 1.7 mm at 10 years. The mean STJ size was 27.2 ± 1.3 mm at discharge, 27.4 ± 1.4 mm at 5 years, and 28.2 ± 1.5 mm at 10 years.

Fig. 5 – The change in degree of aortic regurgitation after reinforced aortic root reconstruction for acute type A aortic dissection involving the aortic root. Data are presented as the mean level of aortic regurgitation

Fig. 4 – Kaplan-Meier curve showing cumulative survival of patients who received reinforced aortic root reconstruction for acute type A aortic dissection involving the aortic root

Table 4. Associations between demographic and clinical variables and mortality and survival during hospitalization (N=161). Variable Age, years Gender (male vs. female) Smoking Hypertension Pericardial effusion Diabetes mellitus Cardiogenic shock Visceral malperfusion Neurological symptoms Creatinine > 2 mg/dL DeBakey type (type II vs. type I) Time from symptom onset to surgery, days Operation time, minutes Cardiopulmonary bypass time, minutes Aortic occlusion time, minutes Deep hypothermic circulatory arrest time, minutes

Mortalitya OR (95% CI) 1.19 (1.07-1.32) NA 1.32 (0.33-5.37) 2.16 (0.44-10.56) 3.38 (0.80-14.31) 1.01 (0.12-8.51) 2.90 (0.55-15.20) 55.13 (11.04-275.35) NA 31.93 (4.57-222.88) NA 1.00 (0.80-1.25) 1.04 (1.02-1.06) 1.03 (1.02-1.05) 1.07 (1.03-1.11) 1.07 (1.03-1.11)

P value 0.001* 0.698 0.340 0.098 0.995 0.209 <0.001* <0.001* 0.997 0.001* <0.001* <0.001* <0.001*

Survivalb,c HR (95% CI) P value 1.02 (0.98-1.06) 0.296 0.38 (0.11-1.33) 0.129 1.28 (0.33-5.00) 0.721 1.88 (0.40-8.91) 0.424 2.28 (0.48-10.88) 0.300 1.06 (0.13-8.40) 0.954 0.04 (0-371.93) 0.494 0.05 (0-2.39×107) 0.766 2.80 (0.35-22.52) 0.334 0.05 (0-1.94×1013) 0.860 0.70 (0.09-5.56) 0.736 1.00 (0.81-1.22) 0.983 1.00 (0.99-1.01) 0.393 1.01 (0.99-1.02) 0.312 1.00 (0.99-1.02) 0.751 1.01 (0.98-1.04) 0.503

Data are presented as odds ratios (OR) with 95% confidence intervals (95% CI). Variables with P<0.2 determined by univariate logistic regression analysis were entered into multivariate logistic regression analysis using a backward conditional method. However, results were not presented since there were no statistically significant variables identified by the multivariate logistic regression analysis. NA: not applicable because of limited numbers. b Ten patients who died during hospitalization were excluded from this analysis. c Data are presented as hazard ratios (HR) with 95% confidence intervals (95% CIs) through Cox regression analysis. * Indicates a significant association between the variable and mortality (P<0.05) a

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197 (10.6%) 1 (0.7%) 0 (0%) 0 (0%)

(9.9%)

1

(0.7%)

0

(0%)

0

(0%)

(20.5%)

44

(27.3%)

39

(24.3%)

7

(4.3%)

(0%)

0

(0%)

0

(1.3%)

2

(10.6%)

16

(0%)

0

(0%)

0

(10%)

15

(24%)

36

(66%)

(0%)

0

(0.7%)

1

(10.8%)

16

(23%)

34

(65.5%)

97

0

(0%)

0

(1.6%)

2

(12.5%)

16

(23.4%)

30

(62.5%)

80

19

1

128

3 years

(0%)

0

(2.7%)

3

(11.7%)

13

(22.5%)

25

(63.1%)

70

17

0

111

4 years

(0%)

0

(7.2%)

7

(10.3%)

10

(19.6%)

19

(62.9%)

61

13

1

97

5 years

(0%)

0

(6.6%)

5

(10.5%)

8

(22.4%)

17

(60.5%)

46

19

2

76

6 years

(0%)

0

(7.9%)

5

(9.5%)

6

(23.8%)

15

(58.7%)

37

13

0

63

7 years

(0%)

0

(8.5%)

4

(10.6%)

5

(27.7%)

13

(53.2%)

25

15

1

47

8 years

(0%)

0

(8.3%)

3

(8.3%)

3

(30.6%)

11

(52.8%)

19

11

0

36

9 years

(0%)

0

(9.1%)

2

(13.6%)

3

(31.8%)

7

(45.5%)

10

13

1

22

10 years

ND

30.9 ± 1.5 30.9 ± 1.5 30.9 ± 1.5 30.9 ± 1.5 30.9 ± 1.5 30.9 ± 1.5 31.0 ± 1.5 31.1 ± 1.6 31.1 ± 1.6 31.3 ± 1.5 31.5 ± 1.6 31.6 ± 1.6 32.1 ± 1.7

16

15

33

(88.1%)

99

0

2

148

2 years

Sinus of Valsalva, mm

(88.7%)

(89.4%)

(23.6%)

133

0

1

150

1 year

20.5 ± 1.2 20.5 ± 1.2 20.6 ± 1.2 20.9 ± 1.4 21.1 ± 1.3 21.0 ± 1.3 21.1 ± 1.3 21.3 ± 1.3 21.3 ± 1.2 21.3 ± 1.2 21.4 ± 1.3 21.4 ± 1.2 21.8 ± 1.3

134

0

0

0

151

6 month

Aortic annulus, mm 20.8 ± 1.5

Severe

Moderate

Mild

Trivial

None

0

10

135

0

Censored patients, n

151

151

3 month

38

0

Patients who died, n

Aortic regurgitation

161

Follow-up, n

Preoperation Discharge

Years of post-operation

Table 5. Table shows slightly increase of aortic annulus, sinus of Valsalva, and sinotubular junction over the 10 year follow-up period.

Han Q, et al. - Reinforced aortic root reconstruction for acute type A aortic dissection involving the aortic root Rev Bras Cir Cardiovasc 2013;28(2):190-9

Rev Bras Cir Cardiovasc 2013;28(2):190-9

Han Q, et al. - Reinforced aortic root reconstruction for acute type A aortic dissection involving the aortic root

into the false lumen. The placement of an autologous pericardial patch in the false lumen reinforces the vessel wall, helping to prevent aneurysm formation and blocking the suture pinholes. Preventing blood from entering the false lumen obviates the risk of blood exudation into the extravascular space or formation of pseudoaneurysm under the adventitia. If the aortic valve has no apparent lesions, the main mechanism of aortic regurgitation associated with AAAD is STJ avulsion and the loss of traction on the valve leaflets. In such cases, the main goal of root construction should be reconstruction of the STJ. With the approach described herein, the main function of the artificial vascular ring is restoration of the normal anatomical morphology of the STJ. This is the most critical step for the long-term maintenance of aortic valvular function. The vascular ring should be a complete ring (to resist longterm vascular dilation) and smaller than the lumen diameter to help facilitate inward contraction. In addition to inserting a vascular ring and pericardial patch, we also reinforced the vessel by wrapping the vessel (outside the adventitia) with Teflon felt strips. Thus the previous 3-layered vessel was modified to a 5-layered vessel. This reinforcement of the aortic root allows for better control of aortic root diameter, maintenance of optimal aortic root shape, and, therefore, maintenance of aortic valvular function. We found that the extent of aortic regurgitation was dramatically improved after surgery and thereafter slightly increased with time. This slight increase with time may reflect the natural increase in aortic regurgitation that occurs with aging and/or indicate that aortic regurgitation was not completely resolved with surgery. Our study is limited in that it was a retrospective study without any comparison group. Although our mortality and survival results compare favorably with those in the literature, a more direct comparison of our surgical approach with alternative surgical approaches is warranted. In summary, we have described a modified surgical technique for the treatment of AAAD with aortic root involvement. We suggest that that this approach is feasible, can be mastered relatively quickly, and according to our results is safe and has acceptable durability as indicated by relatively low mortality and high survival.

DISCUSSION For a technique to be considered successful in cardiac surgery, it should have low operative mortality, excellent durability/effectiveness, and should be easily adoptable by surgeons. We reported the feasibility, safety, and long-term reliability of a novel surgical approach for the treatment of AAAD with aortic root involvement. Key features of our approach include the placement of an autologous pericardial patch in the false lumen, lining of the STJ lumen with a polyester vascular ring, and wrapping the vessel with Teflon strips for reinforcement. We found this approach to be safe and durable/effective, as indicated by low rates of in-hospital/follow-up mortality and postoperative complications. Our long-term survival rate compares favorably with those reported in previous studies after aortic root reconstruction with valve sparing, in which the 10-year survival rates were found to be 57% [12] and 70% [18]. Notably, we did not find that any preoperative factors were associated with survival, indicating that our procedure may be applicable for most patients who meet the specified criteria. Our in-hospital mortality rate (6.2%) and follow-up mortality rate (6.8%) also compares favorably to that associated with supracommissural replacement, which typically ranges from 20% to 30% [1]. Our mortality rates are also lower than those reported for aortic-valve sparing surgery [12,18-21]. Approximately 20% of patients experienced postoperative complications, and around 6% of patients died from postoperative complications, most commonly gastrointestinal tract necrosis and sepsis. Unsurprisingly, postoperative complications were found to be significantly associated with visceral malperfusion, operation time, and cardiopulmonary bypass time. Importantly, none of our patients experienced postoperative recurrent aortic dissection, aortic aneurysm, or pseudoaneurysm, all of which are known complications of supracomissural replacement of the ascending aorta and aortic valve [1,16]. We suggest that the aforementioned complications are a consequence of intimal and adventitial fragility. With our modified method of reinforced aortic root reconstruction, Teflon felt is placed in the false lumen only, and the suture needle is passed through the intima and the adventitia, leaving small pinholes. Under pressure, blood may penetrate into the false lumen through these pinholes, leading to increased pressure in the false lumen and recurrent dissection. If dissection does not occur, blood in the false lumen may be absorbed, resulting vascular wall weakness and an increased risk of aortic aneurysm. Blood within the false lumen may also seep into the extravascular space or form a pseudoaneurysm under the adventitia. Our surgical approach directly addresses the potential leakage of blood through the suture pinholes via the placement of an artificial polyester vascular ring in the lumen. This vascular ring compresses and blocks the suture pinholes, thus preventing the blood from seeping

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7. von Segesser LK, Lorenzetti E, Lachat M, Niederhäuser U, Schönbeck M, Vogt PR, et al. Aortic valve preservation in acute type A dissection: is it sound? J Thorac Cardiovasc Surg. 1996;111(2):381-90.

16. Ergin MA, McCullough J, Galla JD, Lansman SL, Griepp RB. Radical replacement of the aortic root in acute type A dissection: indications and outcome. Eur J Cardiothorac Surg. 1996;10(10):840-4.

8. Kouchoukos NT, Wareing TH, Murphy SF, Perrillo JB. Sixteenyear experience with aortic root replacement. Results of 172 operations. Ann Surg. 1991;214(3):308-18.

17. Kaiser LR, Kron IL, Spray TL. Aortic dissection. Mastery of cardiothoracic surgery. Philadelphia: Lippincott Williams & Wilkins; 2006.

9. Yacoub MH, Gehle P, Chandrasekaran V, Birks EJ, Child A, Radley-Smith R. Late results of a valve-preserving operation in patients with aneurysms of the ascending aorta and root. J Thorac Cardiovasc Surg. 1998;115(5):1080-90.

18. Shrestha M, Baraki H, Maeding I, Fitzner S, Sarikouch S, Khaladj N, et al. Long-term results after aortic valve-sparing operation (David I). Eur J Cardiothorac Surg. 2012;41(1):56-61. 19. Leyh RG, Fischer S, Kallenbach K, Kofidis T, Pethig K, Harringer W, et al. High failure rate after valve-sparing aortic root replacement using the “remodeling technique” in acute type A aortic dissection. Circulation. 2002;106(12 Suppl 1):I229-33.

10. Collins JJ Jr, Cohn LH. Reconstruction of the aortic valve. Correcting valve incompetence due to acute dissecting aneurysm. Arch Surg. 1973;106(1):35-7. 11. Guilmet D, Bachet J, Goudot B, Laurian C, Gigou F, Bical O, et al. Use of biological glue in acute aortic dissection. Preliminary clinical results with a new surgical technique. J Thorac Cardiovasc Surg. 1979;77(4):516-21.

20. Kallenbach K, Oelze T, Salcher R, Hagl C, Karck M, Leyh RG, et al. Evolving strategies for treatment of acute aortic dissection type A. Circulation. 2004;110(11 Suppl 1):II243-9. 21. Niederhäuser U, Künzli A, Seifert B, Schmidli J, Lachat M, Zünd G, et al. Conservative treatment of the aortic root in acute type A dissection. Eur J Cardiothorac Surg. 1999;15(5):557-63.

12. Piccardo A, Regesta T, Pansini S, Dell’Aquila AM, Concistrè G, Martinelli L, et al. Fate of the aortic valve after root reconstruction in type A aortic dissection: a 20-year follow up. J Heart Valve

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Gib MC, et al.ORIGINAL - Mediastinitis: mortality rate comparing single-stage surgical ARTICLE approach and preconditioning of wound

Mediastinitis: mortality rate comparing single-stage surgical approach and preconditioning of wound Mediastinite: mortalidade comparando abordagem cirúrgica em tempo único e o pré-condicionamento da ferida operatória

Marcelo Curcio Gib1, Juglans Souto Alvarez2, Orlando Carlos Belmonte Wender3

DOI: 10.5935/1678-9741.20130029

RBCCV 44205-1458

Abstract Objective: This study aims to compare hospital mortality rate of surgical debridement followed by primary wound closure versus surgical debridement with closure after preconditioning of the wound. Methods: A historical cohort of 43 patients with postoperative mediastinitis type III and IV between 2000 and 2008. The diagnosis of mediastinitis was based on physical examination and laboratory tests. Patients were divided into two groups: patients who received the protocol of preconditioning of the wound (Group 2) and those who did not (Group 1). Results: Of the 43 patients, 15 received the protocol and were assigned to Group 2, and 28 patients to Group 1. Coronary artery bypass grafting was the surgical intervention most affected by infection, accounting for 69.8% of patients in Group 1 and 64.3% in Group 2. Staphylococcus aureus was the predominant pathogen, accounting for 58.1% of all cases, 50% in Group 1 and 73.3% in Group 2. Hospital mortality rate was 42.9% in Group 1 and 20% in Group 2 (P=1.86), with relative risk of 2.14 and CI [0.714-6.043]. Among the 28 (65.1%) patients who underwent single-stage surgical approach, 12 (27.9%) underwent primary wound closure with irrigation, seven (16.3%) only primary closure, six (14%) omental flap, and three (7%) pectoralis muscle flap. Conclusion: Due to the lack of established guidelines, the choice of the surgical approach is based largely on low-level evidence references. Preconditioning of the wound appears to

lead to a reduction in mortality in these patients, being a good surgical option.

1. Master's Degree; Cardiovascular surgeon at Cardiovascular Surgery Department of the Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil. 2. Cardiovascular surgeon at Cardiovascular Surgery Department of the Hospital de Clínicas of Porto Alegre, UFRGS, Porto Alegre, RS, Brazil. 3. PhD, Professor at Faculty of Medicine, UFRGS, Porto Alegre, RS, Brazil.

Correspondence address: Marcelo Curcio Gib Travessa Pedra Redonda, 450 – casa 9 – Porto Alegre, RS, Brazil Zip code: 91760-630. E-mail: mcgib@terra.com.br

Descriptors: Mediastinitis. Mortality. Infection. Surgical wound infection. Resumo Objetivo: Este estudo tem por objetivo comparar a taxa de mortalidade intra-hospitalar do debridamento cirúrgico seguido de fechamento da ferida operatória, com a do debridamento cirúrgico com fechamento após pré-condicionamento da ferida. Métodos: Coorte histórica composta por 43 pacientes portadores de mediastinite pós-operatória tipo III e IV entre os anos de 2000 e 2008. O diagnóstico de mediastinite foi feito com base em exames físico e laboratoriais. Os pacientes foram divididos em dois grupos, os que seguiram o protocolo de pré-condicionamento da ferida operatória (Grupo 2) ou não (Grupo 1). Resultados: Dos 43 pacientes, 15 seguiram o protocolo e foram alocados no Grupo 2. A revascularização do miocárdio foi a cirurgia mais afetada pela infecção, sendo responsável por 69,8% dos pacientes no Grupo 1 e 64,3% no Grupo 2. O Staphylococcus aureus foi o germe mais prevalente, sendo responsável por 58,1% do total dos casos, sendo 50% e 73,3%, respectivamente, nos Grupos 1 e 2. A mortalidade intrahospitalar foi de 42,9% no Grupo 1 e de 20% no Grupo 2

Financial support: FAPERGS e CAPES

This study was carried out at Cardiovascular Surgery Department of the Hospital de Clinicas de Porto Alegre UFRGS - Graduate Program in Medicine: Surgery, Porto Alegre, RS, Brazil.

Article received on November 17th, 2012 Article accepted on January 28th, 2013

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fechamento primário com irrigação, sete (16,3%), a fechamento primário isolado, seis (14%), rotação de retalho de epíplon, e três (7%), interposição de retalho de músculo peitoral. Conclusão: Na ausência de uma diretriz bem estabelecida, a escolha do tipo de intervenção cirúrgica é feita utilizando-se referências com baixo nível de evidência. O pré-condicionamento da ferida operatória parece levar a redução da mortalidade nesses pacientes, sendo uma boa alternativa cirúrgica.

Abbreviations, Acronyms & Symbols CCIH ECC HCPA ICU PRBC PVPI

Commission on Hospital Infection Control Extracorporeal circulation Hospital de Clínicas de Porto Alegre Intensive care unit Packed red blood cells Polyvinylpyrrolidone-iodine

(P=1,86), com risco relativo de 2,14 e IC [0,714-6,043]. Entre os 28 (65,1%) pacientes do estudo que seguiram a abordagem cirúrgica em um único tempo, 12 (27,9%) foram submetidos a

Descritores: Mediastinite. Mortalidade. Infecção. Infecção da ferida operatória.

INTRODUCTION

reintervention(s). From 2007, we implemented the protocol of preconditioning of the wound for all patients. Data were abstracted from the patient’s medical records. The entire patient sample that showed mediastinitis during this period was identified through the Cardiovascular Surgery Division records in combination with those from the Commission on Hospital Infection Control (CCIH) of HCPA. Mediastinitis was defined as deep surgical wound infection with clinical and microbiologic evidence of compromised retrosternal space. During this period, 49 patients developed mediastinitis, an incidence of 1.55%. Of these, 43 patients met the classification criteria (El Oakley) [3] as type III or IV and were included in the study. The diagnosis of mediastinitis was based on physical examination and laboratory tests. Three diagnostic criteria were elected during initial evaluation: sternal instability; leukocytosis of more than 15,000; and wound secretion. All patients were assessed by members of the Cardiovascular Surgery Division at the moment of diagnosis. After the established diagnosis, the following data were collected from all patients: blood cultures, bedside culture of wound secretion, and culture of this same secretion during surgical procedure. After initial data collection, a double intravenous antibiotic regimen, 500 mg of vancomycin every 12 hours and 1000 mg of cefepime every 8 hours, was started until the identification of the pathogen, with subsequent adjustment of treatment according to antibiogram results. Patients were divided into two groups: • Group 1 – Composed of 28 patients who underwent single-stage surgical intervention without preconditioning of the wound, regardless of closure technique; • Group 2 – Composed of 15 patients who received the protocol of preconditioning of the wound.

Median sternotomy is the technical approach most used in the surgical treatment of cardiopathies. Mediastinitis is a severe complication leading to an increase in hospital costs, morbidity and mortality [1,2]. The treatment, however, has progressed with new antibiotics, along with technical and surgical care. Postoperative incidence of mediastinitis ranges from 0.5% to 5% [3-5]. However, mortality associated with such surgical complications, even after appropriate treatment, is extremely high, ranging between 14% and 47% [1,6,7]. Several studies have identified risk factors such as obesity, diabetes, reoperation, smoking, prolonged operative time, bilateral use of the internal thoracic artery, and postoperative bleeding [4,5,8,9]. Surgical management of postoperative mediastinitis counts on several techniques described in the literature [5,10-17]. Treatment may include single- or multiple-stage procedures, with or without the use of muscle or omental flap [11,12,18]. Therapeutic modalities encompass two options: preconditioning of the wound, leaving the wound open for a better cleaning and mediastinal drainage with dressings, or using one of the several closure techniques available. Singlestage closure shows a recurrence rate between 5%-50% in comparison to two-stage closure whose rate ranges from 2%30% [19,20], however the long term exposure of the mediastinum enhances the morbidity. The present study aims to compare inpatient mortality rate from surgical debridement followed by primary wound closure with that from surgical debridement with closure after preconditioning of the wound. METHODS

Protocol of wound preconditioning Radical subcutaneous and sternal edges debridement with complete removal of foreign materials (steel wires, skin and subcutaneous sutures, hemostatic foam). Pericardial cavity wash with 5 L of 0.9% saline solution and 0.5% polyvinylpyrrolidone-iodine (PVPI) solution. Compression dressings and

From January 2000 to December 2008, at Hospital de Clínicas of Porto Alegre (HCPA), southern Brazil, 3,166 cardiac surgeries were performed in adults using median sternotomy andcardiopulmonary bypass (CPB). A historical cohort of patients who had postoperative mediastinitis was followed up during hospital stay after the first surgery and

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clinical follow-up until improvement of the following parameters: fall in leukocyte blood count, negative blood cultures, end of fever peaks, and beginning of wound granulation. Dressing changes three times per day, or more, in the case of abundant secretion, which were performed by the HCPA nursing team specialized in complex dressings and scar care. Clinical assessment guided the surgical team in relation to the solution to be used: papain, if chemical debridement was needed, 0.5% PVPI, when with purulent aspect, or, if none of these situations was present, only saline solution was used. After clinical stabilization and improvement of wound conditions, the patient was then taken to the surgical block for definitive closure of sternotomy wound. For closure, we assessed criteria for viability of the sternal bone, mediastinum aspect, and subcutaneous granulation. Whenever necessary, a plastic reconstruction procedure was associated: pectoralis muscle or omental flap.

I, II and V were excluded from the study, as well as those patients with incomplete inpatient follow-up information in the medical records. The final sample comprised all cases that fulfilled the eligibility criteria for inclusion in the study. Fisher’s exact test and the chi-square test were used for statistical analysis. The level of significance was set at 5% and 95% confidence interval. Data were entered into a database converted into a 2007 Excel spreadsheet for Windows and subsequently exported and analyzed using the Statistical Package for the Social Sciences software, version 17.0. The results obtained were expressed as mean ± standard deviation for quantitative variables and frequency and percentage for categorical variables. RESULTS

Of the 43 patients with mediastinitis included in the study, 15 received the protocol of preconditioning of the wound (Group 2) and the remaining 28 patients composed Group 1. Both groups were matched for the preoperative variables assessed (Table 1). Classic risk factors for mediastinitis were homogeneously distributed between groups, the most relevant being diabetes, obesity and systemic hypertension.

Statistical analysis and ethical aspects The present study was approved by HCPA Graduate and Research Group and the Research Ethics Committee of this institution (Project 08-588 approved in 15/12/2008), as well as the use of medical records. Patients with mediastinitis type

Table 1. Demographic variables. n = 43

Group 1 (n=28)

Group 2 (n=15)

P

31 (72.1%) 12 (27.9%)

22 (78.6%) 6 (21.4%)

9 (60%) 6 (40%)

0.287

Age

62.45 ±10.99

64.71± 10.47

59.67 ± 11.54

Race White Black Mulatto BMI Smoking Diabetes Stroke COPD Immunosuppression HIV Re-do surgery Renal insufficiency Oral anticoagulation Previous AMI Dyslipidemia Hypertension PVD Ejection fraction (%)

41 (95.3%) 1 (2.3%) 1 (2.3%) 28.18 ± 3.72 17 (39.5%) 25 (58.1%) 4 (9.3%) 17 (39.5%) –– –– 3 (7%) 9 (20.9%) 3 (7%) 12 (27.9 %) 16 (37.2%) 40 (93%) 4 (9.3%) 53,71 ± 12,68

27 (96.4%) –– 1 (3.6%) 28.11 ± 3.65 12 (42.9%) 15 (53.6%) 2 (7.1%) 12 (42.9%) –– –– 2 (7.1%) 5 (17.9%) 2 (7.1%) 8 (28.6%) 8 (28.6%) 26 (92.9%) 2 (7.1%) 53.64 ± 13.35

14 (93.6%) 1 (6.7%) –– 28.33 ± 3.96 5 (33.3%) 10 (66.7%) 2 (13.3%) 5 (33.3%) –– –– 1 (6.7%) 4 (26.7%) 1 (6.7%) 4 (26.7%) 8 (53.3%) 14 (93.3%) 2 (13.3%) 53.87 ± 11.81

Gender Male Female

0.154 0.299 0.852 0.745 0.523 0.602 0.745 –– –– 1.0 0.696 1.0 1.0 0.185 1.0 0.602 0.957

BMI = body mass index; COPD = chronic obstructive pulmonary disease; HIV = human immunodeficiency virus; Previous AMI = previous acute myocardial infarction; PVD = peripheral vascular disease

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Coronary artery bypass surgery was the surgical intervention most affected by infection, accounting for 69.8% of patients in Group 1 and 64.3% in Group 2. The left internal thoracic artery was used in 94.7% of patients in Group 1 and 100% in Group 2. None of the patients underwent bilateral mammary grafting. In Group 1, 21.4% of patients were admitted to the intensive care unit (ICU) for some time before the first procedure, whereas in Group 2 the rate was 33.3% (Table 2). One patient in Group 1 needed intra-aortic balloon pump. In none of the groups reintervention was needed due to bleeding.

In 23 (53.5%) patients, blood-derived concentrates were necessary during the surgery of underlying pathology. Of these, 14 patients belonged to Group 1 and 9 to Group 2. Packed red blood cells were the blood component most used in both groups. However, Group 2 used a significantly greater number of transfused units than Group 1 (1.58±0.67 vs. 2.4±0.72). There were no statistical differences in the number of other blood component units transfused, as described in Table 3. Several pathogens were identified as causing mediastinitis (Table 4). Staphylococcus aureus was the predominant

Table 2. First procedure. LPHS (days) Admission via ER ER stay (days) ICU admission ICU stay (days) URG procedure Baseline surgery CABG AVR MVR MV repair Aortic dissection Others Combined approach Use of internal mammary artery n=31 No. of anastomoses CPB time Cross clamp time Procedure time Re-exploration for bleeding Intubation time IABP

n = 43 8.07 ± 11 11 (25.6%) 2.64 ± 1.69 –– 9.17 ± 5.38 3 (%)

Group 1 (n=28) 5.75 ± 6.61 6 (21.4%) 3 ± 2.1 –– 8 ± 6.93 2 (7.1%)

Group 2 (n=15) 12.4 ± 15.75 5 (33.3%) 2.20 ± 1.1 –– 10.33 ± 4.51 1 (6.7%)

30 (69.8%) 7 (16.3%) 3 (7%) 1 (2.3%) 1 (2.3%) 1 (2.3%)

18 (64.3%) 6 (21.4%) 2 (7.1%) 1 (3.6%) 1 (3.6%) ––

12 (80%) 1 (6.7%) 1 (6.7%) –– –– 1 (6.7%)

4 (9.3%) 30 (96.8%) 2.97 ± 0.85 85.44 ± 45.52 60.98 ± 37.06 247.91± 69.62 –– 23.19 ±43.47 1 (%)

3 (11.9%) 18 (94.7%) 2.83 ± 0.78 90.54 ± 51.33 64.64 ± 41.93 251.46 ± 81.32 –– 18.96 ± 16.14 1 (3.6%)

1 (6.7%) 12 (100%) 3.17 ± 0.94 75.93 ± 31.42 54.13 ± 25.53 241.27 ± 41.40 –– 31.07 ± 71.17 ––

P 0.137 0.473 0.464 –– 0.651 1.0

0.467

0.768 1.0 0.301 0.322 0.382 0.653 –– 0.526 1.0

AVR = aortic valve replacement; CABG = coronary artery bypass grafting; CPB = cardiopulmonary bypass; ER = emergency room; IABP = intra-aortic balloon pump; ICU = intensive care unit; LPHS = length of preoperative hospital stay; MV repair = mitral valve repair; MRV = mitral valve replacement; URG = urgent; Preop = preoperative; Reop = reoperation

Table 3. Use of blood components. Transfusion Type of BC PRBC Plasma Platelets Amount of BC PRBC Plasma Platelets

n = 34 23 (53.5%)

Group 1 14 (50.0%)

Group 2 9 (60.0%)

P 0.749

21 (48.8%) 5 (11.6%) 6 (14%)

12 (42.9%) 4 (14.3%) 5 (17.9%)

9 (60%) 1 (6.7%) 1 (6.7%)

0.347 0.643 0.403

1.95 ±0.80 2.40 ± 0.89 11.33 ±1.03

1.58 ± 0.67 2 11.20

2.4 ± 0.72 4 12

0.011 0.618 0.541

BC = blood components; PRBC = packed red blood cells

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pathogen, accounting for 58.1% of all cases, 50% in Group 1 and 73.3% in Group 2. Blood culture was positive in 79.1% of cases. Wound secretion collected during reintervention enabled to identify the causal agent in 74.4% of cases. In four patients (14.3%) in Group 1, none of the diagnostic means used in the study enabled to identify the pathogen. Among 28 (65.1%) study patients who underwent singlestage surgical approach, 12 (27.9%) received primary wound closure with irrigation, seven (16.3%) only primary closure, six (14%) omental flap, and three (7%) pectoralis muscle flap. Inpatient mortality rate was 42.9% in Group 1 and 20% in Group 2 (P=1.86), with relative risk of 2.14 and CI [0.7146.043], as described in Table 5. After definitive treatment, the need for new interventions was similar in both groups, 13 (46.4%) patients in Group 1 and 7 (46.7%) in Group 2.

Classic factors of surgical site infection such as trichotomy, infection in other sites, antibiotic prophylaxis, antisepsis, personal experience, and experience of medical and nursing team remain important. In our cohort, demographic variables as well as risk factors were homogenously distributed between both groups. Coronary artery bypass grafting using the internal thoracic artery remains the surgery most affected by mediastinitis. In none of the cases the bilateral use of the internal thoracic artery showed infection. The use of blood-derived concentrates is high, being used in more than half the patients who developed mediastinitis. Packed red blood cells (PRBC) were the most predominant blood component. The preconditioning group received a significantly higher amount of PRBC during baseline surgery. Erythrocyte transfusion causes immunomodulation, although its extension and deficiency type are variable [21]. Randomized clinical trials, assessing ICU inpatients, demonstrated that the use of non-leukocyte-reduced erythrocyte concentrates leads to multiple organ failure and death in up to 10% of patients, against 5% in those who used leukocyte-reduced erythrocyte concentrates [22]. This is the complication most often associated with blood transfusion and lung injury. Currently, risk of infection associated with PRBC transfusion is 1:2,000 for bacterial infection; 1:58,000-149,000

DISCUSSION

The incidence of postoperative mediastinitis after cardiac surgery is low [3-5]. However, mortality and morbidity rates during treatment are high [1,6,7]. Much has been done to identify and treat its risk factors, which are multiple and, when two or more factors occur concomitantly, its action seems to be enhanced [4,5,8]. When analyzed alone, there seems not to be a most important risk factor in its genesis.

Table 4. Pathogens. Pathogen S. aureus S. epidermidis S. aureus and epidermidis Klebsiella Pseudomonas aeruginosa Morganella Non-identified BC + Swab + Wound secretion +

n = 43

Group 1

Group 2

25 (58.1%) 5 (11.6%) 1 (2.3%) 3 (7%) 4 (9.3%) 1 (2.3%) 4 (9.3%) 34 (79.1%) 7 (16.3%) 32 (74.4%)

14 (50%) 3 (10.7%) 0 3 (10.7%) 3 (10.7%) 1 (3.6%) 4 (14.3%) 21 (75%) 3 (10.7%) 20 (71.4%)

11 (73.3%) 2 (13.3%) 1 (6.7%) 0 1 (6.7%) 0 0 13 (86.7%) 4 (26.7%) 12 (80%)

P

0.121

0.458 0.215 0.719

BC = blood culture; Swab = wound secretion collected before reintervention

Table 5. Management. Surg-reint time ATB time (days) Postop ICU time (days) Mortality Postop time (days) New interventions

n = 43 18.65 ±15.45 27.19 ±24.64 18.40 ±30.75 15 (34.9%) 32.40±41.50 20 (46.5%)

Group 1 16.75 ± 15.29 24.75 ± 25.44 14.25 ± 29.26 12 (42.9%) 26.67 ± 43.27 13 (46.4%)

Group 2 22.20 ± 15.64 31.73 ± 23.31 26.13 ± 32.99 3 (20%) 55.33 ± 27.79 7 (46.7%)

P 0.276 0.372 0.232 0.186 0.301 1.0

ATB = antibiotics; ICU = intensive care unit; Postop = postoperative; Surg-reint time = time between first surgery and reintervention for mediastinitis.

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for hepatitis B; and 1:872,000-1,700,000 for hepatitis C [23]. Analyzing these data, we may consider Group 2 as possibly more severe than Group 1. The attempt to identify a causal agent and a rapid surgical intervention accompanied by a comprehensive antibiotic coverage remains as the best treatment approach to mediastinitis. Staphylococcus aureus was the most frequent causal agent, leading to infections with rapid clinical course and more aggressive characteristics. Its elimination during the preoperative period should have top priority, in addition to strengthened care by the surgical team during the intraoperative period. Brazilian studies indicate Staphylococcus aureus as the most predominant causal agent in mediastinitis, whereas international reports demonstrate a predominance of Staphylococcus epidermis [9,10,24,25]. Using the preconditioning wound can reduce mortality by approximately 22% compared to the procedures of time only. This improvement in survival seems mainly related best clinical conditions of the patient and the wound at the time of final closure of the chest. Despite the clinical relevance motivating obtained statistical significance. However, most modern techniques for the treatment of mediastinitis and still not available in our country, such as vacuum therapy, is worth the preconditioning of the wound, which leads us to believe that this really is the best way to combat mediastinitis. A single approach that may be successfully applied to all mediastinitis cases remains unknown [3]. Several reports have failed to differentiate or classify the type of associated infection always using the same management approach. Acute infection that develops during the two first postoperative weeks have a disease mechanism different from that of chronic or recurrent infection, which may take months or even years to develop after baseline pathology repair surgery [3]. Management approach in these cases, therefore, is different. The lack of knowledge on these facts is likely to be the reason why there are so many conflicting reports in the literature regarding the best approach to poststernotomy mediastinitis. Mediastinitis type I, which was not included in this study, seems to respond well to debridement with primary resuture and use of irrigation. Wound debridement with two-stage closure using or not flaps is considered, for some authors, as the ideal treatment for chronic mediastinitis type V. Pairolero & Arnold [16] reported excellent results with the use of preconditioning of the wound and subsequent reconstruction with flaps. In that case series, 38 consecutive cases of mediastinitis type V were treated with no deaths during the first 30 postoperative days and five deaths during the mean study follow-up period of 24.8 months, none of them related to reconstruction or sepsis. Infection recurrence rate in those patients was 13.2%. Prolonged antibiotic therapy alone is associated with mortality and morbidity rates currently unacceptable, and its use

has been abandoned in early years [6]. An important advance in the treatment of mediastinitis occurred in 1963 when, for the first time, the use of continuous mediastinal irrigation with saline solution using routine chest drainage tubes after closure of the sternum was proposed [14]. Afterward, the addition of antibiotics in the irrigation was suggested, which was associated with an increase in bacterial resistance and fungal contamination, especially of the genus Candida [13]. As an alternative, then, the use of PVPI was started for continuous mediastinal cavity wash since it is a fungicidal and bactericidal solution associated with low toxicity. The use of primary resuture with or without mediastinal irrigation offers the advantage of a procedure that produces a closed wound with stable sternum, but studies have reported high therapy failure associated with a high mortality rate [20]. An approach often used in the presence of compromised sternal edges is the use of muscle and omental flaps. Lee et al. [11], in 1976, were the first to describe the use of omental flaps for filling the substernal dead space. The use of pectoralis muscle flap was described for the first time in 1980, but recent studies have reported conflicting results, and some authors still defend the use of flaps of rectus abdominus muscle as the technique of choice [12]. Reconstruction performed with the use of flaps, which aims at filling anterior mediastinal dead space and an increase in blood supply, has shown low mortality rates. Nevertheless, disadvantages associated with this method include an increase in surgical trauma, persistent pain in the flap, muscle weakness, and hernias [7]. Moreover, there are several series exhibiting poor long-term results with these techniques. Moreschi et al. [18] reported 81 consecutive mediastinitis cases treated with different modalities, early intervention with the use of flaps being a good treatment option with low mortality rates. Therapy failure in mediastinitis leading to infection recurrence aggravates significantly an already difficult situation, resulting in an even higher mortality rate [3,10]. In an attempt to reduce high recurrence and treatment failure rates associated with primary resuture, several alternatives and technical refinements have been suggested over the past decades. Among them, we point out plastic reconstruction procedures using pectoralis muscle or omental flap [11,12]. More recently, the use of vacuum has been introduced as an intermediate stage between first-approach surgical debridement and definitive wound closure, but this approach is yet to be commercially spread in our field [17,20]. Based on our experience, preconditioning of the wound seemed to be a good therapeutic option in severe patients who develop postoperative mediastinitis. Despite the difficulty in maintaining a patient with the chest open, it seems an important technical improvement, which enables a definitive closure of the cavity in better technical and, mainly, clinical conditions. Preconditioning requires a better integration of surgical, clinical, nursing, and physical therapy teams, in

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addition to technical care. Despite showing morbidity, routine dressing changes seem to reduce inpatient mortality. Although without statistical significance, the results herein obtained seem encouraging and in agreement with clinical findings. After the wound preconditioning period, patients were re-assessed and the definitive procedure was performed according to sternum conditions. In cases of viable bone, debridement of sternal edges was performed with resuture and use of irrigation. In cases of compromised bone, sternectomy was performed with filling of dead space. In cases in which the upper two thirds of the sternum were compromised, we used the rotation of the pectoralis major muscles; however, when the defect was in the lower third, omental flap was performed and, in some cases, both techniques were performed. However, the present study has some limitations. First, this was a retrospective study and this is not the best design to evaluate treatment. Due to small number of patients, the different techniques of late esternal closure could not be analyzed individually. Finally, the low annual incidence of this complication may cause small changes in the surgery process along the time.

4. Abboud CS, Wey SB, Baltar VT. Risk factors for mediastinitis after cardiac surgery. Ann Thorac Surg. 2004;77(2):676-83. 5. Eklund AM, Lyytikäinen O, Klemets P, Huotari K, Anttila VJ, Werkkala KA, et al. Mediastinitis after more than 10,000 cardiac surgical procedures. Ann Thorac Surg. 2006;82(5):1784-9. 6. Serry C, Bleck PC, Javid H, Hunter JA, Goldin MD, DeLaria GA, et al. Sternal wound complications. Management and results. J Thorac Cardiovasc Surg. 1980;80(6):861-7. 7. Milano CA, Kesler K, Archibald N, Sexton DJ, Jones RH. Mediastinitis after coronary artery bypass graft surgery. Risk factors and long-term survival. Circulation. 1995;92(8):2245-51. 8. Gummert JF, Barten MJ, Hans C, Kluge M, Doll N, Walther T, et al. Mediastinitis and cardiac surgery--an updated risk factor analysis in 10,373 consecutive adult patients. Thorac Cardiovasc Surg. 2002;50(2):87-91. 9. Ridderstolpe L, Gill H, Granfeldt H, Ahlfeldt H, Rutberg H. Superficial and deep sternal wound complications: incidence, risk factors and mortality. Eur J Cardiothorac Surg. 2001;20(6):1168-75. 10. Sjögren J, Malmsjö M, Gustafsson R, Ingemansson R. Poststernotomy mediastinitis: a review of conventional surgical treatments, vacuum-assisted closure therapy and presentation of the Lund University Hospital mediastinitis algorithm. Eur J Cardiothorac Surg. 2006;30(6):898-905.

CONCLUSION Due to the lack of established guidelines, the choice of the mediastinitis procedure is based largely on low-level evidence references. Our study encourages the search for an effective intervention, there seems to be a reduction in hospital mortality with preconditioning of the wound although this difference was not statistically significant. The preconditioning wound has been in our midst, a good alternative in the treatment of severe mediastinitis. Further studies involving greater standardization of case reports and patient randomization are warranted to better understand the interventions applied to this severe affection.

11. Lee AB Jr, Schimert G, Shaktin S, Seigel JH. Total excision of the sternum and thoracic pedicle transposition of the greater omentum; useful strategems in managing severe mediastinal infection following open heart surgery. Surgery. 1976;80(4):433-6. 12. Jurkiewicz MJ, Bostwick J 3rd, Hester TR, Bishop JB, Craver J. Infected median sternotomy wound. Successful treatment by muscle flaps. Ann Surg. 1980;191(6):738-44. 13. Sarr MG, Gott VL, Townsend TR. Mediastinal infection after cardiac surgery. Ann Thorac Surg. 1984;38(4):415-23. 14. Shumacker HB Jr, Mandelbaum I. Continuous antibiotic irrigation in the treatment of infection. Arch Surg. 1963;86:384-7.

REFERENCES

15. Jones G, Jurkiewicz MJ, Bostwick J, Wood R, Bried JT, Culbertson J, et al. Management of the infected median sternotomy wound with muscle flaps. The Emory 20-year experience. Ann Surg. 1997;225(6):766-76.

1. Loop FD, Lytle BW, Cosgrove DM, Mahfood S, McHenry MC, Goormastic M, et al. J. Maxwell Chamberlain memorial paper. Sternal wound complications after isolated coronary artery bypass grafting: early and late mortality, morbidity, and cost of care. Ann Thorac Surg. 1990;49(2):179-86.

16. Pairolero PC, Arnold PG. Management of recalcitrant median sternotomy wounds. J Thorac Cardiovasc Surg. 1984;88(3):357-64.

2. Nelson RM, Dries DJ. The economic implications of infection in cardiac surgery. Ann Thorac Surg. 1986;42(3):240-6.

17. Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997;38(6):563-76.

3. El Oakley RM, Wright JE. Postoperative mediastinitis: classification and management. Ann Thorac Surg. 1996;61(3):1030-6.

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18. Moreschi AH, Macedo Neto AV, Barbosa GV, Saueressig MG. Aggressive treatment using muscle flaps or omentopexy in infections of the sternum and anterior mediastinum following sternotomy. J Bras Pneumol. 2008;34(9):654-60.

Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg. 2007;83(5 Suppl):S27-86. 22. Bilgin YM, van de Watering LM, Eijsman L, Versteegh MI, Brand R, van Oers MH, et al. Double-blind, randomized controlled trial on the effect of leukocyte-depleted erythrocyte transfusions in cardiac valve surgery. Circulation. 2004;109(22):2755-60.

19. Berg HF, Brands WG, van Geldorp TR, Kluytmans-VandenBergh FQ, Kluytmans JA. Comparison between closed drainage techniques for the treatment of postoperative mediastinitis. Ann Thorac Surg. 2000;70(3):924-9.

23. Yomtovian R, Lazarus HM, Goodnough LT, Hirschler NV, Morrissey AM, Jacobs MR. A prospective microbiologic surveillance program to detect and prevent the transfusion of bacterially contaminated platelets. Transfusion. 1993;33(11):902-9.

20. Catarino PA, Chamberlain MH, Wright NC, Black E, Campbell K, Robson D, et al. High-pressure suction drainage via a polyurethane foam in the management of poststernotomy mediastinitis. Ann Thorac Surg. 2000;70(6):1891-5.

24. Arruda MV, Braile DM, Joaquim MR, Suzuki FA, Alves RH. The use of the vancomycin paste for sternal hemostasis and mediastinitis prophylaxis. Rev Bras Cir Cardiovasc. 2008;23(1):35-9.

21. Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Ferraris VA, Ferraris SP, Saha SP, Hessel EA 2nd, Haan CK, Royston BD, et al; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of

25. Souza VC, Freire ANM, Tavares-Neto J. Mediastinite pósesternotomia longitudinal para cirurgia cardíaca: 10 anos de análise. Rev Bras Cir Cardiovasc. 2002;17(3):266-70.

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Pontes JCDV,ORIGINAL et al. - InitialARTICLE and pioneer experience of transcatheter aortic valve implantation (Inovare) through femoral or iliac artery

Initial and pioneer experience of transcatheter aortic valve implantation (Inovare) through femoral or iliac artery Experiência inicial e pioneira do implante de valva aórtica transcateter (Inovare) por via femoral ou ilíaca

José Carlos Dorsa Vieira Pontes1, João Jackson Duarte2, Augusto Daige da Silva3, Neimar Gardenal4, Amaury Mont’Serrat Ávila Souza Dias2, Ricardo Adala Benfatti2, Guilherme Viotto Rodrigues da Silva5, Amanda Ferreira Carli Benfatti4

DOI: 10.5935/1678-9741.20130030

RBCCV 44205-1459

Abstract Objective: This paper demonstrates the initial and pioneering experience implant of the Inovare prosthesis implant through transfemoral or iliac artery route. Methods: Six patients underwent transcatheter aortic valve implantation. The access was femoral or iliac through which the delivery device, a latex balloon catheter with the crimped prosthesis, was inserted. Through the femoral introducer 24 Fr Gore ® DrySeal sheath, an extra stiff guide wire with non-traumatic tip was positioned in the left ventricle by passing through the valve ring. After balloon valvuloplasty, in cases of native valve stenosis, the prosthesis implantation was performed after hypotension induced by tachycardia and controlled by temporary pacemaker. The valve positioning was guided by TEE (transesophageal ecocardiography) and fluoroscopy, aiming to position a

third of the length of the prosthesis into the left ventricle cavity. Results: The successful valve implantation was possible in six cases. There was no need of conversion to open surgery due to inability to access or graft migration. There were no intraoperative or hospital deaths. We observed a significant reduction in the mean gradient of 66.84±15.46 mmHg to 19.74±10.61 mm Hg postoperatively (P=0.002), a reduction of 70.46%. Conclusion: Inovare prosthesis, implanted by femoral or iliac artery was feasible, and determined adequate hemodynamic performance in the postoperative follow-up, showing no mortality in this small series.

1. Ph.D., General Director of the University Hospital of the Federal University of Mato Grosso do Sul (UFMS), Campo Grande, MS, Brazil. 2. Cardiovascular Surgeon at UFMS University Hospital, Campo Grande, MS, Brazil. 3. Interventional Cardiologist at UFMS University Hospital, Campo Grande, MS, Brazil. 4. Cardiologist at UFMS University Hospital, Campo Grande, MS, Brazil. 5. Resident Physician in Cardiovascular Surgery at UFMS University Hospital, Campo Grande, MS, Brazil.

Work carried out at University Hospital of the Federal University of Mato Grosso do Sul Medical School, Campo Grande, MS, Brazil.

Descriptors: Heart valve diseases. Stents. Heart catheterization. Heart valve prosthesis implantation/methods. Aortic valve/surgery.

Correspondence Address: José Carlos Dorsa Vieira Pontes Universidade Federal de Mato Grosso do Sul – Hospital Universitário Av. Filinto Müller, s/n – Bairro Universitário – Campo Grande, MS, Brazil – Zip code: 79080-190. E-mail: carlosdorsa@uol.com.br Article received on November 17th, 2012 Article accepted on February 7th, 2013

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estenose valvar nativa, implante da prótese foi realizado após hipotensão induzida por taquicardia controlada por marcapasso temporário. O posicionamento da valva foi orientado por ecocardiograma transesofágico (ETE) e radioscopia, objetivando posicionar um terço da extensão da prótese para dentro da cavidade ventricular esquerda. Resultados: O implante valvar com sucesso foi possível nos 6 casos. Não houve necessidade de conversão para cirurgia convencional por impossibilidade de acesso ou migração da prótese. Não houve mortalidade intraoperatória ou hospitalar. Houve redução significativa do gradiente médio pré-operatório de 66,84±15,46 mmHg para 19,74±10,61 mmHg, no pósoperatório (P=0,002), significando redução de 70,46%. Conclusão: A prótese Inovare, implantada por via femoral ou ilíaca, foi factível do ponto de vista técnico, apresentando adequado desempenho hemodinâmico no seguimento pós-operatório e não apresentando mortalidade nesta pequena casuística.

Abbreviations, acronyms & symbols ATM TEE NNT PARTNER PTFE STS TAVI

Atmosphere Transesophageal Echocardiography Number needed to treat Placement of Aortic Transcatheter Valves Polytetrafluorethylene Society of Thoracic Surgeons Transcatheter aortic valve implantation

Resumo Objetivo: O presente trabalho tem por objetivo demonstrar a experiência inicial e pioneira do implante da prótese Inovare pela via transfemoral ou ilíaca. Métodos: Seis pacientes foram submetidos ao implante valvar aórtico transcateter. A via de acesso foi femoral ou ilíaca, por onde foi inserido o dispositivo de entrega, que consiste em um cateter balão de látex com a prótese "crimpada" sobre o mesmo. Com auxílio de introdutor femoral da marca Gore® DrySeal 24 Fr, posicionava-se uma guia extrarrígida com a ponta atraumática no ventrículo esquerdo, passando-se pelo anel valvar. Após valvuloplastia com cateter balão nos casos de

Descritores: Doenças das valvas cardíacas. Stents. Cateterismo cardíaco. Implante de prótese de valva cardíaca/ métodos. Valva aórtica/cirurgia.

INTRODUCTION

described the first human implant, an extremely severe case with satisfactory immediate results. There was significant reduction in the transvalvular gradient and improvement of the ejection fraction as well as of the cardiogenic shock condition. PARTNER (Placement of Aortic Transcatheter) [14], the first randomized trial, showed the superiority of the transcatheter aortic valve implantation over therapeutic treatment when conventional surgical treatment was contraindicated because of both mortality rates and quality of life. Most cases of transcatheter aortic valve implantation are linked to the Edwards prosthesis – Sapien e a Corevalve (Medtronic). In our country, Gaia et al. [15] described the results of using Inovare (Braile Biomédica), a national prosthesis, for a transapical aortic valve implantation. The present study sets out to demonstrate the initial and pioneering experience of the Inovare prosthesis implant through the transfemoral artery, carried out at the University Hospital of the Federal University of Mato Grosso do Sul Medical School.

Degenerative calcification of normal or congenital bicuspid aortic valve is the leading cause of aortic valve stenosis in adults in developed countries [1-3]. Prevalence of severe aortic stenosis increases with age and may affect up to 2% of individuals over 65 years of age [4]. The onset of symptoms constitutes poor prognosis and survival after that is as low as 60% in 1 year and 32% in 5 years [5]. Death in patients with heart failure usually occurs 2 years after the onset of symptoms, and after 3 and 5 years for patients with syncope and angina, respectively [6]. In such cases, surgical intervention alters the natural course of the disease, since surgical mortality, at about 4%, is considered low [7]. However, 33% of patients who are candidates for surgical treatment are not accepted to undergo the procedure, especially due to advanced age and ventricular dysfunction [8]. Other conditions, such as associated comorbidities, previous cardiac surgeries, aortic atheromatosis, and biological fragility, also contribute to a higher surgical risk. These limitations have led to a search for alternatives to the conventional valve replacement for such high risk patients. In 1986, Cribier et al. [9] suggested balloon aortic valvuloplasty, which was deemed unsatisfactory due to an annual mortality of 65%. In addition, one year after the procedure, only 40% of the patients were free of reintervention, surgical aortic valve replacement, atrioventricular block, and death [10]. The first description of a catheter valve implantation was done by Davies [11] in 1965. Then, in 1992, Andersen et al. [12] described the experimental implant of a metal frame onto which cusps were mounted. Later, Cribier et al. [13]

METHODS Patient selection Between April and July 2012, in a prospective study, 6 patients underwent transcatheter aortic valve implantation, after the signing of a written informed consent form and approval by the Ethics Committee of the institution. They came from the valve clinic of the University Hospital of Mato Grosso do Sul, where they had been under clinical care for a few months. Although, all of them were candidates for aortic valve prosthesis implant, surgical intervention kept being postponed

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due to its high risk. STS score was used to determine surgical risk, with scores of 10% or higher representing high risk. Additionally, other criteria were considered: life expectancy greater than 1 year; biological fragility evaluation done by a multidisciplinary team, based on analysis of mobility, strength, ability to perform everyday activities, nutritional status and presence of any cognitive deficit; previous myocardial revascularization with patent grafts; and previous surgeries involving descending aorta. These criteria are described in Table 1. Contraindications to performing the procedure are described in Table 2. P a t i e n t s u n d e r w e n t c l i n i c a l , l a b o r a t o r y, a n d echocardiography examinations in addition to chest and abdomen angiotomography, which determined the aortic valve ring and iliac-femoral arterial system diameters. Cineangiocoronariography was performed to assess the coronary anatomy and the level of emergency of its ostia.

Prosthesis selection In every case, a bovine pericardial bioprosthesis mounted onto a balloon expandable transcatheter cobalt chromium frame (Braile Biomédica®, São José do Rio Preto, Brazil) was used. Bioprosthesis diameter ranged from 22mm to 28mm, according to the aortic valve ring or the inner diameter of the bioprosthesis dysfunction, considering 20% or higher as over size – Table 3. Valvular ring diameter was measured through preoperative transthoracic echocardiogram and confirmed by preoperative angiotomography (Figure 1) and transesophageal echocardiography (TEE) during the procedure (Figure 2). Intraoperative TEE The transesophageal probe was inserted after anesthetic induction and orotracheal intubation. The aortic valve was assessed in order to confirm the level of both insufficiency and valve stenosis. Mean and peak transvalvular gradients as well as estimates of the valvular area before and after the transcatheter valve implantation were recorded. During delivery and release of the device, TEE guided the positioning of the prosthesis in the native ring, the ideal position being the insertion of a third of the prosthesis inside the left ventricle outflow tract.

Table 1. Indication criteria for transcatheter aortic valve implantation. Surgical indications: • Symptomatic severe aortic valve stenosis • Dysfunction of aortic bioprosthesis with surgical indication • Life expectancy > 1 year

Table 3. Correlation between diameters of valvular ring and implanted prosthesis. Patient Disease Valvular ring (mm) Prosthesis (mm) 28 1 AS 26 2 AI Biop 22 24 24 3 AS 22 4 AI Biop 19 22 26 5 AS 24 6 AI Biop 19 22

Contraindications to open surgery: • STS score > 10% • Biological fragility evaluation performed by multidisciplinary team • Porcelain aorta • Previous revascularization with patent grafts • Previous cardiac surgery involving ascending aorta

AS = aortic stenosis; AI Biop = aortic insufficiency due bioprosthesis dysfunction; mm = millimeters

Table 2. Contraindication criteria for transcatheter aortic valve implantation. General Contraindications: • Aortic ring < 18mm or > 27mm • Incidence of thrombi in the left ventricle • Extensive calcification in front of the left coronary trunk • Need for myocardial revascularization and/or any other valve surgery • Low position of coronary ostia • STS score < 10% • Dynamic obstruction of the left ventricle outflow tract • Abdominal aortic aneurysms with thrombi • Significant aortic angulation • < 8mm iliac or femoral diameter and severe iliac tortuosity (contraindication for iliac-femoral access) Relative Contraindications • Bicuspid aortic valve • LV systolic function lower than 20%

Fig. 1 – Measurement of the valvular ring diameter (bioprosthesis)

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placed at aortic ring level. It was done after hypotension, with mean arterial pressure of 30mmHg, induced by increasing heart rate to approximately 180 beats per minute through artificial cardiac pacing with external pacemaker. The balloon catheter was placed inside the aortic valve ring and inflated with 2 ATM. Next, TEE was used to evaluate and verify both the decrease in aortic transvalvular gradient and the onset or increase of valve insufficiency. (Figure 4). Valve prosthesis implantation Implantation was performed after valvuloplasty with balloon catheter in patients with native valve stenosis and without valvuloplasty in patients with pre-existing bioprosthesis dysfunction. The implant was done after hypotension induced Fig. 2 – Measurement of the aortic ring through transesophageal echocardiography

Surgical technique Patients were under general anesthesia and mechanical ventilation after central venous catheterization and placement of temporary pacemaker electrode in the right ventricle. Patients were prepared and monitored as they would have been for a conventional cardiac surgery. Access and catheterization Access was previously determined based on the diameter of femoral and bilateral iliac arteries as well as diagnosis of calcifications, stenosis and tortuosity. Since the diameter needed for the sheath used in the Inovare prosthesis implantation is 24 Fr, femoral arteries with diameter of 8 mm or above without significant stenosis and tortuosity were deemed appropriate for access. If the diameter of the femoral artery was smaller than 8 mm, access was through common external iliac artery. Once access was determined, the artery which would receive the valve delivery device was dissected. Then, the contralateral femoral artery was punctured. The extra-stiff guide wire was inserted through both arteries, with the help of appropriate sheaths placed in the left ventricle, to prepare for both the valvuloplasty balloon catheter and the prosthesis delivery catheter. The right brachial artery was also punctured for cauterization with pigtail catheter, positioned in ascending aorta for the aortography. Valvuloplasty balloon catheter was placed in the ascending aorta under radioscopic guidance. The delivery device, a latex balloon catheter with the crimped prosthesis (Figure 3), was inserted in the femoral artery chosen through a femoral GoreÂŽ DrySeal 24 Fr sheath and placed in the ascending aorta under radioscopic guidance.

Fig. 3 – Transcatheter aortic valve mounted and crimped onto latex balloon

through tachycardia, which was controlled by a previously implanted temporary pacemaker. Mean arterial pressure was kept between 30 and 40 mmHg during release of the prosthesis. The positioning of the valve was guided by TEE and radioscopy so as to place one third of the length of the prosthesis inside the left ventricular cavity. Aortography was performed after the implant to assess for the incidence of regurgitation and the patency of the coronary ostia. In addition, ideal prosthetic positioning was confirmed by TEE. Successful intervention was confirmed through: decrease in transvalvular gradient; increase in valve area in case of stenosis; and improvement in the level of insufficiency in case of bioprosthesis dysfunction. The absence of considerable paraprosthetic regurgitation was also considered a measure of success. Hospital follow-up After the procedure, patients were taken to postoperative ward for intensive care. From the first postoperative on, patients received a dose of 40 mg/day of low molecular

Aortic valvuloplasty The procedure was performed in cases of valve stenosis affecting the native valve, after the positioning of a balloon

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weight heparin. Success was defined as correct implantation of the valve in the aortic ring, improvement in hemodynamic parameters previous to the echocardiogram, and absence of significant valve and perivalve leakage, in the absence of fatal complications. Evaluated outcomes were: mortality for any reason (30 days, global, and after discharge); major cardiovascular events; hospitalization due to either prosthesis dysfunction or clinical deterioration; functional class; stroke; vascular complication; renal failure, and major bleeding. Stroke and acute myocardial infarction were determined in accordance with the Valve Academic Research Consortium [16].

Statistical Analysis Statistical analysis was performed using BioStat version 5.3.5. Confidence level of 0.05 was used as significant. RESULTS Six patients underwent transcatheter aortic valve implantation, 4 male and 2 female. Patients’ average age was 65.83 + 20.18 years old. Procedures were performed at the University Hospital of the Federal University of Mato Grosso do Sul, in a hybrid operating room. Four patients (66.6%) were candidates due to valve stenosis. One of them had early stenosis of aortic valve bioprosthesis implanted a year before. The other 2 patients (33.3%) were candidates due to insufficiency of previously implanted bioprosthesis. Mean STS score for mortality of these patients was 12.09 + 1.28%. Table 4 shows the valvular diseases treated, STS score for each patient, and preoperative echocardiographic parameters. Successful valve implantation was possible in six cases. In 4 patients, the implants were performed through the transfemoral artery; in 2, through the external iliac artery, since the femoral arteries were smaller than 7mm in diameter. There was no need of conversion to open surgery due to access limitation or graft migration. There were no intraoperative or hospital deaths. The sizes of the devices used were: two 22mm, two 24mm, one 26mm, and one 28mm. In the valve-in-valve cases, two 22mm and one 24mm devices were used. Hemodynamics as assessed through echocardiography was satisfactory. In patients with native aortic valve or bioprosthesis stenosis, there was a significant decrease in the mean gradient, from 66.84 ± 15.46 mmHg to 19.74 ±10.61 mmHg, in the postoperative (P=0.002), resulting in a reduction of 70.46%. Figure 5 shows pre and postoperative mean transvalvular gradient. Figure 6 shows pre and postoperative echocardiographic measurements of the transcatheter aortic valve prosthesis. Subsequent examinations confirmed gradient decrease (Table 5). Patients with bioprosthesis insufficiency showed discrete increase in the mean transvalvular gradient, no stenosis with consequence to hemodynamics, and significant

Fig. 4 – Transesophageal echocardiography showing an increase in aortic insufficiency after a balloon valvuloplasty

Echocardiographic parameters Patients were evaluated for echocardiographic parameters right after the procedure, then at days 7 and 30. Evaluated parameters were: left ventricular systolic and diastolic diameters, left ventricular systolic function, mean and peak aortic transvalvular gradients, aortic valve area, and incidence of aortic valvular and paravalvular regurgitation.

Table 4. Aortic valvular disease, STS scores and preoperative echocardiographic parameters. Patient 1 2 3 4 5 6

Disease AS AI Biop AS AI Biop AS AI Biop

STS score (%) 12 13 11.82 14 11.43 10.3

Mean Gd (mmHg) 47 9 81 9 77 62.39

LVEF (%) 25 40 50 50 41 70

LVDD (mm) 71 60 63 60 71 41

LVSD (mm) 51 52 46 43 56 25

AS = aortic stenosis; AI Biop = aortic insufficiency due bioprosthesis dysfunction; mean Gd = mean gradient; LVEF = left ventricular ejection fraction; LVDD = left ventricular diastolic diameter; LVSD = left ventricular systolic diameter; mm = millimeters; mmHg = millimeters of mercury

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improvement in the left ventricular systolic function (Figure 7). Generally, preoperative mean ejection fraction for all patients was 46.66 ± 15.2%, increasing to 61.16 ± 12.25% in the postoperative, an increase of 31.11% (P=0.0001). There was incidence of discrete paravalvular insufficiency in every patient who underwent intervention in native aortic valve whereas there was no residual regurgitation after intervention in bioprosthesis. There was no need to implant more than one valve in the same patient. Figure 8 shows angiographic aspect after a successful implantation, with positioning of the prosthesis and patency of coronary ostia.

polytetrafluorethylene (PTFE) graft. Furthermore, there was a case of hematuria after vesical probing in a patient with prostatic hyperplasia, which was treated with non-surgical methods and solved spontaneously. There was no incidence of atrioventricular blocks needing definitive pacemaker implant. Thrombocytopenia was observed in 5 patients (83.3%), with a mean of 40000 platelets and minimum of 18000 platelets postoperative, with spontaneous recovery during hospitalization. The cause was not identified. One of the patients suffered exacerbated chronic renal failure, treated non-surgically and without need for hemodialysis. The same patient also had pneumonia, which was successfully treated with conventional antibiotic therapy. Average hospitalization period was 7 days. One patient had to be re-hospitalized 4 days after being discharged because of pulmonary congestion caused by pre-existing left ventricular systolic dysfunction (left ventricular ejection fraction=28%), unrelated to the implanted prosthesis. The patient was hospitalized for 4 days for optimal dosage of diuretics and vasodilators and was discharged with improvement. In the present series, neither myocardial infarction nor strokes were observed.

Complications The most serious vascular complication was rupture of the right iliac artery in one of the patients, with significant bleeding. It was solved by inflating a balloon catheter in abdominal aorta with interruption of the distal blood flow, followed by exploratory laparotomy and iliac-femoral anastomosis with

Fig. 5 – Average transvalvular gradient before and after the transcatheter aortic prosthesis implantation (Before, blue; after, red)

Fig. 6 – Echocardiographic representation of the transvalvular gradients (Before, blue; after, red)

Table 5. Pre and postoperative echocardiographic parameters after transcatheter aortic valve implantation. Patient 1 2 3 4 5 6

Disease AS AI Biop AS AI Biop AS AI Biop

Pre mean Gd (mmHg) 47 9 81 9 77 62.39

Post mean Gd (mmHg) Pre LVEF (%) Post LVEF (%) 13.8 25 43 22.3 40 50 19.61 50 64 18 50 73 10,85 41 64 34.7 70 73

P <0.05 <0.05 <0.05 <0.05 <0.05 <0.05

AS = aortic stenosis; AI Biop = aortic insufficiency due bioprosthesis dysfunction; mean Gd = mean gradient; LVEF = left ventricular ejection fraction; LVDD = left ventricular diastolic diameter; LVSD = left ventricular systolic diameter; mm = millimeters; mmHg = millimeters of mercury

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Fig. 7 – Transcatheter aortic valve implantation pre and postoperative left ventricular ejection fraction

Fig. 8 – Angiographic aspect after transcatheter valve prosthesis implantation

DISCUSSION Since 1960, aortic valve replacement has been the only treatment option for severe aortic valve stenosis, increasing patient’s survival rate, regardless of age, and estimated 4% mortality [17]. As previously stated, approximately one third of patients with severe aortic stenosis are ineligible for conventional surgical treatment due to high surgical risk [8]. Drug treatment for these patients leads to a survival rate of 60% in 1 year and 32% in 5 years [5]. Transcatheter aortic valve implantation is a therapeutic option for critically ill patients and it has shown great results. After 1 year of follow-ups, it has demonstrated non-inferiority in relation to conventional aortic valve replacement in addition to a 20% reduction in absolute mortality compared to clinical treatment of inoperable patients, with NNT=5 [14]. In the present study, access was transarterial, femoral, or iliac. Several studies have shown higher mortality in cases of transapical intervention than in transfemoral access cases [1821]. These results stem from higher severity in patients selected for the transapical intervention as well as a steeper learning curve for this kind of approach. However, it is believed that handling of the heart can lead to greater hemodynamic instability and bleeding. Additionally, respiratory dynamics can be impaired by the opening of the pleural cavity and result in worsening of postoperative respiratory function, especially in patients suffering from chronic obstructive pulmonary disease, since this comorbidity acts as an independent predictor of survival [19]. Besides demonstrating higher hospital mortality rates (13.9% versus 8.5%), a French multicenter study [22] showed greater incidence of significant bleeding (3.4% versus 1.5%) and longer hospitalization (13.3±7.8 days versus 10.5±8.1 days) in patients treated via transapical access as opposed to those treated via transfemoral access. In this initial series, the most serious complication was rupture of the right iliac artery with intraoperative bleeding,

solved by inflating a balloon catheter in abdominal aorta to interrupt blood flow, followed by right iliac-femoral anastomosis with PTFE graft. Main registries worldwide describe a higher incidence of vascular complications with transfemoral access [19,21,22]. However, the development and evolution of materials such as sheaths and prosthesis could make access through arteries that are smaller in diameter possible, and consequently, lower the incidence of vascular complications. The approach through the external iliac artery has been used in our series as an alternative to the small caliber of femoral arteries. The Inovare prosthesis, currently designed for transapical access, has presented profile characteristics in addition to the ability to be crimped until the diameter needed for transplant through transfemoral access can be reached. It has good navigability through the aorta and appropriate echogenicity for the echocardiographic guidance of its positioning in the aortic ring. There were no occurrences of transvalvular regurgitation in this group of patients. While three patients (50%) had discrete paravalvular regurgitation, there was none in the valve-in-valve patients, similar to results described by Gaia et al. [15]. Recently, moderate and significant valvular regurgitation have been identified as independent risk factors for short and medium-term mortality after transcatheter aortic valve implantation [19,23]. The same can be observed in the long-term, with mortality being 21% in cases of moderate and significant regurgitation and 6% in cases of discrete or absent regurgitation [24]. In the present series, none of the patients developed total atrioventricular block or needed definitive

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pacemaker implant. Moreover, there was no hospital mortality. Despite this being a small sample, they were critically ill patients with mean STS score of 12.09 + 1.28%, results were deemed very satisfactory for an initial experience, taking into consideration hospital mortality of approximately 5% to 10%, as described by the following: Canadian registry, 10.4% [25]; SOURCE (SAPIEN Aortic Bioprosthesis European Outcome) registry, 8.5% [21]; FRANCE (French Aortic National CoreValve and Edwards) registry, 12.7% [22]; German registry, 8.2% [26]; and Italian registry, 5.4% [23]. In the PARTNER B cohort, mortality in 30 days was 5%, and 5.2% in PARTNER A cohort [20,27]. In our midst, Gaia et al. [28] described overall mortality of 42.42% and hospital mortality of 18.18% in 33 patients who underwent transcatheter aortic valve implantation through transapical access. The patients had mean EuroScore of 39.30% and mean STS score of 30.28%, which means that higher mortality rates than the ones described in major studies worldwide [20-26] can be explained by greater patient severity. A recent study in Italy [29] evaluated 165 patients who had undergone transcatheter aortic valve implantation. They were grouped according to EuroScore, above or below 20%. Hospital mortality was significantly higher in the group with the highest score than in the group with the lowest score, 15.6% and 2.4%, respectively; late mortality (12 months) was 25.7% in more severe patients and 6.8% in the least severe group. This suggests that current mortality rates described in the literature could be significantly influenced by the high risk of the population selected for this procedure. The indication of this procedure to lower risk patients could lead to lower mortality rates, perhaps even comparable to those of conventional surgery. New studies comparing the transcatheter intervention to conventional surgery in groups of low and intermediate risk patients have to be performed for comparative analysis.

2. Selzer A. Changing aspects of the natural history of valvular aortic stenosis. N Engl J Med. 1987;317(2):91-8. 3. Stephan PJ, Henry AC 3rd, Hebeler RF Jr, Whiddon L, Roberts WC. Comparison of age, gender, number of aortic valve cusps, concomitant coronary artery bypass grafting, and magnitude of left ventricular-systemic arterial peak systolic gradient in adults having aortic valve replacement for isolated aortic valve stenosis. Am J Cardiol. 1997;79(2):166-72. 4. Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999;341(3):142-7. 5. Varadarajan P, Kapoor N, Bansal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006;82(6):2111-5. 6. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al; PARTNER Trial Investigators. Transcatheter aorticvalve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-607. 7. Edwards FH, Peterson ED, Coombs LP, DeLong ER, Jamieson WR, Shroyer ALW, et al. Prediction of operative mortality after valve replacement surgery. J Am Coll Cardiol. 2001;37(3):885-92. 8. Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005;26(24):2714-20. 9. Cribier A, Savin T, Saoudi N, Rocha P, Berland J, Letac B. Percutaneous transluminal valvuloplasty of acquired aortic stenosis in elderly patients: an alternative to valve replacement? Lancet. 1986;1(8472):63-7. 10. Davidson CJ, Harrison JK, Leithe ME, Kisslo KB, Bashore TM. Failure of balloon aortic valvuloplasty to result in sustained clinical improvement in patients with depressed left ventricular function. Am J Cardiol. 1990;65(1):72-7.

CONCLUSION Considering the limitations of the present study and the small sample, it can be concluded that the Inovare prosthesis, implanted through femoral or iliac access, proved to be technically feasible with satisfactory hemodynamic profile in the postoperative follow-up.

11. Davies H. Catheter mounted valve for temporary relief of aortic insufficiency. Lancet. 1965;1:250. 12. Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur Heart J. 1992;13(5):704-8. 13. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106(24):3006-8.

REFERENCES 1. Roberts WC, Ko JM. Frequency by decades of unicuspid, bicuspid, and tricuspid aortic valves in adults having isolated aortic valve replacement for aortic stenosis, with or without associated aortic regurgitation. Circulation. 2005;111(7):920-5.

14. Smith CR. Transcatheter vs surgical aortic valve replacement in high risk patients with severe aortic stenosis: results from

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The PARTNER Trial. Presented at: 2011 American College of Cardiology Annual Scientific Session; April 2, 2011; New Orleans, LA.

22. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366(18):1705-15.

15. Gaia DF, Palma JH, Ferreira CBND, Souza JAM, Agreli G, Guilhen JCS, et al. Implante transapical de valva aórtica: resultados de uma nova prótese brasileira. Rev Bras Cir Cardiovasc. 2010;25(3): 293-302.

23. Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123(3):299-308.

16. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. Eur Heart J. 2011;32(2):205-17.

24. Gotzmann M, Korten M, Bojara W, Lindstaedt M, Rahlmann P, Mügge A, et al. Long-term outcome of patients with moderate and severe prosthetic aortic valve regurgitation after transcatheter aortic valve implantation. Am J Cardiol. 2012;110(10):1500-6. 25. Rodés-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010;55(11):1080-90.

17. Kvidal P, Bergström R, Hörte LG, Ståhle E. Observed and relative survival after aortic valve replacement. J Am Coll Cardiol. 2000;35(3):747-56. 18. Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010;122(1):62-9.

26. Zahn R, Gerckens U, Grube E, Linke A, Sievert H, Eggebrecht H, et al; German Transcatheter Aortic Valve InterventionsRegistry Investigators. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011;32(2):198-204.

19. Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011;58(20):2130-8.

27. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187-98.

20. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al; PARTNER Trial Investigators. Transcatheter aorticvalve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-607.

28. Gaia DF, Palma JH, Ferreira CBND, Souza JAM, Gimenes MV, Macedo MT, et al. Implante transcateter de valva aórtica: resultados atuais do desenvolvimento e implante de um nova prótese brasileira. Rev Bras Cir Cardiovasc 2011;26(3):338-47.

21. Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011;124(4):425-33.

29. Tamburino C, Barbanti M, Capodanno D, Sarkar K, Cammalleri V, Scarabelli M, et al. Early - and mid-term outcomes of transcatheter aortic valve implantation in patients with logistic EuroSCORE less than 20%: a comparative analysis between different risk strata. Catheter Cardiovasc Intev. 2012;79(1):132-40.

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Palma JH, et al. - Stent aórtico pulsátil: uma nova alternativa na assistência ORIGINAL ARTICLE ventricular crônica

Pulsatile stent graft: a new alternative in chronic ventricular assistance Stent aórtico pulsátil: uma nova alternativa na assistência ventricular crônica

José Honório Palma1, Diego Felipe Gaia2, Guido Caputi3, Guilherme Agreli4, João Roberto Breda5, Domingo M. Braile6, Enio Buffolo7

DOI: 10.5935/1678-9741.20130031

RBCCV 44205-1460

Abstract Objective: Heart failure is currently one of the most common hospitalization causes. Several chronic circulatory assist devices have been tested and are highly complex. The objective is the description of a pulsatile endoprosthesis capable of applying a chronic pulse within the descending aorta, similar to that produced by intra-aortic balloon. Methods: Pulsatile stents composed of nickel-titanium were built and positioned to engage latex tubes simulating the aorta. Different electric currents were applied to units connected in series in order to cause structure contraction and displacement of a liquid column. There were two sequence tests: first composed of two metallic cages and the second composed of five cages. At first sequence tests was applied a voltage of 16.3 volts and a current of 5 amperes. In the second, voltage of 15 volts and current of 07 amperes. Results: In the first sequence was obtained the pulsatile effect of stent, with contraction of the tube and displacement of the water column sufficient to validate the pulsating effect of the endoprosthesis. The two structures ejected a volume of 2.6 ml per cycle, with a range of 29 mm in height of the column of water equivalent to 8% shrinkage during the pulse. In the second sequence, it reachead a variation of 7.4 mL per cycle.

Conclusion: The results obtained confirm the stent pulsatile contractility activated by electrical current. The continuity of the study and material improvement are necessary to obtain more efficient model from the point of view of energy and pulse, to allow ejection volumes comparable with the intra-aortic balloons.

1. Associate professor at Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil. Project coordination, data analaysis and review. 2. PhD, Adjunct professor of the Cardiovascular Surgery Discipline (UNIFESP), São Paulo, SP, Brazil. Results analysis and writing. 3. PhD, Cardiovascular surgeron at UNIFESP, São Paulo, SP, Brazil. Data analysis. 4. Graduation in Medical Physics, manager of the Endovascular Division of Braile Biomédica, São José do Rio Preto, SP, Brazil. Experimental procedures fulfilment and data analysis. 5. PhD, cardiovascular surgeon at UNIFESP, São Paulo, SP, Brazil. Review and writing. 6. Emeritus professor at State Medical School of Rio Preto and Senior professor at Medical Sciences Faculty of the State University of Campinas (UNICAMP), Editor of the Brazilian Journal of Cardiovascular Surgery, São José do Rio Preto, SP, Brazil. Results analysis.

7. Titular professor of the Cardiovascular Surgery Discipline of UNIFESP, São Paulo, SP, Brazil. Review and data analysis.

Descriptors: Heart failure. Aorta. Stents. Resumo Objetivo: A insuficiência cardíaca é uma das causas mais comuns de internação. Dispositivos para assistência circulatória crônica foram testados e, em sua maioria, são de alta complexidade. O objetivo deste estudo é a descrição de uma endoprótese contrátil com capacidade de pulsação crônica no interior da aorta descendente, de maneira semelhante à produzida pelo balão intra-aórtico. Métodos: Endopróteses pulsáteis compostas de níqueltitânio foram posicionadas de forma a envolver tubos de látex, simulando a aorta. Diferentes correntes elétricas foram aplicadas a unidades ligadas em série, de modo a causar contração da estrutura e deslocamento de uma coluna líquida. Foram realizadas duas sequências de testes: a primeira com

This study was carried out at Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil. Correspendence address: Diego Felipe Gaia Universidade Federal de São Paulo – Disciplina de Cirurgia Cardiovascular Rua Napoleão de Barros 715 – 3o andar – Vila Clementino – São Paulo, SP, Brazil – Zip code: 04024-002 E-mail: drgaia@terra.com.br Article received on December 6th, 2012 Article accepted on April 28th, 2013

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pulsátil da endoprótese. As duas estruturas ejetaram um volume de 2,6 mL por ciclo, com uma variação de 29 mm na altura da coluna de água, equivalente a 8% de contração durante a pulsação. Na segunda sequência, conseguiu-se uma variação de 7,4 mL por ciclo. Conclusão: Os resultados obtidos comprovam a contratilidade da endoprótese pulsátil ativada pela aplicação de corrente elétrica. Continuidade do estudo e aperfeiçoamento do material se fazem necessários para obtenção de modelo mais eficiente do ponto de vista energético e com maior pulsação, para permitir volumes de ejeção comparáveis aos de balões intra-aórticos.

Abbreviations, acronyms and symbols ATP Nitinol PVC SMA

Adenosine triphosphate (Nickel Titanium Naval Ordinance Laboratory) Polyvinyl chloride (shape memory alloy)

duas gaiolas metálicas e a segunda com cinco gaiolas. Na primeira sequência de testes, aplicou-se tensão de 16,3 volts e corrente de 5 amperes e, na segunda sequência, tensão de 15 volts e corrente de 7 amperes. Resultados: Na primeira sequência de testes, obtevese o efeito pulsátil dos 2 stents, havendo contração do tubo e deslocamento da coluna d'água suficientes para validar o efeito

Descritores: Insuficiência cardíaca. Aorta. Stents.

INTRODUCTION

METHODS

Heart failure is currently one of the most common causes of cardiac hospital stay, and also causes significant morbidity and mortality [1]. Several chronic circulatory assist devices have been tested in recent years, and in most cases are often highly complex, and devices difficult to control which implantation depends on major procedures. The devices are also designed to be definitive or temporary, serving as a bridge to heart transplantation [2-4]. In recent years, the alloy NITINOL (Nickel Titanium Naval Ordinance Laboratory) initially used for various applications in the naval branch recognized for being “smart material” or SMA (shape memory alloy), has been used in medicine, in several areas, as orthopedic, cardiac, urological and gastrointestinal prostheses and orthodontic devices. This alloy behaves like a biological system that converts electrical or thermal energy in contraction and movement simulating a “natural muscle” [5-9]. Nitinol has the characteristic of retrieving a defined geometric shape after change in temperature. This ability is due to the modification of the alloy crystalline structure after stimulation. This material exhibits two-phase crystal structure: martensite, which has almost elastic properties, allowing deformation of the material without structural damage, and austenite phase, which has a more rigid and defined structure [10,11]. The aim of this study was to decribe an endoprosthesis contractile made with nitinol frame, still in “in-vitro” laboratory testing, whose function is to apply a chronic pulse inside the descending aorta, similar to that produced by an intra-aortic balloon, being synchronized with the cardiac cycle for outpatient non-invasive chronic circulatory support.

The principle of the device is to change the structure of the stent between two states: relaxed (martensitic structure) and activated (austenitic structure), where the change of the diameter of the stent results in changing the volume of the sample, causing ejection of the resulting difference between the two conditions (Figure 1).

Fig. 1 - Schematic of the variation in volume between the two states of the contractile prosthesis: relaxed and activated

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The endoprosthesis pulsatile tested was constructed with a metal strut of nickel and titanium designed as independent Gianturco Z-endoprostheses with 13.5 mm in height and 10 vertices. The metal structure involved a natural rubber latex tubular membrane, flexible and waterproof, 0.4 mm thick and 28 mm in diameter. The wire comprising nickel and titanium alloy had the following thermoelectric characteristics:

temperature. In the cycle II, with the application of current, the structure temperature rises and the return to the initial diameter in which the stent was molded occurrs. The cycle is then divided in steps relaxation (I) and activation (II). The pulsatile endoprosthesis was connected to a polyvinyl chloride (PVC) tube of 12.5 mm in internal diameter and 500 mm in length. The system was mounted vertically and filled with saline solution with blue dye at room temperature into a column of 400 mm (400 mm H2O pressure equivalent to 30 mmHg) (Figure 3). Cages produced with nickel and titanium wire were connected in series and connected to a pulse controller and an oscilloscope to view the profile of the electric current. This system was connected to a voltage source which supplied up to 7 amps of current, with voltage up to 220 Volts Figure 4.

Resistivity: ρe=76μΩ.cm Density ρm=6,5g/cm3 Boiling point: Tfusão=1310ºC Temperature of total transformation to the austenitic phase: Af=60ºC Coefficient of linear expansion: dl/dT=6,6.10-6/ºC Changing the stent was caused by the application of electrical current in metallic structures, which promoted heating and induced the shape change. When stimulated by temperature or by electricity, the league turns from its martensitic form (relaxed) and returns to its austenitic phase (activated), with its defined geometric shape and can be deformed again without structural damage. Initially, the stent structure is shaped with a diameter of 10 mm and then, upon cooling up to room temperature, expanded to 28 mm in diameter. The cycle shown in Figure 2 illustrates the deformation experienced by the stent. In the first cycle, the structure undergoes forced expansion at low temperatures, from 10 mm to 28 mm in diameter, at room

Fig. 3 - Mounting the pulsatile endoprosthesis with 5 stents connected in series in system of pulse generator, oscilloscope and current source

Fig. 2 - Illustration of the cycle relaxation (I) / activation (II) to which the pulsatile stent is subjected

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In a second test sequence, we used five stents connected in series, coating 80mm of the latex tubular membrane. For this system, we used a voltage of 15 volts, 7 amps current, pulse interval of 2.88 seconds, 7.12 seconds between pulses. RESULTS In the first test sequence was obtained pulsatile effect of two stents, with contraction of the tube and displacement of the water column sufficient to validate the endoprosthesis pulsating effect. The time intervals set in the pulse controller allowed the contraction of the frames, as well as their relaxation in the intervals between pulses. In this condition, the two structures ejected volume of 2.6 ml per cycle, with a range of 29 mm for the height of the water column and the variation in diameter of 2.2 mm (initial diameter 28 mm, end diameter of 25.8 mm in the 30 mm in length of the prosthesis), equivalent to 8% of contraction during pulsation (Figure 5). In the second test sequence (5 stents) we obtained range of 61 mm in the column and a 7.4 mL volume per cycle (initial diameter 28 mm, 25.8 mm end diameter in 80 mm of the prosthesis) equivalent to 8% contraction during pulsation (Figure 6).

Fig. 4 - Illustration showing experimental mouting

The PVC tube was graduated in order to measure the movement of water caused by the contraction of the pulsatile stent. With the variation in the water column we can calculate the displaced volume during contraction. Temperature and relative humidity were, respectively, 21.2°C and 58.3%. There were performed two test sequences: the first sequence with a montage of 2 cages covering the latex membrane and the second sequence with 5 cages. In the first series, with only two cages (length 30 mm) we applied a voltage of 16.3 volts and a current of 5 amperes, with pulses of 1 second at intervals of 0.23 second. Stents were connected in series with the control and power supply system.

Fig. 5 - Schematic of the first test sequence

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abandoned by high energy expenditure, as well as cobaltbased alloys or stainless steel, present major limitation which is the small deformity, limited to around 1%. One of the main reasons for the choice of alloy nitinol for construction of artificial muscles is due to the fact that the energy used seems to be more efficient. In addition, the nitinol alloy presents superelastic or pseudoelastic property, which allows a deformity of more than 10% [11]. The advantages and qualities of the use of nickel-titanium in medicine are known since 1970, when the first ventricular assist devices were manufactured. At that time, however, major problems could not be solved, such as material fatigue, heating and energy source for their stimulation, but the league continued to be widely used as self-expandable stents in the treatment of aneurysms and dissections. Today, one of the first studies using this technology in cardiology is a prosthesis developed with the aim of helping the atrial contraction. In this study, attention is drawn to the fact that there is no need to use an engine because the league contracts alone. In the field of atrial fibrillation, the device already is a reality, proving that actually generates atrial output for ventricular fibrillation, and can even be used to support two biatrial assistant devices. The auxiliary device improves the right atrial ejection fraction in 7% during rapid stimulation, simulating an atrial contraction [16]. The device tested, according the parameters observed in the laboratory, allows researches to continue, because the ejected volume obtained was 7.4 mL per cycle, which leads us to predict a volume of 595.2 mL when adjusted to a frequency of 80 beats per minute. This corresponds to 10% of the approximate cardiac output of a normal adults. These measurements were made with the use of a stent of 80 mm in length and 28 mm in diameter with a contraction of only 8%.

Fig. 6 - Scheme of the second test sequence

DISCUSSION The contractile stent is an initial prototype for cardiac assist, based on “smarts materials” technology, for the treatment of chronic heart failure. The circulatory assist devices for the treatment of chronic heart failure currently available present great complexity of handling, both at the time of implantation and in outpatient. Unlike the engines used in these devices, the called artificial muscles are light and consume little power. The use of nickel-titanium alloy for making assist devices such as artificial muscle opens new horizons in this field. Various materials have been tested and are used in various areas of medicine, and one important class of these are the shape memory polymers that have, or that is, those that return to their shape when stimulated, in adittion to be also biocompatible. This property allows them to be released in a compact form and minimally invasive manner. These polymers are used in orthopedic prostheses and embolization coil for treatment of cerebral aneurysms [12-15]. Each one of some other materials that could be used for these devices present a restriction. The gel polymer,

Example: 7.44mL x 80bpm = 595.2 mL/min Cardiac output = 70 mL per beat x 80 bpm = 5600 mL/min Assistance: 595.2 mL/5600mL = 10.6% aid The amplitude of the material contraction depends on the choice of the ratio between nickel and titanium in the alloy, the thickness of the wire used, the geometry of the stent and the endoprosthesis length to be implanted. All these characteristics influence the efficiency of the device and the energy required for the operation depends on these factors. The biological motor system was so successful during evolution that has been adopted by all types of striated muscle (skeletal muscle and heart). In the sarcomere, the muscle fibers contract from the sliding of actin and myosin, unlike the contraction generated by the proposed alloy, where shortening occurs by changing the molecular structure of the material. The maximum mechanical performance of all natural muscle varies between 40 and 200 watts per kilogram

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of muscle, and the performance efficiency in relation to the consumption of adenosine triphosphate (ATP) is about 50%. In these tests, we obtained efficiency in converting electrical energy into fluid ejection quite low, approximately 1%. The low efficiency is due to the alloy used, which should have its temperature raised to 80°C to have a shape memory enabled. With the use of an alloy with processing at temperatures of about 43°C, the required amount of power falls drastically reducing energy consumption and enhancing efficiency, which will be performed in future tests. The allow stimulation necessary to present contraction is another important point of discussion, because the energy required should ideally be provided by a generator similar to our known pacemaker or defibrillator. In the studies performed for making atrial contraction prosthesis, we used intermittent electrical current of 10 volts, 300 mA and 100 ms. Ont the other hand, in esophageal contractile prosthesis [11], the stimulus was 500 mA at 5 volts. In this study, we used the largest currents and voltages (16V and 5A) due to the characteristic of the alloy tested and its activation at 80°C. Another point to be questioned when we think of using these devices is the durability of the material being subjected to fatigue (contraction) in the long-term. In the state-ofthe-art aortic stents made of nickel-titanium, there is no fracture of the material even when observed that there is a pulsatile movement of the stent following the movement of the aortic wall. The post-implant contractile property can also be changed in view of the same prosthesis interaction with the aortic wall and its consequent inflammatory reaction and long-term change of the alloy crystalline structure, with loss of ability to move. Future tests will probably include a coating. For the contractile function of the stent is similar to an intraaortic balloon of 40cc, it is necessary to optimize the design with the use of a composition of a shape memory alloy which is more efficient from the standpoint of energy for working physiological temperature, which offers greater structural rigidity in its activated form to achieve greater contraction. As an example, a stent of 28 mm in diameter when relaxed and with 130 mm in length has to contract to 17 mm, representing a 40% compliance. It is still possible to synchronize the functioning of individual pulsatile stents comprising the prosthesis to allow it to be unidirectional or bidirectional, directing blood flow to the coronary and carotid arteries or dividing them between visceral and supra-aortic and coronary arteries.

view of energy and greater pulse, in order to allow ejection volumes comparable to intra-aortic balloons used in routine care for circulatory support. If the expectation is confirmed, we have a non-invasive outpatient circulatory assist, with indications and effectiveness of intra-aortic balloon.

REFERENCES 1. Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics: 2012 update: a report from the American Heart Association. Circulation. 2012;125(1):e2-e220. 2. Jokinen JJ, Mildh L, Hämmäinen P, Taal G, Raivio P, SuojarantaYlinen R, et al. Mechanical support for the heart and circulation in adults. Duodecim. 2011;127(19):2045-53. 3. Louis LB 4th, Sun B. Advances in mechanical circulatory support. Curr Opin Organ Transplant. 2008;13(5):522-5. 4. Delgado RM 3rd, Bergheim M. Management of acute and chronic heart failure with left ventricular assist devices. Am Heart Hosp J. 2005;3(3):153-60. 5. Babighian G, Fontana M, Caltran S, Ciccolella M, Amadori M, De Zen M. The heat-activated stapes prosthesis ’SMart’ Piston: technique and preliminary results. Adv Otorhinolaryngol. 2007;65:190-6. 6. Carosio S, Monero A. Smart and hybrid materials: perspectives for their use in textile structures for better health care. Stud Health Technol Inform. 2004;108:335-43. 7. Roosli C, Schmid P, Huber AM. Biocompatibility of nitinol stapes prosthesis. Otol Neurotol. 2011;32(2):265-70. 8. Schaub MC. Artificial muscle: facts and fiction. Swiss Med Wkly. 2011;141:w13319.

CONCLUSION The results obtained confirm the pulsatile stent contractility activated by the application of electric current. The continued study and refinement of the material are needed to obtain a more efficient model from the point of

9. Tarniţă D, Tarniţă DN, Hacman L, Copiluş C, Berceanu C. In vitro experiment of the modular orthopedic plate based on Nitinol, used for human radius bone fractures. Rom J Morphol Embryol. 2010;51(2):315-20.

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10. Dotter CT, Buschmann RW, McKinney MK, Rösch J. Transluminal expandable nitinol coil stent grafting: preliminary report. Radiology. 1983;147(1):259-60.

in biomedicine and electronics. Macromol Rapid Commun. 2010;31(17):1487-91. 14. Lendlein A, Shastri VP. Stimuli-sensitive polymers. Adv Mater. 2010;22(31):3344-7.

11. Stoeckel D, Pelton A, Duerig T. Self-expanding nitinol stents: material and design considerations. Eur Radiol. 2004;14(2):292-301.

15. Lendlein A, Pierce BF, Ambrosio L, Grijpma DW. Advanced functional polymers for medicine. Macromol Biosci. 2011;11(12):1621-4.

12. Sokolowski W, Metcalfe A, Hayashi S, Yahia L, Raymond J. Medical applications of shape memory polymers. Biomed Mater. 2007;2(1):S23-7.

16. Tozzi P, Hayoz D, Thévenaz P, Roulet JY, Salchli F, von Segesser LK. Atria assist device to restore transport function of fibrillating atrium. Eur J Cardiothorac Surg. 2008;33(2):263-7.

13. Lendlein A, Rehahn M, Buchmeiser MR, Haag R. Polymers

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Bordinhão A -ORIGINAL Comparison between the Doppler flowmetry and the free flow ARTICLE of dog's internal thoracic artery with and without use norepinephrine

Comparison between the Doppler flowmetry and the free flow of dog's internal thoracic artery with and without use of norepinephrine Comparação entre a Dopplermetria e o fluxo livre da artéria torácica interna de cães com e sem o uso de noradrenalina

Alessandro Bordinhão1

DOI: 10.5935/1678-9741.20130032

RBCCV 44205-1461

Abstract Objective: This work aims to study comparatively the free flow and the Doppler flowmetry of the internal thoracic artery in anesthetized dogs, with and without continuous intravenous administration of norepinephrine. Methods: The sample was made up of ten mongrel dogs, which dissected the left and right internal thoracic arteries and evaluated your stream; first, by Doppler flowmetry and then by free flow. The mean arterial pressure and the diameter of the arteries at the beginning of the procedure were registered. The workflow checks by two methods occurred in three times: zero time, 10 and 25 minutes. After the first check in time zero, the continuous infusion of norepinephrine in the right atrium; other checks were made in the same way that the first time, to 10 and 25 minutes, in the same arteries and by two methods, each one in his artery, noting the results, as well as the corresponding average blood pressure. Results: The results of the flowscan, between Doppler flowmetry and free flow, there were similar; being the first, zero times, ten and twenty-five minutes, respectively, 183, 230.1 and 237 ml/min compared to seconds, 168.6, 226.8 and 226.4 ml/min (P=0.285). The mean arterial pressures of three times

and the average diameter of the arteries, showed no statistically significant differences between the methods, so did not influence on the comparison of the results. Conclusion: The evaluations, both from Doppler flowmetry and free flow, were similar in three times checked.

1. Masters in Principles of Surgery / Evangelical Hospital of Curitiba, Specialist of the Brazilian Society of Cardiovascular Surgery, Cardiovascular Surgeon at Santa Casa de Presidente Prudente, Curitiba, PR, Brazil.

Correspondence address: Alessandro Bordinhão Al. Augusto Stellfeld 1908 - Bigorrilho - Curitiba, Paraná, Brazil – Zip code: 80730-150. E-mail: alessandrobordinhao@uol.com.br

Descriptors: Mammary arteries. Ultrasonography, Doppler. Continuous flow. Norepinephrine. Dogs. Resumo Objetivo: Este trabalho objetiva estudar comparativamente o fluxo livre e a dopplerfluxometria da artéria torácica interna de cães anestesiados com e sem a administração de noradrenalina endovenosa contínua. Métodos: A amostra foi constituída de 10 cães mestiços, nos quais foram dissecadas as artérias torácicas internas direita e esquerda e avaliado seu fluxo; primeiramente, pela dopplerfluxometria e depois pelo fluxo livre. Foram registrados a pressão arterial média e o diâmetro das artérias no início do procedimento. As verificações do fluxo pelos dois métodos

Work performed at the Evangelical Hospital of Curitiba, Curitiba, Paraná, Brazil.

Article received on September 25th, 2012 Article accepted on November 13th, 2012

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os primeiros, nos tempos zero, 10 e 25 minutos, respectivamente, 183, 237 e 230,1 ml/min, comparados aos segundos, 168,6, 226,8 e 226,4 ml/min (P=0,285). A média das pressões arteriais dos três tempos e o diâmetro médio das artérias não apresentaram diferenças estatisticamente significativas entre os métodos, portanto, não influenciaram na comparação dos resultados. Conclusão: As avaliações, tanto da dopplerfluxometria quanto do fluxo livre, foram semelhantes nos três tempos verificados.

Abbrebiations, acronyms and symbols ITA

Internal Thoracic Artery

ocorreram em três tempos: tempo zero, 10 e 25 minutos. Após a primeira verificação no tempo zero, iniciou-se a infusão contínua de noradrenalina no átrio direito; as avaliações aos 10 e 25 minutos foram feitas da mesma forma que na primeira vez, nas mesmas artérias e pelos dois métodos, anotando-se os resultados, assim como a pressão arterial média correspondente. Resultados: Os resultados da verificação de fluxo, entre Dopplermetria e fluxo livre, apresentaram-se similares; sendo

Descritores: Artéria torácica interna. Ultrassonografia Doppler. Fluxo contínuo. Norepinefrina. Cães.

INTRODUCTION

Experimental study in dogs, conducted by Sasajima et al. [6] demonstrated the histopathological correlation of the ITA in dogs and in humans. Tada et al. [7] have analyzed the dog’s ITA through Doppler flowmetry under the effect of inotropic and vasoactive substances and Suematsu et al. [8] defended the epicardial Doppler flowmetry as a good method for evaluating the ITA in CABG in dogs. This work aims to comparatively study the free flow and ITA Doppler flowmetry in anesthetized dogs with and without continuous intravenous administration of norepinephrine.

The internal thoracic artery (ITA) is used in coronary artery bypass surgery as a graft, and in the anastomosis of the coronary artery for its long patency and adequate perfusion. Compared to the saphenous vein graft, the artery is clear in 85% of patients, 10 years after surgery, while with the vein, it occurs on average in 60% of the cases [1,2]. ITA dissection is simple in most cases. Due to these characteristics, ITA is the first-choice artery for revascularization of the anterior descending artery, the most important in the cardiovascular structure [3]. Due to the importance of ITA in CABG, we should properly evaluate its patency, especially after dissection to avoid early occlusion, assessing its flow. An ITA with low flow can be used as a free graft. The evaluation of the ITA free blood flow is composed of its incision and verify it in a container at a given time. This investigation was compared to measurement by transthoracic Doppler of the same artery, in a study by Canver et al. [4] in 1991, which demonstrated adequate correlation between the methods. Some studies used a scanning method for evaluation of the free flow of the ITA. Wendler et al. [5] in 1999, comparatively evaluated ITA flow dissected with a pedicle and a skeletonized one, comparing them by the free flow. Most studies of ITA aims to analyze their patency over the years and few studies have the objective to evaluate their flow in the intraoperative period, as the present article does, therefore, this is our most relevant aspect.

METHODS This work was performed at the Laboratory for Experimental Surgery of the Medical Research Institute from the Graduate Program in Principles of Surgery, Evangelical University of Paraná. The study was approved by the Research Ethics Committee of the Evangelical University of Paraná (n o 4586/01), according to the Declaration of Helsinki. We followed the principles of ethics in animal experimentation, recommended by the Brazilian College of Animal Experimentation, specifically for dogs, according to the National Research Council [9]. Animal experimentation The sample consisted of 10 mongrel dogs (Canis familiaris), with body weight ranging from 15 kg to 25 kg,

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from the kennel of Curitiba City Hall. The sample size was sufficient to be statistically evaluated.

After dissection of the ITA, 300 mg of papaverine hydrochloride were injected into the artery wall, in order to avoid spasms. 8. The pericardium was longitudinally incised along its entire length before being fixed to the subcutaneous tissue with three 2.0 USP cotton thread (Algofil®, Cirumédica), rising it and exposing the heart. 9. Suturing was performed in tobacco pouch with braided polyester threads (Ethibond 2.0) in the aorta and right atrium. 10. A catheter was inserted into the aortic pouch and connected to a sphygmomanometer clock, functioning as an arterial pressure checking system. 11. A no 8 nasogastric tube was introduced in the atrial pouch, connected to a serum catheter with an infusion pump (Nutrimat II®, B. Braun) and a flask with norepinephrine standard glucose solution consisting of 4 mg of norepinephrine diluted in 250 ml of 5% dextrose solution (16 g/ml) [10]. The infusion has not been started yet. 12. Heparin was intravenously injected (400 IU / kg) in the dog, with the purpose of anticoagulation. The dose of heparin injected was directly correlated to the weight (P=0.00001) (Table 1). 13. Verification by the Doppler method (performed by a cardiologist with subspecialty in echocardiography and Doppler) was initiated by placing the transducer on one of ITAs. The first verification was adopted as the zero time (Vd0) assessing the diameter (Table 1) and the velocity of arterial blood flow, and then calculating the arterial volume per minute. Blood pressure (Pd0) was measured by the sphygmomanometer connected to the aorta. 14. The contralateral ITA has its diameters observed (Table 1) by Doppler and then had its distal end transversely incised. The artery was dissected away from its bed and its caudal end clamped with Bulldog forceps. 15. The clamped artery was displaced over a container and then the clamp released. The bleeding was evaluated for 15 seconds. Blood volume was multiplied by four, defining the 1-minute flow, then, we noted the mean arterial blood pressure when the verification started (P0). The collected blood was injected with a 20 ml syringe through the dog’s venous access. 16. A continuous infusion of norepinephrine solution was started at a constant flow of 0.3 g / kg per minute, it was then calculated for each dog, according to the weight, in milliliters per hour (Table 1) standard dose [10]. 17. After ten minutes of continuous infusion of norepinephrine solution, the methods were evaluated by Doppler (VD10) and the free flow (V10) in the same arteries and the same way as at time zero, verifying the mean arterial pressures corresponding to each method ( PD10 and P10). 18. After 25 minutes of infusion of norepinephrine, further measures were taken in the arteries by Doppler (Vd25) and then the free flow (V25) and the blood pressure was observed in each of the two moments (Pd25) and free flow (P25). 19. All the measures were recorded (Tables 2 and 3).

Preoperative period The animals were fed with dog food (Nuvita® for adult dogs) and had free access to water. The dogs were kept under observation for 15 days, subjected to vaccination and treatment of parasites. They were weighed and fasted for 12 hours before surgery. Anesthetic technique The animal was taken to the operating room where the cephalic vein was punctured with Venofix® nº 21 scalp, which was connected to a 500 ml bag of 0.9 % saline solution (B. Braun S/A) to drip until the end of the procedure. The anesthesia was endovenously induced with sodium thiopental hypnosis (Thionembutal®, Abbott Lab Brazil Ltda.) at a dose of 5 mg/kg. The solution was obtained after diluting 1 g of thiopental sodium lyophilized in 1 ml of 0.9% saline solution, obtaining 25 mg / ml of anesthetic solution. The animal was considered anesthetized when it was unconscious, with the involuntary movements ceased and no reaction to surgical management. We also performed an orotracheal intubation by direct laryngoscopy with 7.5 mm cannula in diameter, with a ballon of cardiac tamponade (RUNCH probe). The animal was kept in ventilation controlled by a respirator (Takaoka® model 671) using inhalation anesthesia with halothane (Halothano ®, Cristália) for continuous vaporization. Surgical Technique 1. The animal was placed in supine position with its cranial and caudal limbs fixed. 2. The fur from ventral thoracic region, close to the skin, was shaved with a razor blade. 3. In antisepsis of the surgical region, the povidone-iodine solution was used (Povedine Degermante®, Darrow), and then, povidone-iodine dye solution (Povedine Tintura®, Darrow). 4. The sterile surgical drapes were positioned, delimiting the area to be incised. 5. Median thoracic incision was performed, from the jugular notch to the xiphoid process with a electric scalpel (Wem ® model BC-160), depthened to the breastbone, where the hemostasis was performed. 6. The sternum was sawed in the midline, with Gigli saw, and hemostasis performed with bone wax (2.5 g, Poly Suture) and infrasternal bleeding vessels with a 4.0 USP cotton thread (Algofil®, Cirumédica). 7. The right ITA and left ITA was dissected using skeletonization, starting from its origin in the subclavian artery and continuing until near the xiphoid process [5], linking its branches with 3-0 USP cotton thread (Algofil®, Cirumédica.)

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Table 1. The weight of the dogs, the volume of heparin performed on each animal, the amount of noradrenaline performed per hour and the diameter of internal thoracic arteries at zero time. Weight

Volume of Heparin

Dog 1 23 kg Dog 2 18 kg Dog 3 24 kg Dog 4 22 kg Dog 5 25 kg Dog 6 24 kg Dog 7 17 kg Dog 8 18 kg Dog 9 19.5 kg Dog 10 17.5 kg

1.9 ml 1.5 ml 1.9 ml 1.8 ml 2.0 ml 1.9 ml 1.4 ml 1.5 ml 1.6 ml 1.4 ml

Volume of Noradrenaline volume 26 ml/h 20 ml/h 27 ml/h 25 ml/h 28 ml/h 27 ml/h 19 ml/h 20 ml/h 22 ml/h 20 ml/h

Initial diameter of LITA 3.4 mm 2.4 mm 4.2 mm 4.2 mm 3.2 mm 3.4 mm 5.2 mm 2.6 mm 4.1 mm 2.6 mm

Initial diameter of RITA 3.1 mm 2.3 mm 4.0 mm 4.1 mm 3.1 mm 3.6 mm 4.6 mm 2.8 mm 3.9 mm 2.5 mm

LITA = left internal thoracic artery. RITA = right internal thoracic artery

Table 2. Results of blood pressures measured by the Doppler method (Pd0, Pd10, Pd25) and the free flow method (P0, P10, P25). Dog 1 Dog 2 Dog 3 Dog 4 Dog 5 Dog 6 Dog 7 Dog 8 Dog 9 Dog 10

Pd0 70 80 100 100 70 100 100 80 90 90

Pd10 85 110 120 140 90 110 120 100 120 130

Pd25 90 120 120 130 80 120 130 100 110 120

P0 70 80 100 100 70 100 90 80 80 90

P10 80 120 120 140 90 110 120 110 120 130

Table 3. Results of Doppler flowmetry flow variables(Vd0, Vd10 and Vd25) and free flow variables (V0, V10 and V25). Dog 1 Dog 2 Dog 3 Dog 4 Dog 5 Dog 6 Dog 7 Dog 8 Dog 9 Dog 10

P25 90 125 120 130 80 110 120 120 110 130

Vd0 146 126 285 287 102 172 264 124 200 126

Vd10 198 160 357 321 166 232 280 143 330 188

Vd25 198 143 376 338 156 220 280 156 268 166

V0 132 136 240 280 130 132 236 120 200 120

V10 240 160 280 320 168 180 260 160 320 180

V25 248 144 320 320 160 168 272 180 280 172

Note: The unit of measurement used for volume was milliliters per minute

Note: The unit of measurement used for pressure was millimeters of mercury

Euthanasia After the completion of the assessments, the animal was sacrificed with 40 ml of 19.1% potassium chloride, endovenously administered.

Variables analyzed Variables were evaluated in three stages; zero time corresponding to the beginning of the experiment and at two different times, 10 and 25 minutes (Tables 2 and 3): 1. The variables of Doppler evaluation were: Vd0, VD10 and Vd25, and mean arterial pressures corresponding to each verification were; Pd0, PD10 and Pd25. 2. The free flow variables were: V0, V10 and V25, and mean arterial pressures corresponding to each verification were, respectively, P0, P10 and P25.

The Doppler flowmetry The Doppler used to perform the measurements was the AU3 Partner and the artery was examined by a 5-10MHz linear transducer, and the volume flow calculated by multiplying the diameter by the average velocity of the blood flow.

Statistical Analysis The analysis was performed by the nonparametric Friedman and Kruskal-Wallis tests. Comparing the results, we adopted the null hypothesis that the flow results measured by the two methods are equal versus the alternative hypothesis

20. Initially, a four-dog pilot group underwent the experiment described above, for technical development and to test the devices used. 21. ITA was evaluated by one and then by the other method, taking turns from one dog to the next.

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that the results would be different. In all tests, we considered a 5% significance level. The variation of the diameter of the internal thoracic arteries and blood pressure were also analyzed by the same tests, as factors that influence the result of the flow between the two methods. Since the null hypothesis has P<0.05, they would be different in the two groups.

The mean arterial flow in Doppler flowmetry was 237.5 ± 78.7 ml/min at the 10-minute time, with a minimum of 143 ml/min and a maximum of 357 ml/min and the free flow was 226.8 ± 65.2 ml/min with the minimum of 160 ml/min and the maximum of 320 ml/min. At the 25-minute time, the mean arterial flow in Dopplermetria method was 230.1 ± 82.1 ml/ min, with a minimum of 143 ml/min and a maximum of 376 ml/min and the free flow was 226 4 ± 68.8 ml/min, with a minimum of 144 ml/min and a maximum of 320 ml / min. The results revealed no significant difference in blood flow between the methods in the times analyzed (P=0.285). Regression analysis shows that blood pressure is the determining factor for the variation in flow (P=<0.00001*). By adjusted R2, approximately 30% of the variation of the flow are due to the pressure variation.

RESULTS The experiments were uneventful. It was easy to dissect the ITA in the animals, presenting a good caliber and a good flow. The average diameter of the ITAs verified by Doppler was 3.54 mm and the free flow of 3.39 mm. No difference was observed between diameters of ITA in the 2 methods, Doppler and free flow (P=0.705). The minimum diameter measured by the arterial Doppler method was 2.3 mm, and the free flow of 2.4 mm, while the maximum diameter was 5.2 mm for the first and, 4.6 mm for the second method. There was a standard deviation of 0.89 for Doppler, while for the free flow of 0.76. The standard error was 0.28 for the first and 0.24 for second method. The values ​​for mean arterial pressure measured by the Doppler method correspond to Pd0, PD10 and Pd25 and the free flow to P0, P10 and P25 (Table 2). The average blood pressure in the Doppler flowmetry method at zero time was 88 ± 12.29 mmHg, with a minimum of 70 mmHg and the maximum of 100 mmHg, whereas in the free-flow method at the same time, the average was 86 ± 11.74 mmHg, with a minimum of 70 mmHg and a maximum of 100 mmHg. The average blood pressure by Doppler method was 112.5 ± 17.20 mmHg at the 10- minute time, the minimum and the maximum of 85 mmHg and 122.5 mmHg, respectively, at the free flow was 114 ± 17.76 mm Hg, with a minimum of 80 mmHg and a maximum of 140 mmHg. At the 25-minute time, the mean blood pressure in Doppler flowmetry method was 112 ± 16.87 mmHg, the minimum and maximum of 80 mmHg and 122.5 mmHg, respectively, the free flow was 113.5 ± 16.67 mmHg, with a minimum of 80 mmHg and the maximum of 130 mmHg. The blood pressure measured by Doppler method and the free flow were compared with analyzes of nonparametric variance (Friedman). No significant difference was found, therefore, the pressure in both methods were similar during the three times (P=0.309). The values ​​found for the arterial flow in the Doppler variables correspond to Vd0, Vd10 and Vd25 and for free flow, V0, V10 and V25, and can be verified in Table 3. The mean arterial flow in the Doppler flowmetry time at zero time was 183 ± 71.6 ml/min, with a minimum of 102 ml/min and a maximum of 287 ml/min, while the free flow method at the same time presented an average of 168.6 ± 59.7 ml/min, with the minimum of 120 ml / min and the maximum of 280 ml/min.

DISCUSSION The importance of this experiment was evidenced by demonstrating similar results between the standard method (Doppermetry) and the free flow method, equaling them in daily clinical practice and allowing the free flow method as an option in studies, for example, to evaluate the effect of drugs into the blood flow, or to test methods of ITA dissection [11] and others. The free flow is also useful in the daily assessment of ITA dissected in coronary artery bypass surgery. The animal chosen was the adult dog for having a ITA with good caliber and good flow [12]. The artery of the dog has similar histopathological characteristics with the human’s, as demonstrated by Sasajima et al. [6]. All experimental work used the dog to the assessment of ITA flow [6,7,12,13]. Norepinephrine was used in order to compare the two methods in different blood pressures and consequently different blood flow speeds, therefore, it provides other data for the comparison between Doppler flowmetry and free flow [14]. It is important to note that drug was used in a constant volume by means of an infusion pump, not showing significant fluctuations in blood pressure during the analysis of the two types of verification. We used the halothane inhalational anesthetic, since it was continously administered with the same quantity. The continuous inhalation anesthesia is the one which causes less oscillations in blood pressure [15]. In studies analyzed, the maintenance of anesthesia during surgery was performed in the same manner as in this experimental work [6,7,12,13]. The factors that can influence the arterial flow results between the methods are: 1. The difference in diameters between the arteries in both methods. The experiment showed the similarity between the diameters of arteries verified in Doppler flowmetry and free flow, being statistically significant (P=0.705). 2. The difference between the blood pressures during

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Doppler flowmetry and free flow verification. The experiment showed the similarity between the mean arterial pressure, recorded at the beginning of the Doppler flowmetry and free flow, being statistically significant (P=0.309). 3. The decrease in blood flow due to the blood loss during the free flow verification. It would be important if the measurement taken at the 1-minute time were corrected by performing the measurement in 15 seconds, the blood loss was lower, and then injected into the animal. There are few studies comparing the two methods. Canver et al. [4] separately used the two types of flow verification of the internal thoracic artery, the Doppler flowmetry in the preoperative period and free flow in the intraoperative period, demonstrating the correlation of them with a “P” statistically significant, as in this work. In the study of Cagli et al. [16] performed on humans, there was a comparison between the free flow in the intraoperative period with Doppler flowmetry in the pre-and postoperative period, with a smaller flow in the first method. However, there is a strong bias in this study, for comparing a method in which the patient is anesthetized (free flow) whose blood pressure is different from a nonanesthetized patient (Doppler flowmetry), demonstrating a lower flow in the first one, and other problems such as the manipulation of the dissection be present in only one method (free flow). Authors as Tada et al. [7] used the free flow to assess the inotropic action of substances on the arterial flow, while Choi and Lee [17] and Wendler et al. [5] used to compare the free flow of the dissected ITA with and without the pedicle, demonstrating that both methods are reliable. Hata et al. [18] demonstrated that ITA even with flow under 20 ml/min can be used in CABG, increasing the flow in the coronary artery with severe obstruction, similar to the ITA with greater flow. The flow verification by Doppler can identify factors of early occlusion of arterial or venous graft in the coronary artery, as the low flow in the coronary bed after the anastomosis. This method is more comprehensive than the free flow. Van der Meulen et al. [19] used the intraoperative Doppler to verify blood flow speed in six internal thoracic artery before and after anastomosed to the anterior descending coronary artery. Suematsu et al. [8] used the Doppler flowmetry compared to histological examination in dogs and then compared to angiography, in humans, in evaluating the flow of anastomoses graft to the coronary arteries, showing good correlation between the methods (P<0.001) [8 ]. Doppler would be an excellent evalution method of ITA in situ and after the graft anastomosis in CABG [20,21]. The free flow is currently used on a smaller scale than the Doppler and angiography, but it is still an efficient method in different papers [22,23]. Its easy and simple applicability, no need for a device or an expert in the field, can increase the number of surveys assessing blood flow, being especially

useful in countries with deficits of research financial resources, as in Brazil. CONCLUSION A comparative evaluation between the free flow and Doppler flowmetry of the ITA in anesthetized dogs with and without administration of norepinephrine presents results without statistically significant difference.

REFERENCES

1. Cameron A, Davis KB, Green G, Schaff HV. Coronary bypass surgery with internal-thoracic-artery grafts: effects on survival over 15-year period. N Engl J Med. 1996;334(4):216-9. 2. Cameron AA, Green GE, Brogno DA, Thornton J. Internal thoracic artery grafts: 20-years clinical follow-up. J Am Coll Cardiol. 1995;25(1):188-92. 3. Barner HB. The internal mammary artery as a free graft. J Thorac Cardiovasc Surg. 1973;66(2):219-21. 4. Canver CC, Ricotta JJ, Bhayana JN, Fiedler RC, Mentzer RM Jr. Use of duplex imaging to assess suitability of the internal mammary artery for coronary artery surgery. J Vasc Surg. 1991;13(2):294-300. 5. Wendler O, Tscholl D, Huang Q, Schäfers HJ. Free flow capacity of skeletonized versus pedicled internal thoracic artery grafts in coronary artery bypass grafts. Eur J Cardiothoracic Surg. 1999;15(3):247-50. 6. Sasajima T, Bhattacharya V, Wu MH, Shi Q, Havashida N, Sauvage LR. Morphology and histology of human and canine internal thoracic arteries. Ann Thorac Surg. 1999;68(1):143-8. 7. Tada Y, Tsuboi H, Suzuki K, Katoh T, Zempo N, Fujimura Y, et al. The response of blood flow between the internal thoracic and ileocecal arteries to inotropic agents in a canine model. Surg Today. 1998;28(1):70-5. 8. Suematsu Y, Takamoto S, Ohtsukat T. Intraoperative echocardiographic imaging of coronary arteries and graft anastomoses during coronary artery bypass grafting without cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2001;122(6):1147-54.

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17. Choi JB, Lee SY. Skeletonized and pedicled internal thoracic artery grafts: effects on free flow during bypass. Ann Thorac Surg. 1996;61(3):909-13.

10. Mosby’s Drug Consult. Norepinephrine bitartrate, drug resume. St Louis: Mosby; 2002.

18. Hata M, Shiono M, Orime Y, Hata H, Yagi S, Yamamoto T, et al. Should use of the internal thoracic artery be avoided under conditions of low free flow? Postoperative hemodynamic assessment using pulsed Doppler echocardiography. Jpn Circ J. 1999;63(7):533-6.

11. Mannacio V, Di Tommaso L, De Amicis V, Stassano P, Vosa C. Randomized flow capacity comparison of skeletonized and pedicled left internal mammary artery. Ann Thorac Surg. 2011;91(1):24-30.

19. Van der Meulen J, van Son JA, van Asten WN, Skotnicki SH, Lacquet LK. Intraoperative Doppler spectrum analysis of blood flow in the internal mammary artery used for myocardial revascularization. Thorac Cardiovasc Surg. 1991;39(5):281-3.

12. Lee CN, Orzulak TA, Schaff HV, Kaye MP. Flow capacity of the canine internal mammary artery. J Thorac Cardiovasc Surg. 1986;91(3):405-10.

20. Louagie YA, Haxhe JP, Jamart J, Buche M, Schoevaerdts JC. Intraoperative assessment of coronary artery bypass grafts using a pulsed Doppler flowmeter. Ann Thorac Surg. 1994;58(3):742-9.

13. Gitter R, Anderson JM Jr, Jett GK. Influence of milrinone and norepinephrine on blood flow in canine internal mammary artery grafts. Ann Thorac Surg. 1996;61(5):1367-71.

21. Forte AJV, Lobo Filho JG, Leitão MCA. Padrão ecocardiográfico do fluxo da artéria torácica interna esquerda após revascularização do miocárdio com enxerto composto. Arq Bras Cardiol. 2007;89(5):e163-4.

14. Shimizu T, Hirayama T, Suesada H, Ikeda K, Ito S, Ishimaru S. Effect of flow competition on internal thoracic artery graft: postoperative velocimetric and angiographic study. J Thorac Cardiovasc Surg. 2000;120(3):459-65.

22. Une D, Shimizu S, Kamiya A, Kawada T, Shishido T, Sugimachi M. Both skeletonized and pedicled internal thoracic arteries supply adequate graft flow after coronary artery bypass grafting even during intense sympathoexcitation. J Physiol Sci. 2010;60(6):407-13.

15. Massone F. Anestesiologia veterinária: farmacologia e técnicas. 3ª ed. Rio de Janeiro:Guanabara Koogan;1999. p.225. 16. Cagli K, Emir M, Kunt A, Ergun K, Muharrem T, Murat T. Evaluation of flow characteristics of the left internal thoracic artery graft: perioperative color Doppler ultrasonography versus intraoperative free-bleeding technique. Tex Heart Inst J. 2004;31(4):376-81.

23. Ozkara C, Dogan OF, Furat C. Effect of topical vasodilator on internal thoracic artery blood flow. A placebo-controlled clinical study. World J Cardiovasc Dis. 2012;2:204-7.

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Nina VJS, et al. - Acute kidney injury after coronary artery bypass grafting: ORIGINAL ARTICLE assessment using RIFLE and AKIN criteria

Acute kidney injury after coronary artery bypass grafting: assessment using RIFLE and AKIN criteria Lesão renal aguda no pós-operatório de revascularização do miocárdio: avaliação pelos critérios RIFLE e AKIN

Vinicius José da Silva Nina1, Maryanne Miranda Matias2, Dyego José de Araújo Brito3, José Albuquerque de Figueiredo Neto4, Léa Barroso Coutinho5, Rayssa Fiterman Rodrigues6, Vinícius Giuliano Gonçalves Mendes7, Shirlyne Fabianni Dias Gaspar8

DOI: 10.5935/1678-9741.20130033

RBCCV 44205-1462

Abstract Objective: To compare the RIFLE (Risk, Injury, Failure, Loss and End-stage Renal Failure) and AKIN (Acute Kidney Injury Network) criteria for diagnosis of acute kidney injury after coronary artery bypass grafting. Methods: Retrospective cohort. 169 patients who underwent coronary artery bypass grafting from January 2007 through December 2008 were analyzed. Information was entered into a database and analyzed using STATA 9.0. Results: Patients' mean age was 63.43 ± 9.01 years old. Predominantly male patients (66.86%) were studied. Acute Kidney Injury was present in 33.14% by AKIN and in 29.59% by RIFLE. Hemodialysis was required by 3.57% and 4.0% of the patients when AKIN and RIFLE were applied respectively. There was 4.0% and 3.57% mortality of patients with Acute Kidney Injury according to the RIFLE and AKIN criteria, respectively. In 88.76% of the cases, there was good agreement

between the two methods in the detection (kappa=0.7380) and stratification (kappa=0.7515) of Acute Kidney Injury. Conclusion: This study showed that the RIFLE and AKIN criteria have a good agreement in the detection and stratification of acute kidney injury after coronary artery bypass grafting.

1. PhD. Adjunct Professor. Head of the Cardiac Surgery Unit at University Hospital of Maranhão, São Luís, MA, Brazil. Discussion of outcomes and final review of the study. 2. Physician at University Hospital of Maranhão, São Luís, MA, Brazil. Literature review and data collection. 3. Physician at University Hospital of Maranhão, São Luís, MA, Brazil. Outcomes assessment. 4. PhD. Adjunct Professor at University Hospital of Maranhão, São Luís, MA, Brazil. Outcomes discussion. 5. Master's Degree from University Hospital of Maranhão, São Luís, MA, Brazil. Data collection. 6. Medical student at University Hospital of Maranhão, São Luís, MA, Brazil. Preparation and review of the study. 7. Physician at University Hospital of Maranhão, São Luís, MA, Brazil. Statistical analysis.

8. Resident Physician at University Hospital of Maranhão, São Luís, MA, Brazil. Translation and literature review.

Descriptors: Myocardial revascularization. Acute kidney injury. Risk factors. Resumo Objetivo: Comparar os critérios RIFLE (Risk, Injury, Failure, Loss and End­ Stage Renal Failure) e AKIN (Acute Kidney Injury Network) para diagnóstico de lesão renal aguda em pacientes no pós-­operatório de revascularização do miocárdio. Métodos: Coorte retrospectiva, a partir dos prontuários

This study was carried out at University Hospital of Federal University of Maranhão, São Luís, MA, Brazil. Correspondence address: Vinicius José da Silva Nina Hospital Universitário da Universidade Federal do Maranhão Rua Barão de Itapary, 227 – Centro – São Luís, MA, Brazil – Zip code: 65020-070. E-mail: rvnina@terra.com.br Article received on November 23rd, 2012 Article accepted on March 7th, 2013

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Resultados: A média de idades dos pacientes foi de 63,43 ± 9,01 anos, havendo predominância do gênero masculino (66,86%). A lesão renal aguda foi detectada em 33,14% pelo AKIN e 29,59% pelo RIFLE. A hemodiálise foi necessária em 3,57% e em 4% dos pacientes, quando o AKIN e RIFLE foram aplicados, respectivamente. Foram a óbito 4% e 3,57% dos pacientes com Lesão Renal Aguda pelos critérios RIFLE e AKIN, respectivamente. Em 88,76% dos casos, ambos os métodos demonstraram boa concordância para detecção (kappa=0,7380) e estratificação (kappa=0,7515) de lesão renal aguda. Conclusão: O presente estudo permitiu concluir que os critérios RIFLE e AKIN possuem boa concordância na detecção e estratificação da lesão renal aguda no pós-operatório de revascularização do miocárdio.

Abbreviations, acronyms & symbols ADQI AKI AKIN AMI ARF CABG CPB HD ICU RIFLE RRT

Acute Dialysis Quality Initiative Group Acute kidney injury Acute Kidney Injury Network Acute myocardial infarction Acute renal failure Coronary artery bypass grafting Cardiopulmonary bypass Hemodialysis Intensive care unit Risk, Injury, Failure, Loss and End-stage Renal Failure Renal replacement therapy

de 169 pacientes submetidos à cirurgia de revascularização do miocárdio, de janeiro de 2007 a dezembro de 2008. As informações foram inseridas em um banco de dados e analisadas pelo software STATA 9.0.

Descritores: Revascularização miocárdica. Lesão renal aguda. Fatores de risco.

INTRODUCTION

comparing the two classification systems and they shown little difference between the two systems [12]. Therefore, there is no insight into the advantages of choosing one approach to define and classify the AKI as opposed to the another [12]. AKI is a serious complication in the postoperative period of cardiac surgery with major impact on mortality and length of intensive care unit (ICU) stay [13]. Early detection of AKI is of utmost importance in making decisions regarding appropriate therapy. The aim of this study was to compare the “RIFLE and AKIN” criteria in patients undergoing cardiac surgery at a university hospital, in order to identify the one that provides the best classification of renal injury and thereby contribute to better monitoring and outcome of these cases.

Acute kidney injury (AKI) is an important and prevalent complication in the prognosis of cardiac surgery [1]. The term AKI is used to reflect the entire spectrum of what is defined as the abrupt reduction in renal function, in hours or days, in which acute renal failure (ARF) is characterized by a decrease in the glomerular filtration rate and/or urinary volume, in addition to the loss of basic functions, such as the inability to maintain the hydro-electrolyte and basic acid balance [2]. Most estimates demonstrates that over 30% of patients undergoing cardiac surgery develop clinically severe renal damage [3], with the need for dialysis ranging from 1.4% to 7% [4,5] and mortality rate of 5% to 44% [6,7]. As a result of the lack of a standardized definition, AKI has received numerous definitions. In 2002, the Acute Dialysis Quality Initiative Group (ADQI) proposed the classification Risk, Injury, Failure, Loss and End-stage Renal Failure (RIFLE) classification. This classification system uses measurements of serum creatinine levels and urine output [8], having been validated in over 550,000 patients worldwide [9]. In 2005, the Acute Kidney Injury Network (AKIN), proposed improvements to the RIFLE criteria in order to make the detection of acute kidney injury clear and faster, by adopting a lower cutoff point for variation in serum creatinine [10]. Both RIFLE and AKIN criteria, used to rate the degree of AKI associated with mortality seems to correlate in a progressive manner and may predict its severity [11]. Thus, both classification systems help to standardize the definition and management of this disease. There have been few studies

METHODS Type of Study We performed an analytical, retrospective cohort study, based on data obtained from medical records of patients undergoing cardiac surgery for coronary artery bypass grafting (CABG) at a University Hospital, from January 2007 to December 2008. Of the 305 patients who underwent this type of surgery, 169 were included in the study after the application of inclusion and non-inclusion criteria, considering a prevalence of AKI of 30% [4] a sample power of 80% and an alpha error of 5%. Inclusion Criteria We included all patients older than 18 who underwent CABG alone.

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Non-inclusion criteria Patients undergoing CABG surgery associated with other procedures, patients with stage 5 chronic kidney disease and patients who died within 24 hours after surgery were not included in this study.

0.60, good for kappa values between 0.61 and 0.80, and excellent for kappa values above 0.80 [18]. Data processing was performed in STATA statistical software, version 9.0. The results were considered significant when P<0.05. Ethical Aspects This study was approved by the Research Ethics Committee of the institution under record number 001811/2010-00 complying with the requirements of the Resolution of the National Health Council 196/96 for research involving humans.

Data Collection Laboratory tests, clinical presentation, hemodynamic and therapeutic monitoring, and postoperative evolution data for filling the protocol form were obtained from the medical records. Creatinine clearance was estimated using the CockcroftGault formula [14]. To assess the impairment of renal function in the postoperative period, RIFLE [15] and AKIN [16] ratings were used. The RIFLE classification provides a uniform definition for the AKI that includes criteria for three categories of injury: risk renal failure (R - Risk), renal injury (I) and renal failure (F). In addition it includes two classes of renal disease: renal function (L) and end-stage kidney disease (E) [17], defined according to function impairment, in a period of 4 weeks and 3 months, respectively [9] (Table 1). The AKIN criteria adopted higher baseline serum creatinine levels: between 150 – 200%, 200 – 300% and > 300% for classifying the AKI in stages 1, 2 and 3, respectively. Since AKI stage 1 is analogous to RIFLE Risk, kidney injury corresponds to stage 2, and renal failure/renal replacement therapy (RRT) to stage 3 of AKIN [12] (Table 2).

RESULTS Among the 169 patients studied, there was a predominance of males (66.86%). The mean age was 63.43 ± 9.01 years-old, and 63.91% (108) were over 60 years-old. Of all patients studied, 33.14% (56) met the diagnostic criteria for AKI, based on the AKIN classification. According to the RIFLE criterion, 29.59% (50) of the patients developed AKI (Table 3). Although forty-four (26.03%) patients were classified as having AKI by both criteria, 12 (7.10%) patients were considered ARF carriers only by AKIN, and 6 (3.55%) patients only by RIFLE. There was no statistically significant association between the variables for gender, age, prior hypertension, extent and severity of coronary artery disease, the times cardiopulmonary bypass (CPB) and anoxia, number of grafts, need for blood transfusion, postoperative bleeding, use of vasopressors and the development of AKI by both criteria. In patients with renal injury by RIFLE classification, obesity (36%, P=0.011) and intraoperative ventricular tachycardia (4%, P=0.026) were significantly associated with the development of AKI. In the group of patients with AKI by AKIN classification, prior angina (67.86%, P=0.024), obesity (37.50%, P=0.002), intraoperative ventricular tachycardia (3.57%, P=0.043), postoperative acute myocardial infarction (AMI) (3.57%, P=0.043) and vasodilators (73.36% P=0.006) were significantly associated with the occurrence of renal impairment (Table 4).

Statistical Analysis Quantitative variables were expressed as means and standard deviation, whereas qualitative variables were expressed as proportions and were compared using the chi-square test. The t test was used to compare means. The level of agreement of the RIFLE and AKIN classification criteria was assessed through kappa’s test. Agreement was considered weak when kappa values were below 0.4, moderate for kappa values between 0.41 and

Table 1. RIFLE classification. Classification Glomerular filtration rate Urine output Without ARF Increased SCr < 1.5 x baseline or decrease in GFR ≥ 25% ≤ 0.5 ml/kg/h Risk (RIFLE-R) Increased SCr from 1.5 to < 2.0 x baseline or decrease in GFR between 25-50% <0.5 ml/kg/h for 6h Injury (RIFLE-I) Increased SCr from 2.0 to <3.0 x baseline or decrease in GFR > 50-75% <0.5 ml/kg/h in 12 hours Failure (RIFLE-F) Increased SCr from 3.0 x baseline or decrease in GFR> 75% or Crs> 4mg/dL <0.3 ml/kg/h in 24 hours or anuria for 12h Loss Complete loss of renal function; loss for more than 4 weeks CKD stage 5 Final stage of the disease for more than 3 months Source: Adapted from Bellomo, 2004. SCr = serum creatinine, GFR = glomerular filtration rate; CKD stage 5 = chronic kidney disease with = GFR <15 ml/min/1.73m2

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Table 2. AKIN classification. Stage 1

Serum creatinine criteria Increased SCr > or = 0.3 mg/dl (> or = 26.4 micromol/L) or increased > or = 150 - 200% (1.5 to 2-fold) from baseline 2 Increase SCr > at 200 - 300% (> 23 times) the basal value 3 Increased SCr > 300% (3 times) the basal value (or Scr > or = 4mg/dl) with surge increase greater than 0.5 mg/dL Source: Adapted from Mehta, 2007. SCr = serum creatinine

Urine output criteria < 0.5 ml/kg/h for more than 6 hours < 0.5 ml/kg/h for more than 12 hours < 0.3 ml/kg/h for 24 hours or anuria for 12 hours

Table 3. Incidence of AKI stratified by RIFLE and AKIN criteria. Rate (n = 169) AKIN RIFLE Rate (n = 169) Without AKI 70.41% (119) Without AKI 66.86% (113) 25.44% (43) Risk Risk 29.59% (50) Injury 3.55% (6) Injury 2.96% (5) 0.59% (1) Failure Failure 0.59% (1) AKI = acute kidney injury

Table 4. Relationship of clinical variables and anthropometric ratings from AKI. Variables Angina not yes BMI weight normal overweight obesity IVA no yes PO-AMI no yes Vasodilator no yes

With AKI

RIFLE Without AKI

P

With AKI

AKIN

Without AKI

P

16 (32%) 34 (68%)

59 (49.58%) 60 (50.42%)

0.05

18 (32.14%) 38 (67.86%)

57 (50.44%) 56 (49.56%)

15 (30%) 16 (32%) 19 (38%)

15 (38.65%) 20 (46.22%) 21 (15.13%)

0.011

15 (26.78%) 20 (35.72%) 21 (37.50%)

46 (40.71%) 51 (45.13%) 16 (14.16%)

48 (96%) 2 (4%)

119 (100%) 0

0.026

54 (96.43%) 2 (3.57%)

113 (100%) 0

0.043

49 (98%) 1 (2%)

118 (99.16%) 1 (0.84%)

0.51

54 (96.43%) 2 (3.57%)

113 (100%) 0

0.043

14 (28.57%) 35 (71.43%)

50 (42.37%) 68 (57.63%)

0.122

13 (23.64%) 42 (76.36%)

51 (45.54%) 61 (54.46%)

0.006

0.024

0.002

AKI = acute kidney injury, BMI = body mass index; IVA = intraoperative ventricular arrhythmia

Only two (1.18%) patients required hemodialysis (HD) by both criteria, corresponding to 3.57% of patients with AKI by AKIN criteria (P=0.043) and 4% by the RIFLE criteria (P=0.026). Of these, only the AKIN or RIFLE-F stage 3 patient died (P=0.001). Overall mortality rate was 2.96%, where two of the five patients who died, were AKI carriers

by both criteria (Table 5). When comparing the RIFLE and AKIN methods, there was good agreement in the detection of AKI in 88.76% of the cases (kappa = 0.738). Additionally, AKI stratification, also showed good agreement in 88.76% of the cases (kappa = 0.7515).

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Table 5. Clinical outcomes stratified by the RIFLE and AKIN classifications. Outcomes Total Hemodialysis AKI Hemodialysis Total deaths AKI deaths Discharge

Classification systems

RIFLE (n = 50) 2 (4%)* Risk Injury Failure Risk Injury Failure

0 1 (2%) 1 (2%) 2 (3.57%)

48

1 (2%) 0 1 (2%) ***

AKIN (n = 56) 2 (3.57%) ** 0 Stage I 1 (1.78%) Stage II 1 (1.78%) Stage III Stage I Stage II Stage III

2 (4%)

54

1 (1.78%) 0 1 (1.78%) ***

AKI = acute kidney injury; *P = 0.026, **P = 0.043, ***P = 0.001 (Pearson chi-square test)

DISCUSSION

all patients underwent CABG with CPB, and, for both criteria, those who developed AKI, had longer cardiopulmonary bypass; however, the sample size did not allow for statistical significance between the CPB time and acute renal injury outcome to be determined. In this study obesity was associated with the development of AKI by RIFLE and AKIN criteria. Similar findings using other classification methods of AKI have been found by Conlon et al. [24] and Pontes et al. [28]. This finding can be attributed to greater endothelial dysfunction in obese patients [24]. Although not statistically significant, the transfused patients in this study had more AKI, as in the TRACS study in which transfusion was associated with postoperative AKI [29]. Ventricular tachycardia during surgery was also associated with AKI by both criteria. The postoperative AMI was statistically associated only by AKIN criteria. The low cardiac output due to these events may be directly responsible for renal hypoperfusion which culminates with AKI [13]. Furthermore, it was observed that angina pectoris was also associated with AKI according to the AKIN classification. The ischemic acute syndrome may be secondary to the formation of atherosclerotic plaques or thrombus development [23] and thus suggest greater likelihood of ischemic attacks in other organs and systems leading to hypoperfusion. This association was reported in other studies in patients who developed AKI [4,7]. Association of use of vasopressors with AKI, although well established [7], was not observed in this study. However, vasodilator drugs are statistically associated with AKI, which is not very clear in the literature. It is possible that this association is a result of AMI cases in this study, since the use of vasodilator drugs is useful in cases where the appropriate volume replacement and optimization of cardiac output with inotropic agents do not reverse the condition of low output, as in cases of cardiogenic shock after AMI [30]. Two (1.9%) patients required hemodialysis (HD), one being classified as AKIN stage 2 or RIFLEI; the other, AKIN stage 3 or RIFLE-F.

Acute kidney injury associated with cardiac surgery is a clinical problem, with significant higher rates of mortality [13,19]. Volkmann et al. [20] demonstrated that AKI may be hidden in over 25% of patients who underwent CABG. Thus, the existence of a classification criterion to detect early kidney as well as a proposal to unify the classification/definition of AKI are essencial [4,6,7]. Similar to others, this study demonstrates that, by adopting lower values of variation in serum creatinine as a marker of renal injury the AKIN criteria identified more acute kidney injury than RIFLE [12,21]. Patients rated with AKI by both criteria were predominantly elderly (> 60 years), male, with hypertension, angina, obesity and overweight. The same profile was found by Brito et al. [4], using other classification criteria. AKI after CPB has occurred between 1% and 15% [22]. Several authors have associated CPB time with the development of AKI in the cardiac surgery postoperative [23-25]. Changes such as contact with nonendothelial surfaces, exclusion of pulmonary flow, presence of minimally pulsatile or nonpulsatile continuous flow may contribute to the pathogenesis of AKI associated with this procedure [12,19]. The positive impact of the absence of CPB on renal function during the postoperative period of cardiac surgery has been described in a coronary randomized clinical trial where 4752 patients undergoing CABG were randomly allocated into two groups according to whether cardiopulmonary bypass was used. The authors observed a lower incidence of AKI in the off-pump group (28%) when compared to the on-pump group (32.1%), with P=0.01 [26]. In the same context, Chawla et al. [27], studying patients with chronic kidney disease in nondialytic stages, observed a reduction in mortality and a need for renal replacement therapy among those patients who had undergone surgery without CPB, especially when the levels of glomerular filtration rate were lower. In the present study,

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Other studies show a rate among dialysis patients who develop AKI, according to various classifications ranging from 1.4% to 7% [4,5,31]. Although AKIN has been proposed in order to improve RIFLE sensitivity, in this study, there was not a significant difference in the incidence and mortality of AKI in the CABG postoperative detected by both criteria, similar to the study by Cruz et al. [32], which found that mortality rates in RIFLE and AKIN groups did not differ significantly. Bagshaw et al. [12] also found no statistical significance in terms of incidence and hospital mortality of AKI, according to RIFLE or AKIN criteria in the first 24 hours after admission. In this study, the RIFLE and AKIN methods showed good concordance in relation to the incidence and strata of severity of acute kidney injury in agreement with studies by Dan et al. [31] and Zappitelli et al. [33] who found excellent concordance between RIFLE and AKIN in AKI classification in adult and pediatric patients, respectively. The retrospective design and sample size are limitations of this study. However, it has clinical relevance and it was not limited to assessment of only the first 24 hours of ICU admission, allowing for the assessment of other outcomes, such as the need for dialysis and the occurrence of death secondary to AKI.

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Brasil CKOI,ORIGINAL et al. - Cardiovascular ARTICLEprevention in coronary heart disease patients: guidelines implementation in clinical practice

Cardiovascular prevention in coronary heart disease patients: guidelines implementation in clinical practice Prevenção cardiovascular abrangente em pacientes com doença arterial coronária: implementação das diretrizes na prática clínica

Clarisse Kaoru Ogawa Indio do Brasil1, Álvaro Avezum Junior2, Luciana Uint3, Maria Isabel Del Monaco3, Valéria Mozetic de Barros3, Soraia Youssef Rachid Campos3, Amanda M. R. Sousa4

DOI: 10.5935/1678-9741.20130034

RBCCV 44205-1463

Abstract Objective: To demonstrate the utilization of a clinical improvement program in stable coronary artery disease patients to increase the evidence-proven treatment utilization, and to describe the ongoing clinical practice and lifestyle change counseling. Methods: Cross-sectional study followed by a longitudinal component in which the tools utilization to improve clinical practice was assessed by means of additional cross-sectional data collection. 710 consecutive patients were included (Phase 1). After tools implementation, within 6 months period, 705 patients were included (Phase 2) for comparative analysis. Randomly, 318 patients from Phase 1 were selected, 6-12 months after the first evaluation (Phase 3). Results: Phase 1 to Phase 2: there were improvement on smoking cessation (P=0.019), dyslipidemia (P<0.001), hypertension and physical activity (P<0.001). There was significant difference on angiotensin converting enzyme inhibitors

– ACEI (67.2% vs. 56.8%, P<0.001); angiotensin II receptor blockers – ARB II (25.4% vs. 32.9%, P=0.002) and beta-blocker (88.7% vs. 91.9%, P=0.047). Phase 1 to Phase 3: there was both weight (P=0.044), and blood pressure reduction (P<0.001). There was statistical significant difference on ACEI (64.8% vs. 61.6%, P=0.011) and ARB II (27.0% vs. 31.3%, P=0.035). Conclusion: There was no significant change on the evidencebased pharmacological treatment utilization between pre and post-intervention phases; there was significant improvement concerning smoking and physical activity in phase 2; substantial improvement on blood pressure levels in both comparisons (Phase 1 to 2 and Phase 1 to 3). The inclusion of a case-manager for the process management was crucial for program efficacy. Comprehensive programs for clinical practice should be pursued for longer follow-up period.

1. Head of the Medical Unit of Coronary Diseases at Dante Pazzanese Institute of Cardiology, São Paulo, SP, Brazil. 2. Director of the Research Division at Dante Pazzanese Institute of Cardiology, São Paulo, SP, Brazil. 3. Assistant Physician of the Medical Unit of Coronary Diseases at Dante Pazzanese Institute of Cardiology, São Paulo, SP, Brazil. 4. General Director at Dante Pazzanese Institute of Cardiology, São Paulo, SP, Brazil.

Correspondence address: Clarisse Kaoru Ogawa Indio do Brasil Instituto Dante Pazzanese de Cardiologia Av. Dr. Dante Pazzanese, 500 – Prédio dos Ambulatórios I – Seção Médica de Coronariopatias – Vila Mariana – São Paulo, SP, Brazil – Zip code: 04012-909 E-mail: brasilcki@uol.com.br

This study was carried out at at Dante Pazzanese Institute of Cardiology, São Paulo, SP, Brazil.

Article received on April 22th, 2013 Article accepted on May 15th, 2013

Descriptors: Coronary disease. Secondary prevention. Risk factors. Guidelines as topic.

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Após aplicação de ferramentas para melhoria da prática clínica, foram incluídos, após seis meses, 705 pacientes com coleta dos mesmos dados (Fase 2). Foram selecionados aleatoriamente, a partir do primeiro grupo, 318 prontuários para comparação desses mesmos pacientes (Fase 3). Resultados: Comparação entre as Fases 1 e 2: melhora em relação a tabagismo (P=0,019), dislipidemia (P<0,001), hipertensão arterial e atividade física regular (P<0,001). Diferença significativa para inibidores da enzima de conversão da angiotensina – IECA (67,2% vs. 56,8%, P<0,001); antagonistas do receptor da angiotensina II – ARA II (25,4% vs. 32,9%, P=0,002) e betabloqueador (88,7% vs. 91,9%, P=0,047). Comparação entre as Fases 1 e 3: houve redução do peso (P=0,044) e pressão arterial (P<0,001). Em relação à prescrição de medicamentos recomendados, diferença para IECA (64,8% vs. 61,6%, P=0,011) e ARA II (27,0% vs. 31,3%, P=0,035). Conclusão: Não houve mudança significativa na utilização de medicamentos; entretanto, observou-se melhora significativa em relação ao tabagismo e atividade física na Fase 2; melhora substancial nos níveis de pressão arterial, na comparação tanto entre as Fases 1 e 2 como entre as Fases 1 e 3. A inclusão de enfermeiro treinado para gerenciar o processo foi fundamental. Programas abrangentes de melhoria de qualidade assistencial, provavelmente, devem ser continuados por período de seguimento maior.

Abbreviations, acronyms and symbols ASA ARA II CHAMP

acetylsalicylic acid Angiotensin receptor antagonism II Cardiac Hospitalization Atherosclerosis Management Program COURAGE Outcomes Utilizing Revascularization and Aggressive Drug Evaluation CAD Coronary Artery Disease EUROASPIRE European Action on Secondary Prevention through Intervention to Reduce Events HDL High-density lipoprotein ACE inhibitors Angiotensin converting enzyme BMI Body Mass Index LDL Low-density lipoprotein DBP Diastolic Blood Pressure SBP systolic blood pressure PURE Prospective Urban Rural Epidemiological SPSS Statistical Package for the Social Sciences STABILITY STabilization of Atherosclerotic plaque By Initiation of darapLadIb Therapy

Resumo Objetivo: Demonstrar a eficácia de um programa de otimização da prática clínica em pacientes com doença arterial coronária para prescrição de medicamentos e documentar a prática clínica vigente quanto aos medicamentos e medidas para a mudança do estilo de vida. Métodos: Estudo de corte transversal, seguido de componente longitudinal. Foram incluídos 710 pacientes consecutivos (Fase 1).

Descritores: Doença das coronárias. Prevenção secundária. Fatores de risco. Guias como assunto.

INTRODUCTION

Epidemiological (PURE) aimed to assess the use of drugs recommended by the guidelines: antiplatelet agents, statins, angiotensin-converting enzyme inhibitors (ACEI) or antagonists of the angiotensin II receptor (ARB) and betablockers in patients with CAD or stroke in high, middle and low income countries, [6]. This study demonstrated that the use of these drugs was far from desirable, even in developed countries [6]. In an attempt to try to reduce the gap between scientific knowledge and the application of it in clinical practice, there were programs that consist of implementing tools and strategies to improve appropriate prescribing of these medications and compliance with them, in order to achieve the aims in relation to the control of risk factors and lifestyle modification. The Cardiac Hospitalization Atherosclerosis Management Program (CHAMP) assessed patients hospitalized for acute myocardial infarction, unstable angina, cardiac catheterization, for procedures such as coronary artery bypass grafting or percutaneous coronary intervention and ischemic heart failure [7]. The program demonstrated that treatment for secondary prevention, started early, brought

Despite guidelines recommendations on chronic coronary artery disease (CAD) and available scientific evidence to show that the optimal pharmacological treatment, in addition to vigorous intervention on risk factors and lifestyle has benefits in relation to reducing nonfatal cardiovascular events and mortality [1-4], there is a substantial gap between knowledge (availability of data and scientific evidence) and its application in clinical practice, which needs to be filled, due to the secondary prevention therapy is underutilized in clinical practice in patients with CAD. This fact occurs worldwide, as demonstrated by studies EUROpean Action on Secondary Prevention through Intervention to Reduce Events (EUROASPIRE) I, II and III, which revealed that the prevention of cardiovascular disease in clinical practice is inadequate in European countries [5]. These studies concluded that there is need for more effective management regarding the prescription of drugs with proven efficacy and lifestyle modification, with control of risk factors in patients with CAD [5]. Similarly, the study Prospective Urban Rural

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improvement in the prescription of drugs and compliance with them, which resulted in significant reduction of events in one year after discharge [7]. The study Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE), in addition to compare optimal medical therapy alone with optimal medical treatment associated with percutaneous coronary intervention in patients with stable CAD, it included all patients in a program of lifestyle modification life administered by trained nurses to manage processes (“case manager”) and demonstrated significant changes in behavior, improving the parameters dependent of change of lifestyle and medication adherence, as well as control of risk factors [8]. Although these studies cited in the international literature, there is lack of information related to this issue, especially in tertiary care hospitals specialize in cardiology in the country.

interviews and specific guidance in each area, as needed; g) delivery of booklets with the guidelines of the multidisciplinary team. Patients included Phase 1: pre-intervention: consisting of 710 patients who had their medical records assessed for collection of the described data. Phase 2: post-intervention: consists of 705 consecutive patients who were seen in the section, with the same information collected in phase 1. Phase 3: consisting of 318 patients selected from the initial sample (Phase 1), randomly, whose medical records were assessed for new data collection, after six to twelve months. Analysis plan a) comparison between the data of Phases 1 and 2 (preand post-intervention); b) comparing the data from Phases 1 and 3, with the aim of comparing the same patients between them. The study design involved cross-section, followed by longitudinal component. The minimum sample size calculation was performed proposing that it would be considered a proper difference of the use of acetylsalicylic acid (ASA) between the two samples, increased from 90% to 95% and the probability of type 1 error α = 95% and power of Test 1-β=0.90, resulting in 620 patients for each of the samples. Numerical variables were described by their minimum and maximum values, averages, standard deviations and medians and categorical variables were described by absolute and relative frequencies (%). Inferential analysis was performed taking into account the characteristics of the study:

METHODS We included patients of both genders, CAD patients with proven coronary angiography showing at least one epicardial coronary artery lesions with ≥ 50%, clinically stable, with or without previous myocardial infarction, pharmacological treatment alone or who underwent revascularization procedures. Patients were identified through the review of medical records of patients seen consecutively in the Medical Section of Coronary Artery Disease, and collected data regarding demographic and anthropometric characteristics, clinical features, risk factors, laboratory tests and treatment used in routine clinical practice. After this initial collection, the tools used for optimization of clinical practice were: a) meeting with physicians and health sector, reinforcing the importance of prescription drugs and non-pharmacological measures recommended by guidelines; b) monthly meeting with residents, instructing and guiding for recommendations; c) printed posters set in all offices on the drugs recommended for all patients with stable CAD, with their doses and the aims to be achieved regarding the levels of low density lipoprotein (LDL)-cholesterol, systolic (SBP) and diastolic blood pressure (DBP) and the levels of fasting glucose and glycated hemoglobin levels in diabetic patients; d) process manager (“case manager”) to assess the prescription of therapies recommended by spreadsheets distributed daily in the offices to be filled by physicians; e) guidance to physicians about the need to inform patients about the CAD, which and what are the risk factors and their importance in disease development and progression, how to control them and the benefits of this control; f) multidisciplinary team consisting of physician responsible for the anti-smoking group, a physical education teacher, dietician and psychologist available for individual

Phases 1 and 2 For numeric variables, we used the nonparametric MannWhitney test for comparison of independent groups, and for categorical variables, the chi-square test. Phases 1 and 3 For numeric variables, we used the nonparametric Wilcoxon test for comparing dependent groups for categorical variables, and the nonparametric McNemar test for comparison of proportion before and after. The level of significance for the tests was 5% (alpha=0.05) and statistical packages used were SPSS for Windows, version 19.0 (SPSS Inc. Chicago, Illinois) and R software (version 2.15.2). RESULTS Comparative results between patients in Phases 1 and 2 The demographic characteristics Gender, age and ethnicity were comparable between the

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two groups. Regarding clinical characteristics, there was a statistically significant difference with respect to stable angina (P<0.001), CABG (P=0.001) and renal failure (P=0.018), more prevalent in Stage 2, and in relation with heart failure (P=0.003) and asymptomatic ventricular dysfunction (P <0.001) more prevalent in Step 1 (Table 1)

deviation and median were calculated. For these variables there was no significant difference between the two groups (Table 4). In addition, we calculated the proportion of patients with laboratory tests within the targets and the results were: LDL <70 mg/dl: 31.6% vs. 34.8% (P=0.198), HDL> 40 mg> dL (men): 41.0% vs. 37.0% (P=0.118) HDL>45 mg/dl (women) vs 19%. 19% (P=0.784), triglycerides <150 mg/dl 67% vs. 68% (P=0.847) and among diabetics, fasting glucose <100 mg/dl: 15.4% vs. 19.1% (P=0.235), and HbA1c <7.0%: 46% vs. 40.3% (P=0.167). Comparing the prescription of drugs recommended by the guidelines between the pre- and post-intervention, the results showed significant differences, with lower use of ACE inhibitors (P<0.001) and greater use of ARBs (P=0.002) and beta blockers (P=0.047) (Table 5). Assessing the number of patients of whom ACE inhibitor or ARB were prescribed, the results were: 657 (92.5%) in Phase 1 and 627 (89.0%) in Phase 2 (P=0.025).

Regarding associated risk factors Smoking, diabetes, dyslipidemia, LDL >100 mg/dl and/ or high-density lipoprotein (HDL) <40 mg/dl (men) and HDL <45 mg/dl (women), hypertension (BP > 140/90 mmHg) , hypertriglyceridemia (TG>150 mg/dl) and physical activity, there was significant difference compared to nonsmokers (P=0.019) and information about smoking more prevalent in Stage 2 (P<0.001), a lower proportion of dyslipidemia (P<0.001), a lower proportion of hypertensive patients (P<0.001) and an increase in the proportion of regular physical activity (P<0.001) in Phase 2 (Table 2). Regarding anthropometric data For weight, height, body mass index (BMI), waist circumference, SBP and DBP and heart rate, the minimum, maximum, average, standard deviation and median significant difference were calculated regarding the improvement for abdominal circumference between men (P=0.022), SBP (P<0.001) and DBP (P<0.001) in Phase 2 (Table 3). A significant increase in the number of collected information comparing the two phases, demonstrating the efficiency of program service quality with respect to the collection of important data for clinical practice: information on weight were available in 56.5% vs. 93.8% of the time vs. 56%. 94%, on BMI, 55.6% vs. 93% and the abdominal circumference, 5.6% vs. 71.6% respectively for Phases 1 and 2 (P<0.001). As to laboratory, total cholesterol, LDL-cholesterol, HDLcholesterol, triglycerides, fasting glucose and glycated hemoglobin, the minimum, maximum, average, standard

Comparative results between patients in Phases 1 and 3 Whereas patients in Phase 3 are a subset of patients randomly selected from the first group (Phase 1), the demographic data are similar. Likewise, information about the clinical characteristics were similar, but there was a significant difference only for peripheral arterial disease: 31 (9.7%) patients and 42 (13.3%) between Stages 1 and 3, respectively (P=0.007). Regarding risk factors, we considered only modifiable risks: smoking and physical activity. For both smoking and physical activity, the results showed no significant differences between the two phases. Regarding anthropometric measurements, there was significant differences for weight, with increase from Phase 1 to 3 (P=0.044) and reductions in SBP and DBP from Phase 1 to 3 (P<0.001) (Table 6).

Table 1. Clinical characteristics Phase 1 (N = 710) N % Stable angina 160 22.5 Myocardial infarction 451 63.5 Surgical MR 373 52.5 Percutaneous MR 142 20.0 Heart failure 129 18.2 Asymptomatic ventricular dysfunction (EF <50%) 175 24.6 TIA / stroke 38 5.4 PAD 66 9.3 CRF (Cr > 2.0mg/dl) 29 4.1 Chronic AF 7 1.0

Phase 2 (N = 705) N % 222 31.5 423 60.1 438 62.2 131 18.6 88 12.5 98 13.9 43 6.1 68 9.7 49 7.0 13 1.8

P Value < 0.001 0.195 0.001 0.524 0.003 < 0.001 0.532 0.789 0.018 0.168

CABG = coronary artery bypass grafting, EF = ejection fraction; TIA = transient ischemic attack, PAD = peripheral arterial disease; CRF = chronic renal failure, Cr = creatinine, AF = atrial fibrillation

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Table 2. Associated risk factors.

Smoking Never Ex-smoker Current No information Diabetes (FPG > 126 mg/dl) Dyslipidemia LDL > 100 mg/dl HDL < (male) 40 mg/dl LDL >100 mg/dl HDL < (fem) 45 mg/dl Arterial Hypertension (AP > 140/90 mmHg) Hypertriglyceridemia (TG > 150 mg/dl) Physical activity Regular Sedentary No information

Phase 1 (N = 710) N %

Phase 2 (N = 705) N %

122 388 65 135 302 686/710 473/487

17.2 54.6 9.2 19.0 42.5 96.6 97.1

175 409 60 61 305 543/705 376/495

25.0 58.0 8.5 8.5 43.3 77.7 76.6

213/223

95.5

165/205

78.6

679

95.6

613

87.2

< 0.001

260

36.6

237

33.6

0.253

19 103 588

2.7 14.5 82.8

157 311 232

22.4 44.4 33.1

< 0.001

P Value 0.019 0.134 0.289 < 0.001 0.729 < 0.001

< 0.001

FPG = fasting plasma glucose, LDL = low density lipoprotein, HDL = high density lipoprotein, BP = blood pressure, TG = triglycerides Table 3. Anthropometric measurements.

Age (years) Weight (kg) Height (cm) BMI (kg/m²) WC (cm) Male Female SAP (mmHg) PDAP (mmHg) HR (beat/min)

Min 32 45.0 135 16.5 79 83 80 50 44

Phase 1 (N = 710) Max Mean SD 93 64.9 9.09 136 76.2 14.09 189 164.3 8.75 489 28.13 4.40 140 126 240 140 120

105.7 100.6 136.3 81.54 68.61

13.61 11.80 22.66 11.52 10.21

Median 65 75.0 165 27.68

Min 29 35.0 136 14.80

Max 96 151.0 193 64.5

104.5 98.0 130.0 80.0 68.0

61 63 65 40 41

195 130 210 120 124

Phase 2 (N = 705) Mean SD 65.2 9.9 74.8 14.08 163.5 8.72 27.88 4.57 99.76 96.88 129.1 77.63 68.50

11.55 11.13 18.75 10.5 9.35

Median 65 74.0 164 27.40

P Value 0.390 0.209 0.182 0.357

99.0 97.0 130.0 80.0 68.0

0.022 0.414 <0.001 <0.001 0.755

kg = kilogram, cm = cm, BMI = body mass index, m2 = meters squared, WC = waist circumference, SBP = systolic blood pressure, DBP = diastolic blood pressure, HR = heart rate, mmHg = millimeters of mercury, beat/min = beats per minute, Min = minimum, Max = maximum, SD = standard deviation Table 4. Laboratory exams Min Total Cholesterol (mg/dl) 79 LDL (mg/dl) 23 HDL (mg/dl) Man 24 Women 20 Triglycerides (mg/dl) 34 Blood glucose (mg/dl) 50 Hb A1c (%) 4.8

Max 469 255 77 113 1111 497 15.9

Phase 1 (N = 710) Mean SD 162.95 45.17 87.77 34.41 43.68 50.60 144.77 117.87 6.9

9.74 13.83 100.3 44.56 1.59

Median 155.00 81.00

Min 64 23

Max 311 217

43.00 50.00 120.00 106.00 6.4

27 31 36 51 4.7

96 96 800 316 15.0

Phase 2 (N = 705) Mean SD 157.78 38.51 84.80 30.15 43.95 50.31 138.77 114.71 6.84

11.10 11.64 81.67 38.08 1.57

Median 152.00 81.00

P Value 0.139 0.317

42.00 48.00 120.00 103.00 6.3

0.049 0.549 0.624 0.259 0.393

LDL = low-density lipoprotein, HDL = high-density lipoprotein, mg/dl = milligrams per deciliter, HbA1c = hemoglobin, A1c, Min = min, Max = maximum, SD = standard deviation

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Table 5. Recommended medications. Phase 1 (N = 710) N % 684 96.3 676 95.2 14 2.0 5 0.7 699 98.5 599 85.7 93 13.3 6 0.9 212 29.6 477 67.2 403 84.5 66 13.8 6 1.3 180 25.4 177 98.3 1 0.6 630 88.7 8 1.3 339 53.8 240 38.1 44 6.9

Antiplatelet AAS Clopidogrel Ticlopidine Statins Simvastatin Atorvastatin Rosuvastatin Ezetimibe ACEI Enalapril Captopril Ramipril ARA II Losartan Candesartan Beta-blocker Propranolol Atenolol Carvedilol Metoprolol

Phase 2 (N = 705) N % 676 96.4 668 94.8 17 2.5 4 0.6 686 97.7 465 67.8 219 31.9 2 0.3 65 9.2 398 56.8 363 91.2 32 8.0 2 0.5 229 32.9 221 96.5 0 0 644 91.9 4 0.62 371 57.6 223 34.6 47 7.3

P Value 0.923 0.846 0.572 0.716 0.317 < 0.001 < 0.001 0.288 < 0.001 < 0.001 0.047 < 0.001 0.159 0.002 0.070 1.000 0.047 0.953 0.067 0.384 0.719

ASA = acetylsalicylic acid, ACE inhibitors = Angiotensin converting enzyme, ARA II = antagonist receptor angiotensin II

Table 6. Anthropometric measurements. Weight (kg) BMI (kg/m2) WC (cm2) SAP (mmHg) DAP (mmHg) HR (bat/min)

Phase 1 3 1 3 1 3 1 3 1 3 1 3

N 73 73 66 66 6 6 305 305 304 304 280 280

Min 460 460 17.85 17.30 83.0 84.0 90.0 80.0 60.0 40.0 48.0 50.0

Max 136.0 137.0 41.89 41.90 117.0 113.0 240.0 215.0 140.0 120.0 113.0 143.0

Mean 76.37 77.37 27.76 28.15 101.0 103.1 136.76 131.93 81.49 78.06 67.93 69.05

SD 16.56 16.62 4.64 4.55 11.82 11.27 23.20 20.54 12.11 11.05 9.79 11.64

Median 74.0 74.0 27.68 28.15 102.0 106.0 130.0 130.0 80.0 80.0 67.0 68.0

P Value 0.044 0.184 0.255 < 0.001 < 0.001 0.255

kg = kilogram, BMI = body mass index; m2 = meters squared, cm = centimeter, WC= waist circumference, SBP = systolic blood pressure, DBP = diastolic blood pressure, mmHg = millimeters of mercury, HR = heart rate; beat/ min = beats per minute, Min = minimum, Max = maximum, SD = standard deviation

Regarding laboratory tests, the results showed no significant difference (Table 7). When comparing the proportion of patients in Phases 1 and 3 who had laboratory tests within the targets, the results were: LDL <70 mg/dl: 34.6% and 37.3% (P=0.509), HDL> 40 mg/dl (men): 54.3% and 58.8% (P=0.073), HDL> 45 mg/

dl (women): 62.2% and 60.2% (P=0.630), fasting glucose < 100 mg/dl: 13.6% and 21.2% (P=0.136), and HbA1c <7.0%: 47.4% and 51.3% (P=1.00), respectively. Comparing the prescription of recommended medications, there was a significant difference for lower use of ACE inhibitors (P=0.011) and increased use of ARBs (P=0.035) - Table 8.

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Table 7. Laboratory tests. N SD Phase Min Max Mean Median P Value 274 43.74 1 93.0 398.0 158.98 150.0 0.762 3 274 82.0 323.0 157.15 39.92 151.0 276 34.83 LDL (mg/dl) 1 34.0 255.0 84.41 81.5 0.762 276 30.47 3 30.5 194.0 82.62 80.9 195 9.66 HDL (mg/dl) 1 24.0 77.0 44.01 43.0 0.453 195 11.14 Men 3 27.0 96.0 44.02 42.0 HDL (mg/dl) 1 82 29.0 113.0 51.96 14.11 50.5 0.276 82 11.69 Women 3 31.0 96.0 50.24 48.0 276 99.38 TG (mg/dl) 1 34.0 1111.0 146.12 120.5 0.387 276 95.81 3 35.0 827.0 146.76 125.5 280 31.36 FG (mg/dl) 1 63.0 339.0 115.66 106.50 0.956 280 39.23 3 63.0 314.0 115.99 104.00 147 1.39 HbA1C (%) 1 4.8 12.5 6.69 6.3 0.312 147 1.50 3 5.0 12.8 6.79 6.3 mg/dL = milligrams per deciliter, LDL = low density lipoprotein, HDL = high density lipoprotein, TG = triglycerides, FG = fasting glucose, HbA1c = hemoglobin H1c, Min = minimum, Max = maximum, SD = standard deviation Total cholesterol (mg/dl)

Table 8. Recommended medications

Antiplatelet AAS Clopidogrel Ticlopidine Statin Simvastatin Atorvastatin Rosuvastatin Ezetimibe ACEI Enalapril Captopril Ramipril ARA II Losartan Candesartan Beta-blocker Propanolol Atenolol Carvedilol Metoprolol

Phase 1 N % 308 96.9 304 98.7 7 2.3 2 0.6 314 99.7 272 85.5 39 12.3 2 0.6 85 26.7 206 64.8 178 56.0 26 8.2 2 0.6 86 27 86 27 0 0.0 285 89.6 4 1.4 156 54.7 103 36.14 22 7.7

Phase 3 N % 309 97.2 307 99.36 3 0.97 1 0.37 315 99.1 236 74.2 76 23.9 3 0.9 16 5.2 191 61.6 180 56.6 10 3.1 1 0.3 99 31.3 97 30.5 1 0.3 286 89.9 3 0.9 155 54.2 111 38.1 17 5.9

DISCUSSION

P Value

Results of Phases 1 and 2 The demographic characteristics, gender, age and ethnicity, were comparable. Regarding clinical characteristics, there was significant differences related to the higher proportion of stable angina (P<0.001), CABG (P=0.001) and in relation to the lower proportion of heart failure (P=0.003) and asymptomatic ventricular dysfunction (P<0.001). Comparing the risk factors, we found the proportion of dyslipidemia and hypertension significantly lower (P<0.001 for both variables) in Phase 2. There was improvement in regard to smoking, as the category of never-smokers. For regular physical activity, there was a significant improvement in Phase 2, from 2.7% to 22.4% (P<0.001), but the proportion of patients with missing information on this variable was very high in Phase 1: 82.8 % vs. Phase 2 33.1% (P<0.001). Regarding anthropometric measurements between the two populations, the study showed significant improvement compared to waist circumference in men (P=0.022), SBP (P<0.001) and DBP (P<0.001), demonstrating substantial improvement in the last two parameters, which can be attributed to increased adherence to prescribed medications and better understanding about the importance of diet and

1.000 0.453 0.289 1.000 1.000 < 0.001 < 0.001 1.000 0.011 0.011 0.878 < 0.001 1.000 0.035 0.080 1.000 1.000 1.000 1.000 0.229 0.186

ASA = acetylsalicylic acid; ACE inhibitors = Angiotensin converting enzyme; ARA II = antagonist receptor angiotensin II

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physical activity after intervention. With respect to weight, BMI and waist circumference among women, there was a reduction in numbers, but without reaching statistical significance. We note that there was a significant increase in the number of information collected in Phase 2: for the weight from 56.5% to 93.8%, for height from 56% to 94%, for BMI from 55.6% to 93.9% and for waist circumference from 5.6% to 71.6%, all P<0.001, demonstrating the effectiveness of the intervention for improving quality of care. The comparison of laboratory tests showed a significant difference for the variable HDL-cholesterol in men (P=0.049). As for total cholesterol, LDL-cholesterol, triglycerides, fasting glucose and HbA1c, we found numerical reduction, but without reaching statistical significance. Again, this finding may reflect lack of statistical power to detect difference. The substudy of the COURAGE trial that assessed intensive multifactorial intervention for patients with stable CAD assessing medication adherence and the parameters resulting from the modification of lifestyle through program managed by trained nurses (“case manager”) showed: significant reduction of smoking from 23% to 19% (P<0.025), increased physical activity of 58% to 66% (P<0.001), reduced SBP (P<0.001), LDL-cholesterol (P<0.0014) , increasing HDLcholesterol (P<0.001) and triglycerides (P<0.001). Among diabetic patients, glycated hemoglobin remained unchanged (P=1.0). The BMI increased after 5 years (P<0.001). Comparing the results of this clinical study with the present project, we found some similarities and differences. Regarding the blood pressure, there was significant decrease in both. With respect to smoking, there was significant reduction in the COURAGE trial and in the present study, significant reduction of never-smokers. A significant increase of patients who practiced regular physical activity in COURAGE, as in this study. As for LDL-cholesterol, there was a significant reduction in COURAGE, and in this study, only numerical reduction, but without statistical significance. We note that the average LDL-cholesterol prerandomization was higher in COURAGE: 101 ± 0.83 mg/dl, compared to the average of the present study, even before the intervention: 87.77 ± 34.41 mg/dl, possibly due to the higher level of prescribing in our service, because it is a tertiary and academic hospital. The BMI in the present study showed numerical reduction, but without statistical significance, while there was significant increase in COURAGE. The glycated hemoglobin in diabetic patients remained unchanged in both studies. Additionally, in the present study, we calculated the proportion of patients with laboratory tests within the recommended targets in Phases 1 and 3: LDL <70 mg/dl: 31.6% vs. 34.8% (P=0.198), HDL> 40 mg/dl (men) and > 45 mg/dl (women): 41% vs. 37% (P=0.118) and 19% vs. 19% (P=0.784), respectively; triglycerides <150 mg/dl 67% vs. 68.0% (P=0.847) and among diabetics, fasting glucose <100 mg/dl: 15.4% vs. 19.1% (P=0.235) and glycated hemoglobin

<7%: 46% vs. 40.3% (P=0.167). Except triglyceride levels, all other parameters showed ratios below 50% within the targets. We can, in an exploratory way, interpret the absence of differences in these parameters after implementation of the intervention program, as a result of the lack of statistical power to detect differences that may exist, short observation period so that the improvement could be demonstrated and finally the lack of efficacy the tools used in the program. Comparing the prescription of recommended medications, the results of this study showed antiplatelet: 96.3% vs. 96.4% (P=0.923), statins: 98.5% vs. 97.7% (P=0.317) and statistically significant lower use of ACE inhibitors: 67.2% vs. 56.8% (P <0.001) and greater use of ARBs: 25.4% vs. 32.9% (P=0.002) and beta-blockers: 88.7% to 91.9% (P=0.047). The use of medication deemed appropriate in the COURAGE trial after five years was higher as antiplatelet agents: from 87% to 96%, statins: 64% to 93%, ACEI or ARB: 46% to 72% and beta-blockers: 69 % to 85% (P <0.001). In the present study, the proportion of patients on ACE inhibitors or ARBs, set amidst Phases 1 and 2 was: 92.5% and 89%, respectively (P=0.025). The reduction in the use of this class of drugs may be in fact higher proportion of patients with chronic renal failure in Phase 2. The CHAMP program assessed patients with the characteristics already discussed and demonstrated that preventive treatment initiated early, during admission and before discharge, substantially improved the prescription of drugs and adherence to the same of those which resulted in significant reduction of events one year after discharged in relation to recurrent myocardial infarction, hospitalization and cardiac and total mortality (P <0.05 for all events). This program also showed that medication adherence was maintained during the period of six years, 68%, 92%, 91% and 94% for aspirin, 12%, 68%, 72% for beta-blockers in 78%, 4%, 52 %, 64% and 70% for ACEI and 6%, 88%, 89% and 90% for statins in periods respectively the 1992/1993 1994/1995, 1996/1997 and 1998/1999. Comparing the present study regarding the use of medicines, this study showed similar proportion of use in relation to all drugs after six years of evolution. The CHAMP project was performed twelve years before the present study and, on that date, the use of evidence-based medications was substantially lower, e.g., 12% beta-blockers, statins 6% and 4% of ACE inhibitors. This study was performed in a tertiary and academic hospital, where the use of these therapies is already in reasonable proportions, with lower propensity to increase in use after programs of quality of care improvement. Recent publication of the preliminary results of the study Stabilization of Atherosclerotic plaque By Initiation of darapLadIb Therapy (STABILITY), involving 15,828 patients in 39 countries with chronic CAD, showed that the proportion of the prescription of recommended therapy for secondary prevention of CAD was adequate: antiplatelet (96%), statins

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(97%), ACE inhibitors and ARBs (77%) and beta-blockers (79%). Despite this, many patients did not reach treatment goals for blood pressure (46%), LDL-cholesterol (29%), glycemic control among diabetics and the prevalence of overweight and obesity were high (79% and 36%, respectively) with considerable regional differences. Among diabetic patients, 44% achieved target HbA1c <7% [9]. These results show many similarities with the present study, since the proportion of use of drugs recommended, both during pre- and post-intervention, was quite satisfactory, but the patients who achieved the proposed targets were lagging behind: waist circumference (21.1%), LDL-cholesterol (34.8%), HDL cholesterol (56%) and HbA1c (40.3%). The exception was the control of blood pressure, both systolic and diastolic, whose averages significantly reduced in comparison with the Phase 1 and 2 [9]. Comparing these data with the results of the present study, we consider some differences: a) the setting of a clinical trial is different from what happens in the real world, because the profile of the patients and the inclusion and exclusion criteria are not always the same and, in the present study, patients were included in the outpatient care routine and b) differences in follow-up time: 4.6 years on average for COURAGE, six years in CHAMP and, in this study, between six to twelve months, c) in studies under discussion the same patients in the pre- and post-intervention period were compared, whereas in the present study, the comparison between Phases 1 and 2 were independent populations, and Phases 1 and 3 were dependent groups.

compare the prescription of recommended medications, there was a significant difference for lower use of ACE inhibitors (P=0.011) and increased use of ARBs (P=0.035). In Phase 3, different from that observed in Phase 2, there was no increase in the number of collected information, particularly with respect to demographics, making difficult the appropriate methodological data analysis. We can attribute this to the fact of not acting managing process nurse at this stage. The STABILITY study, which involved patients with a profile similar to the current study aimint the atherosclerotic plaque stabilization in patients with chronic CAD using the suitable standard medication, based on the ACC/AHA guidelines for secondary prevention, established as targets: proportions ≥ 90 % of patients on aspirin, ≥ 80% of patients on statin therapy, ≥ 80% of patients with LDL-cholesterol <100 mg/dL, ≥ 80% of patients with SBP <140 mmHg and DBP <90 mmHg and ≥ 70% of diabetic patients with HbA1c <7%. After four years of follow-up, this study obtained the following proportions of use of medicines: aspirin, 96% and 94.3%, statins, 96.7% and 95%, beta-blockers, 76.3% and 79%, ACEI/ARBs , 82.7% and 86.7%; in relation to the targets: LDL cholesterol <70 mg/dl, 33% and 33.7%, SBP <140 mmHg, 76.3% and 66.4%, DBP < 90 mmHg, 85.5% and 89.3%, HbA1c <7%, 29.8% and 39.3%, respectively [9]. Assessing data related to our center in this clinical study, comparing the initial visit to the last visit, the results showed: use of AAS: 100% and 100%, statins: 94.1% and 100%, betablockers: 76.5% and 88.2%, ACEI/ARBs: 70.6% and 76.5%, LDL-cholesterol <70mg/dL: 17.6% and 29.4%, SBP <140 mmHg: 42.9% and 85, 7%, DBP <90 mmHg: 74.4% and 100% and HbA1c <7.0%: 16.7% and 33.3%, respectively. Comparing the results of STABILITY in our center with this study, it was observed proportion of prescription medications comparable, however, regarding some targets, although it deals with an assessment of daily clinical practice in the institution, showed relatively better results than STABILITY, as follows: LDL-cholesterol <70 mg/dl: 37.3% vs. 29.4% and HbA1c: 51.3% vs. 33.3%.

Results of the Phase 1 and Phase 3 The demographic and clinical characteristics were similar except for peripheral arterial disease, whose proportion was 9.7% in Phase 1, and 13.3% in Phase 3 (P=0.007). Regarding risk factors, we consider only the modifiable: smoking and physical activity, and for both variables, there was no significant differences between the two phases. Regarding anthropometric measures, there was a significant increase of the weight (P=0.004) and a significant reduction in SBP (P<0.001) and DBP (P<0.001). For BMI and waist circumference, there was increased number, but without reaching statistical significance. Regarding laboratory tests, there was no significant differences between the two phases, although total cholesterol and LDL-cholesterol showed numerical reduction, but other variables remained in similar levels. Comparing the proportion of patients’ exams within the targets, we observed: LDL cholesterol <70 mg/dl: 34.6% vs. 37.3% (P=0.509), HDL-cholesterol> 40 mg/dl (men): 54.3% vs. 58.8% (P=0.073), HDL-cholesterol> 45 mg/dl (female): 62.2% vs. 60.2% (P=0.630) and among diabetics, fasting glucose <100 mg/dl: 13.6% vs. 21.2% (P=0.136), and HbA1c <7.0%: 47.4% vs. 51.3% (P=1.00). When we

CONCLUSION There was no significant change in the use of medications with proven efficacy in secondary prevention of CAD between the pre- and post-intervention, both between Phases 1 and 2 and between Phases 1 and 3, considering their proper prescription from pre- intervention. Regarding the parameters related to the modification of lifestyle through non-pharmacological measures, there was a significant improvement in relation to smoking and physical activity in Phase 2 compared to Phase 1, and numerical improvement, but did not reach statistical significance for other parameters such as waist circumference, BMI, LDL-cholesterol, HDLcholesterol, and in relation to the targets of HbA1c for

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diabetics. There was substantial improvement in the levels of SBP and DBP in both comparison between Phases 1 and 2 and between Phases 1 and 3. The inclusion of nurses trained to manage the “case manager” process is critical to the effectiveness of a comprehensive prevention program for patients with CAD. Programs for improving quality of care in tertiary and academic hospitals, should probably be continued by follow-up period exceeding one year.

Management of Stable Angina Pectoris of the European Society of Cardiology. Eur Heart J. 2006;27(11):1341-81. 3. César LAM, Mansur AP, Armaganijan D, Amino JG, Sousa AC, Simão AF, et al. Diretrizes de doença coronariana crônica angina estável. Arq Bras Cardiol. 2004;83(supl. II):1-43. 4. Spolito AC, Caramelli B, Fonseca FAH, Bertolami AC, Rassi Jr. A, Sposito AC, et al. IV Diretriz brasileira sobre dislipidemias e prevenção da aterosclerose. Arq Bras Cardiol. 2007;88(supl I):1-19.

ACKNOWLEDGMENTS

5. Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009;373(9667):929-40.

To Wellington Cícero de Carvalho, systems analyst at Division of Translational Epidemiology of the Dante Pazzanese Institute of Cardiology. To Soane Mota dos Santos, Statistics at Laboratory of Epidemiology and Statistics of the Dante Pazzanese Institute of Cardiology. To Nilza Tamashiro, biologist and study coordinator.

6. Yusuf S, Islam S, Chow CK, Rangarajan S, Dagenais G, Diaz R, et AL; Prospective Urban Rural Epidemiology (PURE) Study Investigators. Use of secondary prevention drugs for cardiovascular disease in the community in highincome, middle-income, and low-income countries (the PURE Study): a prospective epidemiological survey. Lancet. 2011;378(9798):1231-43. 7. Fonarow GC, Gawlinski A, Moughrabi S, Tillisch JH. Improved treatment of coronary heart disease by implementation of a Cardiac Hospitalization Atherosclerosis Management Program (CHAMP). Am J Cardiol. 2001;87(7):819-22.

REFERENCES 1. Fraker TD Jr, Fihn SD, Gibbons RJ, Abrams J, Chatterjee K, Daley J, et al. 2007 chronic angina focused update of the ACC/ AHA 2002 Guidelines for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Writing Group to develop the focused update of the 2002 Guidelines for the management of patients with chronic stable angina. Circulation. 2007;116(23):2762-72.

8. Maron DJ, Boden WE, O’Rourke RA, Hartigan PM, Calfas KJ, Mancini GB, et al; COURAGE Trial Research Group. Intensive multifactorial intervention for stable coronary artery disease: optimal medical therapy in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial. J Am Coll Cardiol. 2010;55(13):1348-58. 9. Vedin O, Hagströn E, Stewart R, Brown R, Krug-Gourley S, Davies R, et al. Secondary prevention and risk factor achievement in a global, high-risk population with established coronary heart disease: baseline results from the STABILITY study. Eur J Prev Cardiol. 2012. Disponível em: http://cpr.sagepub.com/ content/ early/ 2012/04/ 10/ 2047 487312444995. Acesso em: 10/4/2013.

2. Fox K, Garcia MA, Ardissino D, Buszman P, Camici PG, Crea F, et al; Task Force on the Management of Stable Angina Pectoris of the European Society of Cardiology; ESC Committee for Practice Guidelines (CPG). Guidelines on the management of stable angina pectoris: executive summary: The Task Force on the

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Neirotti RA - Cardiac surgery: the infinite quest. Part III SPECIAL ARTICLE

Cardiac surgery: the infinite quest. Part III Pediatric cardiac surgery: a discipline on its own Cirurgia cardíaca: a busca infinita. Parte III - Cirurgia cardíaca pediátrica: uma disciplina por si só

Rodolfo A. Neirotti1 O último dos três tópicos deste ensaio enfatiza as particularidades da cirurgia cardíaca pediátrica. Espero que a série de textos possa ter levado à reflexão sobre como lidamos com vários aspectos ligados à nossa especialidade e sirva de impulso para adoção de novas medidas, a fim de elevar o nível de excelência da cirurgia cardiovascular, proporcionando o bem-estar do paciente, que é nosso objetivo maior. Domingo Braile Editor-Chefe/RBCCV/BJCVS

DOI: 10.5935/1678-9741.20130035

RBCCV 44205-1464

Ultramini-abstract: Although there are common grounds with adult cardiac surgery, it is important to understand the differences in the business plan, paths, manpower, mindset, training, and infrastructure that are essential in those institutions where pediatric cardiac surgery can and should be performed. Time to start thinking, it is not what we can do, but should we do it? Pediatric cardiac surgery Pediatric cardiac surgery has been available for many years in several developing countries, thanks to the creative adaptation of individuals who were able to stretch the limits of their abilities in spite of the restricted resources that forced them to work harder but not allowing them to work smarter. In this context, economic constraint is a constant problem forcing those involved to focus on short-term solutions for tomorrow’s needs. It was sometimes tougher to deal with the multiple stumbling blocks than with the patient condition. After all, we were trying to keep our feet on the ground and our heads in the clouds. Leadership, patience, reflection, self-discipline, perseverance, dedication, the capacity to adapt, and the creativity that comes with having to work under adverse circumstances were the keys to success but do not necessarily ensure sustainability [1]. Still, worldwide we have islands of

excellence in an ocean where millions of people living outside North America, Australia, and Europe have limited or no access to pediatric cardiac surgery. Making the impossible possible: The most conspicuous advantage of the human mind is its remarkable ability to simplify complex tasks, but due to the limitations of simplification it is both a strength and a weakness. The escalating costs and the lack of money required to simplify the surgical process led to implementing an ingenious multiprinciple adaptive work —the KISS (Keep It Simple and Safe) approach — in order to help more patients with the available funds, equipment and manpower. However, the danger of oversimplification of the complex process of policy formulation is substantial. Solutions often reside not in the executive suite but in the collective intelligence of people at all levels, who need to use each other’s resources and learn their way to those solutions [1]. The road to successful development and change in a program depends on numerous variables that include government and hospital administration support, consistent medical staff leadership, and a medical staff that is receptive and committed to protocolizing peri-operative diagnosis and management algorithms, data acquisition, and implementation of a quality assurance program.

1. MD, MPA, PhD, FETCS, Honorary member of the Brazilian Society of Cardiovascular Surgery.

Article received on April 23rd, 2013 Article accepted on May 10th, 2013

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Catholic, the world’s most unequal region, is a good example of relatively modest philanthropic efforts with many opportunities for leadership. Culture and/or interpretation of the concept of philanthropy may be responsible for weak philanthropic efforts. In the United States philanthropy is mainly the donation of money for a good cause. In other parts of the world where money is scarce, people donate their time and skills to help other persons without expecting personal benefits. Lack of tax incentives and tax evasion also has a negative impact on philanthropy and charitable donations. Even when tax incentives are available, deductions are only possible for the minority that pays taxes. In addition, lack of trust and accountability are powerful deterrents. However, not everybody is poor in the emerging countries. There are often people with enough education and resources to organize and participate in local philanthropic efforts, to help their own “have nots”. The philanthropic leadership will come once the elites have the opportunity to cross the physical and psychological barriers that make it difficult to get to know the poor, recognizing them as fellow citizens. Philanthropy can also add to the total sum of efforts necessary to rescue the education systems.

Abbreviations, acronyms & symbols CPB HLHS KISS PCCC RACHS TGA

Cardiopulmonary by-pass Hypoplastic left heart syndrome Keep It Simple and Safe Pediatric Cardiac Care Consortium Risk Adjustment for Congenital Heart Disease Transposition of the great arteries

International/National Cooperation: Because the world faces many formidable problems, we cannot expect to solve the mal-distribution and poor access to cardiac surgery through the regular channels for international aid. Currently, there are numerous groups around the world involved with structured international projects with the support of nongovernmental organizations together with other members of civil society, but without coordination among them. In humanitarian medicine, there is room for cooperation rather than competition, because the people in need outnumber those able to provide assistance. In those countries where mal-distribution of access is the main problem, the existing centers of excellence can contribute to the creation and support of new centers – “national twinning programs” – an alternative model to be explored. Recipient selection: Although some of the following recommendations were included in PART I of this article, it is pertinent to reiterate them: • To avoid squandering energy and resources it is important to identify places, “fertile sites”, and their needs, with receptive individuals where good work is already being done. • The majority of donor programs focus on developing an on-going relationship with a host program. This relationship involves visiting teams, teaching, training, collaborative research, and donation of equipment. • Twining programs in Pediatric Cardiac Surgery. These “twinning processes” result in a transfer of knowledge, ideas and skills. A visiting team usually includes: surgeon, anesthesiologist, cardiologist, perfusionist, critical care specialist, interventional cardiologist, and nurses. • Do they work? Yes, in selective places with the potential of eventually becoming autonomous, with the donor program assuming a consultant role. • This strategy is based on a long-term educational and technical support model. • This approach will be most effective when local governments, doctors, and hospitals have a genuine learning interest. • It is important to using metrics and evaluations as a tool for learning and sensing the feasibility of the project.

Basic Requirements: After analyzing concepts and theories, we can now move to the practices required in our daily work such as: • Institutional enabling support: Needless to say, this means enabling the faculty to do the work through the active participation of those on the top in addressing and resolving other limiting factors which can eventually reduce the number of binding constraints — thereby, with synergy, creating the mutual benefit of changing for the better in a partnership. High quality institutions provide the required enabling support to achieve better care in cardiac surgery. • Integrated approach: Team work exist when all members of the cardiovascular services — a cluster of people with similar interests and focused on excellence — contribute, although in different degrees, to the quality of the final outcome; in another words, the members of the team show the willingness to face reality and agree to do adaptive work throughout the organization. • Volume for a safe and sustainable care: Many hospitals want to have a pediatric cardiac surgery program. It might be that this is a specialty that has to be done only in centers with enough volume [2]. A minimum of approximately 100 surgical cases per year, with the potential to increase to 300 cases per year or more over an approximate 5-year period, is needed to ensure that heart surgery is not being carried out on children where the low volume of patients or other factors makes it unsafe to perform such surgery. National standards should be developed, as a matter of priority, for all aspects of the care and treatment of children with congenital heart disease.

Domestic Philanthropic Endeavors Philanthropy in the developing countries is suboptimal and has no solid tradition. Latin America, predominantly

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• Diagnosis and Treatment: 1) Pediatric cardiologists and related specialties; 2) Congenital cardiac surgery, 24/7, with 100 pediatric cardiac surgery procedures per year/surgeon as a minimum; 3) Congenital cardiac anesthesia 24/7; 4) Nursing (24/7; 4) Interventional cardiology 24/7; 6) Other allied health services such as perfusion, social work, pharmacy, blood bank 24/7. • Pediatric Intensive Care: Preoperative evaluation and optimization of patient condition; postoperative care 24/7. • Follow-up and application of methods for meaningful comparisons of in-hospital mortality for groups of children undergoing surgery for congenital heart disease: such as the Risk Adjustment for Congenital Heart Surgery (RACHS-1) methodology or the Aristotle Basic Complexity Score (ABC Score) and Aristotle Basic Complexity Levels (ABC Levels). • Utilization of the clinical material: for contributions to professional society’s national and international journals. Make the best and most effective use of their organization’s resources. • Open mindedness: Institutional sclerosis is a major obstacle to progress. In those institutions with rigid structures, all of their tenured staff should cooperate, be prepare to compromise and agree to work toward these basic requirements, using the method of self criticism and rectification to address not only technical issues but also dysfunctional behaviors. Human factors — especially those affecting interpersonal relationships, interactions and collaboration — are frequent causes of lasting problems [3]. “Minds are like parachutes. They only function when they are open.” Sir James Dewar

increased hospitalization is expected to persist into the near future. We need to flex new muscles as the demands of the business environment are changing. One size does not fit all: In the current era, it is an artificial construct cemented together by an elite that ignores the increasing trend for sub-specialization in both fields and the challenges around the safety and sustainability of these services in the future. Rather than artificially repressing them, those institutions in which pediatric cardiac surgery is combined with the adults program need to understand the differences in the business plan, paths, manpower, mindset, training, and infrastructure of both disciplines. It is possible to modernize the structural needs of outdated institutions by applying the concept of spatial thinking, a cognitive skill that can help in understanding the world around us by using the properties of space in everyday life, the workplace, and science, to structure problems, find answers, and express solutions. In a case of co-habitation, it is helpful for analytic purposes, to develop a modern vision based in a constructive co-existence — to exist in peace with others at the same time or in the same place despite differences — preserving the necessary connectivity to solve common problems.1 Furthermore, spatial thinking is also a tool to consider for designing a structure with core groups of dedicated specialists — human capital — covering critical areas in which different practices and protocols are required, such as surgery, anesthesia, intensive care, and perfusion. While preserving their identity, this approach can improve the quality and the efficiency of the services by finding paths to allow synergies among all disciplines involved, thus avoiding a “perfect storm”, an event where a rare combination of circumstances will aggravate a situation drastically. Such a significant change can only succeed with a strong bottom up leadership, involvement, and cooperation. Open governance should facilitate the integration. Closed means a small nonresponsive and non-expandable number of decision makers. The context should determine the strategies and processes to address these issues, and what parts of the professionals, administration, and professional societies should be engaged in planning, setting and articulating the goals and participating in the negotiations. As Charlene Barshefsky, Great Negotiator Award Winner, reminds us: “The goal tells you what you need to know. It informs who should be at the table, and which parties are extraneous…. If the goal is framed too broadly, the results are likely to be ambiguous and unenforceable.” In other words, critical thinking is fundamental to understand the limitations of the current model and to address creatively and effectively the needs of the users with a long

Rethinking the Adult and Pediatric Cardiac Surgery under one roof An outdated model at a crossroad: Up to the late seventies, most of the new developments in cardiac surgery were coming out of centers doing both adult and pediatric work. By 1975, ten percent of the patients coming to operation were within the first 6 months of life and 19% were within the first 12 months of life. Currently, around 60% of the patients are operated on their first year of life, and 30 % in the first month of life [4]. This trend — the movement of pediatric cardiac surgery to the very young — has developed because of the numerous biological and socio-economic benefits of early repairs, as well as the excellent outcomes that are being obtained particularly in pediatric cardiac surgery centers as a result of an ongoing generation of knowledge. “In some specialties, such as pediatric cardiac surgery, clinical practice has become so sophisticated and the technology has become so advanced that those patients who would otherwise have died only 10 years ago can now be safely treated with confidence” [5]. In addition, hospital admissions for adults with congenital heart disease are increasing at a higher rate than for children, supporting the need for optimizing health delivery for adults, as the drift in

1. Karen Lee Bar-Sinai, “The role of architects in negotiations” Harvard School of Education. Cambridge, November 20, 2012.

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term objective. Then there should be a path to execute and reach that objective that can be frequently evaluated and adjusted accordingly. Compromise can minimize the resistance that might be encountered in implementing the recommended strategies, and help to reach an agreement with a smooth transition, allowing differentiation with advantages for the various components of the system. Work groups ought to consider what should be the design of each program and how this should be enacted — all at once, phased-in, etc. The majority adult cardiac surgeons (number of cases) need to learn how to make their minority pediatric colleagues feel that they are a pillar of the governing structure. Minority pediatric surgeons must embrace their place in the new structure by becoming fully contributing partners while leaving behind any ill sentiments. Because things always change it is important to take measurements to know what the differences are. “This institutional decision needs to be made in a framework of deep reflection, commitment to the well-being of each individual patient and requires considerable study and integrity” [4].

problems. For example, poor cerebral protection can have catastrophic consequences for the patient, the family and the society, such as poor outcomes in learning, behavior, and both physical and mental health. As Shonkoff has made clear, “Every second, a baby’s brain makes 700 new synapses. These connections can be strong or faulty and once made, they cannot be rewired. Early events shape the architecture of the developing brain” [6]. In spite of these particular handicaps an early approach to the initial phase of repair should be attempted whenever possible, since leaving these patients untreated or unnecessarily delaying surgery, contributes to high mortality. To mention only two important neonatal heart problems, for both transposition of the great arteries (TGA) and hypoplastic left heart syndrome (HLHS), a surgical repair performed in the first days after birth has dramatically modified the natural history of these malformations. This progress is well explained in Brooks’ definition of path dependence which refers to the notion that often “something that seems normal or inevitable today began with a choice that made sense at a particular time in the past, but survived despite the eclipse of the justification for that choice” [7]. The operative mortality of HLHS was as high as 40% in the 1990s and has dropped to less than 10% recently [8]. Although the accuracy and quality of the surgical procedure are the most important determinants of survival after surgery for neonates and infants, in addition to early diagnosis, capabilities for transportation and pre-operative resuscitation, require expensive sophisticated support, expertise, manpower, and advanced technology. Given that this cohort of patients has a limited physiologic reserve, complex cardiac lesions that often require technically demanding procedures, and are prone to complications and/or residual related to cardiopulmonary bypass, they are an example in which complexity demands complexity. In all fields there is a residue of anomalies unexplained by the dominant theory. Unsolved observable facts do not necessarily nullify good theories. It just means that more work needs to be done to bring those anomalies into the accepted paradigm. Neonates face unique incremental risk factors related to the patient’s variables and to structural hospital characteristics that should be properly individualized and addressed in a timely fashion in order to improve surgical results. The development of a successful neonatal heart surgery program requires institutional quality, medical expertise and resources — an integrated approach — in which every component of this complex system (individuals, activities, connections, and pathways) should be activated. In other words, a meaningful institutional commitment and staff partnership is necessary to meet the current demand for excellence. Because individual medical leadership and skills are not enough to solve these problems — a puzzle with multiple challenges — neonatal cardiac surgery will linger last in

Neonatal Surgery: an example of complexity The frequent advances in the diagnosis and treatment of congenital heart disease during the last two decades have changed the way these patients are currently managed. Neonatal heart surgery aims at the prompt anatomical and physiological restoration of the anatomy and physiology, or seeks the best feasible palliation, in order to improve functional capacity and life expectancy. In this particular field, the progress in multiple medical and technological areas allows successful early surgical approach to complex pathologies that carried a devastating mortality not long ago. In order to obtain the best possible results and minimize the multiple risks involved in this practice, various considerations have to be taken into account. These are related to the institution where the surgery takes place, the human resources available, and the particular characteristics of the new born patient that presents distinctive critical issues that deserve a few words of caution, including: • Preoperative circumstances requiring a preoperative management according to the anatomic and physiological variants. • Limited physiologic reserve — organ immaturity — lungs, liver, kidneys. • Transient organ dysfunction: cardiac, respiratory, renal. • Known complications and/or consequences related to cardiopulmonary by-pass (CPB) that is unique because of immaturity. • Diverse and complex physiopathology of the cardiac lesions. • Prematurity and low birth weight (2.5 kg or less). • Complex surgical procedures and risks of residual

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most developing countries. Well-trained and skillful surgeons, while being able to generate excellent results in children, have difficulties reproducing the same kind of outcomes with neonates and infants. I am mindful of the danger of being unjust to people who make choices in conditions of uncertainty and circumstances over which they often had little control. It will require efforts at multi-levels of national governments — leaders with a passion for reducing suffering, capable of changing minds and mental models — and civil society to face reality, adjust values and priorities causing social exclusion, and the need to overhaul the health care system. Institutionalizing change is not an easy task but it is probably the road to sustainability [1].

tell them what their own complications and success rates are. The question of what the doctor’s obligation is remains unresolved. Statistical evaluation and comparison of results: "No human investigation can claim to be scientific if it doesn't pass the test of mathematical proof" Leonardo Da Vinci Repair of congenital heart anomalies involves an enormous anatomic variety and offers a diversity of surgical procedures of different complexity that makes a comparative analysis of mortality and quality of results very difficult, even within the same center or among different centers or regions. Often, comparison it is not about how bad you are, but rather about how good others are. Meaningful quality of care evaluation needs to take into consideration the variations of the population — the so called “case mix”. This concept is less important in the adult population due to significant differences in the size of the samples and the diversity of operations [12]. The statistical analysis of crude mortality without taking into consideration case mix complexity is inadequate for comparison and erroneous in itself. Neonatal evaluation carries an additional challenge due to the small numbers and the larger diversity of the procedures. In January 2002, Jenkins & Gauvreau [13] reported a new and original consensus-based method called RACHS-1 (Risk Adjustment for Congenital Heart Disease) which permits a meaningful and adjusted comparison of mortality in children undergoing surgery for congenital heart disease. Two years later, Lacour-Gayet et al. [14] reported another method called “The Aristotle Score”: a complexity-adjusted method to evaluate surgical results. Risk Adjustment for Congenital Heart Disease (RACHS-1): This method was developed to adjust for baseline case mix differences in comparisons to discharge mortality among pediatric patients less than 18 years old. The surgical procedures were classified by a panel of 11 experts (pediatric cardiologists and cardiovascular surgeons) into six categories, 1 being the lowest and 6 the highest risk of expected in-hospital mortality, based on information obtained from the Pediatric Cardiac Care Consortium (PCCC) with 4,370 surgical procedures done in 32 hospitals and the American Hospital Discharge data. This classification is based on the type of surgery rather than on the anatomical diagnosis; for example, in the sequential surgical approach of the HLHS, the first surgical intervention (Norwood procedure) has a risk 6; the second step, the connection of the superior vena cava to the pulmonary artery (bidirectional Glenn) carries a risk 2, and the final surgical intervention (total cavo-pulmonary connection) a risk 3. This system, used to predict mortality and risk adjustment in pediatric cardiovascular surgery constitutes a valid tool

Ethics, experience, decision making for children, and risks Recognition of institutional and individual limitations is imperative for ethical pediatric cardiac care. “When confronted with an ethical dilemma, most of us like to think we would stand up for our principles. But we are not as ethical as we think we are. We overestimate our ability to do what is right and how we act unethically without meaning to. We can become more ethical by bridging the gap between who we are and who we want to be” [9,10]. Experience matters: The more experience physicians and teams have in treating patients with a particular disease or condition, the more likely they are to create better outcomes — and ultimately realize lower cost. By performing particular procedures over and over, teams increase their learning opportunities and thereby reduce mortality rates. Having to think about everything each time leads to imperfect performances. Although procedure volume is relevant, other institutional factors can also contribute to the quality of outcomes. Recognition of institutional limitations is imperative for ethical patient care [11]. Decision making for children: At the beginning and at the end of life, children and elders are not part of the decisionmaking process regarding procedures, risks, or by whom, and where the care should take place. Therefore, adults, parents, and doctors making decisions for them should be aware of their responsibility by including in their considerations the information available regarding risks, prognosis, suffering, quantitative improvement, and long term quality of life. Talking about medical risks, the uncomfortable truths: What duties and responsibilities arise with regard to the physician-patient/parents relationship? Should patients and parents be told of better care elsewhere? [11]. Notwithstanding that some people prefer to be treated close to home even if the risks are higher there, patients are not often told during the informed-consent process that the results of treatment can vary among hospitals and the volume-outcome relationships, particularly for those requiring complex risky procedures. Often, patients and families get some numbers from the literature, but very few physicians sit down and

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people’s behavior. It is difficult to judge anything at all without walking a few miles in the other person's boots. My leadership challenges in my home country and abroad — where I always tried to lead from the middle — resulted in a mix of successes and failures. Like everybody else, I have made my share of mistakes, related at time to insufficient resources, my personality, my emotional intelligence, the feasibility of the task, the limitations in my authority and sometimes not enough knowledge of the local cultural narrative. Effective leadership from the middle is possible but can be extremely difficult and even impossible when those holding the platforms of power at the top are not receptive. This means that a good leader in the right place at the right time still might not necessarily save the day. Politics is about leadership and the ability to get things done. Actions in addition to words! The elasticity of reality describes the relative size of the principle/rhetoricalimplementation/reality gap, resulting in poor implementation of good ideas—a concern about the growing skepticism of future rhetoric. Yet as the gap between reality and rhetoric expands, the risk increases that the public will grow skeptical of future oratory.

to compare the results between different health centers and has been statistically validated worldwide by several authors [15-18]. There is a vast literature referring to the benefits and limitations of both methods, which are at present being used in many institutions all over the world. Moreover, there are currently studies in progress to improve them, adding new elements such as standardization of morbidity measurements and a new development of complexity stratification system based on objective data (the sum of mortality, and morbidity) and subjective technical difficulty [19-21]. Understandable data and analytic leaders — individuals who are at ease with numbers and able to explore solutions based on a rational analysis of complex issues — are needed. Risk stratification for adult congenital heart surgery: This is a large and growing group of patients that require different business models, mindsets, and pathways than the one in use for the pediatric population. Currently no risk stratification score is available for adult congenital cardiac surgery. The discriminatory power of the pediatric risk scores are suboptimal for the adult population, but improve when adding age as a score component. A best performance can be achieved by the combination of age and the Comprehensive Aristotle Score, for both 30-day and 1-year mortality. Proper risk stratification scores for this cohort of patients will be useful to decide who should treat them and where [22,23].

Challenges facing cardiac surgeons and the science of cardiac surgery “Together, as it was the case in the recent past during which enormous progress was made — the list of achievements is long — we need to bring our specialty into a brighter future, it must be something we cannot possibly do!” [24]. We have been able to see so far because we stood on the shoulder of giants. Therefore, we need to nurture our youth in order to give rise to a new generations of giants that will prolong the path to success. Their tools being commitment, technology, creativity, and learning how to learn by cultivating their ability to ask questions that include cause and effect, the cornerstone of critical thinking. In addition, collaboration with other sciences by breaking down the boundaries around academic disciplines, and by strengthening the capacity to adapt, can play a role in finding answers for a future that seems to have no limits. In other words, we must continue to be a resilient system in the face of the inevitable new stumbling blocks — problems or difficulties that stop one from achieving something. However, the history of complexity research indicates that our can-do optimism should always be tempered by caution [25].

Leadership and culture Leaders are individuals who significantly affect others, transforming the way the individuals with whom they come in contact think and go about doing things. They lead by their example; therefore, it is important to recognize that no matter how good you are, you are only as good as the people who are working for you and how good you are developing them. If leaders tell one story but lead contradictory lives, they are hypocrites. A leader is best when people barely know he exists. He is not so good when people obey and acclaim him. But he is worst when they despise him. But of a good leader who talks little, when his work is done and his aim fulfilled, they will say: “We did it ourselves.” (Lao-tzu, 6th Century B.C., Chinese Philosopher) It is important to understand medicine, health care, illness and disease from a socio-cultural perspective. What is medically obvious in one culture might be incomprehensible in another. What is possible in a rich country might be almost impossible in the developing world regardless of authority, leadership and technical competence. Having worked in South America, Europe, and most recently in the United States, I have found that the differences in culture, resources and technology have had a significant impact in my practice and interactions with colleagues, patients and the public. In complex cross-boundary interactions, it is difficult to assess risks and make decisions requiring the calculation of the probability of outcomes and the prediction of

Inferences • Talking directly about problems is risky because most people do not like it. • Enumerating the problems may be easy, finding the solution is proving increasingly difficult in settings without political stability and sustainable economic growth. • We do not have yet the clout — due to lack of cohesion — to advocate successfully for our “orphan” pediatric

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cardiovascular services particularly in the developing world. • It is important to determine what should be preserved, what needs improvement, how it can be done, by whom, and what we must transform [26]. • Those institutions in which pediatric cardiac surgery is combined with the adult program need to understand the differences in the business plan, paths, manpower, mindset, training, and infrastructure of both disciplines. Each group’s bosses should have a clear understanding of what they want from the alliance before signing up. Most important is gaining support at all levels of each discipline for working together. • We need to improve the quality of the decisions we make. How we decide often determines what we decide.2 Ask yourselves, what strategies and processes would you advise to overcome these problems, and what parts of society and other professionals would you want to engage to aid the process? What problems do you expect might be encountered in implementing the recommended strategies? [27]. • Centers of development with the necessary funds and manpower for research to generate new knowledge, particularly in the field of rare diseases, and adults with congenital heart diseases, may be needed for a more efficient treatment, cost benefit ratio, and sustainability of the care. These centers can then disseminate the new knowledge, minimizing or even eliminating the learning curve and develop policies for the future of the specialty [28]. • These centers, can improve their analytic capabilities through adding estimative intelligence to gauge uncertainty and make assumptions about different scenarios, to anticipate the consequences and probabilities [29].

REFERENCES

1. Neirotti R. Pediatric cardiac surgery in less privileged parts of the world. Cardiol Young. 2004;14(3):341-6. 2. Jancin B. Quoting Dr Roger Winkle in “Atrial fibrillation ablation mortality is volume dependent. Elsevier Global Medical News, Thoracic Surgery News, May, 2010. 3. Dearani JA, Neirotti R, Kohnke EJ, Sinha KK, Cabalka AK, Barnes RD, et al. Improving pediatric cardiac surgical care in developing countries: matching resources to needs. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010;13(1):35-43. 4. Kirklin JW. The movement of cardiac surgery to the very young. In: Crupi G, Parenzan L, Anderson R, eds. Perspectives in pediatric cardiac surgery. Mount Kisco: Futura Publishing; 1989. 5. Meeting of the Joint Committee of Primary Care Trusts (JCPCT) United Kingdom, 16th February 2011. 6. Shonkoff J. Center on the Developing Child at Harvard University; 2009. 7. Brooks D. Tools for thinking. The New York Times, March 28, 2011. 8. el-Zein C, Ilbawi MN. Recent advances in neonatal cardiac surgery. World J Surg. 2008;32(3):340-5. 9. Bazerman MH, Tenbrunsel AE. Blind spots: why we fail to do what’s right and what to do about it. Princeton: Princeton University Press; 2011. 10. Birkmeyer JD. Leapfrog Patient safety standards: the patient benefits of universal adoption. The Business Round Table. November 2000.

Final thoughts Some readers may consider this paper “philosophical”. If we accept that philosophy — the base of critical thinking — is “The critical analysis of fundamental assumptions or beliefs”; “A set of ideas or beliefs relating to a particular field or activity” or “A system of values by which one lives”, it could be rightly regarded as philosophical. However, I thought that the title of “Philosophy of Cardiac Surgery” may not sound attractive to the surgeons’ mindset [30].

11. Grady D. Should patients be told of better care elsewhere? The New York Times, January 5, 2009. 12. Ithuralde M, Neirotti R. Neonatal heart surgery: evaluation of risk factors. Neo Reviews. 2011;12;e252-9. 13. Jenkins KJ, Gauvreau K. Center-specific differences in mortality: preliminary analyses using the Risk Adjustment in Congenital Heart Surgery (RACHS-1) method. J Thorac Cardiovasc Surg. 2002;124(1):97-104.

ACKNOWLEGMENTS

14. Lacour-Gayet F, Clarke D, Jacobs J, Comas J, Daebritz S, Daenen W, et al; Aristotle Committee. The Aristotle score: a complexityadjusted method to evaluate surgical results. Eur J Cardiothorac Surg. 2004;25(6):911-24.

The author is grateful to Eugene Blackstone MD, Cleveland Clinic Foundation, William Williams MD, Hospital for Sick Kids of Toronto for their useful recommendations and to Professor Gilbert R. Davis, PhD, Emeritus, Grand Valley University, Grand Rapids MI, for his valuable suggestions and help in preparing the different parts of this manuscript.

15. Jacobs JP, Jacobs ML, Lacour-Gayet FG, Jenkins KJ, Gauvreau K, Bacha E, et al. Stratification of complexity improves the utility and accuracy of outcomes analysis in a Multi-Institutional Congenital Heart Surgery Database: Application of the Risk Adjustment in Congenital Heart Surgery (RACHS-1) and Aristotle Systems in the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database. Pediatr Cardiol. 2009;30(8):1117-30.

2. Iris Bohnet. Institute of Politics. Harvard Kennedy School.

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16. Jenkins KJ. Risk adjustment for congenital heart surgery: the RACHS-1 method. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2004;7:180-4.

stratification for adult congenital heart surgery. Eur J Cardiothorac Surg. 2011;39(4):490-4. 23. O’Leary JM, Siddiqi OK, de Ferranti S, Landzberg MJ, Opotowsky AR. The changing demographics of congenital heart disease hospitalizations in the United States, 1998 through 2010. JAMA. 2013;309(10):984-6.

17. Boethig D, Jenkins KJ, Hecker H, Thies WR, Breymann T. The RACHS-1 risk categories reflect mortality and length of hospital stay in a large German pediatric cardiac surgery population. Eur J Cardiothorac Surg. 2004;26(1):12-7.

24. Colson Y. Looking to the future of cardiothoracic surgery. Editorial Thoracic Surgery News, March 2009.

18. Larsen SH, Pedersen J, Jacobsen J, Johnsen SP, Hansen OK, Hjortdal V. The RACHS-1 risk categories reflect mortality and length of stay in a Danish population of children operated for congenital heart disease. Eur J Cardiothorac Surg. 2005;28(6):877-81.

25. Horgan J. Can engineers and scientists ever master “complexity”? Scientific American; December 10, 2012. Disponível em: http:// blogs.scientificamerican.com/cross-check/2012/12/10/canengineers-and-scientists-ever-master-complexity/

19. Jacobs JP, Mavroudis C, Jacobs ML, Maruszewski B, Tchervenkov CI, Lacour-Gayet FG, et al. What is operative morbidity? Defining complications in a surgical registry database: a report of the STS Congenital Database Taskforce and the Joint EACTS-STS Congenital Database Committee. Ann Thorac Surg. 2007;84(5):1416-21.

26. Caneo LF. Pediatric cardiovascular surgery: what we must preserve, what we should improve and what we must transform. Rev Bras Cir Cardiovasc. 2012;27(2):ix-xi. 27. Norris P. Strengthening Gender Equality in Egypt” Briefing paper for the United Nations Development Program. Regional Conference on Women’s Political participation. Ulaanbaatar, Mongolia. April 4, 2012.

20. Clarke DR, Lacour-Gayet F, Jacobs JP, Jacobs ML, Maruszewski B, Pizarro C, et al. The assessment of complexity in congenital cardiac surgery based on objective data. Cardiol Young. 2008;18(Suppl 2):169-76.

28. Del Nido P. Personal communication. 2012.

21. O’Brien SM, Clarke DR, Jacobs JP, Jacobs ML, Lacour-Gayet FG, Pizarro C, et al. An empirically based tool for analyzing mortality associated with congenital heart surgery. J Thorac Cardiovasc Surg. 2009;138(5):1139-53.

29. Zeckhauser R, Friedman J. When uncertainty can be helpful. Harvard Kennedy School. 2012;4(4). Disponível em: http://www. hks.harvard.edu/news-events/publications/impact-newsletter/ archives/summer-2012/when-uncertainty-can-be-helpful

22. van Gameren M, Putman LM, Takkenberg J, Bogers AJ. Risk

30. Philosophy definition. Free online dictionary.

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Regionalization of Brazilian pediatric cardiovascular surgery Regionalização da cirurgia cardiovascular pediátrica brasileira

Valdester Cavalcante Pinto Júnior1, Maria de Nazaré de Oliveira Fraga2, Sílvia Maria de Freitas3, Ulisses Alexandre Croti4

DOI: 10.5935/1678-9741.20130036

RBCCV 44205-1465

Descriptors: Health policy. Child health. Congenital heart defects.

Descritores: Política de saúde. Saúde da criança. Cardiopatias congênitas.

INTRODUCTION

year old [2]. In another study in 2010 in the state of São Paulo, for the same age group, a 8.5% mortality rate was reported [3]. Even with the implementation of regulations and investments, deficits of surgical procedures remain high. In 2002, the deficit in Brazil was 65% [4] and in 2008, 62% [2]. In the state of São Paulo, in 2010, 50% of children under 1 year old were without surgical treatment [3]. In 2009, Pinto Jr et al. [5] concluded that the nonobservation by the Ministry of Health, regional differences in publishing standard rules for all and an inadequate remuneration per procedure should hinder the expansion in the care.

The National Policy of High Complexity Cardiovascular Care published in 2004 in Ordinance no 210, Annex IV, sets parameters of distribution Services for High- Complexity Pediatric Cardiovascular Surgery, signaling for a network of care to patients with congenital heart disease [1]. Such an attitude aimed to distribute specialized services in pediatric cardiovascular surgery nationwide, using the population criteria as the calculation basis. Congenital heart disease has an impact on perinatal mortality, accounting in Brazil in 2007 for 6% of infant deaths under 1

1. Cardiovascular Surgery Specialist, Master in Public Policy Evaluation at the Federal University of Ceará (UFC), Chief of Pedriatic Cardiovascular Surgery at Hospital Messejana, Fortaleza, CE, Brazil. 2. PhD in Nursing, Federal University of Ceará, faculty member of the Professional Master’s Course in Public Policy Evaluation at UFC, Fortaleza, Ceará, Brazil. 3. Professor of Professional Masters in Public Policy Evaluation at UFC, Fortaleza, Ceará, Brazil. 4. Tenured Professor, Head of the Department of Pediatric Cardiovascular Surgery, São José do Rio Preto – Hospital de Base - FUNFARME / FAMERP, São José do Rio Preto, São Paulo, Brazil.

Correspondence address: Federal University of Ceará / Heart Institute for Children and Teenagers Av University, 2853 - Benfica - Fortaleza, Ceará, Brazil – Zip code: 60020-181 E-mail: contatoicca@yahoo.com.br

Article received on February 14th, 2012 Article approved on March 27th, 2013

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for each of the units, economy of scale in production and transportation costs [9]. The regionalization strategy proposes to find a balance between excessive structural centralization and complete decentralization of health services. For some sectors, this approach, the distance traveled between the housing and the primary centers should not exceed more than 30 minutes and they should provide coverage to a population ranging between 20,000 and 50,000 inhabitants in urban areas. General hospitals should not be more than two hours from their homes and should provide coverage ranging between 50,000 and 200,000 inhabitants. [9] Specialized tertiary hospitals with over 400 beds, should cover a population of approximately 1,000,000 inhabitants, in conjunction with universities and with other services from the secondary level. The highest amount of beds of these establishments would be determined by technological complexity and by economies of scale. These units could assist a geographical radius located in a relatively larger temporal distance (3 to 4 hours) [9]. The distance would be the most important criterion to establish the geographical distribution of health institutions within a regionalized system. We have to point out that, in a country with huge distances, huge regional differences, especially between the extremes almost depopulated regions and overpopulated urban centers, we need to think creatively and context parameters through viable adaptations which can bring positive impacts on the problematic situation. The great criterion is the access [8]. An interrelation with other principle is necessary to make the regionalization effective, hierarchization based on the fact that it is possible to effectively solve certain health problems with production functions of different complexities and therefore with different social costs classified by level of care. The levels of care are different “appropriate technologies” as to the effectiveness, social cost and feasibility of health problems of various complexities, classified into primary, secondary and tertiary. Consequently, the hierarchization is determined by ensuring solution according to the technological complexity required at each level and the system level as a whole [8]. Regionalization could meet several criteria: homogeneous region; polarized region; regional planning. In the first case, it would be based on the possibility of territorial aggregation with uniform characteristics, arbitrarily specified. In the second case, it would correspond to a geographical area influenced by a economic development pole, represented by a company, industrial agglomeration, prominent tertiary activity or an urban center. This area may have a regionalized format, in so far as that around the most developed pole may be distributed more prominent smaller sites of production and distribution, aiming at the economic transportation and economies of scale and adjustements to the demand. The area would correspond to a space articulated by flow productions and commerce. In

Abbreviations, acronyms and symbols CHD USA IBGE SAS UACAC HU

Congenital heart disease United States of America Brazilian Institute of Geography and Statistics Health Care Secretariat (acronym in Portuguese) High Complexity Assistance Unit in Cardiology (acronym in Portuguese) Hospital Unit

The theme regionalization, premise of public health policies, has been studied by the surgeons, although it interferes with patient access to treatment, with an impact on early and late results. This article contributes to enlarge the bibliographic collection, by revealing the national scene as the distribution of pediatric cardiac surgery centers in the light of speeches and concepts of regionalization. CONCEPTS OF REGIONALISATION Regionalization is a scheme of rational deployment of health resources, organized in a hierarchical arrangement, which is the maximum possible care in the primary centers, while other services are being appropriately used according to the patient’s individual needs [6]. According to Somers & Somers [7], regionalization is a formal system of resource allocation with appropriate geographical distribution of health facilities, human resources and programs, so that the different professional activities cover the entire spectrum of comprehensive, primary, secondary, tertiary and long stay care, with all agreements, connections and referral mechanisms required to integrate various levels and institutions in a coherent and efficient way to assist all the patients’ needs in a defined base population. The basic principle of regionalization is that levels of care should be offered as much as possible, by the lowest level of the system. For that, it is necessary to balance the desires and needs of the public to have health services close to their homes, as well as more prestigious and complex centralized facilities. Regionalization requires the allocation of health resources in a particular area, in an order that facilitates the access, offering high quality services, low cost, equity, with a better and faster response to the consumers’ needs and desires [8]. Regionalization is also referred to in private services in the United States of America (USA). The private health system are organized by the market. This distribution can be prioritized according to the company size, the smallest being located in the states and the biggest ones in the large urban centers. This spatial distribution of private services is called “central place theory” and is driven by three factors: the volume of demand

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the case of the ​​planning area, this derives from the application of political-administrative criteria inserted the in planning activity. We define a region based on the intentionality of political authority, which claims an understanding of territory based on the implementation requirements of certain public services, in the exercise of the regulatory power of the state or, for example, the focus of public sector policies on a particular part of the territory [10]. In the case of health care, regionalization obeys to the criterion of planning of a service provision, the need to rationalize the dynamics of articulation, establishing greater coordination and achieving results in terms of increased access and equity. The first two criteria may also be considered in a more subordinate way [8]. Regionalization of care in pediatric cardiology and collaboration among regional centers can not only improve results by focusing the experience, but also facilitates the quality evaluation due to the increased surgical volume [11]. Another aspect that must be emphasized is the need to take into account and deepen the analysis of the public-private mix, aimed at understanding what is possible and beneficial to establish a relationship of real complementarity, which includes a suplementary health care, filling an empty spaces of complexity of the public sector by the private one and vice versa [8]. These agreements represent extra resources for university hospitals that would help compensate for the reduced values​​ of federal resource transfers and contribute to improving their autonomy management. To avoid a loss to the care of SUS patients, it is assumed that hospital capacity and bed allocation shoud be expanded [12]. Some hospitals adopt new methods of management, called “partnerships”. Modalities that propose change in the publicprivate sector relationships in the production of health services, through, for example, the provision of state hospital beds to the market, which is conventionally called “cross-subsidy”: the connection between the state health system (public and free) and the supplementary system (private and paid) [13].

of Health Care (SAS) of the Ministry of Health provided DATASUS / Ministry of Health. IBGE data were basically obtained by the acquisition of publications and also by accessing its website. Currently, there are 240 health facilities qualified for highcomplexity cardiovascular care (UACAC). Among them, 199 are qualified as assistance units and 41 as reference centers. There are 140 hospitals qualified to perform cardiovascular surgeries only in adult patients, eight qualified exclusively for pediatric cardiovascular surgery and 58 to perform adult and pediatric surgeries, 166 for vascular surgery, 201 for interventional cardiology, 58 for extracardiac endovascular procedures and 54 for electrophysiology, as listed in Table 1. For the geographical distribution of Support Services for Highly Complex Pediatric Cardiovascular Surgery, Ordinance no. 210 (Annex IV) builds a proportion of 1:800.000 inhabitants. These parameters were applied to the estimated population in 2009 (IBGE) of the federated units and Brazilian regions, the correlation between the registration goal and quantitative services were effectively made. Thus, we elaborated Table 2 that shows that the country and specialty deal with deficits, and a total absence of services in some territories. So now we can say that the principle of regionalization has not been accomplished in the implementation of the policy. This fact can be explained by various causes, such as the regional differences, the lack of qualified professionals and hospitals with good infrastructure for the complex procedures. Regionalization: An Analysis of the Frequency of Procedures The health service units qualified to perform procedures in congenital heart disease can be classified according to age of patients they assist. Eight units perform procedures on patients under 18, 58 in both adults and children and 140 units are for people over 12 years old.

Table 1. Distribution of High Complexity Assistance Unit in Cardiology (UACAC).

Regionalization of Pediatric Cardiovascular Surgery The data analyzed in this article were obtained from DATASUS, the Department of Health Care (SAS) / MS and the Brazilian Institute of Geography and Statistics (IBGE). Some secondary data collected from the Ministry of Health-DATASUS are public domain and were obtained via the Internet, such as those related to quantitative hospitalizations. Other groups of information are not available on the internet and are composed of number of adults and pediatrics cardiovascular surgery, spread across states and regions, frequency of procedures and investment in pediatric cardiovascular surgery, distributed according to region, federative unit, institutions and age groups. For such data to be released, a specific request was made, and the Department

Qualification Types

Total

Qualified at the High Complexity Assistance Unit in Cardiology 240 Assistance Care Unit

199

Reference Center

41

Total number of establishments performing Cardiovascular

206

Surgery

258

Qualified for Adult Cardiovascular Surgery

140

Qualified for Adult and Pediatric Cardiovascular Surgery

58

Qualified for Pediatric Casdiovascular Surgery Source: SAS/MS, 2010

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Table 2. Distribution of Units (HU) in pediatric cardiovascular surgery (CS) in regions and states of the Federation in 2009 *. Region Population Aim CS CS Total Deficit 1:800.000 (adult and child) pediatric (%) 191,480,630 239 58 8 66 72.43 BRAZIL North 15,359,608 19 2 0 2 89.58 Rondônia 1,503,928 2 100.00 Acre 691,132 1 100.00 3,393,369 4 100.00 Amazonas 421,499 1 100.00 Roraima Pará 7,431,020 9 2 2 78.49 Amapá 626,609 1 100.00 Tocantins 1,292,051 2 100.00 53,591,197 67 19 3 22 67.16 Northeast Alagoas 3,156,108 4 1 1 74.36 Bahia 14,637,364 18 7 7 61.75 Ceará 8,547,809 11 1 2 3 71.96 Maranhão 6.367,138 8 2 2 75.00 Paraíba 3,769,977 5 1 1 78.72 Piauí 3,145,325 4 2 2 48.72 Pernambuco 8,810,256 11 3 3 72.73 RN 3,137,541 4 1 1 74.36 Sergipe 2,019,679 3 1 2 20.00 Southeast 80,915,332 101 23 1 23 77.25 Espírito Santo 3.487,199 4 1 0 1 77.27 Minas Gerais 20,033,665 25 6 6 76.00 Rio de Janeiro 16,010,429 20 4 4 80.00 São Paulo 41,384,039 52 12 12 76.79 South 27,719,118 35 11 3 14 59.54 Paraná 10,686,247 13 5 2 7 47.76 Santa Catarina 6,118,743 8 1 1 86.84 RGS 10,914,128 14 6 6 55.88 Midwest 13,895,375 17 3 2 5 71.26 Distrito Federal 2,606,885 3 2 2 39.39 MGS 2,360,498 3 1 1 66.67 Mato Grosso 3,001,692 4 1 1 73.68 Goiás 5,926,300 7 1 1 86.49 Source: SAS/MS 2010 *Estimated population: IBGE

The age groups studied were: between 0-29 days, and one month to 11-year-old patients. It is worth noting that the twenty largest institutions by the volume of surgeries in 2008, are qualified as units of pediatric cardiovascular surgery or associated with adult cardiovascular surgery. Taking into consideration the care of all age groups, the distribution of the twenty largest institutions by region was: six (30%) units in the Northeast, three (15%) in the Midwest, seven (35%) in Southeast, four (20%) in the South and none in the North.

With over 200 procedures performed in 2008, seven (35%) units were found, two in the South, one in the Midwest and four in the Southeast. Between 100 and 200 procedures performed in the same year, there are 12 (60%) units, five, three, two two, respectively, in the Northeast, Southeast, Midwest and in the South. Less than 100 procedures performed that year there is just a unit (5%) in the Northeast region (Figure 1). The frequency of procedures in the 185 institutions that had production ranged from one to 536, with an average corresponding to 36.2 ± 69.5. It is noteworthy that 108 institutions performed less than 12 procedures in 2008. Since

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the frequency of procedures of the 20 largest institutions varied from 95 to 536, with an average corresponding to 200 ± 107. When the 20 largest institutions that assist the age of one month to less than a year were stratified, we coud find a geographic distribution: one (5%) unit in the North, five (25%) units in the Northeast, three (15% ) units in the Midwest, six (30%) in the Southeast and five (25%) in the South. For the same age group, considering over 100 procedures performed per year, two (10%) units were idenfified, one in the South and one in the Southeast. Between 50 and 100 procedures performed per year, there are six units (30%), one in the Northeast, three in the Southeast, one in the Midwest and South. Under 50 procedures performed per year, there are 12

units ( 60%), one in the North, four in the Northeast, two in the Southeast, two in the Midwest and three in the South (Figure 2). Therefore, the major hospitals assisting children from one month to less than one year are relatively well distributed in all geographic regions, with the exception of the northern region, which has the lowest percentage among them (5%). Compared to the same age group in the 66 institutions that had production, this ranged from one to 114 procedures per year, with an average of 21.2 ± 27.2, and 38 institutions that had less than 12 procedures per year. In the 20 largest institutions, production ranged from 26 to 114 procedures per year, with an average of 55 ± 27. For the surgical treatment of neonates, in other words, children between zero and 29 days, the location of the 20 largest institutions is as follows: two units in the Northeast (10%), three in the Midwest (15%), nine in Southeast (45%) and six in the South (30%). Regarding the volume of procedures performed, the distribution found was: only one unit in the South performing over 50 procedures per year; seven units, one in the Midwest, four in the South and two in the Northeast between 20 and 50 procedures per year; 12 units, two in the Northeast, five in Southeast, two in the Midwest and three in the south presented less than 20 procedures per year, (Figure 3). Thus, the major institutions that perform surgical procedures are located between the South and Southeast (75%) and only the small and mid-sized intitutions are better geographically distributed, due to the absence of institutions in the North.

Figure 1 - Distribution of the top 20 hospitals operating patients of all age groups

Figure 3 - Distribution of the top 20 hospitals operating patients between 0-29 days

Figure 2 - Distribution of the top 20 hospitals operating patients between 1 month and <1 year

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Regarding the surgical procedures in 56 institutions that had production, it ranged from one to 51 procedures per year, with an average of 11 ± 9, 41 institutions, we also found 41 institutions that performed less than 12 procedures per year. The frequency of procedures of the 20 largest institutions ranged from seven to 51, with an average of 20.6 ± 11.7. Therefore, there is a densification of the largest qualifed centers for the treatment of patients with congenital heart disease in the South and Southeast, and to a lesser extent in the Midwest and Northeast, with the exception of the treatment for patients suffering from one month to one year old in the Northern region, excluded from the map of the largest institutions in Brazil. When the Public Power expects society interventions, they are transfering their responsibility to others which is to promote health. The Public sector should have a different look for minorities, where the congenital and acquired heart disease of the pediatric group are, establishing sufficient resources to meet the specific demands. “Using only criteria of cost-effectiveness can result in discrimination against the minority groups, such as disabled people and those with diseases whose expression is smaller in a given population” [14]. Managers of the Ministry of Health, in a study [2], did not defend a specific number of centers for pediatric cardiovascular care in the country, but the concentration of procedures in a smaller number of centers as an option to provide better results. “The high complexity procedures has a different regionalization because they are more centralized. [...] Sometimes, reference is made to various macroregions, and even to states “(EG1). “The structure of pediatric cardiac surgery is so heavy that some concentration is not harmful. From the general point of view, I prefer fewer centers performing more surgeries, a more efficient structure than many centers [...] You do not need around two hundred centers in the country, it is better to have fewer and more effective ones well-distributed in the country. [...] I do not have this magic number here”(EG2). The speeches indicate convenience to rethink their own regionalization and parameters proposed in isolation and their associations with others seems more appropriate. They also show that the Public Power can not abdicate its role as articulator and the greatest responsible for the regulation of what they defined in their policy. In the same study [2], the medical society directors that put the specialty into question, were asked about the ideal type of services that would assist patients with congenital heart diseases. “The pediatric hospital that takes care of congenital heart disease will have much trouble trying to give assistance to patients with congenital heart diseases that exceeded the pediatric, adult and young adults age, and this is a population that is significantly imcreasing [...]. So, it seems much more logical to me an institution assisting the cardiac patients with

congenital heart disease at any age, as most model centers. It is more difficult for you to equip a prediatric institution with a structure for adult care, than equip an cardiology institution with a structure for child care”(CC2). “Maybe one or two large institutions in the country focused on the treatment of congenital heart disease could be replicating knowledge and technology in this area, which would be important. In a country with continental dimensions, it would be very difficult to have specific hospitals in each area [...]. Under certain conditions there can be important reference centers for the treatment of certain complex congenital heart disease such as hypoplastic left heart syndrome. So if we want better results, maybe the concentration of cases in centers that have maximum and better conditions to work with this kind of child [...] is the idea “(CC4). “Once the patient has congenital heart defect, even if operated, the individual will need to be monitored and, depending on the disease, the patient will also need other surgical procedures throughout life. Thus, the ideal would be an institution in which there was communication between pediatricians and adult physicians, with continuity of care with no interruptions and it may happen if there is an agreement between a pediatric and an adult institution”( CCE). According to these speeches, the people interviewed pointed to the creation of specialized centers where, regardless of age, patients with congenital heart defect would really have the care they need. Some of these centers would also train professionals from various fields, working as knowledge replicators. The representatives of the medical specialty also considered the possibility of maintaining hospitals directed to the treatment of adults or even children’s hospitals, since these formalize agreements with hospitals that perform cardiac surgery in children or adults, respectively, and teams that have qualified treatment demanded by patients. This strategy would be a way to leverage the network of health institutions in regions with significant deficits procedures. These arguments are corroborated by the thought of Oechslin & Hoffmann [15], which recommend suprarregional reference centers with cardiologists trained in congenital heart disease in adults and children, and experienced in their special needs, problems and management of this unique population. They conclude by saying that the close collaboration between pediatric and adult cardiologists is very important, when participating in the care of patients of congenital heart disease, In short, we identified and mapped by regions, the twenty largest Brazilian hospitals responsible for the treatment of congenital heart defects. Therefore, it is possible to build a regionalized network of care equitably distributed in all regions of Brazil; promoting a Suprarregional Reference Center as a reference in the treatment of complex congenital heart disease, institutions with history of attention to all congenital heart defects in all age groups, and create multi-professional training centers, starting from the Suprarregional Reference

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Centers. However, pediatric cardiac care in a continental country, requires intentionality of political authority, which must have an understanding of the territory based on the implementation requirements of certain public services, with public sector policies in certain part of the territory taking the risk of promoting unfair and discriminatory public policies against minority groups.

6. Novaes HM, Mir RC. Sistemas locales de salud: um medio para la regionalización de los servicios de salud. In: Paganini JM, Mir RC, eds. Los sistemas locales de salud: conceptos, métodos, experiencias. Publicación Científica no 519. Washington: OPAS; 1990. 7. Somers AR, Somers HM. Certificate of need regulation, the case of New Jersey. In: Regionalization and Health Policy.U.S. Department of Commerce. N.T.I.S., 1977. 8. Artmann E, Rivera FJU. Regionalização em saúde e mix públicoprivado. 2003. [Internet]. Disponível em: http://www.ans. gov.br/data/files/8A958865266CAFE201267FB74FC828E9/ TT_AS_05_EArt mann_RegionalizacaoEmSaude.pdf. Acesso em: 21/5/2009. 9. Stanback TM. Regionalization of professional services: private sector analogue. In: Regionalization and Health Policy.US. Department of Commerce.N.T.I.S.; 1977. p.7-15.

REFERENCES

10. Hilhorst J. Planejamento regional, enfoque sobre sistemas. Rio de Janeiro: Zahar; 1975.

1. Pinto Jr VC, Fraga MNO, Freitas FM. Análise das portarias que regulamentam a Política Nacional de Atenção Cardiovascular de Alta Complexidade. Rev Bras Cir Cardiovasc. 2012;27(3):463-8.

11. Chang RK, Klitzner TS. Can regionalization decrease the number of deaths for children who undergo cardiac surgery? A theoretical analysis. Pediatrics. 2002;109(2):173-81.

2. Pinto Jr VC. Avaliação da política nacional de atenção cardiovascular de alta complexidade com foco na cirurgia cardiovascular pediátrica [Dissertação de mestrado]. Fortaleza: Universidade Federal do Ceará; 2010.

12. Souza RG, Bodstein RCA. Inovações na intermediação entre os setores público e privado na assistência à saúde. Ciênc Saúde Coletiva. 2002;7(3):481-9. 13. Cohn A, Elias PE, Ianni AMZ. O público e o privado no Hospital de Clínicas de São Paulo. In: Negri B, Viana ALA, orgs. O SUS em dez anos de desafio. São Paulo: Sobravime/Cealag; 2002.

3. Caneo LF, Jatene MB, Yatsuda N, Gomes WJ. Uma reflexão sobre o desempenho da cirurgia cardíaca pediátrica no Estado de São Paulo. Rev Bras Cir Cardiovasc. 2012;27(3):457-62. 4. Pinto Jr VC, Daher CV, Sallum FS, Jatene MB, Croti UA. Situação das cirurgias cardíacas congênitas no Brasil. Rev Bras Cir Cardiovasc. 2004;19(2):III-VI.

14. Fortes PAC. Reflexões sobre o princípio ético da justiça distributiva aplicado aos sistemas de saúde. In: Fortes PAC, Zoboli ELCP, orgs. Bioética e saúde pública. São Paulo: Edições Loyola; 2003. p.35-47.

5. Pinto Jr VC, Rodrigues LC, Muniz CR. Reflexões sobre a formulação de política de atenção cardiovascular pediátrica no Brasil. Rev Bras Cir Cardiovasc. 2009;24(1):73-80.

15. Oechslin E, Hoffmann A. Organizational and medical aspects of transition of juveniles with congenital heart defects to adult cardiology care. Ther Umsch. 2001;58(2):111-8.

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Mejía OAV, etSPECIAL al. - Heart ARTICLE surgery programs innovation using surgical risk stratification at the São Paulo State Public Healthcare System: SP-SCORESUS STUDY

Heart surgery programs innovation using surgical risk stratification at the São Paulo State Public Healthcare System: SP-SCORE-SUS STUDY Estratificação de risco cirúrgico como instrumento de inovação em programas de cirurgia cardíaca no Sistema Único de Saúde do Estado de São Paulo: ESTUDO SP-SCORE-SUS

Omar Asdrúbal Vilca Mejía1, Luiz Augusto Ferreira Lisboa2, Luis Alberto Oliveira Dallan3, Pablo Maria Alberto Pomerantzeff4, Evelinda Marramon Trindade5, Fabio Biscegli Jatene6, Roberto Kalil Filho7

DOI: 10.5935/1678-9741.20130037

RBCCV 44205-1466

Abstract Cardiovascular diseases represent the greatest burden of morbidity and mortality for the health system and cardiac surgery has an important impact on their resolutivity. The association and correlation of patients’ demographic and clinical relevant information with the resources required for each stratum represent the possibility to adapt, improve and innovate into the healthcare programs. This project aims to remodel the “InsCor” risk score for the formulation of the SP-SCORE (Sao Paulo System for Cardiac Operative Risk Evaluation) in order to better reflects the complexity of cardiac surgical care. The participating hospitals include the Health Technology Assessment Centers in of the Health Secretariat’ HTA Network of São Paulo State (HTA-NATSs / SES-SP). The SP-SCORE will use 10

variables of the InsCor model and others 8 variables with presumed influence in Brazil. The primary endpoints are morbidity and mortality. Bootstrap technique besides automated selection of variables (stepwise) will be used to develop a parsimonious model by multiple logistic regression. This project will contribute for the SUS-SP regionalized health-care (RRAS) sustainability and financing of the CABG and/or heart valve surgery programs promoting equitable allocation, increasing access and effectiveness, as well as characterizing the magnitude of available resources and its impact.

1. Postdoctoral student in Cardiovascular Surgery at the University of São Paulo Medical School (FMUSP), Assistant physician at Beneficência Portuguesa Hospital of São Paulo, São Paulo, SP, Brazil. 2. Full Professor at FMUSP, Assistant Physician in the Cardiovascular Surgery Unit at the Heart Institute of Clínicas Hospital, FMUSP, São Paulo, SP, Brazil. 3. Associate Professor at FMUSP, Director of the Coronary Heart Diseases Unit at the Heart Institute of Clínicas Hospital, FMUSP, São Paulo, SP, Brazil. 4. Associate Professor at FMUSP, Director of the Valve Diseases Surgical Unit at the Heart Institute of Clínicas Hospital, FMUSP, São Paulo, SP, Brazil. 5. PhD in Preventive Medicine from FMUSP, Health Technologies Assessment Advisor at the Heart Institute of Clínicas Hospital, FMUSP, São Paulo, SP, Brazil. 6. Head Professor of the Cardiovascular Surgery Discipline at FMUSP, São Paulo, SP, Brazil. 7. Head Professor of the Cardiology Discipline at FMUSP, São Paulo, SP, Brazil.

This study was carried out at the Heart Institute of Clínicas Hospital, University of São Paulo Medical School, São Paulo, SP, Brazil.

Descriptors: Risk factors. Cardiovascular surgical procedures. Hospital mortality. Morbidity. Database.

Correspondence Address Omar Asdrúbal Vilca Mejía Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Av. Dr. Enéas de Carvalho Aguiar, 44 – Cerqueira César – São Paulo, SP, Brazil – Zip code: 05403-000. E-mail: omarvmejia@sbccv.org.br Support: FAPESP, CNPq and DCIT/MS. Article received on February 1st, 2013 Article approved on May 17th, 2013

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assistenciais. Este projeto tem por objetivo remodelar o escore de risco “InsCor” para formulação do SP-SCORE (São Paulo System for Cardiac Operative Risk Evaluation), visando refletir melhor a complexidade da assistência cirúrgica cardíaca. Os hospitais participantes integram os Núcleos de Avaliação de Tecnologias da Secretaria de Estado da Saúde de São Paulo (NATSs/SES-SP). Para a elaboração do SP-SCORE, serão utilizadas as 10 variáveis do modelo InsCor e 8 outras com suposta influência no Brasil. Os desfechos primários consistem na morbidade e na mortalidade hospitalar. A técnica de bootstrap junto a procedimentos de seleção automatizada de variáveis “stepwise” será utilizada para desenvolver um modelo parcimonioso por meio da regressão logística múltipla. Este projeto visa subsidiar a sustentabilidade e o financiamento do SUS-SP para as Redes Regionalizadas de Atenção à Saúde (RRAS) de cirurgias de coronária e/ou valva, promovendo alocação equitativa, incremento do acesso e efetividade, bem como caracterizar a magnitude dos recursos disponíveis e seu impacto.

Abbreviations, acronyms & symbols ADGs CAPPesq

Aggregated Diagnosis Groups Ethics Committee for Research Projects Analysis Extended Diagnosis Clusters EDCs Health Care Financing Administration HCFA Health Technology Assessment Centers of the Health NATSs/SES-SP Secretariat of the state of São Paulo NYHA New York Heart Association RRAS Regionalized Healthcare Network SP-SCORE São Paulo System for Cardiac Operative Risk Evaluation

Resumo Doenças cardiovasculares representam a maior carga de morbimortalidade para o sistema de saúde e a cirurgia cardíaca desempenha importante impacto na sua resolutividade. O agrupamento das informações demográficas e clínicas relevantes dos pacientes acometidos, no nível de estratos específicos e em correlação com os conjuntos de recursos requeridos, representa a possibilidade de adaptar, aprimorar e inovar nos programas

Descritores: Fatores de risco. Procedimentos cirúrgicos cardiovasculares. Mortalidade hospitalar. Morbidade. Base de dados.

INTRODUCTION

cardiac surgery results in the beginning of the century as much as integration and monitoring through EuroScore [11]. However, caution should be exercised when using models derived from different realities as they must first be validated and ideally remodeled [12]. As an example, rheumatic disease is highly prevalent in Brazil, where the application of known models derived from populations with diseases of predominantly degenerative etiology is questionable. In our midst, formulation of InsCor [13], a product of the remodeling of two of the most popular models [10,14] that had been validated [15] and adapted to our reality, has become an important instrument for patients being treated at InCor-HCFMUSP. Therefore, in order to better reflect the complexities of cardiac surgical assistance in the state of São Paulo, this study sets out to remodel InsCor to create the SPSCORE (São Paulo System for Cardiac Operative Risk Evaluation).

Cardiovascular diseases represent the greatest burden of morbidity and mortality for the health system and cardiac surgery has had major impact on their resolution [1]. However, Brazilian programs lack many subsidies. The grouping of relevant demographic and clinical data of affected patients, in specific strata and correlated with a set of required resources, can help in adapting, improving and innovating assistance programs. The biggest example is in the state of New York, where a public mandatory registry of every cardiac surgery performed in the state allows for gradual improvement of results [2]. Great Britain was the first to learn from this process [3] followed by other American states [4-7]. The same happens in Brazil, with better systematization and technology in one of the countries with the largest volume of cardiac surgery in the world [8]. Currently, the use of risk scores for decision making (indication level) in cardiac surgery is based on good levels of scientific evidence [9]. That is why the use of EuroScore [10], the most popular model, in main European services has led to the Hawthorne effect, showing that nothing has improved

METHODS Design Prospective cohort, blind, and multicenter study; based at state level and on consecutive case reports.

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Sample Patients who underwent coronary and/or heart valve surgery, within established inclusion period, will be consecutively included in the study. Initially, data will be collected from eight centers belonging to the Health Technology Assessment Centers of the Health Secretariat of the state of São Paulo (NATSs-SES-SP). Blinding will take place in terms of data origin. Stratified analysis of diagnostic subgroups will be performed so that no hospital data will be assessed in isolation.

mg/dl; ejection fraction < 30%; and events (including at least one of the following situations prior to surgery: intra-aortic balloon, cardiogenic shock, tachycardia or ventricular fibrillation, orotracheal intubation, acute renal failure, use of inotropic drugs, and cardiac massage). Other variables with alleged influence in Brazil, according to their prevalence are [15]: differences in clinical presentation due to socioeconomic, cultural, and geographical factors; uneven distribution of medical facilities; and high endemicity of subclinical inflammation, infection and rheumatic disease. Thus, the other variables collected would be: heart rheumatic disease, defined by Jones criteria adapted for heart rheumatic disease [16]; functional class, established by New York Heart Association (NYHA) [17] to assess the progression of the disease in its presentation [18]; educational level, defined as none, primary, secondary, and university, based on available evidence [19] correlated with differences found in Brazil; previous coronary stent, as evidenced in the national context [20]; systolic pulmonary pressure, determined through echocardiographic methods and directly related to severity and progression of cardiac disease [21]; emergency, defined as high risk of death unless surgery is performed within 24 hours of hospitalization, and urgency, defined as high risk of death with surgery being performed after the first 24 hours of hospitalization (these variables, though not very objective, have proven to be predictors of death in major risk models) [10,14]; atrial fibrillation, diagnosed through electrocardiogram or heart monitor before the beginning of surgery, considered as an independent variable in mortality of patients who underwent cardiac surgery [22]; and insulin-dependent diabetes, defined by continuous use of any type of insulin [23], where category would be chosen in accordance with the new EuroScore II [24].

Outcomes A. Structure and resources installed (defined as a set of departments, processes, approaches, and personnel available for diagnosis, therapy, and rehabilitation used in these cases); B. Morbidity (stroke; postoperative myocardial infarction; acute renal failure) or; C. Surgical mortality (defined as death from any cause occurred within 30 days after the surgical procedure). Participating centers • Clínicas Hospital of State University of Campinas; • Irmandade Santa Casa of Marília; • Clínicas Hospital of Ribeirão Preto; • Base Hospital of State Medical School of São José do Rio Preto; • Heart Institute – HCFMUSP; • Irmandade Santa Casa de Misericórdia of São Paulo; • Clínicas Hospital of Botucatu Medical School. Duration of study 24 months.

Statistical analysis The acquired database will be randomly divided into two groups: a development group (2/3 of the sample), which will be used to build the risk model, and a validation group (1/3 of the sample), which will be used to test and validate the model.

Inclusion criteria • Patients aged 18 or older; • Indications for coronary and/or heart valve surgery; • Agreement to participate in the study and signing of a written informed consent form.

Model development group: SP-SCORE-SUS Bootstrapping as well as automated selection of variables (stepwise) will be used to develop a parsimonious model by multiple logistic regression [25]. This technique attempts to do what would be desirable in real life: “replicate the experiment”. Observations are randomly selected and estimates are recalculated. The technique assumes that the observed sample is representative of the population, and then same-size samples are repetitively selected, generating a large number of samples. The statistic solution in applied to each individual sample in order to extract desired estimates. It is expected that these separate estimates will converge into a single one.

Exclusion criteria • Indications for associated surgery, except coronary + valve; • Inability to access variables relevant to the study. Variables Variables chosen were the ones derived from the InsCor model [13]: age ≥ 70 years old; female; associated surgery (myocardial revascularization + valve); recent myocardial infarction < 90 days; reoperation; surgical treatment of aortic valve; surgical treatment of tricuspid valve; creatinine > 2

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The variables used in the present study had a P<0.10 in the initial univariate analysis. Continuous variables will be analyzed according to the partition previously chosen during the analysis. Next, bootstrapping will be used in 2/3 of the population by selecting 1000 repeated samples (every one of them containing the same number of cases of death and non-death as the original sample). Later, stepwise multiple logistic regression models will be carried out for every sample and the variables that are selected for every one of the 1000 models generated will be recorded. Ranking of variables will consist of the number of times a variable is selected. Hence, chosen variables will be not be adjusted in the final model, keeping their odds ratio from the initial univariate analysis.

tended Diagnosis Clusters (EDCs) [31]. Other studies have shown that recognizing the complexity of cases, in terms of both outpatient [32-35] and hospital care [36-38], can lead to optimized and patient-oriented management strategies and solutions. In the state of São Paulo, stratification adjusted for risk factors together with underlying morbidity can help to identify improvement opportunities, policy strategies for allocation of differentiated resources, or cases where there is a need to structure more complex services so that procedures in cardiac surgeries can be done. Jones et al. [39], regarding myocardial revascularization specifically, suggest that most of the information related to prognoses is in relatively few clinical variables. At the time, Tu et al. [40], and, currently, Ranucci et al. [41] tested this proposition (PANEL Group) and concluded that simpler models containing only essential variables not only would reduce the risk of juxtaposition, multicollinearity, and human error, but would also be cheaper than complex models. That is the explanation for dropping the number of variables collected per patient for EuroScore and EuroScore II, from 97 to 29, respectively. Thus, the current trend when choosing an instrument for risk assessment in cardiac surgery is based on the comeback of the remodeling concept described by the groups, who besides applying a model, reshape it, by adding or simplifying variables according to their reality. New unique models, which have been validated and compared to international ones, have been created out of these applications [42-45]. In our midst, it has been proven that InsCor and EuroScore performed better than the 2000Bernstein Parsonnet in every step of the validation process. However, InsCor, besides identifying with local risk factors, was simpler and more objective when predicting mortality in patients who had undergone coronary and/or heart valve surgery at InCor-HCFMUSP [13]. Therefore, taking InsCor statewide (remodeling it) is a key strategy to disclose the appropriate model for evaluating results of coronary and/or heart valve surgeries in the state of São Paulo. Consequently, this project sets out to build arguments to subsidize SUS-SP regionalized health-care (RRAS) sustainability and financing of coronary and/or heart valve surgeries (conventional and new technologies), promoting equitable allocation, increasing access and effectiveness, as well as characterizing the magnitude of available resources and their impact. Throughout the study, every center will be able to better observe the complexity of patients who underwent surgery, the resources they require, their own performance as surgeons in addition to differences and changes in the risk profile of these patients. During the preliminary and the final analysis, every center will be assigned a state average compiled from data provided by every participating center to parametrize their own observed average in terms of complex-

Model validation group Assessment of model performance of data not derived from the development group (1/3 of the population) is known as internal validity. In this regard, model accuracy will be assessed through computation of sensibility, specificity, and positive and negative predictive values in addition to sequential tests for calibration (Hosmer Lemeshow goodness-of-fit test) and discrimination (ROC curve) [26]. Ethics This study was approved by the Ethics Committee for Research Projects Analysis (CAPPesq), Clínicas Hospital, University of São Paulo Medical School, under number 9696, in accordance with the Declaration of Helsinki. DISCUSSION In the history of cardiovascular surgery, the event that led to the advent of risk scores for patient stratification was the publication of gross results, without risk adjustment, of mortality in American hospitals by the Health Care Financing Administration (HCFA) in March 1986 [27]. Twenty years later, a similar event took place in Brazil [28] when it was published that there was 8% mortality (without risk adjustment) in patients who undergo cardiac surgery in Brazil’s Unified Public Health System (SUS). Results that are stratified according to complexity groups help health system managers to predict how many and which resources are needed for diagnosis, therapy, and rehabilitation so that excellence programs can be established. Furthermore, they allow for estimation of specific probabilities of transitions among several stages of morbidity which are present or prevalent in our midst [29]. In Canada, a description of the 5% top users of the health system enabled the identification of the combination of factors and chronic and acute diagnoses of these patients in addition to the most efficient and integrated strategies to assist them [30]. Different but complementary perspectives on the prevalent morbidity in these cases can be verified through the Aggregated Diagnosis Groups (ADGs) and Ex-

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ity strata of their cases. At the same time, with the support of Health Secretariat of the state of São Paulo, the present study will start the “Registro Estadual Paulista de Cirurgia Cardiovascular” (Paulista State Registry of Cardiovascular Surgery), in order to improve the quality of the results as well as the safety of patients who underwent cardiac surgery in the state of São Paulo.

5. The California report on coronary artery bypass graft surgery: 2007 hospital data. California CABG Outcomes Reporting Program. California Office of Statewide Health Planning and Development, June 2011. Disponível em: http://www.oshpd. ca.gov/HID/Products/Clinical_Data/CABG/07-08Breakdown. html. Acesso: 23/5/2012. 6. Adult coronary artery bypass graft surgery in the Commonwealth of Massachusetts: fiscal year 2009 report, Harvard Medical School, January 2011. Disponível: http://www.massdac.org/sites/ default/files/reports/CABG FY2009.pdf. Acesso: 23/4/2012.

ACKNOWLEDGEMENTS Besides the authors of this study, the SP-Score-SUS study group consists of the following professors: Dr. Nelson Yatsuda, Dr. Fátima Bombarda, Dr. Paula Tanaka, Dr. Daniele Marie Guerra, Dr. Orlando Petrucci Junior, Dr. Joaquim Murray Bustorff Silva, Dr. Rubens Tofano de Barros, Dr. Lucieni Oliveira Conterno, Dr. Marcos Gradim Tiveron, Dr. Walter Villela de A. Vicente, Dr. Paulo Roberto Barbosa Évora, Dr. Domingo Marcolino Braile, Dr. Carlos Alberto dos Santos, Dr. Marcelo Nakazone, Dr. Maurício de Nassau Machado, Dr. Luiz A. Rivetti, Dr. Eduardo Gregório Chamlian, Dr. Antônio Sérgio Martins, and Dr. Silvana Andrea Molina Lima.

7. Cardiac surgery in New Jersey: 2008. Health Care Quality Assessment, Office of Policy and Strategic Planning, New Jersey Department of Health and Senior Services, June 2011. Disponível em: http://www.state.nj.us/ health/ healthcarequality/ cardiacsurgery.shtml#CSR. Acesso em: 23/4/2012. 8. Gomes W. Brasil é o segundo país do mundo em cirurgias cardíacas; SAÚDEweb. Disponível em: http://saudeweb.com. br/30501/brasil-e-o-segundo-pais-do-mundo-em-cirurgiascardiacas/ Acesso em: 19/6/2012. 9. Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, et al; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/ AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011;58(24):e123-210.

This study is supported by the Foundation for Research Support of the State of São Paulo (FAPESP), in partnership with the Health Secretary of São Paulo (SES-SP), the Ministry of Health (MOH) and National Council for Scientific and Technological Development (CNPq).

10. Nashef SA, Roques F, Michel P, Gauducheau E, Lemeshow S, Salamon R. European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg. 1999;16(1):9-13.

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23. D’Alessandro C, Leprince P, Golmard JL, Ouattara A, Aubert S, Pavie A, et al. Strict glycemic control reduces EuroSCORE expected mortality in diabetic patients undergoing myocardial revascularization. J Thorac Cardiovasc Surg. 2007;134(1):29-37.

37. Ovens HJ, Chan TB. Heavy users of emergency services: a population-based review. CMAJ. 2001;165(8):1049-50.

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39. Jones RH, Hannan EL, Hammermeister KE, Delong ER, O’Connor GT, Luepker RV, et al. Identification of preoperative variables needed for risk adjustment of short-term mortality after coronary artery bypass graft surgery. The Working Group Panel on the Cooperative CABG Database Project. J Am Coll Cardiol 1996;28(6):1478-87.

26. Altman DG, Vergouwe Y, Royston P, Moons KG. Prognosis and prognostic research: validating a prognostic model. BMJ. 2009;338:b605. 27. Health Care Financing Administration. Medicare Hospital Mortality Information, volume I, 1986 (HCFA publication No. 01-002). Washington: US Government Printing Office; 1987.

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41. Ranucci M, Castelvecchio S, Conte M, Megliola G, Speziale G, Fiore F, et al. The easier, the better: age, creatinine, ejection fraction score for operative mortality risk stratification in a series of 29,659 patients undergoing elective cardiac surgery. J Thorac Cardiovasc Surg. 2011;142(3):581-6.

artery bypass graft patients in Pakistan: comparison between additive and logistic EuroSCORE models. Interact Cardiovasc Thorac Surg. 2011;13(2):137-41. 44. Shih HH, Kang PL, Pan JY, Wu TH, Wu CT, Lin CY, et al. Performance of European system for cardiac operative risk evaluation in Veterans General Hospital Kaohsiung cardiac surgery. J Chin Med Assoc. 2011;74(3):115-20.

42. Antunes PE, Eugénio L, Ferrão de Oliveira J, Antunes MJ. Mortality risk prediction in coronary surgery: a locally developed model outperforms external risk models. Interact Cardiovasc Thorac Surg. 2007;6(4):437-41.

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Cueva CNC, et al. - Clinical andSTUDY ultramicroscopic myocardial randomized EXPERIMENTAL study of beating versus arrested heart for mitral surgery

Clinical and ultramicroscopic myocardial randomized study of beating versus arrested heart for mitral surgery Estudo randomizado clínico e ultramicroscópico na cirurgia valvar mitral com o coração com atividade elétrica versus sem atividade elétrica

Clotario Neptali Carrasco Cueva1, Maiara dos Santos Rocha2, Carlos Maurício Cardeal Mendes3, Luiz Antonio Rodrigues de Freitas4, José Augusto Baucia5, Roberto Badaró6

DOI: 10.5935/1678-9741.20130038

RBCCV 44205-1467

Abstract Introduction: Beating heart surgery on normothermic bypass simulates physiologic cardiac status. Objectives: This study compared clinical and transmission electron microscopic aspects of myocardial protection during mitral valve replacement using warm retrograde perfusion in empty beating versus arrested heart with cold blood anterograde cardioplegia. Methods: Randomized study to evaluate myocardial cellular ischemia-reperfusion of both techniques to replace the mitral valve. Thirty-four patients were randomly assigned into group A (beating heart) and group B (arrested heart). The following parameters were assessed: echocardiography, blood chemistry, hemoglobin, lactate. During the surgical procedure a total of 102 myocardial biopsies were performed for ultrastructural analysis from anterior left ventricular wall: before cardiopulmonary bypass, before aortic desclamping and 10 minutes after reperfusion.

Results: Elevation of lactate at 3 hours during the procedure was higher in group A, but similar at the end of surgery (P=0.06). Cardioversion was necessary in 5/17 (A) vs. 13/17 (B) P=0.07. Median intraoperative systemic temperature was significantly lower in the group B compared to A (32ºC vs. 36ºC), P<0.001. There was no significant difference of the ultramicroscopic aspects of the heart biopsies before, during and after surgery in both groups. Cellular and mitochondrial transient abnormalities such as mitochondrial swelling, glycogen loss and cytosol swelling were detected independently of the moment of the biopsies. Conclusion: Myocardial protection and ultrastructural abnormalities were similar for both types of mitral valve replacement beating or arrested heart techniques.

1. Adjunct IV Professor of the Medical School of the Universidade Federal da Bahia (UFBA), teacher and cardiovascular surgeon, Salvador, BA, Brazil. Participated in all stages from project design, execution, analysis of results and writing of the article for publication. 2. Student of the Medicine Course of the UFBA, Salvador, BA, Brazil. Participated in the entire project with emphasis on the collection and organization of data. 3. Professor of Postgraduate Interactive Processes of Organs and Systems/ ICS/UFBA, Salvador, BA, Brazil. Performed the statistical analysis of the database. 4. Adjunct Professor of the Medical School of the UFBA, Salvador, BA, Brazil. Senior reseacher of FIOCRUZ. Performed histological analysis with electron ultramicroscopy. 5. Adjunct Professor of the Medical School of the UFBA, Salvador, BA, Brazil, Salvador, BA, Brazil. Participated in the project design, the execution of operations and in the writing.

6. Professor of the Medical School of the UFBA, Salvador, BA, Brazil. Participated in all stages from project design, execution, analysis of results and writing of the article for publication.

Descriptors: Heart Arrest, Induced. Myocardium. Mitral Valve, Surgery.

This study was carried out at Hospital Ana Nery and Centro de Pesquisas Gonçalo Moniz – Fiocruz, Bahia, Salvador, BA, Brazil. Correspondence address: Clotario Neptali Carrasco Cueva Departamento de Anestesiologia e Cirurgia, Disciplina de Cirurgia Torácica e Cardiovascular da Faculdade de Medicina da Universidade Federal da Bahia Av. Augusto Viana, S/N – Canela – Salvador, BA, Brasil – Zip code: 40110-160. E-mail: calvence@yahoo.com.br Article received on February 24th, 2013 Article accepted on May 6th, 2013

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grupo A (batendo) e grupo B (parado). Os parâmetros foram: hematológico, bioquímico, ecocardiográfico, lactato. Foram realizadas 102 biopsias da parede anterior do ventrículo esquerdo preparadas para análise ultraestrutural: antes da circulação extracorpórea, antes do despinçamento aórtico e 10 minutos após a interrupção da circulação extracorpórea. Resultados: Verificou-se elevação do lactato 3 horas após o início do procedimento, que foi maior no grupo A (P=0,06), todavia semelhantes no final da cirurgia. A cardioversão foi necessária em (A) 5/17 vs. (B) 13/17, P=0,07. A temperatura intraoperatória média foi significativamente menor no grupo B em relação ao grupo A (32oC vs. 36oC), P<0,001. A análise ultramicroscópica das amostras das biopsias do coração antes da circulação extracorpórea, ao término do pinçamento aórtico e após a saída da circulação extracorpórea, revelou anormalidades transitórias semelhantes no citoplasma, núcleos e mitocôndrias em ambos os grupos, independentemente do momento das biopsias. Conclusão: A proteção miocárdica na cirurgia valvar mitral apresentou aspectos semelhantes na preservação da integridade ultraestrutural dos cardiomiócitos quando realizada com o coração com ou sem atividade elétrica.

Abbreviations, acronyms & symbols ATC ATP BMI CPB ECG FDR Fiocruz ICU KCl LAD MVR NYHA TEM

Activated time coagulation Adenosine triphosphate Body mass index Cardiopulmonary bypass Electrocardiogram False discovery rates Osvaldo Cruz Foundation Intensive care unit Potassium chloride Left anterior descendent artery Mitral valve replacement New York Heart Association Transmission electron microscopy

Resumo Introdução: A cirurgia valvar mitral pode ser realizada com o coração com atividade elétrica, vazio e normotérmico com pinçamento aórtico, perfusão sanguínea no seio coronário, simulando um estado fisiológico. Objetivos: Comparar as manifestações clínicas e ultramicroscópicas do miocárdio, na cirurgia valvar mitral, com o coração com atividade elétrica versus sem atividade elétrica. Métodos: Estudo randomizado constituído de 34 pacientes:

Descritores: Parada Cardíaca Induzida. Miocárdio. Valva Mitral/Cirurgia.

INTRODUCTION

advocating one or the other technique should be taken into consideration to decide between either a beating or arrested heart surgery procedure. In this report we present the results of clinical and transmission electron microscopy (TEM) myocardial assessment in the immediate and postoperative period in a randomized prospective study to compare mitral valve replacement using arrested versus on-pump empty beating heart surgery.

During open-heart surgery prevention of ischemia and reperfusion following cardioplegic arrest are essential for myocardial protection [1]. It has been demonstrated that empty beating heart surgery simulates a physiologic cardiac status and is a good method for myocardial protection [2]. On the other hand, most surgeons prefer the conventional hypothermic arrested heart surgery justified by the low risk of air embolism and less blood in the surgical site that improves visualization [3,4]. Several complications are well documented in arrested heart surgery such as increasing the need for inotropic drug support, intra-aortic balloon pumping, prolonging of the length of intensive care, prolonging of hospital stays, increasing cost and mortality rates [5]. Also, low cardiac output syndrome and severe arrhythmias are associated with postoperative morbidity and mortality [6]. Although beating heart valve replacement with continuous coronary sinus perfusion is a good method for myocardial protection because eliminate the use of cardioplegia corollary risk of ischemic reperfusion injury [7,8]. In addition, beating heart surgery produces less cardiac arrhythmia events and no major differences in cerebrovascular events [9,10]. Beating heart technique is being demonstrated to produces less alterations on the biochemistry markers so, have better myocardium protection [11]. The pros and cons for

METHODS Design of study This was a randomized prospective study to compare mitral valve replacement using arrested versus on-pump beating heart surgery. The objective of this study was to evaluate the immediate clinical findings and cellular ischemia and reperfusion injury of both techniques to replace the mitral valve. Herein we will report the clinical and the preliminary cellular and mitochondrial TEM findings of biopsies of the myocardium performed during the surgery heart procedure in both groups. Local of study This study was performed at the Hospital Ana Neri, the reference Center for Cardiac surgery of the Federal University

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of Bahia, Brazil and the transmission electron microscopy studies were performed at Osvaldo Cruz Foundation (Fiocruz), Bahia, Brazil.

as diabetes mellitus and uremia, b) with coronary artery diseases, c) dilated myocardiopathy, d) with severe chronic pulmonary obstructive diseases, e) with present or past history of malignances diseases, f) acute endocarditis, g) with severe pre-operatory laboratory parameters such as creatinine levels >3mg/dL, hemoglobin ≤ 7.0 g/dL, prothrombin time/activity ≤70% and clotting time ≥ 10 minutes.

Data collection period The patients were enrolled from April 2010 to March 2011. Demographic, history of dyslipidemia, hypertension personal habits, history of rheumatic fever and other valvulopathies. History of stroke, hematological and laboratory chemistry profiles. Body mass index (BMI) was calculated using the height in relation to weight formula.

Randomization procedure We used a simple method that consisted in use of a randomization list for the enrollment of the patients: This list was provided by the biostatistician to consecutively enroll into group A or B according to the following random sequence: AAAAAAABBABABBAAABABAABBBBA BBBBABB. A Runs Test of validation for randomization was applied Standard Normal = -0.6966, P-value = 0.486; alternative hypothesis: two sided, this test accepted the null hypothesis that this sequence was random. As recommended by CONSORT 2010 [12] a flow diagram was constructed to depict the enrollment of the patients (Figure 1). Surgical risk was measured using EuroScore formula available on web: euroscore.org/calc.htlm

Population of study A total of 34 patients were selected to have mitral valve substitution. Inclusion criteria: a) all patient included into the study were adults 18-60 years old, b) with an echocardiography diagnosis of mitral and/or tricuspid valve disease due to inflammatory acquired diseases, c) no previous history of cardiac surgery and d) elective indication for valve replacement. Exclusion criteria: a) with metabolic diseases such

Fig.1 – CONSORT flow diagram constructed to depict the enrollment of the patients

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Surgery techniques Anesthetic protocol was identical for all patients. All procedures were performed with median sternotomy. Prior to aortic and venous cannulation for the institution of CPB, 400 U/kg heparin sulphates was administrated to the patients in order to maintain the activated time coagulation (ATC) values above 480 seconds. During cardiopulmonary bypass (CPB), non-pulsatile flow was kept at 2.0 L/m2/min to 2.5 L/m2/min with a roller pump and hollow-fiber membrane oxygenator were used. Mean arterial pressure during CPB was maintained between 60 mmHg and 70 mmHg. Oxygen flow was maintained during CBP a saturation of 90% concentration. Group A: All patients received normothermic blood cardioplegia delivered retrograde via coronary sinus [13]. After cross-clamping aorta to avoid air embolism the left heart was kept vented in the ascendant aorta and right pulmonary vein. Surgery was performed under a temperature of 36oC using an actively warmer system for blood perfusion. Systemic temperature was monitored with a catheter placed into nasopharyngeal. The flow rate was kept between 250-300 mL/min and a peak perfusion pressure of 40-60 mmHg [14]. Myocardial function was monitored continuously during the intraoperative procedure with 5-lead electrocardiogram (ECG). Occurrences of bradycardia or ST-segment changes were considered as sign of myocardial ischemia and were immediately corrected. Group B: surgery was performed under intentionally actively cooled moderate hypothermia of 32oC and monitored as same as in group A also a beating alarm sound when threshold limit of 31-34oC were reached. Myocardial protection was performed using blood cardioplegia 4:1, anterograde, intermittent. With the following components of the solution; for induction: Potassium chloride (KCl) 15 ml, sodium bicarbonate 60 ml, glucose 5% 350 ml, sodium aspartate 13.5 ml, sodium glutamate 13,5 ml. For maintenance: KCl 5 ml, Sodium bicarbonate 60 ml, glucose 5% 350 ml, sodium aspartate 13.5 ml, sodium glutamate 13.5 ml. In all patients, the heart was arrested with 300 ml/min of the induction solution delivered at 4oC during 2 minute with an interval of 15 minutes into the aortic root at a pressure of 60 mmHg measured directly through a separate port of the cardioplegic cannula. After arrest, low potassium cardioplegia solution (maintenance) was infused via anterograde cannula and the aortic root was perfused through the cannula with oxygenated blood at the same rate as for the induction. Measurement of intramyocadial temperature was not performed. Inotropic support was done using a dopamine solution at the dose of 5 mcg/kg/min when blood pressure was inferior to 50 mmHg. In both groups, the right atrium was opened longitudinally and another incision was made into the fossa ovale: superiorly toward the superior vena cava and inferiorly behind coronary

sinus. Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. The tricuspid valve repair was done following De Vegas’ technique in both groups and the CPB was disconnected [15]. Hemodynamic studies Echocardiogram was performed before and after the surgery procedure in both groups using a transthoracic technique to measure ejection fraction and the systolic pressure of pulmonary artery. New York Heart Association (NYHA) functional class protocol was adopted to classify the degree of cardiac dysfunction of each patient before and after surgery. Briefly, Class I: cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). Comfortable only at rest Class IV: severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. Myocardial biopsy During the surgery biopsies were performed as full thickness transmural specimen of three small fragments measuring 0.5 to 15 mm2 from the left ventricle anterior free wall, near to the apex and between distal left anterior descendent artery (LAD) and the diagonal branch. Biopsies were taken with Tru-Cut biopsy needle (Travenol Laboratories Inc.™) at three different times: (a) before ischemia (b) at the end of ischemia and (c) 10 min after reperfusion. The samples were immediately fixed in cold 2.5% glutaraldehyde diluted in a 0.1-M cacodilate buffer at pH of 7.4. After rinsing in a buffer, fragments were postfixed in a 1% osmium tetroxide solution mixed with the same buffer during one hour at 4oC. Fragments were dehydrated with increasing concentration solutions of acetone and then infiltrated with polibed resin. Ultra-fine sections measuring between 50-70 nm were obtained using an automatic ultramicrotome, Leica EM UC7™ and collected with 200-mesh copper grids. Histological semi-thin sections and ultrastructural photomicrographs were performed after samples analysis, registering repetitive patterns. Photomicrographs were obtained using a Zeiss EM-109 TEM operated at 80 KV. Classification of the microscopic alterations The assessment of the ultramicroscopic photography’s was based of the system grade 0-4. It was observed the mitochondria, cytoplasmic and nuclear changes according to the following criteria: Grade 0: no structural changes, Grade 1: mild intermyofibrillar and intramitochondrial edema, recent chromatic margination and fragmentation and recent lost of glycogen. Grade 2: moderated edema. Mitochondrial swelling, chromatic margination and fragmentation with

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lost of glycogen. Grade 3: severe edema, sarcolemma bled, myocardial contraction band, mitochondrial amorphous densities, and disruption of sarcolemma membrane. Grade 4: lost of cytoplasmic architecture, myocardial contraction bands, mitochondrial amorphous densities, and disruption of sarcolemma membrane. All analysis of these subcellular ultramicroscopic alteration of the myocytes was done blinded by the pathologist without known which study group were the sample.

of non-normal quantitative variables between groups we performed the Mann-Whitney test. For quantitative variables with repeated measurement throughout the study we use the analysis of variances. Due to simultaneous analysis of numerous hypotheses we calculated the recommended false discovery rates (FDR) by direct transformation of the P values according to the method proposed by Rosner [16]. Ethical issues Written informed consent was obtained from each individual patient prior to enrollment into the study. The study was approved by the Ethics Committee of the University Hospital Professor Edgard Santos under the number 098/2009.

Anatomopathology of the replaced valve All valve that was replaced, immediately after removal was sent to the laboratory for study. Statistical analysis A data bank was constructed and analyzed using the R statistical analysis program. Each individual received a code number and the bank was accessed through an individual password. Because this was a randomized trial of superiority hypothesis tests we performed a comparison for proportions using Fisher’s exact test. For the comparison of distribution

RESULTS Table 1 summarized the preoperative patients profile data obtained in both groups. Of note, the degree of functional classification of the extent of heart failure according NYHA was significantly different between the two groups.

Table 1. Preoperative clinical profiles of studied patients in both groups. Variables Age, years mean [SD] Sex (M:F) IMC mean [SD] Hypertension Dyslipidemia Heart failure NYHA class II III IV Stroke Cardiac rhythm Sinus rhythm Atrial fibrillation Flutter Nephropathy Smoking LVEF mean (SD) sPAP mmHg mean (SD) Etiology of valvular disease Rheumatic fever Infectious endocarditis Disruption of chordae Prior valvuloplasty Valve lesion Stenosis Insufficiency Double lesion EuroScore Mean

P value * 1.00 1.00 0.99 1.00 0.77

Beating heart (%) 37 [11.2] 6:11 22.7 (3.2) 7/17 (41.2) 3/17 (17.6) 17/17 (100)

Arrested heart (%) 38 (11.9) 4:13 24.5 (5,8) 9/17 (53) 0/17 (0) 17/17 (100)

2/17 (11.8) 13/17 (76.5) 2/17 (11.8) 2/17 (11.8)

0/17 (0) 9/17 (52.9) 8/17 (47.1) 3/17 (17.6 )

7/17 (41.2) 10/17 (58.8) 0/17 (0) 1/17 (5.9) 5/17 (29.4) 64.7 (6.88) 54.6 (15.97)

5/17 (29.4) 11/17 (64.7) 1/17 (5.9) 0/17 (0) 2/17 (11.8) 65.6 (8.28) 69.1 (25.51)

16/17 (94,1) 1/17 (5,9) 0/17 (0) 2/17 (11,8)

14/17 (82,4) 2/17 (11,8) 3/17 (17,6) 4/17 (23,5)

0.99 1.00 0.77 1.00

1/17 (5.9) 4/17 (23.5) 12/17 (70.6) 3.03 (2.22)

0/17 (0) 3/17 (17.6) 14/17 (82.4) 3.8 (2.42)

1.00 1.00 1.00 0.77

0.47

1.00 1.00

1.00 0.92 0.99 0.77

FDR = False Discovery Rate; NYHA = New York Heart Association; SD = standard deviation; M:F: ratio male:female; LVEF = Left ventricular ejection fraction; sPAP = systolic pressure artery pulmonary

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Patients included in the arrested heart group had more severe heart failure. However, heart failure did not correlate with more alteration in the cardiac rhythms. There was no significant difference in cardiac rhythms between the two groups. Also the rate of rheumatic mitral valve disease was found to be similar in both groups.

group A that had a blood clotting dysfunction and accounted for total blood lost in this group. The follow up variable analysis are shown in Table 3. There was no difference between both groups for intensive care unit (ICU) time for recovery also occurrence of heart failure independently of the NYHA functional class before and after surgery. Also, the frequencies of arrhythmias were similar in both groups. Overall, the outcomes of the patients after surgery were similar for both groups. Only one patient died in the arrested heart group ten days after surgery due to septic shock and two in the beating heart group ten and 42 days after surgery due to septic shock and endocarditis respectively. Figure 2 shows the monitoring of hemoglobin values during and immediately after the surgery procedure. As expected the hemoglobin levels in the blood dropped off in both group without significant difference related with the type of surgical procedure. Figure 3 demonstrates the lactate monitoring levels in both groups during the surgery. There was a significant elevation of lactate at 3 hours during the procedure in group A compared with group B, but at the end of the surgery in both groups the levels were similar.

Intraoperatory aspects Table 2 summarized all variables that could be compared. Basically, surgery time, CPB and aorta cross clamp time were almost identical. But, the need for defibrillation was marginally significant higher in group B than group A. Also temperature was significant lower in group B as expected because the technique requirement P=0.005). Group A required less use of inotropic drugs during and after surgical procedure than group B since the heart was constantly beating (P=0.005). The most common association procedure was tricuspid annuloplasty (8/17 group A and 14/17 group B), P=0, 07. The median size of the biological or mechanical prosthetic valve was 31 mm in both groups. Only one patient was submitted to comissurotomy mitral valve in group A. Blood loss analysis was confounded by a single patient in

Table 2. Comparison of the intraoperatory parameters between the two surgery procedures of mitral valve replacement replacement. Variables Beating heart (%) Arrested heart (%) P value* N=17 N=17 Surgery time min mean [SD] 214 [SD=36] 234 [SD=72] 0.94 Cardiopulmonary bypass (IQR) (min) 85 [SD=30] 95 [SD=27] 1.00 Aorta cross clamp time (min) Median (IQR) 60 [SD=14] 60 [SD=27] 0.94 Defibrillation. n 5/17 (29.5) 13/17 (76.5) 0.63 Temperature oC median (IQR) 36 [SD=0.5] 32 [SD=0] 0.00 Blood lost mL median (IQR) 1150 [SD=600] 1100 [SD=1400] 1.00 Mean arterial pressure 60 (SD=10) 64 [SD=18] 1.00 Inotropic requirement 4/17 (23.5) 13/17 (76.5) 0.12 Tricuspid annuloplasty 8/17 (47.1) 14/17 (82.4) 0.63 Min = minutes; SD = standard deviation; IQR = median; n = number of defibrillation episodes; mL - milliliters; * P value: FDR *FDR Table 3. Clinical and after surgery characteristics of mitral valve replacement in both group. Variables ICU time hours median (IQR) Extubation time hours mean [SD] 24h diuresis mL median [IQR] Reoperation Heart failure post-op NYHA class I II III Post-operative rhythm Sinus rhythm Atrial fibrillation Hospital stay mean [SD] Death

Beating heart (%) 71 (48) 12 [7.42] 1575 [1585] 2/17 (11.8) 11/17 (64.7)

Arrested heart (%) 63 (47) 15 [69.25] 2500 [1125] 2/17 (11.8) 15/17 (88.2)

6/17 (40) 9/17 (60) 0/17 (0)

2/17 (12.5) 12/17 (75) 2/17 (12.5)

6/17 (35.3) 11/17 (64.7) 27 [88.89] 2/17 (11.8)

7/17 (41.2) 10/17 (58.8) 30 [86.67] 1/17 (5.9)

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P value* 0.99 0.77 0.77 1.00 0.77 0.69

1.00 0.77 1.00

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Fig. 2 – Hemoglobin levels of the patients of both groups during procedure

Fig. 3 – Lactate levels

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TEM myocardial biopsy findings Figures 4 (Group A) and 5 (Group B). The figures A, B and C represent the ultramicroscopic aspects of the mitochondria and cytoplasm: figure A (biopsy 1) - before the bypass; figure B (biopsy 2) - at the end of ischemic arrest; and figure C (biopsy 3) - 10 minutes after reperfusion pre, during and post cardiac surgery of the three performed biopsies for both groups respectively. Figures 4A and 5A are biopsies performed before ischemic arrest that demonstrates cytosolic edema with mitochondria swelling grade 1 and glycogen loss seen in the biopsy before ischemic arrest. Figure 4B and 5B are biopsies performed at the end of ischemic arrest that show a sarcoplasmic reticule and mitochondrial swollen with

focal cristae disruption grade 1 and 2. Figure 4C and 5C are biopsies performed 10 minutes post CPB, after reperfusion shows the mitochondrial swelling with cristae disruption and condensation, sarcomeres were intact. Counting the frequencies of that alteration was performed a quantitative analysis. In Table 4 we summarized the frequencies of those cellular and mitochondria alterations studied. At the end of ischemic arrest there was an increasing in cellular and mitochondria alterations in both groups. The statistical analysis of the comparison of both groups revealed no significant difference; however, a more detailed description is under preparation and will be subject of another specific publication.

Fig. 4 – Myocardial ultramicroscopic representative pictures of the biopsies during mitral valve replacement of group A (beating heart). Figures 4A is a biopsy before ischemia, 4B is a biopsy at the end of ischemia, and figures 4C is a biopsy 10 minutes during reperfusion

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Fig. 5 – Myocardial ultramicroscopic representative pictures of the biopsies during mitral valve replacement of group B (arrested heart). Figures 5A is a biopsy before ischemia, 5B is a biopsy at the end of ischemia, and figures 5C is a biopsy 10 minutes during reperfusion Table 4. Cellular and mitochondrial quantitative frequencies of alterations in both groups. Ultraestrutural abnormalities (type of alteration) 1st biopsy (cellular) 1st biopsy (mitochondrial) 2nd biopsy (cellular) 2nd biopsy (mitochondrial) 3rd biopsy (cellular) 3rd biopsy (mitochondrial)

Beating heart (%) Group A N=17 Present Absent 7/17 (41.2) 10/17 (58.8) 3/17 (17.6) 14/17 (82.4) 8/17 (47.1) 9/17 (52.9) 9/17 (52.9) 8/17 (47.1) 4/17 (23.5) 13/17 (76.5) 3/17 (17.6) 14/17 (82.4)

Arrested heart (%) Group B N=17 Present Absent 10/17 (58.8) 7/17 (41.2) 7/17 (41.2) 10/17 (58.8) 11/17 (64.7) 6/17 (35.3) 13/17 (76.5) 4/17 (23.5) 8/17 (47.1) 9/17 (52.9) 8/17 (47.1) 9/17 (52.9)

*P value 0.94 0.77 0.94 0.77 0.77 0.77

N: number of patients; (%) percentage of patients; *FDR: false Discovery rates

DISCUSSION

mitochondria, nuclei or cytoplasmic alterations related to the type of surgical method. In general, most authors that have compared the techniques beating heart surgery versus the arrested heart for coronary artery bypass graft advocate that the beating heart technique better protects the heart and has better outcomes in terms of duration of mechanical ventilation support, less need of transfusion, less episodes of arrhythmia and lower length of hospitalization. Indeed, less cost is seen with this approach [17-19]. However, fewer are the studies that analyzed the ultrastructural aspects of human cardiomyocites during the

In this comparative randomized prospective study of mitral valve replacement using arrested heart versus onpump empty beating heart surgery we demonstrated that there is no significant difference in terms of clinic aspects between the two surgical procedures independently of the NYHA heart failure classification before and after the surgical intervention. Also, preliminary studies of TEM myocardial biopsies performed pre and post procedure do not favor one method over the other particularly when looking at

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surgical procedure. In a systematic review of beating-heart valve surgery, published by Salhiyyah & Taggart [10], 39 reports were reviewed, however only two were randomized control trials. Indeed, the report of Matsumoto et al. [9] that studied 50 patients (25 each group ) concluded that the perfusion technique of either retrograde warm blood or blood perfusion on beating had similar outcome including mortality and complications even though ultra microscopy study were not performed, the biochemical markers of myocardial injury were significantly lower in the retrograde technique. Despite of our study limitation present incomplete biochemistry analysis, were similar for the mortality rates and complications. Otherwise, in the report of Karadeniz et al. [20] that focused on the comparison of neurological parameters for the three groups with a total of 50 patients, even though the beating heart technique did not cross-clamp the aorta to avoid embolism, the results of neurological findings were similar. In our study all 34 patients had none neurological alteration at the immediately post surgery follow up. Also, in the 31 remain patients during 12 moth follow up. Since 1971 [21] when a warm blood cardioplegia surgery was introduced and routinely used most studies that compared with hypothermic cardioplegia, despite of the majority were observational studies, all of them agree that the major advantage of this technique is that heart beating protects against ischemia reperfusion injury in addition to reduced workload and cardiopulmonary bypass time, special for mitral valve replacement that the repair are done close to physiological conditions in the state of left ventricular beating tonus [10,21,22]. This knowledge has been extrapolated, but not proven by most these studies that beating heart protects against mitochondrial and cellular damage [6,10,23]. Even though our study had the limitation of small number of patients included into the study, the analysis of 2400 microphotographies from 102 biopsies performed among those 34 patients studied patients, do not support the idea of more injury occur in one technique than the other. The preliminary results presented here do not support the idea of beating heart surgery better protects the myocytes of ultrastructure alterations induced by the type of reperfusion, at least in terms of myocardial necrosis, cellular and mitochondrial alterations. Indeed, suggesting that the myocardial protection for subcellular damages is independent of keep the heart beating or arrested. In the experimental work reported by Kamlot et al. [24] also they reported that dog heart submitted to 180 minutes of cardiopulmonary bypass either with continuous warm or intermittent cold cardioprotection, no difference was noted in the electron microscopy damage with both cardioplegic protections. Interesting, adenosine triphosphate (ATP), creatine phosphate and lactates levels were slightly degraded in both cardioplegia groups, but the adenosine triphosphate levels were significantly reduced in the right

ventricular of the warm compared to the cold group. In our study, the time of cardiopulmonary bypass was around 8595 minutes. Even though we have not analyzed the ATP levels in our study further we will present details of the qualitative and quantitative ultra structural aspects of the myocardium biopsies compared in both groups. As we have presented here, there are no significant differences cellular and mitochondrial alterations between both groups. This is similar to the work of Schaper et al. [1] who reported an ultra-structural morphometric study of myocardial biopsies performed in 31 patients submitted to aortic valve replacement with cardiopulmonary bypass after induction of cardiac arrested surgery which revealed similar results to those we have encountered in our study. Biopsies performed before and after clamping show cellular and mitochondria alteration compatible with ischemia, which apparently are reversible after desclamping. It has been suggested that the coronary sinus pressure should be maintain 60-80 mmHg when beating heart procedures are selected. Also, the optimal flow rate are not yet determined, it has been suggested that between 150-250ml/min is the minimal necessary to warrant 4-5% of the total cardiac output [6,9]. A limitation of our study was a small number of patients in both groups to careful evaluate this variable. Another important point is the degree of severity of the damage of the valve. Simultaneous antegrade/retrograde warm blood perfusion with a beating heart has been used independent of the severity of valve disease [13]. Even, we used the NYHA class IV cardiac failure score no significant difference was noted using one or another technique. On the other hand studies monitoring troponin I levels monitoring shown no significant difference on the cardiac troponin I concentration of warm reperfusion to cold blood cardioplegia [8,25]. The need of more utilization of dopamine in the arrested group in our study was due to the routine procedure adopted by our anesthesiologist of keep the blood pressure above 50mmHg all time during the surgery. Another limitation of our study was not having done the biopsy of the right ventricle, which could provide better evaluation of this ventricle. CONCLUSION We conclude that no significant cellular and mitochondrial damage occurs with heart surgery for valve replacement using arrested or on-pump empty beating heart surgery. Also, both techniques are safe and have minimal risk of death direct related to the procedure. ACKNOWLEDGEMENT We are in debt to Professor Jehorvan Carvalho chief of the Cardiovascular Surgery for his strong support to this work and everybody of the cardiovascular surgery involved

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in this work. Also, we thank Maria Lucia Vieira for her strong technical support on the Ultramicroscopic tissue sections preparation. We thank Dr. Sanjay Mehta for English revision of the manuscript.

without aortic cross-clamping. Jpn J Thorac Cardiovasc Surg. 2006;54(10):454-7. 12. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152(11):726-32.

DISCLOSURE

13. Salerno TA, Panos AL, Tian G, Deslauriers R, Calcaterra D, Ricci M. Surgery for cardiac valves and aortic root without cardioplegic arrest (“beating heart”): experience with a new method of myocardial perfusion. J Card Surg. 2007;22(6):459-64.

There is no conflict of interest and no participation or approvals from manufactures companies.

14. Ikonomidis JS, Yau TM, Weisel RD, Hayashida N, Fu X, Komeda M, et al. Optimal flow rates for retrograde warm cardioplegia. J Thorac Cardiovasc Surg. 1994;107(2):510-9.

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15. Bara C, Zhang R, Haverich A. De Vega annuloplasty for tricuspid valve repair in posttraumatic tricuspid insufficiency: 16 years experience. Int J Cardiol. 2008;126(3):e61-2. 16. Rosner B. Fundamentals of biostatistics. 6a ed. New York: Duxbury Press; 2006.

2. Ricci M, Macedo FI, Suarez MR, Brown M, Alba J, Salerno TA. Multiple valve surgery with beating heart technique. Ann Thorac Surg. 2009;87(2):527-31.

17. Hannan EL, Wu C, Smith CR, Higgins RS, Carlson RE, Culliford AT, et al. Off-pump versus on-pump coronary artery bypass graft surgery: differences in short-term outcomes and in long-term mortality and need for subsequent revascularization. Circulation. 2007;116(10):1145-52.

3. Kaplon RJ, Pham SM, Salerno TA. Beating-heart valvular surgery: a possible alternative for patients with severely compromised ventricular function. J Card Surg. 2002;17(2):170-2. 4. Cressoni ES, Avanci LE, Braile DM, Cicogna AC, Lima-Oliveira AP, Gerez MA, et al. Myocardial protection to the hypertrophied heart: the eternal challenge. Rev Bras Cir Cardiovasc. 2008;23(1):97-107.

18. Karolak W, Hirsch G, Buth K, Légaré JF. Medium-term outcomes of coronary artery bypass graft surgery on pump versus off pump: results from a randomized controlled trial. Am Heart J. 2007;153(4):689-95. 19. Kloner RA, Jennings RB. Consequences of brief ischemia: stunning, preconditioning, and their clinical implications: part 1. Circulation. 2001;104(24):2981-9.

5. Salerno TA, Houck JP, Barrozo CA, Panos A, Christakis GT, Abel JG, et al. Retrograde continuous warm blood cardioplegia: a new concept in myocardial protection. Ann Thorac Surg. 1991;51(2):245-7.

20. Karadeniz U, Erdemli O, Yamak B, Genel N, Tutun U, Aksoyek A, et al. On-pump beating heart versus hypothermic arrested heart valve replacement surgery. J Card Surg. 2008;23(2):107-13.

6. Babaroglu S, Yay K, Parlar AI, Ates C, Mungan U, Cicekcioglu F, et al. Beating heart versus conventional mitral valve surgery. Interact Cardiovasc Thorac Surg. 2011;12(3):441-7.

21. Follette DM, Steed DL, Foglia RP, Fey KH, Buckberg GD. Reduction of postischemic myocardial damage by maintaining arrest during initial reperfusion. Surg Forum. 1977;28:281-3.

7. Chambers DJ, Fallouh HB. Cardioplegia and cardiac surgery: pharmacological arrest and cardioprotection during global ischemia and reperfusion. Pharmacol Ther. 2010;127(1):41-52.

22. Gersak B. Mitral valve repair or replacement on the beating heart. Heart Surg Forum. 2000;3(3):232-7.

8. Evora PR, Pearson PJ, Seccombe JF, Schaff HV. Ischemiareperfusion lesion. Physiopathologic aspects and the importance of the endothelial function. Arq Bras Cardiol. 1996;66(4):239-45.

23. Botta L, Cannata A, Bruschi G, Fratto P, Martinelli L. Beating heart mitral valve surgery: innovation or back to the past? J Card Surg. 2010;25(3):318.

9. Matsumoto Y, Watanabe G, Endo M, Sasaki H, Kasashima F, Kosugi I. Efficacy and safety of on-pump beating heart surgery for valvular disease. Ann Thorac Surg. 2002;74(3):678-83.

24. Kamlot A, Bellows SD, Simkhovich BZ, Hale SL, Aoki A, Kloner RA, et al. Is warm retrograde blood cardioplegia better than cold for myocardial protection? Ann Thorac Surg. 1997;63(1):98-104.

10. Salhiyyah K, Taggart D. Beating-heart valve surgery: A systematic review. Asian Cardiovasc Thorac Ann. 2009;17(6):650-8.

25. Shirai T, Rao V, Weisel RD, Ikonomidis JS, Hayashida N, Ivanov J, et al. Antegrade and retrograde cardioplegia: alternate or simultaneous? J Thorac Cardiovasc Surg. 1996;112(3):787-96.

11. Mizuno T, Arai H. On-pump beating-heart mitral valve plasty

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Cacau LAP,EXPERIMENTAL et al. - The use of the virtual reality as intervention tool in the STUDY postoperative of cardiac surgery

The use of the virtual reality as intervention tool in the postoperative of cardiac surgery O uso da realidade virtual como ferramenta complementar no pós-operatório de cirurgia cardíaca

Lucas de Assis Pereira Cacau2, Géssica Uruga Oliveira1, Luana Godinho Maynard1, Amaro Afrânio de Araújo Filho1, Walderi Monteiro da Silva Junior2, Manoel Luiz Cerqueria Neto2, Angelo Roberto Antoniolli1, Valter J. Santana-Filho2

DOI: 10.5935/1678-9741.20130039

RBCCV 44205-1468

Abstract Introduction: Cardiac surgery has been the intervention of choice in many cases of cardiovascular diseases. Susceptibility to postoperative complications, cardiac rehabilitation is indicated. Therapeutic resources, such as virtual reality has been helping the rehabilitational process. The aim of the study was to evaluate the use of virtual reality in the functional rehabilitation of patients in the postoperative period. Methods: Patients were randomized into two groups, Virtual Reality (VRG, n = 30) and Control (CG, n = 30). The response to treatment was assessed through the functional independence measure (FIM), by the 6-minute walk test (6MWT) and the Nottingham Health Profile (NHP). Evaluations were performed preoperatively and postoperatively. Results: On the first day after surgery, patients in both groups showed decreased functional performance. However, the VRG showed lower reduction (45.7±2.3) when compared to

CG (35.06±2.09, P<0.05) in first postoperative day, and no significant difference in performance on discharge day (P>0.05). In evaluating the NHP field, we observed a significant decrease in pain score at third assessment (P<0.05). These patients also had a higher energy level in the first evaluation (P<0.05). There were no differences with statistical significance for emotional reactions, physical ability, and social interaction. The length of stay was significantly shorter in patients of VRG (9.4±0.5 days vs. 12.2 ± 0.9 days, P<0.05), which also had a higher 6MWD (319.9±19.3 meters vs. 263.5±15.4 meters, P<0.02). Conclusion: Adjunctive treatment with virtual reality demonstrated benefits, with better functional performance in patients undergoing cardiac surgery.

Veja reportagem sobre o tema desenvolvido neste artigo acessando o link: http://globotv.globo.com/tv-sergipe/se-tv-2a-edicao/v/games-sao-terapiapara-pacientes-cardiacos-em-aracaju/2194856/

Correspondence address: Lucas de Assis Pereira Cacau Department of Physical Therapy, Federal University of Sergipe Rua Cláudio Batista, s/n. – Santo Antonio – Aracaju, SE Brazil – Zip code 49060-100 E-mail: lucas.cacau@yahoo.com.br

Descriptors: Video games. Cardiac surgical procedures. Motivation. Physical therapy modalities.

1. Graduate Program in Health Science, Federal University of Sergipe, Aracaju, SE, Brazil. 2. Department of Physical Therapy, Federal University of Sergipe, Aracaju, SE, Brazil.

Article received on January 3rd, 2013 Article accepted on May 17th, 2013

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estudo foi avaliar o uso da realidade virtual na reabilitação funcional de pacientes pós-cirurgia cardíaca. Métodos: Os pacientes foram randomizados em dois grupos, Realidade Virtual (GRV, n=30) e Grupo Controle (GC, n=30). A resposta ao tratamento foi avaliada por meio do Questionário de Medida de Independência Funcional (MIF), Teste de caminhada de 6 minutos e do Perfil de Saúde de Nottingham (PSN). Os questionários foram aplicados no pré e pós-operatório. Resultados: No primeiro dia de pós-operatório, os pacientes de ambos os grupos demonstraram diminuição do desempenho funcional. No entanto, essa perda foi menor no GRV (45,7±2,3) em relação ao GC (35,06±2,09, P<0,05), sem diferença significativa no momento da alta hospitalar (P>0,05). Na avaliação do PSN, foi observada menor intensidade da dor no terceiro momento de avaliação no GRV (P<0,05). Esses pacientes também apresentaram maior nível de energia na primeira avaliação (P<0,05). Não foram encontradas diferenças com significância estatística para reações emocionais, habilidade física e interação social. O tempo de internação foi significativamente menor nos pacientes do GRV (P<0,05), que também apresentaram maior distância percorrida no TC6 (319,9±19,3 metros vs. 263,5±15,4 metros, P<0,02). Conclusão: O tratamento com a realidade virtual foi eficaz em proporcionar melhor desempenho funcional pós-operatório.

Abbreviations, acronyms & simbols 6MWT BP CG CR CVD FIM HR ICF ICU MET MV NHP PO RR SpO2 SPSS VR VRG WHO

Six minutes walk test Blood pressure Control group Cardiac rehabilitation Cardiovascular diseases Functional Independent Measure Heart rate Informed consent form Intensive care unit Metabolic equivalents of task Mechanical ventilation Nottingham Health Profile Postoperative day Respiratory rate Peripheral saturation of oxygen Statistical Package for the Social Sciences Virtual reality Virtual reality group World Health Organization

Resumo Introdução: A cirurgia cardíaca tem sido a intervenção de escolha em muitos casos de doenças cardiovasculares. Pela susceptibilidade a complicações pós-operatórias, a reabilitação cardíaca é indicada. Recursos terapêuticos, como a realidade virtual, tem favorecido o processo reabilitacional. O objetivo do

Descritores: Jogos de vídeo. Procedimentos cirúrgicos cardíacos. Motivação. Modalidades de fisioterapia.

INTRODUCTION

In the past few years, the development of a more accurate diagnosis and therapeutic methods has dramatically reduced mortality and negative outcomes of these diseases [13]. Nevertheless, the physiotherapeutic rehabilitation protocols have became necessary in the prevention of post-operatory complications [14]. The benefits of inserting a post-operated patient in a cardiac rehabilitation (CR) program are well established [14] and physiotherapy is highlighted as a fundamental tool in the period of post cardiac surgery, acting from the evaluation of mechanical ventilation (MV) weaning, in the prevention of pulmonary complications, to the caring of patients’ functional capacity. However, the treatment faces some restrictions due to pain, fear, insecurity and post-operatory unwillingness [15]. Focusing on greater development in the rehabilitation processes, virtual reality (VR) has been described as an additional tool for the physiotherapeutic protocols [16,17] and for the auxiliary treatment of many diseases [18-20]. The insertion of VR as a support for the physiotherapeutic treatment brings several benefits, including less pain after painful procedures [21] and greater motivation during treatment [22]. VR may use advanced interface technologies where the user is not in front of a monitor, but immersed in a tridimensional world generated by the software [22]. In order to achieve its goals during treatment, this virtual environment

Cardiovascular diseases (CVD) have had great impact on the world heath scenario [1]. In the USA, one in every three adults have one or more CVD and the total number of patients that have undergone cardiovascular surgeries have increased 33% in the last decade, which accounts for around $ 500 billion a year for CVD and $ 155 billion for hospitalization [2]. Approximately one million hospitalizations and around 30% of deaths in Brazil are due to CVD. It is also the number one cause of death among the elderly. Although clinical treatment have made the approach to individuals with cardiovascular diseases less invasive [3], the cardiac surgery is the intervention adopted in some cases of cardiovascular diseases and it aims at increasing patients’ life expectancy and life quality [4]. In 2011, around 100 thousand cardiac surgeries were performed in Brazil in more than 170 centers around all the Brazilian states [5]. Patients that have undergone cardiac surgeries are likely to develop complications during and after the operations, such as pain, respiratory complications, functional loss, neurocognitive decline, depression and increased anxiety [6-9]. These complications are the main causes of morbidity and mortality after a cardiac surgery [10], contributing for the increase of length of hospital stay and its cost [11,12].

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works with specific functions wished to be recovered, mainly in attention, memory, physical strength and using challenging strategies [22]. The main reason for the use of treatment strategies with VR is based on the necessity of adding a motivation factor, which helps patients use movements expected by physiotherapeutic treatment. Thus, helping in the recuperation process [21,22].

0180.0.107.107-11) and was conducted at the Fundação de Beneficência Hospital Cirurgia, Aracaju, Sergipe, Brazil from August 2010 to June 2011. The study included 102 individuals that have undergone elective cardiac surgery (coronary artery bypass grafting and / or valve replacement). In order to be included in the study the patient should agreed to participate in the research and signed the informed consent form (ICF). It was excluded patients with age over 75 years, patients hemodynamically instable, presence of arrhythmia or respiratory distress during the protocol; use of mechanical ventilation on the first postoperative day, patient dropouts removing the ICF, patients that present psychiatric disorders, muscular or neurological disease that would preclude protocol execution (Figure 1).

METHODS This is a controlled clinical trial, longitudinal, contemporary and quantitative study. The study protocol was approved by the Human Research Ethics Committees of the Federal University of Sergipe (CAAE number

Fig. 1 – Diagram representing the flow of participants in each study phase

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Functional performance was evaluated on admission and demographic characteristics (age and gender) and information about surgical procedure were also collected. After these initial evaluations patients were divided into two groups by using randomized sampling. Patients allocated in control group (CG), performed conventional physical therapy treatment twice a day (in the morning and afternoon). The treatment protocol included: breathing exercises, airway clearance techniques, metabolic exercise and motor exercise [20]. Patients allocated in virtual reality group (VRG) were treated twice a day (in the morning and afternoon), performing the same techniques than conventional treatment however the motor exercise was performed using virtual reality. The application of virtual reality and kinesiotherapy were performed in accordance with the phases of rehabilitation and energy expenditure (Metabolic Equivalent of Task MET) [21,22]. Through this method, the exercise is prescribed by determining the percentage of exercise capacity of the individual and by selecting the activities included in the series [23-26]. All patients had their functional performance reassessed on the first, third, postoperative day (PO) and at the discharge day. The Six minutes walk test (6MWT) was also performed on the day the patientes were discharged. The length of hospitalization was monitored in both groups.

with different levels of dysfunction and for detecting important alterations in the patient’s health status. An algorithm was used to quantify the values within its domains, which uses the American version for data interpretation. As for the analysis, a delta difference was used between the pre-operatory and the 1st postoperative day (PO) (delta 1), between the pre and the 3rd PO (delta 2), and between the pre and the day of hospital discharge (delta 3). Six-minute walk test (6MWT) The 6MWT was used to determine the walking capacity by measuring the maximum distance that an individual is able to walk within six minutes [30]. Thus, the 6MWT was performed identically in both groups. A 30-m indoor course was delineated with cones, which were arranged in a straight line on level ground. While the patient remained seated, respiratory rate (RR), heart rate (HR), blood pressure (BP), peripheral oxygen saturation (SpO2) and subjective sensation of dyspnea (modified Borg scale) were obtained [31]. Each participant was instructed to complete as many laps as possible in 6 min, walking briskly, but without running or jogging. At the end of every minute, the patient was informed of how many minutes remained and was given verbal encouragement in a neutral tone of voice (“You’re doing well” and “Keep up the good work”). The investigator stood at one end of the walking course holding a stopwatch [31]. After 6 min, the patient was instructed to stop. The distance from the cone to the spot where the patient stopped was then measured. While the individual remained seated, HR, RR, SpO2, and Borg scale scores [32] were again obtained, immediately after the test and after a 3-min rest period. Each test was administered to one individual at a time. It was explained to participants that, during the test, they could stop walking at any time if they experienced discomfort, but that test time would continue to be counted [32].

Functional Performance Evaluation The Functional Independence Measure (FIM) is an 18item ordinal scale (range: 0 to 126) with seven levels per item (from complete independence to total assist) that includes assessment of disability in the areas of self-care, sphincter control, mobility, locomotion, communication, psychosocial adjustment, and cognitive function [27]. The physical FIM subscore refers to the summed sub-scores for self-care, sphincter control, mobility, and locomotion items, whereas cognitive FIM sub-score includes the sub-scores for communication, psychosocial adjustment, and cognitive function. It is internationally accepted as a measure of functionality [28] and was already validated to be used in Brazil [29].

Statistical Analysis The Statistical Package for the Social Sciences (SPSS), version 17.0 (SPSS Inc., Chicago, IL), was used for data analysis. Descriptive statistics (mean±SEM) were calculated for age and perfusion time in both groups. Frequency counts were calculated for gender and type of surgery. All variables were consistent with normal distribution (Shapiro Wilks), except perfusion time. Mann-Whitney (Test U) test was conducted to compare perfusion time between groups. FIM (physical, cognitive and total domain) scores were analyzed by two-way ANOVA. Bonferroni test was used for post hoc analyses. The Student t test was used to compare 6MWT, length of hospitalization and age. Chi-square (X2) was used to compare type of surgery between the groups. The threshold of statistical significance was set at P<0.05.

Health profile Nottingham Health Profile (NHP) is a generic life quality evaluation instrument, originally developed to evaluate patients' quality of life with chronicle diseases [25]. It is a yes/no question survey made of 38 items based on the classification of incapacity described by the World Health Organization (WHO). The survey measures six dimensions of health including: physical mobility, pain, social isolation, emotional reactions, energy, and sleep. The evaluator quantifies each positive answer as score one (1), and each negative answer as zero (0), to a maximum of 38 points [26]. Using an easily comprehensible language, the NHP gives a simple measure of someone’s physical, emotional and social health. The NHP is clinically valid for distinguishing patients

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RESULTS

statistical improvement in the VRG in delta 3 (P<0.05) (Figure 4). In delta 1 of the NHP energy level domain (Figure 5), there was significant improvement in the VRG, when compared to the CG (P<0.05). During treatment improvement remained significant as for treatment time (P<0.0001) in both groups, with no significant difference between them in the other deltas of the evaluation for this domain. In the emotional reaction, sleep, physical abilities and social interaction domains, evaluated by NHP, both treatments proved effective in optimizing recovery (P<0.05), with no significant difference between the CG and VRG (P<0.05). Moreover, VRG showed lower length of hospitalization (Figure 6) (CG 12.2 ± 0.9 days and VRG 9.46 ± 0.5 days, P<0.05) and higher walking capacity, evaluated by 6MWT (Figure 7) (CG 263.5 ± 15.4 meters and VRG 319.96 ± 19.3 meters, P<0.05).

In this study, no differences were observed between groups regarding to age, gender, surgical type and perfusion time (Table 1). When performing the analysis between the groups at the motor and total FIM score there were significant differences only on the 1st PO (Figure 2). The comparison between groups at the cognitive FIM score showed no significant difference (Figure 3). NHP was applied and evaluated through its six domains and total score. No significant difference was observed in the total score between the CG and the VRG (P>0.05). However, this difference was significant in treatment time in both groups (P<0.05). As for the pain domain, a positive reply was noticed in treatment time, reflecting lower score (P<0.05) among deltas 1, 2 and 3 as well as the type of treatment, with a significant

Table 1. CG - Control Group, VRG - Virtual Reality Group. Data were analyzed using the X2 test. P> 0.5 - no statistically significant. Age (years) Gender (male/female) Surgery Coronary artery bypass graft surgery Valve replacement surgery Perfusion time (minutes)

VRG (n=30) 49.2±2.6 13/17

CG (n=30) 52±2.4 16/14

P value >0.05 >0.05

16 14 93.1±40

12 18 99.25±26

>0.05 >0.05 >0.05

Fig. 3 – Effects of treatment on the cognitive FIM score in patients undergoing cardiac surgery. CG = Control Group; VRG = Virtual Reality Group; FIM = Functional Independence Measure, Pre = Pre operative; 1POD = first postoperative day; 3POD = third postoperative day; Discharge = Discharge day. Data were analyzed using two-way ANOVA. No differences were observed

Fig. 2 – Effects of treatment on the motor FIM score in patients undergoing cardiac surgery. CG = Control Group; VRG = Virtual Reality Group; FIM = Functional Independence Measure, Pre - Pre operative; 1POD = first postoperative day; 3POD = third postoperative day; Discharge = Discharge day. Data were analyzed using two-way ANOVA (*VRG x CG at 1st PO, P< 0.05)

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Fig. 6 - Total length of stay between CG and VRG. CG - Control Group; VRG - Virtual Reality Group; Data were analyzed using Student t test (*VRG x CG, P<0.05)

Fig. 4 – Effect of cardiac rehabilitation versus time of post surgical pain in the field of NHP in CG and VRG. NHP = Nottingham Health Profile; CG = Control Group; VRG = Virtual Reality Group; Delta 1 (difference of pre-operative score for first postoperative day); Delta 2 (difference of pre-operative score for third postoperative day) and Delta 3 (difference of preoperative score for the discharge day). Data were analyzed using two-way ANOVA (Delta 3 *VRG x CG, P<0.05)

Fig. 7 - Mean distance covered in the 6MWT between the groups. CG - Control Group; VRG - Virtual Reality Group; 6MWT – Six minute walk test. Data were analyzed using Student t test (*VRG x CG, P<0.05) Fig. 5 – Effect of cardiac rehabilitation versus time of post surgical energy level in the field of NHP in CG and VRG. NHP = Nottingham Health Profile; CG = Control Group; VRG = Virtual Reality Group; Delta 1 (difference of pre-operative score for first postoperative day); Delta 2 (difference of pre-operative score for third postoperative day) and Delta 3 (difference of preoperative score for the discharge day). Data were analyzed using two-way ANOVA (Delta 1 *VRG x CG, P<0.05)

contribute to functional loss [27-29]. There was a reduction in the postoperative functionality in patients of both studied groups evaluated with total FIM, with a gradual improvement in both groups until the hospital discharge day. This functional loss has not suffered influence from these patients’ cognitive function. Although commonly found, they were not noticed in the patients of this study [8]. The greatest loss was noticed on the 1st PO, because this is the postoperative critical moment. Besides the pain in the surgical region, the patient was still at the intensive care unit (ICU), requiring closer monitoring and consequently greater devices that contribute to bed mobility restriction, such as electrodes, accesses, as well as the use of tubes and drains, which besides promoting restriction, they also contribute to pain, fear, insecurity and increase of anxiety. Despite the notorious functional loss in patients of both groups, patients in the VRG evolved with lower decrease in their functional performance when compared to patients in the

DISCUSSION In this study, VR, as an adjunct treatment to the rehabilitation protocols, has shown benefits in functional performance, higher energy levels, less pain and better walking capacity in patients submitted to cardiac surgery. Moreover, it provided faster recovery and early hospital discharge to operated patients. Patients in the postoperative period of cardiac surgery are susceptible to developing operatory complications that

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CG. Thus showing significant difference on the 1st POD and FIM motor analysis. During the patient’s critical moment, the adoption of a motivational factor was able to generate greater involvement of this patient in the rehabilitation process. Studies have shown that treatment with VR was also able to provide motor-sensorial improvement [30] and function of upper limbs in patients with cerebrovascular accident [31] sequels. In another study, when used during phase II cardiac rehabilitation, VR was able to reduce time to reach target cardiac frequency during treatment, by adding motivation and distraction to the treatment [32]. The lower functional loss found in the VRG, might be associated with the higher level of energy when comparing to the patients in the CG in delta 1. With a better energy level, the required motor functions during the physiotherapeutic protocols, may be done with less restriction. These motor functions were performed in both groups, aiming at the same metabolic expenditure, as expected by the phase 1 cardiac rehabilitation program. However, in the VRG, besides the motor work, the involvement with the “virtual world� through interactive games generated the addition of a motivational factor that contributed to the physiotherapeutic rehabilitation program, assuring better functionality [33,34]. Although inserted in a postoperative rehabilitation program, there are intra and postoperative factors such as pain and the increase of anxiety that contribute to functional loss [8,10]. Pain was evaluated in patients from this study through NHP and has shown greater intensity in delta 1 in patients from both groups. However, it was lower in patients from VRG in all evaluation moments (delta 1, 2 and 3) when compared to the CG and this difference was statistically significant in delta 3, showing that patients from the VRG were hospital discharged with less pain intensity. During hospital stay, the analgesic routine procedure was kept to all operated patients from both groups. No direct physiotherapeutic resource was used to reduce pain. We then could say that, as the patients from the VRG were trying to achieve a goal while playing a game, they may have reduced the psychosomatic effect of pain, participating more effectively in the rehabilitation process. Corroborating with this hypothesis, studies have shown that the use of VR is capable of providing distraction during physiotherapeutic approach during procedures that cause exacerbating pain, generating better results in physical movement and mobility [21]. VR was also able to reduce anxiety and the perception of pain in pediatric patients submitted to postoperative physiotherapy as they had a fun motivating element [35]. It also provided greater relieve of pain during the treatment of burned patients [36]. Although the patients from both groups presented similar function capacity on the hospital discharge day, the patients from the VRG showed a significant reduction in hospital stay. Such fact is clearly associated with lower pain intensity in the VRG on the hospital discharge day [6].

Besides earlier hospital discharge compared to patients from the CG, patients from the VRG had gone further on the six minute walk test, performed on the hospital discharge day. Greater walking capacity means greater cardiovascular condition [37]. This was demonstrated in these patients, confirming the validity and safety of VR as a rehabilitation tool. Benefits from the use of VR include improvement in the visual perception and gait rehabilitation process in diabetic patients [38]. The psychological effects of cardiac rehabilitation have been described so far as being weaker than those from the physical domain, though the physical domain effects may serve as base for the effects from the psychological domain [37]. When using VR as an auxiliary tool, we bind the motivational effect to the physical therapy, which generates greater therapeutic participation, which could explain the already mentioned results. The results of the two domains (pain and energy level) analyzed show the functional improvement described by the FIM on the patients form the VRG on the 1st POD, because it is known that pain limits functional recovery [39]. When we analyze the emotional reaction, physical abilities and social interaction domains form the NHL, we notice a progressive improvement in the health profile with the time of treatment, without significant difference between groups, thus confirming the results from the literature that show the positive effect of cardiac rehabilitation during the postoperative period of cardiac surgery [37,40]. The results of the sample characterization found in this study show that it is a homogenous one, with no elderly adults, as there was no significant difference in either group that would characterize it. For most patients, it was their first experience with video games and even though they were adults, it did not seem to be a barrier; on the contrary, they were eager to learn something new, something that could help them recover sooner. The search for recovery and learning may have been influencing factors for a better social interaction of the patients from the VRG. It is importantly to say that both groups underwent respiratory physiotherapy during the study. Thus, the better functional performance of the VRG could be associated with greater motivation for the performer and a better involvement in the treatment program achieved with the minimization of anxiety and fear that are often felt in the immediate postoperative period [40]. According to our results, we can speculate that the use of virtual reality, acting as a motivating factor to encourage the patient to perform the exercise, increases patients' self-esteem, providing a challenge to perform an action associated with a functional activity. The positive effect of cardiac rehabilitation in post-cardiac surgery has been well documented [17,18]. Both groups demonstrated an increase in the motor FIM score and in the total FIM accordant with the progression of treatment.

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However, despite the groups showed similar functional capacity on the day of hospital discharge, patients in the VRG presented a reduction in hospital length of stay due to to their improvement in functional capacity recovery in consequence of pain attenuation and greater level of energy what leads to a better functionality. Moreover, despite the similarities in functionality between the groups from discharged individuals, patients allocated in VRG also demonstrated a greater 6MWD. Because it is the idealization of a new therapeutic approach, this finding suggests that although the functional impairment promoted by the surgical procedure, the treatment with the VR was able to provide greater therapeutic involvement during postoperative recovery.

3. Grossi EA, Loulmet DF, Schwartz CF, Ursomanno P, Zias EA, Dellis SL, et al. Evolution of operative techniques and perfusion strategies for minimally invasive mitral valve repair. J Thorac Cardiovasc Surg. 2012;143(4 Suppl):S68-70. 4. Loures DRR, Carvalho RG, Mulinari L, Silva Jr. AZ, Schmidlin CA, Brommelströet M, et al. Cirurgia cardíaca no idoso. Rev Bras Cir Cardiovasc. 2000;15(1):1-5. 5. Braile DM, Godoy MF. History of heart surgery in the world. 1996. Rev Bras Cir Cardiovasc. 2012;27(1):125-36. 6. Giacomazzi CM, Lagni VB, Monteiro MB. A dor pós-operatória como contribuinte do prejuízo na função pulmonar em pacientes submetidos à cirurgia cardíaca. Rev Bras Cir Cardiovasc. 2006;21(4):386-92.

CONCLUSIONS

7. Baumgartner WA. Neurocognitive changes after coronary bypass surgery. Circulation. 2007;116(17):1879-81.

The use of virtual reality for rehabilitation of patients subjected to cardiac surgery proved effective, providing greater functional independence, better energy levels, less pain and shorter hospitalization, as well as improving walking capacity of patients from the VRG. It is also clear that at the end of cardiac rehabilitation phase I, the patient has not recovered all preoperative function and, therefore, it is essential to include these patients in cardiac rehabilitation programs phase II.

8. Mallik S, Krumholz HM, Lin ZQ, Kasl SV, Mattera JA, Roumains SA, et al. Patients with depressive symptoms have lower health status benefits after coronary artery bypass surgery. Circulation. 2005;111(3):271-7. 9. Polese G, Lubli
P, Mazzucco A, Luzzani A, Rossi A. Effects of open heart surgery on respiratory mechanics. Intensive Care Med. 1999;25(10):1092-9. 10. Orcutt ST, Bechara CF, Pisimisis G, Barshes NR, Kougias P, et al. Impact of perioperative events on mortality after major vascular surgery in a veteran patient population. Am J Surg. 2012;204(5):586-90.

Funding This work was supported by grants from the National Council for Scientific and Technological Development (Conselho Nacional de Desenvolvimento Científico e Tecnológico/ CNPq/ Brazil) and the Research Foundation of the State of Sergipe (Fundação de Apoio à Pesquisa e à Inovação Tecnológica do Estado de Sergipe/FAPITEC-SE).

11. Baser O, Burkan A, Baser E, Koselerli R, Ertugay E, Altinbas A. High cost patients for cardiac surgery and hospital quality in Turkey. Health Policy. 2013;109(2):143-9. 12. Muedra V, Llau JV, Llagunes J, Paniagua P, Veiras S, FernándezLópez AR, et al. Postoperative costs associated with outcomes after cardiac surgery with extracorporeal circulation: role of antithrombin levels. J Cardiothorac Vasc Anesth. 2013;27(2):2307.

Conflicting of interests declaration There are no affiliations with any organization to any author’s knowledge that has a direct interest in the subject matter discussed.

13. Nielsen DV, Bhavsar R, Greisen J, Ryhammer PK, Sloth E, Jakobsen CJ. High thoracic epidural analgesia in cardiac surgery: part 2-high thoracic epidural analgesia does not reduce time in or improve quality of recovery in the intensive care unit. J Cardiothorac Vasc Anesth. 2012;26(6):1048-54.

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38. Deutsch JE. Using virtual reality to improve walking post-stroke: translation to individuals with diabetes. J Diabetes Sci Technol. 2011;5(2):309-14.

26. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the sixminute walk test. Am J Respir Crit Care Med. 2002;166(1):111-7.

39. Chapman CR, Zaslansky R, Donaldson GW, Shinfeld A. Postoperative pain trajectories in cardiac surgery patients. Pain Res Treat. 2012;2012:608359.

27. Van Caenegem O, Jacquet LM, Goenen M. Outcome of cardiac surgery patients with complicated intensive care unit stay. Curr Opin Crit Care. 2002;8,(5):404-10.

40. Penko AL, Barkley JE. Motivation and physiologic responses of playing a physically interactive video game relative to a sedentary alternative in children. Ann Behav Med. 2010;39(2):162-9.

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Dallan LAO, et al.COMMUNICATION - Cardiogenic shock due to coronary artery disease SHORT associated with interrupted aortic arch

Cardiogenic shock due to coronary artery disease associated with interrupted aortic arch Choque cardiogênico decorrente de cardiomiopatia isquêmica associada à interrupção do arco aórtico

Luís Alberto Oliveira Dallan1, Adriano Milanez2, Luiz Augusto F. Lisboa3, Fabio B. Jatene4 DOI: 10.5935/1678-9741.20130040

RBCCV 44205-1469

Abstract Acute pulmonary edema is a serious event. Its occurrence in association with interrupted aortic arch and coronary heart disease is rare. Recently, an old patient developed cardiogenic shock and acute pulmonary edema due to acute coronary insufficiency, associated with interrupted aortic arch. The coronary angiography revealed occlusion of the right coronary artery and 95% obstruction in the left main coronary artery, associated with interruption of the descending aorta. Coronary artery bypass graft was performed, without extracorporeal circulation, to the anterior descending coronary artery. We discuss the initial management, given the seriousness of the case.

Resumo A associação de interrupção do arco aórtico e doença coronária é rara. Entretanto, recentemente nos deparamos com um paciente nessa condição, que culminou com choque cardiogênico e edema agudo de pulmão. A finalidade desta comunicação breve é transmitirmos e discutirmos se a conduta adotada foi a mais indicada. Sua coronária direita estava 100% ocluída e havia obstrução de 95% em tronco de coronária esquerda, associada à interrupção de aorta descendente. Realizamos apenas enxerto de veia safena para ramo da coronária esquerda, sem circulação extracorpórea. O paciente apresentou boa evolução imediata. Destacamos a conduta inicial adotada, diante da gravidade do caso.

Descriptors: Acute coronary syndrome. Aorta, thoracic. Cardiomyopathies. Shock, cardiogenic.

Descritores: Síndrome coronariana aguda. Aorta torácica. Cardiomiopatias. Choque cardiogênico.

INTRODUCTION

A 61-year-old male patient presented sudden illness on his way to work. As there was an outbreak of H1N1 flu, the test was requested and it was negative. He had a previous stent in the left carotid artery due to an ischemic vascular accident four years ago. He developed acute pulmonary edema a few minutes after being admitted to the emergency room, requiring mechanical ventilation. The chest X-ray revealed pulmonary congestion, presence of Q wave in inferior leads and alteration of ventricular

Acute pulmonary edema is a severe condition caused by several mechanisms. Its occurrence in association with interrupted aortic arch and coronary heart disease is rare. Recently, we faced a similar serious situation, and the purpose of this brief communication is to discuss the best treatment option for patients in the same condition.

1. Associated professor at the Medical School, University of São Paulo (FMUSP), director of the Surgical Coronary Diseases Unit at Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (INCOR-HC-FMUSP), São Paulo, SP, Brazil. 2. Cardiovascular surgeon, São Paulo, SP, Brazil. 3. Assistant physician at Surgical Coronary Diseases Unit at INCOR-HCFMUSP, São Paulo, SP, Brazil, São Paulo, SP, Brazil. 4. Full professor of Cardiovascular Surgery at FMUSP, director of the Cardiothoracic Division at INCOR-HC-FMUSP, São Paulo, SP, Brazil.

Correspondence address: Luís Alberto Oliveira Dallan Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Av. Dr. Enéas de Carvalho Aguiar, 44 – 2º andar – sala 11 – Cerqueira César – São Paulo, SP, Brazil – Zip Code: 05403-000. E-mail: dcidallan@incor.usp.br Work carried out at Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (INCOR-HC-FMUSP), São Paulo, SP, Brazil. Article received on December 19th, 2012 Article accepted on March 26th, 2013

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repolarization in the anterior wall. The echocardiogram showed inferior ventricular wall akinesia and marked hypokinesia in the other walls. The cineangiocoronariography showed occlusion of the right coronary artery and a 95% obstruction in the left main coronary artery in addition to an interruption at the descending aorta, just after the left subclavian artery origin (Figure 1). Besides developing unstable hemodynamics, requiring inotropic agents, the patient suffered two more pulmonary edema episodes. for Intra-aortic balloon pump was not an option, because of the aortic disease. Percutaneous coronary intervention with stent in the left main coronary artery was suggested, however two interventional cardiology teams did not accept the case. After 10 days in the intensive care unit, we performed an off -pump left anterior descending artery bypass, with a saphenous graft. Mechanical ventilation was discontinued in the first postoperative day, followed by a good recovery. Just before the patient’s discharge, a chest angiotomography was carried out to confirm the aortic arch interruption and to evaluate saphenous graft patency (Figure 2).

the simplest surgical approach (saphenous graft to left anterior descending) because we believed that such a critical patient’s condition would not let allow a simultaneous correction (tube between ascending and descending aorta as well as myocardial revascularization) [5]. After more than one year of follow-up, patient remains asymptomatic, despite no intervention being done on the interrupted aortic arch.

Fig. 2 – Postoperative angiotomography shows interruption of aortic arch after subclavian artery origin (arrow) and a patent saphenous graft (arrow) REFERENCES 1. Alam M, Simpson L, Virani SS, Cheong B, Loyalka P, Civitello AB. Incidental diagnosis of interrupted aortic arch in a 72-yearold man. Tex Heart Inst J. 2009;36(5):494-5. Fig. 1 – Preoperative cineangiocoronariography. a. Left main artery: 95% stenosis (arrow). b. Right coronary artery: proximal occlusion (arrow). c. Aortic arch with complete interruption at descending thoracic aorta (arrow). d. The descending thoracic aortogram shows complete interruption at descending thoracic aorta (arrow). Catheter is inserted thru femoral artery

2. Wong CK, Cheng CH, Lau CP, Leung WH, Chan FL. Interrupted aortic arch in an asymptomatic adult. Chest. 1989;96(3):678-9. 3. Kosucu P, Kosucu M, Dinc H, Korkmaz L. Interrupted aortic arch in a adult: diagnosis with MSCT. Int J Cardiovasc Imaging. 2006;22(5):735-9. 4. Sari I, Davutoglu V, Soydinc S, Ozer O. A case of misdiagnosed interrupted aortic arch as primary hypertension for almost two decades. N Z Med J. 2007;120(1258):U2635.

DISCUSSION Interrupted aortic arch is an extremely rare congenital malformation, and only a few cases in adults have been reported [1-4]. In this particular patient, the association of such a severe coronary disease with the interrupted aortic arch might have worsened the pulmonary edema. We chose

5. Lisboa LAF, Abreu Filho CAC, Dallan LAO, Rochitte CE, Souza JM, Oliveira SA. Tratamento cirúrgico da coarctação do arco aórtico em adulto: avaliação clínica e angiográfica tardia da técnica extra-anatômica. Rev Bras Cir Cardiovasc 2001;16(3):187-94.

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Feng Z, etSHORT al. - Extracorporeal membrane oxygenation as a support for TGA/ COMMUNICATION IVS with low cardiac output syndrome and pulmonary hemorrhage

Extracorporeal membrane oxygenation as a support for TGA/IVS with low cardiac output syndrome and pulmonary hemorrhage Oxigenação extracorpórea por membrana como suporte para TGA /IVS com síndrome de baixo débito e hemorragia pulmonar

Xiaoyang Hong1,2, Zhichun Feng1, Gengxu Zhou3, Xuan Xu3 DOI: 10.5935/1678-9741.20130041

RBCCV 44205-1470

Abstract A 15-day-old neonate with complete transposition of the great arteries/intact ventricular septum was admitted with lifethreatening hypoxemia and heart arrest. After successful resuscitation, heart beat recovered but blood lactate began to arise and maintained above 15 mmol/L 6 hours later. Emergency arterial switch operation was done at 20 hours after resuscitation. Planned extracorporeal membrane oxygenation support was employed postoperatively. The baby experienced severe pulmonary hemorrhage and severe hypoxemia after weaning from cardiopulmonary bypass, which were treated with extracorporeal membrane oxygenation support.

Resumo Um recém-nascido de 15 dias de idade, com transposição completa das grandes artérias/septo ventricular intacto, foi internado com hipoxemia com risco de vida e parada cardíaca. Após a reanimação bem sucedida, o coração voltou a bater, mas o lactato elevou-se e manteve-se acima de 15 mmol/L, 6 horas após. Operação de emergência para correção da transposição das grandes artérias foi realizada 20 horas após a ressuscitação. Suporte de oxigenação por membrana extracorpórea foi empregado no pós-operatório. O bebê apresentou hemorragia pulmonar e hipoxemia graves após desconexão da circulação extracorpórea, que foram tratadas com suporte da xigenação por membrana extracorpórea.

Descriptors: Extracorporeal membrane oxygenation. Transposition of great vessels. Low cardiac output. Cardiopulmonary bypass. Extracorporeal circulation.

Descritores: Oxigenação por Membrana Extracorpórea. Transposição dos grandes vasos. Baixo débito cardíaco. Ponte cardiopulmonar. Circulação extracorpórea.

INTRODUCTION

favorable clinical outcome. Unfortunately, in some patients, the treatment of TGA/IVS is usually delayed. Under this condition, the ASO was inapplicable for them, because the left ventricle is unable to accommodate the systemic pressure [1]. Here in, we reported our experience in the treatment

Arterial switch operation (ASO) has long been as a treatment of choice for neonates with transposition of the great arteries/intact ventricular septum (TGA/IVS) achieving

1. Dr./Affiliated Bayi Children Hospital, Beijing Mlilitary General Hospital, Beijing 100007, China (Director) – drafting the article and revising it critically for important intellectual content. 2. Dr./Affiliated Bayi Children Hospital, Beijing Military General Hospital, Beijing 100007, China; Affiliated Bayi Children Hospital, Bayi Clinical Medical Institute, Southern Medical University 100007, China – substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data. 3. Dr./Affiliated Bayi Children Hospital, Beijing Military General Hospital, Beijing 100007, China – acquisition of data, or analysis and interpretation of data.

Work carried out at Affiliated Bayi Children Hospital, Beijing Military General Hospital, Beijing, China. Correspondence address: Dr. Zhichun Feng, Affiliated Bayi Children Hospital, Beijing Military General Hospital – 100007 –Beijing, China E-mail: feng5201314@yahoo.com.cn Article received on September 28th, 2012 Article accepted on January 28th, 2013

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Feng Z, et al. - Extracorporeal membrane oxygenation as a support for TGA/ IVS with low cardiac output syndrome and pulmonary hemorrhage

CLINICAL CASE

Abbreviations, acronyms & simbols ACT ASO CPB ECMO H2O Hct LCOS PCICU PCO2 PDA PEEP PO2 TGA/IVS

A male neonate with TGA/IVS was admitted into the Pediatric Cardiac Intensive Care Unit (PCICU) of our hospital due to life threatening hypoxemia. He was 15-day old and 3.6 kg in body weight on admission. Patent foramen and patent ductus arteriosus were normal (2 mm and 2.3 mm in diameter, respectively) and the ventricular septum obviously deviated to the left ventricle by bed-side trans-thoracic echocardiography. Blood gas analysis showed the partial pressure of carbon dioxide (PCO2) and partial pressure of oxygen (PO2) was 37 mmHg and 9 mmHg, respectively, the lactate level was 1.5 mmol/L on admission. The prostaglandin E1 was used immediately after admission. At 5 hours after admission, the PCO2 and PO2 were 51 mmHg and 7 mmHg, respectively, and the lactate level was 7.0 mmol/L as shown in arterial blood gas analysis. At 10 hours after admission, heart arrest

Activated clotting time Arterial switch operation Cardiopulmonary bypass Extracorporeal membrane oxygenation Water Hematocrit Low cardiac output syndrome Pediatric cardiac intensive care unit Partial pressure of carbon dioxide Patent ductus arteriosus Positive end-expiratory pressure Partial pressure of oxygen Transposition of the great arteries/Intact ventricular septum

of a 15-day-old newborn with TGA/IVS by mechanical circulatory support for severe low cardiac output syndrome (LCOS) and pulmonary hemorrhage after ASO.

Fig. 1 – Lactate level at 25 hours after surgery ■: time of cardiac arrest occurring; ♦: time of ASO; ▲: time of CPB discontinuation and ECMO initiation; ▼: time of ECMO discontinuation

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occurred. After resuscitation, inotropic agents (dopamine and epinephrine) were continuously infused. The lactate level gradually increased to 13.6 mmol/L, and PO2 was elevated to 9 mmHg. At 19 hours after admission, this patient received ASO under moderate hypothermia CPB with ultrafiltration. The blood flow in cardiopulmonary bypass (CPB) was adjusted from 150 to 200 ml/kg/min, and the activated clotting time (ACT) was controlled from 450 s to 650 s. The lactate level was maintained at >15 mmol/L for 9 hours and the LV/RV at 0.5 hour before surgery. The time of aorta cross clamp and total CPB was 80 min and 175 min, respectively. After releasing of aortic clamp, the heart beat with sinus rhythm was observed at 130 beats/min. After surgery, the lactate level was still at a high level (>15 mmol/L), and pulmonary hemorrhage occurred. The estimated amount of blood loss from the trachea tube was 100 ml. Then, the positive end-expiratory pressure (PEEP) was increased from 3 cm H2O to 8 cm H2O aiming to control the pulmonary hemorrhage. The heart beat or blood pressure was unstable although the volume load and hematocrit (Hct=31%) was acceptable and inotropic agents (dopamine: 10 μg/ kg/min, epinephrine: 0.15 μg/kg.min) were continuously infused during the weaning from CPB. Because of LCOS and pulmonary hemorrhage, extracorporeal membrane oxygenation (ECMO) was prepared for cardiopulmonary support. A 10-Fr aortal cannula and a 16-Fr right atrium cannula were cut off from the CPB system and connected to the ECMO circuit immediately (Medtronic Inc. Minneapolis, MN, USA). The ECMO system was composed of a heparin-

coated circuit, hollow fiber oxygenator and centrifugal pump (Medtronic Inc. Minneapolis, MN, USA). The ECMO blood flow rate was maintained at 0.6 l/min and this neonate was transferred to PCICU with delayed wound closure. The serum lactate level was still remained at >15 mmol/L for 9 hours after surgery in PCICU, and there after decreased gradually. The lactate level was 2.2 mmol/L at 25 hours after surgery (Figure 1). The patient regained clear consciousness at 16 hours. With favorable urine output, acceptable arterial blood pressure (70-80/30-40 mmHg) and favorable findings in chest X-ray (Figure 2A and 2B), the patient weaned off the ECMO after 96 hours support, and the wound was closed simultaneously. During the ECMO support, heparin was used to maintain ACT at 160250 s. Platelets were infused daily to keep the platelet level at >50000/L. This patient was extubated at 6 days after operation and discharged eventually. DISCUSSION Now, ASO is the treatment of choice for TGA/IVS in neonates. However, in China, the treatment of TGA/ IVS is usually delayed and the pulmonary arterial pressure is significantly declined in these neonates. Thus, the left ventricle is unable to accommodate the systemic pressure after ASO. Under this situation, rather than ASO, two-stage ASO is performed [1]. However, many authors thought that the degradation of left ventricle was reversible, and were more inclined to perform primary ASO followed by ECMO support [2-4].

Fig. 2 – A: Anteroposterior chest X-ray (POD1 after ECMO initiation). B: Anteroposterior chest X-ray (POD6 after ECMO discontinuation)

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In the present case, the patient gradually deteriorated after admission, and the life-threatening hypoxemia resulted in cardiac arrest and high level lactate. We speculated that the patent ductus arteriosus (PDA) was almost closed. Echocardiography after admission showed the ventricular septal obviously deviated to the left ventricle. Considering this, rapid two-stage ASO was infeasible for this patient. Thus, ECMO was prepared before ASO. Although the use of EMCO-based left ventricle support for TGA/IVS after ASO has been reported previously [5], to our knowledge EMCO used in such critical TGA/IVS patient who had high level lactate (>15 mmol/L) before ASO and pulmonary hemorrhage after ASO has not been reported in previous studies. In this patient, the ventricular septum deviated toward the left, and the LV/RV was 0.5, suggesting that the left ventricle may not endure the systemic pressure if the ASO is performed under CPB. On the other hand, life-threatening hypoxemia and high lactate level might make his cardiopulmonary function worse after operation, and rapid two-stage ASO was not feasible for life-saving. Because ECMO is able to provide both cardiac and pulmonary support immediately, ECMO was performed after the ASO was finished, and pulmonary hemorrhage was found. ECMO was performed as soon as CPB discontinued. Massive transfusion had to be done, and this resulted in hypothermia, which may recover after treatment with the heat-exchanger of the ECMO system. The time of initiation of ECMO is crucial for life saving. In this case, ECMO was performed as soon as possible in the operation room. Recent reports [6,7] revealed that ECMO in operation room could avoid the prolonged hypoperfusion and multiorgan failure. In the support with ECMO, the heparincoated circuit could omit the use of heparin, and platelets were transfused daily to keep the platelet at > 50000/L, which may improve the coagulation. After 92 hours ECMO support, this patient’s hemodynamics was stable enough and weaned from ECMO. Then, the wound was closed in the PCICU.

REFERENCES

1. Lacour-Gayet F, Piot D, Zoghbi J, Serraf A, Gruber P, MacĂŠ L, et al. Surgical management and indication of left ventricular retraining in arterial switch for transposition of the great arteries with intact ventricular septum. Eur J Cardiothorac Surg. 2001;20(4):824-9. 2. Sarris GE, Chatzis AC, Giannopoulos NM, Kirvassilis G, Berggren H, Hazekamp M, et al. The arterial switch operation in Europe for transposition of the great arteries: a multi-institutional study from the European Congenital Heart Surgeons Association. J Thorac Cardiovasc Surg. 2006;132(3):633-9. 3. Bisoi AK, Sharma P, Chauhan S, Reddy SM, Das S, Saxena A, et al. Primary arterial switch operation in children presenting late with d-transposition of the great arteries and intact ventricular septum. When is it too late for a primary arterial switch operation? Eur J Cardiothorac Surg. 2010;38(6):707-13. 4. Kang N, de Leval MR, Elliott M, Tsang V, Kocyildirim E, Sehic I, et al. Extending the boundaries of the primary arterial switch operation in patients with transposition of the great arteries and intact ventricular septum. Circulation. 2004;110(11 Suppl 1):II123-7. 5. Shah SA, Shankar V, Churchwell KB, Taylor MB, Scott BP, Bartilson R, et al. Clinical outcomes of 84 children with congenital heart disease managed with extracorporeal membrane oxygenation after cardiac surgery. ASAIO J. 2005;51(5):504-7. 6. Ko WJ, Lin CY, Chen RJ, Wang SS, Lin FY, Chen YS. Extracorporeal membrane oxygenation support for adult postcardiotomy cardiogenic shock. Ann Thorac Surg. 2002;73(2):538-45. 7. Chaturvedi RR, Macrae D, Brown KL, Schindler M, Smith EC, Davis KB, et al. Cardiac ECMO for biventricular hearts after paediatric open heart surgery. Heart. 2004;90(5):545-51.

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Disli OM, et al.CASE - UseREPORT of autologous pericardium for mitral leaflet reconstruction in a child with endocarditis

Use of autologous pericardium for mitral leaflet reconstruction in a child with endocarditis Uso de pericárdio autólogo para reconstrução de folheto mitral em criança com endocardite

Olcay Murat Disli1, Cemsit Karakurt2, Nevzat Erdil3, Bektas Battaloglu3 DOI: 10.5935/1678-9741.20130042

RBCCV 44205-1471

Abstract We present a case of successful repair of the mitral valve for active infective endocarditis. Mitral valve repair was performed through debridement of vegetation and abscess, resection and repair of the posterior mitral leaflet and posterior repair with autologous pericardium. Postoperative period was uneventfully, with no evidence of recurrent infection, and echocardiogram showed mitral valve competence with mild mitral regurgitation. We demonstrate that valve repair is a feasible choice in cases of active endocarditis in children.

Resumo Apresentamos um caso de reparo bem-sucedido da valva mitral decorrente de endocardite infecciosa ativa. Reparo da valva mitral foi acompanhado de desbridamento da vegetação e do abscesso, ressecção e plastia do folheto mitral posterior, e anuloplastia posterior com pericárdio autólogo. Pós-operatório sem evidências de infecção recorrente, e ecocardiograma demonstrou competência da valva mitral com regurgitação mitral trivial. Concluímos que o reparo valvar é uma escolha viável em caso de endocardite ativa nas crianças.

Descriptors: Endocarditis, subacute bacterial. Child. Mitral valve/surgery. Pericardium.

Descritores: Endocardite bacteriana subaguda. Criança. Valva mitral/cirurgia. Pericárdio.

INTRODUCTION

of successful mitral endocarditis treatment by describing how valve repair was performed in this particular case.

Infective endocarditis (IE) is a condition that is rarely observed among children. It is associated with a postoperative mortality rate of less than 5%. In general, mitral valve replacement is performed for the treatment of mitral valve regurgitation that develops as a result of infective endocarditis. However, recently performed clinical studies have shown that patients with isolated mitral valve IE may also benefit from mitral valve repair [1]. There are considerable technical difficulties associated with the surgical procedures involved when the mitral valve is affected by endocarditis. In the article, we describe a case

CASE REPORT Signs of infection accompanied by weakness and high fever were observed in a 9 year old boy, despite antibiotic administration for the previous 2 weeks. Severe mitral regurgitation 3x2 cm was observed during transesophageal echocardiography (TEE) (Figure 1A), and a perforation was identified on the posterior leaflet together with a considerably large mobile vegetation that had spread to the posterior wall of the left atrium. Blood cultures revealed the presence of

1. Associate professor at Inonu University, School of Medicine, Malatya, Turkey. Had primary responsibility for protocol development, outcome assessment, preliminary data analysis and writing the paper. 2. Associate professor at Inonu University, School of Medicine, Malatya, Turkey. Participated in the development of the protocol and cardiologic assessment. 3. Professor at Inonu University, School of Medicine, Malatya, Turkey. Participated in the development of the protocol.

Correspondence address: Olcay Murat Disli Inonu University, School of Medicine, Turgut Ozal Medical Center, Department of Cardiovascular Surgery, 44280 Malatya, Turkey. E-mail: olcay.disli@inonu.edu.tr

Work carried out at Inonu University, School of Medicine, Department of Cardiovascular Surgery, Malatya, Turkey.

Article received on September 4th, 2012 Article accepted on November 8th, 2012

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with fresh autologous pericardium (Figure 2). Recovery from cardiopulmonary bypass was without any adverse events. Intraoperative TEE demonstrated competence for the valve. Following surgery, antibiotic treatment was administered for the ensuing 6 weeks, and recurrence of infection was not observed. No adverse events occurred during the postoperative period, and the mitral valve displayed minimal regurgitation. Mitral valve competence was measured 6 months after the surgery, and cardiac performance was eventually observed to be normal. (Figure 1B) Patient was discharged 14 days after the surgery, with perioral antibiotic therapy being continued following discharge. The bacterial mass was mostly composed of Gram positive bacteria within the vegetation, but no specific pathogen developed from the culture of the excised vegetation.

Abbreviations, acronyms & simbols IE TEE

Infective endocarditis Transesophageal echocardiography

Staphylococcus aureus, and abscesses were visible beyond the posterior leaflet on the adjacent wall. Standard cardiopulmonary bypass, with blood cardioplegia maintained at mild hypothermia, was used for surgery. During the procedure, the abscess was debrided and the mitral valve was reconstructed. Mitral repair was performed on the posterior mitral valve leaflet using quadrangular resection, and the body of the posterior valve and the locations of abscess resection were reconstructed

Fig. 1 – Transthoracic echocardiogram showing large mitral vegetation (31x 22 mm)

DISCUSSION According to the American College of Cardiology/ American Heart Association 2006 Guidelines, mitral valve repair is strongly recommended in active infective endocarditis against the risk of infection with prosthetic materials [2]. Endocarditis surgery involves full excision of the infective and necrotic areas, which serves to restore the structure of the operated regions. For infective valve diseases, Carpentier [3] and Dreyfus et al. [4] have recommended the thorough debriding of the infected valve by means of direct surgical intervention at an early stage. Hence, the surgery is to be performed while infection is only limited to the area of the heart valve tissue, and before ventricular function is impaired in the patient. Tenório et al. [5] suggested that pericardial patch must comprise the body of the posterior leaflet to which the anterior leaflet will coopt during the systole. It is important that the coopting area between the leaflets presents at least 8 mm.

Fig. 2 – Following aggressive debridement of the posterior leaflet and the left atrial wall, the infected zone was resected and replaced with autologous pericardium

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An independent risk factor associated with surgeries for mitral valve repair is annular abscesses. It is possible for pericardial patch or bovine pericardium to be employed for annular reconstruction. For coaptation between the two leaflets, annuloplasty can be performed while the mitral annulus is dilated. However, we chose not to follow this approach for this patient. By conserving subvalvular apparatus, it is possible to preserve left ventricular function and to increase the long-term survival of the patient. In patients with infective endocarditis there is a definite advantage of TEE to provide better visualization of the shape and size of a vegetation, as well as the surrounding tissues, severity of valvar regurgitation, and associated hemodynamics. Therefore, in this case, intraoperatively saline injection through the valves and TEE were performed to assess the adequacy and success of repair. We infer from the abovementioned case that further emphasis should be placed on preserving the patient’s native valve, regardless of the unfavorable clinical and pathological picture that the patient may display. This is especially important in child patients, since mitral repair reduces the risk of thromboembolism, and thereby removes the need for using anticoagulants that are difficult to manage in a pediatric population. Furthermore, an advantage of mitral repair is that it that removes the risk of prosthetic valve endocarditis. On the other hand, difficulties concerning its mechanical use are the potential patient-prosthesis mismatch and the eventual necessity of reoperation due to the child outgrowing the prosthetic valve. Mihaljevic et al. [6] have described patients with advanced endocarditis and annular destruction need to have their prosthesis replaced. We consider that the percentage of repair can be increased by an active annulus. However, we also consider that the unstable preoperative hemodynamics nevertheless leads immediate valve replacement to be preferred over complicated valve repair for many surgeries, as this approach may have the benefit of shortening the surgery period and increasing the chances for survival.

late survival, elimination of the necessity for re-operation, and functional outcomes can be achieved by preserving the valve tissue. As such, the case described above demonstrates that valve repair is an alternative approach for the treatment of active infective endocarditis that affects the mitral valve in children.

REFERENCES 1. Iung B, Rousseau-Paziaud J, Cormier B, Garbarz E, Fondard O, Brochet E, et al. Contemporary results of mitral valve repair for infective endocarditis. J Am Coll Cardiol. 2004;43(3):386-92. 2. American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons, Bonow RO, Carabello BA, Kanu C, de Leon AC Jr, Faxon DP, Freed MD, et al. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 Guidelines for the Management of Patients with Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation. 2006;114(5):e84-231. 3. Carpentier A. Cardiac valve surgery: the “French correction”. J Thorac Cardiovasc Surg. 1983;86(3):323-37. 4. Dreyfus G, Serraf A, Jebara VA, Deloche A, Chauvaud S, Couetil JP, et al. Valve repair in acute endocarditis. Ann Thorac Surg. 1990;49(5):706-11. 5. Tenório EM, Moraes Neto F, Chauvaud S, Moraes CR. Experience with the posterior leaflet extension technique for correction of rheumatic mitral insufficiency in children. Rev Bras Cir Cardiovasc. 2009;24(4):567-9.

CONCLUSION

6. Mihaljevic T, Paul S, Leacche M, Rawn JD, Aranki S, O'Gara PT, et al. Tailored surgical therapy for acute native mitral valve endocarditis. J Heart Valve Dis. 2004;13(2):210-6.

Mitral valve repair with autologous tissue is an approach that is likely to yield better surgery and results. Improved

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Disli OM, et al. - MEMORY Use of autologous pericardium for mitral leaflet reconstruction in a child with endocarditis

Extracorporeal Circulation System DeWall Oxygenator (1955) DOI: 10.5935/1678-9741.20130043

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I received the e-mail and photo below from friend Paulo Prates. I appreciate the thought and the relevance of the equipment for the development of cardiovascular surgery, and I share with readers. Domingo Braile Editor-in-Chief BJCVS

At the Congress of the American Association for Thoracic Surgery (AATS), I came across this machine so important to us. According to the receptionist who was on the Mayo Clinic’s stand, it was found in the shed of Dr. Lillehei after his death. Restored, it is now part of the Mayo Clinic museum. I do not think many felt the same thrill that I felt, touching the machine developed by DeWall, under the command of W.

Lillehei. With this device, Lillehei performed about 80 surgeries in the years 1955 and 1956. The first feeling was of excitement and, the second, was reminded of Dr. Braile. My warmest regards, Paulo Prates

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"Scientists can tell an accurate story" SCIENTIFIC DISSEMINATION

"Scientists can tell a story without losing accuracy" Frances Jones

DOI: 10.5935/1678-9741.20130044

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Agência FAPESP – Dan Fay, an engineer at Microsoft for more than 20 years, is a member of a select group of professionals in search of partnerships between the software giant and scientists heading projects related to energy, earth, and environmental sciences. They are projects such as the World Wide Telescope software, developed with the help of researchers from John Hopkins University. The software allows scientists from around the globe to access, manipulate, and share images of celestial objects collected by space telescopes, observatories, and research institutions. “Our challenge is finding researchers to whose research we can add not only hardware, but also more value”, says Fay. Besides being director of the Earth, Energy, and Environment effort at Microsoft Research Connections, a division of the Microsoft Research organization, Fay also serves as a member of the Purdue University Computer and Information Technology Industrial advisory board in the state of Indiana. He was in São Paulo to take part in the Latin American eScience Workshop, sponsored jointly by FAPESP and Microsoft from May 13 to 15, 2013. Fay gave two presentations to researchers and students from different countries about how advances in the handling of massive amounts of information have led to improvements in a variety of areas. The first one was about how to integrate science and cloud computing; the other, “how to achieve international visibility”. After the event, he sat down with Agência FAPESP for an interview, parts of which are reproduced below.

future challenges. You can’t take for granted that a piece of information means something. You have to be sure. Agência FAPESP – How can researchers use cloud computing in their studies? Fay – Cloud computing offers a paradigm shift in the way data analysis and computational challenges are met by numerous areas of scientific study. Unlike supercomputers which are isolated and centralized, cloud computing is everywhere and it can support different computing styles suitable for data analysis and collaboration. We’ve been working with academic researchers for the past three years, exploiting the full potential of this new platform. There are more than 90 research projects using Windows Azure [Microsoft’s cloud platform] and we’ve learned a lot from them. As with any new technology, some people start using it before, others later on. Several researchers have started using it to understand how it can change the way they do research. Agência FAPESP – In your opinion, will we see a shift in the way science is promoted? Fay – I told the students in the workshop that there will always be traditional, peer-reviewed articles from scientific journals. However, with the amount of information we have today, data can also be presented in different ways in order to make articles available to other people and the general public. An article that is rich in detail can become accessible to people from other areas. Producing photos and videos, among other resources, can help as well.

Agência FAPESP – What are your expectations for the future of eScience, the use of technology and computational tools in doing science? Fay – What is interesting about eScience is its ability to mix computational data and new techniques in a number of areas. We’re seeing an increase in the use of computing, but the next step is the merger of different areas and the combined use of information generated by them, like, for instance, a cross-sectional analysis of data from the biological and environmental domains. Both of them speak different languages. The transition between areas will be one of the

Agência FAPESP – Is that one of the roles of scientists? Fay – You can use the same accurate scientific data and tell stories about them, allowing people to listen to the story told visually straight from the source. This interaction is very powerful. It is the same as going to the museum and looking at a variety of artwork: people connect with them. Scientists want that same connection to happen between colleagues and the general public and their information, data, and articles. I think finding other mechanisms to explain data is good. These are fascinating times, in which there is a worry to disclose

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Fay – Yes. They should always adhere to scientific rigor, but it helps to use design or marketing techniques. Even in their posters. It is a better way of displaying information.

information in an interesting way. That is true not only when talking to your peers, but especially if you want policymakers, the government or financing bodies to understand your work. Sometimes it has to be presented in a certain way in order to be digested more easily.

Agência FAPESP – Will new technologies foster the disclosure of scientific data? Fay – Beyond data disclosure, there is a social problem, where people feel like they own their ideas or their information. It is important to find ways to share data and, at the same time, acknowledge the people that collected, processed, and made it available. I believe that is where many of the challenges are. There is also the issue of medical and other kinds of data which you don’t want out there.

Agência FAPESP – Does technology help with that? Fay – Yes. In part because it makes people have a more indepth reading of the articles. There is a researcher at Harvard, an astronomer, who created one of these virtual tours we have about galaxies. She estimates that more people have seen her tours than read her articles. This kind of understanding is growing. If I can help someone to read an article by seeing this somewhere else, that is advancement.

Published by Agência Fapesp on May 21, 2013.

Agência FAPESP – In your opinion, should scientists use social media, such as Facebook, to show their work?

URL: http://agencia.fapesp.br/17304

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Letter to the Editor

Letter to the Editor DOI: 10.5935/1678-9741.20130045

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About Health and Disease

We conclude with just three of the various information of the study: 1. There was a decrease in mortality of children under five years of age. 2. Deaths from traffic accidents rose by almost 50%. 3. The life expectancy for people increased, exceeding 70 years in most countries, but this population was more prone to cardiovascular (myocardial infarction, hypertension), neoplastic (cancer), cerebrovascular (stroke), ophthalmologic, orthopedic trauma, renal and diabetes diseases, among others. Under the proposals reported, the primary health care performed by trained governments produced satisfactory outcomes, but the disease is not having the same attention, due to the ineffectiveness of governments to the longevity of the human being is worthy and happy.

At the International Conference on Primary Health Care held in Alma-Ata, capital of Kazakhstan (then part of the Soviet Socialist Republics of Russia), in the period from 6 to 12 September 1978, attended by representatives of 136 countries and more 64 specialized agencies, was drafted the famous Declaration of Alma-Ata: I. The Conference stresses that Health is state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity – it is a fundamental human right and the attainment of the highest possible level of health is the most important social aim worldwide, whose realization requires the action of many other social and economic sectors in addition to the health sector. II. The existing gross inequality in the health status of the people particularly between developed and developing countries as well as within countries is politically, socially and economically unacceptable and is, therefore, of common concern to all countries. These are the first two items of the statement among the ten supplementing it. The goals to be achieved were scheduled for all peoples of the world from the next decade until the year 2000. Through this document, the responsible for the basic health of the population of their countries began a process of evolution and transformation in their ideas on public health. This caused new conferences in order to prepare the matter more in accordance with the possibilities of each country which highlight the “Ottawa Charter” (Canada), “Adelaide Declaration” (Australia), “Sundsvall Statement” (Sweden) and “Charter of Bogota” (Colombia), among others. The world prestigious British medical journal “The Lancet” published in volume 380, number 9859, December 15th, 2012, a series of articles on diseases of the decade between 1990 and 2010. The studies were published reportedly of GBD 2010 - Global Burden of Disease Study, Estudo da Carga Global de Doença 2010. The GBD 2010 is composed of centers of excellence in the world, such as Harvard University, Institute for Health Metrics and Evaluation, University of Washington, Johns Hopkins University (USA), University of Queensland (Australia), Imperial College London (England), University of Tokyo (Japan) and the World Health Organization. The World Bank sponsored the program, which was supported by the Bill & Melinda Gates Foundation.

We will return to the issue. Jauro Collaço Cardiovascular Surgeon, Professor of the Federal University of Santa Catarina (UFSC) and University of Southern of Santa Catarina (Unisul) - Florianópolis, SC

Technical Modification for Total Cavopulmonary Connection in a 9-year-old girl: a 20-Year Postoperative Approach Introduction The side-to-side anastomosis between the superior vena cava and the pulmonary artery with the exclusion of the right atrium for total cavopulmonary connection was described by us in 1993 as a technical modification in patients with tricuspid atresia or single ventricle associated with transposition of the great arteries [1]. In both cases, the pulmonary artery is positioned very close to the vena cava, allowing a single and large anastomosis. This technical modification that replaces the double cavopulmonary anastomosis was performed on a 9-year-old girl and is currently 29 years. The aim of this report is to present the excellent clinical and laboratory evolution of this patient [2].

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Case report

lion RBC/100 ml. Arterial blood gases showed partial oxygen pressure of 53 mmHg and oxygen saturation of 89.7% in room air. Transthoracic two-dimensional color Doppler echocardiography performed at 20 years postoperatively showed laminar flow in the inferior vena cava (0.2 m/s) in the superior vena cava (0.5 m/s) and the site of anastomosis (0.58 m/s). The pulmonary trunk measures 26 mm and the ascending aorta, 20 mm, there is normal systolic function of the left ventricle and no mitral regurgitation. CT angiography demonstrated extensive anastomosis (30.5 x 30.8 mm) between the superior vena cava and the dextroposed pulmonary artery trunk (Figures 2 and 3).

A 9-year-old patient, functional class IV according to the New York Heart Association (NYHA) was admitted to the Hospital EvangĂŠlico de Londrina with perioral and extremity cyanosis at rest. The hematocrit was 60% and blood hemoglobin level of 18.9 g/100 ml. The patient had tricuspid atresia associated with transposition of the great arteries and had undergone pulmonary artery banding at 21 days of age. The left ventricle was well developed, the pulmonary artery was dilated and was positioned behind the aorta, near the medial aspect of the superior vena cava. The surgical indication was a complete cavopulmonary connection. Cardiopulmonary bypass was established, moderately hypothermic, with bicaval cannulation, of which the superior vena cava was near the innominate vein. After aortic clamping and myocardial protection (crystalloid), the right atrium was opened and an intra-atrial tunnel was performed using bovine pericardium preserved in glutaraldehyde, connecting the inferior vena cava to the superior vena cava, using the atrial wall. A hole of about 3 mm was left in the intra-atrial portion of the tube in case of eventual decompression. The remainder of the interatrial septum was resected, resulting in virtually a single atrium and the pulmonary artery was ligated with the prior cerclage, separating it thus from the left ventricle. The proximity of the pulmonary artery (dextroposed) to the superior vena cava suggested us the possibility of performing a wide and single anastomosis between them, instead of double anastomosis [3,4]. Two longitudinal incisions were performed, one in the main pulmonary artery and another in the medial aspect of the superior vena cava from the innominate vein, up to 1 cm from its entry into the right atrium. An anastomosis between these two openings was performed with a continuous suture using 5-0 polypropylene threads (Figure 1). The postoperative course was uneventful and the patient was discharged on the tenth postoperative day in good hemodynamic conditions and without cyanosis. The coronary angiography showed excellent contrast flow of the vena cava to the pulmonary artery and its branches. The patient has been followed outpatiently, and is 20 years after surgery with 1,70 m tall, in excellent overall condition, functional class I, no cyanosis, no jugular venous distension, hepatomegaly or edema of lower limbs. She works eight hours a day as a clerk, making her home-work commute by bicycle. A year ago she had a full term pregnancy without signs or symptoms of heart failure, however, although appropriate clinical and laboratory monitoring, the child died, caused by pulmonary hypertension. The patient underwent laboratory tests which revealed: hematocrit 45%, hemoglobin 14.9 g/100 ml and 5.37 mil-

Fig. 1 - Tricuspid atresia and transposition of the great arteries: A side-to-side anastomosis between the medial superior vena cava and the pulmonary artery, previously submitted to cerclage at 21 days of age is performed. An intra-atrial tunnel connects the inferior vena cava to the superior vena cava using bovine pericardium preserved in glutaraldehyde, while using the right atrial wall. VCS = superior vena cava, VCI = inferior vena cava, TIA - intra-atrial tunnel, AD= right atrium, Ao = aorta, CAP = pulmonary artery cerclage, VE = left ventricle

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Letter to the Editor

the upper limit of normal, and conducted and rare isolated supraventricular ectopic activity (5 beats). Discussion The pathological changes that have led to the realization of the side-to-side anastomosis between the medial aspect of the vena cava and pulmonary artery were dextroposition of the latter and its large diameter. This is almost always present in patients with tricuspid atresia or single ventricle, due to increased pulmonary blood flow, or sharp after conducting a pulmonary artery banding or even under presence of an associated pulmonary stenosis. Therefore, in these cases there is a great approximation of structures, making it extremely easy to perform this anastomosis. Easier procedure is obtained if the superior vena cava is dissected widely, including the innominate artery, the pulmonary artery and the pulmonary branches. The area of the anastomosis obtained with this technique far exceeds the sum of the areas when employing the double cavopulmonary anastomosis proposed by Lins et al. [2] in 1982, and disclosed by DeLeval et al. [3] in 1988. The blood flow from the vena cava to the pulmonary artery promotes excellent distribution to their branches, this observed under Doppler echocardiography and well visualized by CT angiography in the case reported here. Moreover, the pulmonary artery banding at 21 days of life protected the pulmonary vascular network in order to present late low arterial pressures. The result has been the normal physical development of the patient at 20 years postoperatively and her excellent clinical status (NYHA functional class I), despite the discreet unsaturation in their blood pressure (89.7%). A pregnancy at term, without any sign of heart failure, also confirmed the good clinical condition described above. In conclusion, the excellent long-term results observed in our patient led us to affirm this technical modification be a good option for the surgical treatment of patients with tricuspid atresia.

Fig. 2 - CT angiography (posterior view) showing total cavopulmonary connection with wide side-to-side anastomosis between the superior vena cava (vena cava superior) and dextroposed pulmonary artery

Francisco Gregori Junior1, Marcia Thomson2, Roberto Jonathas Lopes Menescal3, Celso Otaviano Cordeiro4, Alexandre Noboru Murakami4, Rogério Toshio Teruya4 1. Professor Associado, chefe da Disciplina de Cirurgia Cardíaca do Centro de Ciências da Saúde da Universidade Estadual de Londrina, Londrina, PR, Brasil. 2. Cardiologista pediátrica, ecocardiografista infantil, responsável pelo Serviço de Cardiologia Pediátrica do Hospital Universitário da Universidade Estadual de Londrina, Londrina, PR, Brasil. 3. Cardiologista e especialista em Imagem Cardiovascular da Ultramed e do Hospital Evangélico de Londrina, Londrina, PR, Brasil. 4. Cirurgião cardiovascular do Hospital Evangélico de Londrina, Londrina, PR, Brasil.

Fig. 3 - CT angiography demonstrating wide anastomosis between the superior vena cava and the pulmonary artery trunk (sectional), measuring 30.5 x 30.8 mm without signs of thrombosis

Examination of dynamic electrocardiography (Holter 24 hours) recorded sinus rhythm, average heart rate of 72 bpm, PR interval within normal limits, QRS complex varying to

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Lung Transplant, being held at the FMUSP Theatre, which was crowded. Prof. Paulo Pêgo Fernandes had great performance, being much applauded at the end of his presentation. The public oral test was held at the FMUSP Congregation’s room, which was also crowded. Several questions were raised by examiners, composed of Profs. José Eduardo Krieger, Samir Rasslan, Henrique Murad, Roberto Saad Junior and Jose Osmar Medina Pestana and the oral test went on the highest level.

REFERENCES 1. Gregori F Jr, Silva SS, Ribeiro IA, Cordeiro CO, Couto WJ. Modified technique for total cavopulmonary connection. Ann Thorac Surg. 1994;57(6):1649-51. 2. Croti UA, Braile DM, Godoy MF, Avona FN. Glenn bidirecional com cianose precoce por conexão veno-venosa pela veia hemiázigo. Rev Bras Cir Cardiovasc. 2009;24(1):94-7. 3. Lins RF, Lins MF, Cavalcanti C, Miranda RP, Mota JH. Orthoterminal correction of congenital heart diseases: double cava-pulmonary anastomosis. J Thorac Cardiovasc Surg. 1982;84(4):633-5. 4. DeLeval MR, Kilner P, Gewillig M, Bull C. Total cavopulmonary connection: a logical alternative to atriopulmonary connection for complex Fontan operations. Experimental studies and early clinical experience. J Thorac Cardiovasc Surg. 1988;96(5):682-95.

Dr. Paulo Pêgo Fernandes is the new Titular Professor of Thoracic Surgery at the Faculty of Medicine, USP On June 4, 2013, Dr. Paulo M. Pêgo Fernandes was approved to the post of Titular Professor of Thoracic Surgery at Faculty of Medicine, USP (FMUSP), previously occupied by Prof. Fabio B. Jatene. The contest consisted of analysis of memorial, oral evidence of scholarship and public oral test. Proof of scholarship revolved around about

From left to right: Professores Henrique Murad, Samir Rasslan, Roberto Saad Junior, Paulo M. Pêgo Fernandes, José Osmar Medina Pestana, José Eduardo Krieger

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Almeida RMS, et al. - Regimento Interno para a obtenção do Título de Especialista - Sociedade Brasileira de Cirurgia Cardiovascular

Reviewers BJCVS 28.2 Below, the names of the reviewers of the papers published in this issue of the Brazilian Journal of Cardiovascular Surgery/ Revista Brasileira de Cirurgia Cardiovascular (BJCVS/RBCCV). Thanks to them.

Domingo Braile Editor-in-Chief RBCCV

Alfredo José Rodrigues

João de Deus e Brito

Ana Maria Rocha Pinto e Silva

Jorge Luis Valiati

Carlos Manuel de Almeida Brandão

Luiz Fernando Caneo

Carlos Marcelo Pastre Manuel Antunes

Edmo Atique Gabriel

Marcelo Arruda Nakazone

Eduardo Keller Saadi

Marcos Aurélio Barboza Oliveira

Elaine Soraya Barbosa de Oliveira Severino

Michel Pompeu Barros de Oliveira Sá

Eliana Márcia Sotello Cabrera Enio Buffolo

Orlando Petrucci

Fernando Moraes Neto

Raquel Ferrari Piotto

Francisco Costa

Renato A. K. Kalil

Frederico José Di Giovanni

Ricardo Carvalho Lima Rui M. S. Almeida

Gilberto Venossi Barbosa Gustavo Callado Aguiar Ribeiro

Tomas Salerno Helcio Giffhorn Henrique Murad

Walter José Gomes

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RBCCV em números 27 anos de circulação ininterrupta Fator de Impacto 0,809

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