Implante Percutâneo Transeptal de Bioprótese em Disfunção de Prótese Valvar Cirúrgica Mitral - Experiência Multicêntrica Brasileira / Percutaneous Transseptal Bioprosthetic Implantation in Failed Prosthetic Surgical Mitral Valve - Brazilian Multicenter Experience

Resumo Fundamento A intervenção percutânea em pacientes com disfunção de prótese biológica mitral apresenta-se como uma alternativa ao tratamento cirúrgico convencional. Objetivo Relatar a primeira experiência brasileira de implante transcateter de bioprótese valve-in-valve mitral via transeptal (TMVIV-via transeptal). Métodos Foram incluídos pacientes portadores de disfunção de bioprótese cirúrgica submetidos ao TMVIV-transeptal em 12 hospitais brasileiros. Foram considerados estatisticamente significativos valores de p<0,05. Resultados Entre junho/2016 e fevereiro/2019, 17 pacientes foram submetidos ao TMVIV-via transeptal. A mediana de idade foi 77 anos (IIQ,70-82), a mediana do escore STS-PROM foi 8,7% (IIQ,7,2-17,8). Todos os pacientes tinham sintomas limitantes de insuficiência cardíaca (CF≥III), tendo 5 (29,4%) sido submetidos a mais de uma toracotomia prévia. Obteve-se sucesso do TMVIV-via transeptal em todos os pacientes. A avaliação ecocardiográfica demonstrou redução significativa do gradiente médio (pré-intervenção, 12±3,8 mmHg; pós-intervenção, 5,3±2,6 mmHg; p<0,001), assim como aumento da área valvar mitral (pré-intervenção, 1,06±0,59 cm2; pós-intervenção, 2,18±0,36 cm2; p<0,001) sustentados em 30 dias. Houve redução significativa e imediata da pressão sistólica de artéria pulmonar, com redução adicional em 30 dias (pré-intervenção, 68,9±16,4 mmHg; pós-intervenção, 57,7±16,5 mmHg; 30 dias, 50,9±18,7 mmHg; p<0,001). Durante o seguimento, com mediana de 162 dias (IIQ, 102-411), observou-se marcada melhora clínica (CF≤II) em 87,5%. Um paciente (5,9%) apresentou obstrução de via de saída de ventrículo esquerdo (VSVE), evoluindo para óbito logo após o procedimento, e outro morreu aos 161 dias de seguimento.Conclusão: A primeira experiência brasileira de TMVIV-transeptal demonstra a segurança e a efetividade dessa nova técnica. A obstrução da VSVE é uma complicação potencialmente fatal, reforçando a importância da seleção dos pacientes e do planejamento do procedimento. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Abstract Background Percutaneous intervention in patients with bioprosthetic mitral valve dysfunction is an alternative to conventional surgical treatment. Objectives To report the first Brazilian experience with transseptal transcatheter bioprosthetic mitral valve-in-valve implantation (transseptal-TMVIV). Methods Patients with surgical bioprosthetic dysfunction submitted to transseptal-TMVIV in 12 Brazilian hospitals were included. The significance level adopted was p<0.05. Results From June/2016 to February/2019, 17 patients underwent transseptal-TMVIV. Their median age was 77 years (IQR,70-82) and median Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) score was 8.7% (IQR,7.2-17.8). All patients had limiting symptoms of heart failure (FC≥III) and 5 (29.4%) had undergone more than one previous thoracotomy. Transseptal-TMVIV was successful in all patients. Echocardiographic assessment showed a significant reduction in mean mitral valve gradient (pre-intervention, 12±3.8 mmHg; post-intervention, 5.3±2.6 mmHg; p<0.001), in addition to an increase in mitral valve area (pre-intervention, 1.06±0.59 cm2; post-intervention, 2.18±0.36 cm2; p<0.001) sustained for 30 days. There was a significant and immediate reduction in the pulmonary artery systolic pressure, with an additional reduction in 30 days (pre-intervention, 68.9±16.4 mmHg; post-intervention, 57.7±16.5 mmHg; 30 days, 50.9±18.7 mmHg; p<0.001). During follow-up (median, 162 days; IQR, 102-411), significant clinical improvement (FC≤II) was observed in 87.5% of the patients. One patient (5.9%) had left ventricular outflow tract (LVOT) obstruction and died right after the procedure, and another died at 161 days of follow-up. Conclusion The first Brazilian experience with transseptal-TMVIV shows the safety and effectivity of the new technique. The LVOT obstruction is a potentially fatal complication, reinforcing the importance of patients' selection and of procedural planning. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Impacto Atual da Circulação Extracorpórea na Cirurgia de Revascularização Miocárdica no Estado de São Paulo / Current Impact of Cardiopulmonary Bypass in Coronary Artery Bypass Grafting in São Paulo State

Resumo Fundamento Resultados prévios com o uso de circulação extracorpórea (CEC) geram dificuldades na escolha do melhor tratamento para cada paciente na cirurgia de revascularização miocárdica (CRM) no contexto atual. Objetivo Avaliar o impacto da CEC no cenário atual da CRM no estado de São Paulo. Métodos Foram analisados 2.905 pacientes submetidos à CRM de forma consecutiva em 11 centros do estado de São Paulo pertencentes ao Registro Paulista de Cirurgia Cardiovascular (REPLICCAR) I. Dados perioperatórios e de seguimento foram colocados via on-line por especialistas treinados e capacitados em cada hospital. Foram analisadas as associações das variáveis perioperatórias com o tipo de procedimento (com ou sem CEC) e com os desfechos. A mortalidade esperada foi calculada por meio do EuroSCORE II (ESII). Os valores de p menores de 5% foram considerados significativos. Resultados Não houve diferença significativa em relação à idade dos pacientes entre os grupos (p=0,081). Dentre os pacientes, 72,9% eram de sexo masculino; 542 pacientes foram operados sem CEC (18,7%). Das características pré-operatórias, pacientes com infarto agudo do miocárdio (IAM) prévio (p=0,005) e disfunção ventricular (p=0,031) foram operados com CEC; no entanto, pacientes de emergência ou em classe funcional New York Heart Association (NYHA) IV foram operados sem CEC (p<0,001). O valor do ESII foi semelhante para ambos os grupos (p=0,427). Na CRM sem CEC, houve preferência pelo uso do enxerto radial (p<0,001) e com CEC pela artéria mamária direita (p<0,001). No pós-operatório, o uso de CEC esteve associado com reoperação por sangramento (p=0,012). Conclusão Atualmente, no REPLICCAR, reoperação por sangramento foi o único desfecho associado ao uso da CEC na CRM. (Arq Bras Cardiol. 2020; 115(4):595-601)

Abstract Background Previous results on the use of cardiopulmonary bypass (CPB) have generated difficulties in choosing the best treatment for each patient undergoing myocardial revascularization surgery (CABG) in the current context. Objective Evaluate the current impact of CPB in CABG in São Paulo State. Methods A total of 2905 patients who underwent CABG were consecutively analyzed in 11 São Paulo State centers belonging to the São Paulo Registry of Cardiovascular Surgery (REPLICCAR) I. Perioperative and follow-up data were included online by trained specialists in each hospital. Associations of the perioperative variables with the type of procedure and with the outcomes were analyzed. The study outcomes were morbidity and operative mortality. The expected mortality was calculated using EuroSCORE II (ESII). The values of p <5% were considered significant. Results There were no significant differences concerning the patients' age between the groups (p=0.081). 72.9% of the patients were males. Of the patients, 542 underwent surgery without CPB (18.7%). Of the preoperative characteristics, patients with previous myocardial infarction (p=0.005) and ventricular dysfunction (p=0.031) underwent surgery with CPB. However, emergency or New York Heart Association (NYHA) class IV patients underwent surgery without CPB (p<0.001). The ESII value was similar in both groups (p=0.427). In CABG without CPB, the radial graft was preferred (p<0.001), and in CABG with CPB the right mammary artery was the preferred one (p<0.001). In the postoperative period, CPB use was associated with reoperation for bleeding (p=0.012). Conclusion Currently in the REPLICCAR, reoperation for bleeding was the only outcome associated with the use of CPB in CABG. (Arq Bras Cardiol. 2020; 115(4):595-601)

Revascularização cirúrgica do miocárdio - análise crítica da evolução e estado atual / Surgical mocardial revascularization - critical analysis of its evolution and current state

O desenvolvimento da cinecoronariografia por Sones, no início da década de 1960, abriu caminho para a moderna cirurgia de revascularização do miocárdio. Em 1967, Favarolo realizou as primeiras pontes de veia safena e a técnica se expandiu mundialmente. Apesar de seu começo empolgante, no início da década de 1970, estudos angiográficos mostraram taxas de oclusão dos enxertos venosos, no primeiro ano, entre 10 a 15%. Em 1986, Loop e colaboradores mostraram o aumento da sobrevida dos pacientes em 10 anos, quando utilizava-se a artéria torácica interna esquerda anastomosada na artéria descendente anterior. Lytle, em 1999, indicou que esse benefício era melhorado quando utilizava-se ambas as artérias torácicas internas. Paralelamente, novas técnicas também foram surgindo, como a cirurgia sem o uso da circulação extracorpórea e, também, a partir de 1995, a utilização de mini acesso. Durante todos esses anos, inúmeros estudos foram realizados, dentre eles podemos destacar: o estudo SYNTAX e sua grande contribuição com o desenvolvimento do syntax score ; o estudo Freedom, mostrando que pacientes diabéticos apresentam maior benefício com a cirurgia de revascularização do miocárdio em comparação ao tratamento percutâneo. Em relação às lesões de tronco de coronária esquerda, dois grandes estudos (NOBLE e EXCEL) mostraram que o tratamento percutâneo, em pacientes com syntax score baixo, é uma boa opção terapêutica. Nas síndromes coronarianas agudas sem elevação do segmento ST no eletrocardiograma, a opinião do Heart Team é de extrema importância para decisão de qual tratamento realizar, seja ele clínico, percutâneo ou cirúrgico. Já nas SCA com elevação do segmento ST no eletrocardiograma, o tratamento por cateter, com a colocação de stent, é o preferencial, reservando o tratamento cirúrgico apenas para casos de falha no tratamento percutâneo ou quando há aparecimento de complicações mecânicas

The development of coronary angiography by Sones, in the early 1960s, opened the way for modern myocardial revascularization surgery. In 1967, Favarolo performed the first saphenous vein coronary artery bypass grafting (CABG) surgery, and the technique expanded worldwide. Despite its exciting start, at the beginning of the 1970s, angiographic studies showed vein graft occlusion rates, in the first year, of between 10% and 15%. In 1986, Loop and colleagues showed increased 10-year patient survival when the left anastomosed internal thoracic artery was used in the left anterior descending artery. Lytle, in 1999, indicated that this benefit was improved when both internal thoracic arteries were used. Meanwhile, new techniques were also emerging, such as off-pump CABG and since 1995, the use of minimally invasive surgery. During these years, numerous studies were carried out, including: the SYNTAX Trial, with its major contribution with the development of the syntax score; and the Freedom Trial, which showed that diabetic patients still benefit most from myocardial revascularization surgery compared to percutaneous treatment. In relation to lesions of the left coronary trunk, two large studies (NOBLE and EXCEL) showed that percutaneous treatment in patients with a low syntax score is a good therapeutic option. In acute coronary syndromes without ST segment elevation in the electrocardiogram, the opinion of the Heart Team is extremely important for deciding on the best treatment, be it clinical, percutaneous, or surgical. In ACS with ST segment elevation in the electrocardiogram, catheter treatment with stent placement is the preferred choice, reserving surgical treatment only for cases of percutaneous treatment failure, or where there are mechanical complications.

Off-pump versus on-pump coronary artery bypass grafting in frail patients: study protocol for the fragile multicenter randomized controlled trial

Abstract Introduction: Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. Methods: FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. Discussion: FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. Trial registration: ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.

Resultados imediatos e seguimento clínico dos pacientes submetidos a implante valvar aórtico transcateter / Immediate results and clinical follow-up of patients undergoing transcatheter aortic-valve implantation

INTRODUÇÃO: Um terço da população idosa portadora de estenose aórtica calcificada sintomática não apresenta condições cirúrgicas em decorrência do elevado risco operatório. O implante valvar aórtico transcateter (IVAT) surgiu como uma alternativa terapêutica para esses pacientes. MÉTODOS: Incluímos, no período de novembro de 2008 a abril de 2012, todos os pacientes submetidos a IVAT em nosso serviço. Relatamos as características clínicas basais, os dados dos procedimentos, os resultados hospitalares e o seguimento clínico dessa população. As definições utilizadas foram baseadas nos critérios do Valve Academic Research Consortium. RESULTADOS: O IVAT foi realizado em 23 pacientes, com 79 ± 6,7 anos de idade, 56% do sexo feminino. O EuroSCORE foi de 20,4 ± 11,1%. A prótese CoreValve® foi utilizada em 19 pacientes (82,6%) e a Edwards SAPIEN TM nos demais. A taxa de sucesso do procedimento foi de 96%. O tempo médio de seguimento clínico foi de 22 ± 12,8 meses, observando-se 6 óbitos (26,1%) nesse período, 3 dos quais ocorreram nos primeiros 30 dias (13%) e outros 2 (21,7%), até o final do primeiro ano. Um paciente apresentou ataque isquêmico transitório na fase hospitalar (4,3%), mas não ocorreram episódios de acidente vascular encefálico ou de infarto do miocárdio no período periprocedimento ou no acompanhamento tardio. O desfecho combinado de segurança aos 30 dias ocorreu em 5 pacientes (21,7%) e o desfecho combinado de eficácia aos 12 meses foi de 78,3%. CONCLUSÕES: Os resultados obtidos neste estudo demonstram o IVAT como procedimento atrativo para o tratamento de pacientes portadores de estenose aórtica calcificada de alto risco cirúrgico.

BACKGROUND: One third of the elderly population with symptomatic calcified aortic stenosis cannot undergo surgery due to their high operative risk. The transcatheter aortic-valve implantation (TAVI) has emerged as an alternative therapy for this group of patients. METHODS: All patients submitted to TAVI from November 2008 to April 2012 were included in our study. We report the baseline clinical characteristics, procedural data, hospital outcomes and clinical follow-up of this population. Definitions were based on the Valve Academic Research Consortium criteria. RESULTS: TAVI was performed in 23 patients, with 79 ± 6.7 years of age, and 56% were female. The EuroSCORE was 20.4 ± 11.1%. The CoreValve® prosthesis was used in 19 patients (82.6%) and the Edwards SAPIEN TM valve was used in the remaining ones. Procedure success rate was 96%. The mean follow-up was 22 ± 12.8 months, with 6 deaths (26.1%) in this period, 3 of which were observed in the first 30 days (13%) and other 2 (21.7%) by the end of the first year. One patient had a transient ischemic attack during hospitalization (4.3%), but there were no episodes of stroke or myocardial infarction in the periprocedural period or in the follow-up. The composite safety endpoint at 30 days was observed in 5 patients (21.7%) and the composite efficacy endpoint at 12 months was 78.3%. CONCLUSIONS: The results of this study demonstrate that TAVI is an attractive procedure for the treatment of patients with calcified aortic stenosis and high operative risk.