Implante Por Cateter de Bioprótese Valvar Aórtica: Estado Atual

Transcrição

1 Implante Por Cateter de Bioprótese Valvar Aórtica: Estado Atual CURSO DE REVISÃO EM HEMODINÂMICA E CARDIOLOGIA INTERVENCIONISTA da SBHCI, São Paulo, 2011 Fábio S. Brito Jr. fsbrito@einstein.br

2 Estenose Aórtica Importante Sintomática > 30% sem tratamento cirúrgico!!! SEM CIRURGIA CIRURGIA 1. Bouma B J et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999;82: Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal 2003;24: (*includes both Aortic Stenosis and Mitral Regurgitation patients) 3. Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation Charlson E et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis2006;15:

3 Tecnologias Disponíveis para Substituição Percutânea da Valva Aórtica Edwards-Sapien CoreValve

4 Tecnologias Disponíveis para Substituição Percutâneas da Valva Aórtica EDWARDS-SAPIEN Bioprótese balão-expansível 23, 26 e 29 mm Cr-Cb e pericárdio bovino, 18-20F Acesso anterógrado, retrógrado ou transapical

5 Tecnologias Disponíveis para Substituição Percutâneas da Valva Aórtica CoreValve Bioprótese auto-expansível de nitinol. Via retrógrada. 3 a geração: 18F; pericárdio suíno Tamanhos: 26, 29 e 31mm

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7 Consenso SBHCI: Indicações 1) Presença de estenose valvar aórtica acentuada, sintomática, definida como orifício valvar aórtico com área < 1cm² (ou < 0,6 cm²/m²). 2) Idade > 75 anos e alta probabilidade de morbidade e mortalidade cirúrgicas pela presença de comorbidades. 3) Presença de condição anatômica e morfológica favorável para o procedimento por cateter.

8 DIRETRIZES SOCIEDADE BRASILEIRA DE CARDIOLOGIA Inoperáveis: Classe I; Nível de Evidência B Alto Risco: Classe IIa; Nível de Evidência B Diretrizes SBC 2011; no prelo.

9 PARTNER (B): Inoperable All-Cause Mortality at 1 Year Leon, M. NEJM 2010

10 PARTNER (A): High Surgical Risk All-Cause Mortality at 1 Year TAVR AVR 26.8 HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = Months No. at Risk 348 TAVR AVR

11 Patients Surviving, % PARTNER (A): High Surgical Risk NYHA Functional Class P = 1.00 P < P = 0.05 P = 0.75 Baseline 30 Days 6 Months I II III IV 1 Year

12 Incidence Rate (%) PARTNER (A): High Surgical Risk Clinical Outcomes and Complications p = 0.44 p = 0.73 p = 0.69 p < 0.01 p = 0.04 p = 0.07 AVR (n = 351) TAVI (n = 348) Presented by Craig Smith, MD, ACC 2011

13 % COREVALVE REGISTRIES: 30-Day All-Cause Mortality 25% 20% 15% 15.2% 15.1% 12.4% 10% 5% 5.6% 7.4% 9.0% 5.5% 7.2% 9.8% 0% 18 Fr S&E 1 N = 125 ANZ 2 N = 118 Spain 3 N = 108 French 4 N = 66 Belgian 5 N = 119 German 6 N = 588 UK 7 N = 460 Italian 8 N = 772 Brazilian N = Medtronic Data on File. COR : 18 Fr Safety & Efficacy Study Re-Analysis, August 14, Meredith. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. TCT 2010, Washington, DC. 3. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63: Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 5. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 6. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 7. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 8. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.

14 Percent of Patients (%) COREVALVE REGISTRIES: One Year Survival 100% 90% 80% 70% 71.9% 79.0% 81.6% 85.1% 60% 50% 40% 30% 20% 10% 0% 18 Fr S&E 1 N = 126 Belgian 2 N = 141 UK 3 N = 460 Italian 4 N = 772 Survival rates comparable with octogenarians who have had savr or savr+cabg 5 Survival rates reported are based on Kaplan-Meier Analysis. 1. Medtronic. Data on file. COR : 18 Fr Safety & Efficacy Study Re-Analysis, August 14, Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 3. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 4. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 5. Moat, Neal. UK TAVI Registry, TAVI Mid and Long-term Clinical Outcomes. EuroPCR 2010.

15 Effective Orifice Area (cm 2 ) COREVALVE REGISTRIES: Haemodynamic Performance at 2 Years EOA Mean Gradient P < Mean Gradient (mmhg) Baseline n = 109 Discharge n = Day n = 60 6 Month n = 47 1 year n = 52 2 Year n = Fr S&E Study 1,2 1. Gerckens, Ulrich, MD. Safety, Durability and Effectiveness at Two Years with the 18 Fr CoreValve Transcatheter Aortic Valve. EuroPCR Medtronic data on file. Addendum to COR : 18 Fr Safety & Efficacy Study Re-Analysis, April, 2010.

16 Percent of Patients (%) COREVALVE REGISTRIES: Pacemaker Implantation Weighted Average 28.5% 60% 50% 40% 30% 20% 31.3% 40.0% 35.2% 26.9% 23% 42.5% 26% 18.5% 29.5% 10% 0% 18 Fr S&E N = 125 ANZ N = 118 Spain 1 N = 108 French 2 N = 66 Belgian 2 N = 119 German 2 N = 588 UK 2 N = 460 Italian 2 N = 772 Brazilian N = Avanzas P, et al; Rev Esp Cardiol. 2010;63: TAVI Facts, Figures and National Registries. EuroPCR 2010

17 Eur Heart J Jun 2011

18 TAVI: Desafios Melhoria dos dispositivos: Menor perfil (100% percutâneo) Tamanhos de próteses Possibilidade de reposicionamento Redução da regurgitação perivalvar Proteção cerebral