RESUMO
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.
Assuntos
Valva Aórtica/cirurgia , Ensaios Clínicos como Assunto/métodos , Próteses Valvulares Cardíacas/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Dispositivos de Oclusão Vascular/normas , Valva Aórtica/patologia , Insuficiência da Valva Aórtica/complicações , Insuficiência da Valva Aórtica/cirurgia , Cateterismo Cardíaco/métodos , Cateterismo Cardíaco/normas , Ensaios Clínicos como Assunto/normas , Ecocardiografia/métodos , Determinação de Ponto Final , Próteses Valvulares Cardíacas/normas , Humanos , Avaliação de Resultados em Cuidados de Saúde , Projetos de Pesquisa , Medição de Risco , Índice de Gravidade de Doença , SuturasRESUMO
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.