| Literature DB >> 28427582 |
Carlos E Ruiz1, Rebecca T Hahn2, Alain Berrebi3, Jeffrey S Borer4, Donald E Cutlip5, Greg Fontana6, Gino Gerosa7, Reda Ibrahim8, Vladimir Jelnin9, Hasan Jilaihawi10, E Marc Jolicoeur8, Chad Kliger11, Itzhak Kronzon11, Jonathon Leipsic12, Francesco Maisano13, Xavier Millan14, Patrick Nataf15, Patrick T O'Gara16, Philippe Pibarot17, Stephen R Ramee18, Charanjit S Rihal19, Josep Rodes-Cabau17, Paul Sorajja20, Rakesh Suri21, Julie A Swain22, Zoltan G Turi23, E Murat Tuzcu21, Neil J Weissman24, Jose L Zamorano25, Patrick W Serruys26, Martin B Leon2.
Abstract
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.Entities:
Keywords: closure devices; regurgitation; transcatheter
Mesh：
Year: 2017 PMID： 28427582 DOI： 10.1016/j.jacc.2017.02.038
Source DB: PubMed Journal: J Am Coll Cardiol ISSN： 0735-1097 Impact factor: 24.094