| Literature DB >> 28430909 |
Carlos E Ruiz1, Rebecca T Hahn2, Alain Berrebi3, Jeffrey S Borer4, Donald E Cutlip5, Greg Fontana6, Gino Gerosa7, Reda Ibrahim8, Vladimir Jelnin1, Hasan Jilaihawi9, E Marc Jolicoeur8, Chad Kliger10, Itzhak Kronzon10, Jonathon Leipsic11, Francesco Maisano12, Xavier Millan13, Patrick Nataf14, Patrick T O'Gara15, Philippe Pibarot16, Stephen R Ramee17, Charanjit S Rihal18, Josep Rodes-Cabau16, Paul Sorajja19, Rakesh Suri20, Julie A Swain21, Zoltan G Turi22, E Murat Tuzcu20, Neil J Weissman23, Jose L Zamorano24, Patrick W Serruys25, 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:
Mesh：
Year: 2018 PMID： 28430909 DOI： 10.1093/eurheartj/ehx211
Source DB: PubMed Journal: Eur Heart J ISSN： 0195-668X Impact factor: 29.983