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Review
. 2017 Apr 25;69(16):2067-2087.
doi: 10.1016/j.jacc.2017.02.038.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement

Carlos E Ruiz  1 , Rebecca T Hahn  2 , Alain Berrebi  3 , Jeffrey S Borer  4 , Donald E Cutlip  5 , Greg Fontana  6 , Gino Gerosa  7 , Reda Ibrahim  8 , Vladimir Jelnin  9 , Hasan Jilaihawi  10 , E Marc Jolicoeur  8 , Chad Kliger  11 , Itzhak Kronzon  11 , Jonathon Leipsic  12 , Francesco Maisano  13 , Xavier Millan  14 , Patrick Nataf  15 , Patrick T O'Gara  16 , Philippe Pibarot  17 , Stephen R Ramee  18 , Charanjit S Rihal  19 , Josep Rodes-Cabau  17 , Paul Sorajja  20 , Rakesh Suri  21 , Julie A Swain  22 , Zoltan G Turi  23 , E Murat Tuzcu  21 , Neil J Weissman  24 , Jose L Zamorano  25 , Patrick W Serruys  26 , Martin B Leon  2 ; Paravalvular Leak Academic Research Consortium
Affiliations
Free article
Review

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement

Carlos E Ruiz et al. J Am Coll Cardiol. .
Free article

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.

Keywords: closure devices; regurgitation; transcatheter.

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