MedStar Authors catalog › Details for: Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement. [Review]
Normal view MARC view ISBD view

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

by Weissman, Neil J.
Citation: Journal of the American College of Cardiology. 69(16):2067-2087, 2017 Apr 25.Journal: Journal of the American College of Cardiology.Published: 2017ISSN: 0735-1097.Full author list: Ruiz CE; Hahn RT; Berrebi A; Borer JS; Cutlip DE; Fontana G; Gerosa G; Ibrahim R; Jelnin V; Jilaihawi H; Jolicoeur EM; Kliger C; Kronzon I; Leipsic J; Maisano F; Millan X; Nataf P; O'Gara PT; Pibarot P; Ramee SR; Rihal CS; Rodes-Cabau J; Sorajja P; Suri R; Swain JA; Turi ZG; Tuzcu EM; Weissman NJ; Zamorano JL; Serruys PW; Leon MB; Paravalvular Leak Academic Research Consortium.UI/PMID: 28427582.Subject(s): *Aortic Valve | Clinical Trials as Topic | Echocardiography | *Heart Valve Prosthesis/ae [Adverse Effects] | Humans | *Outcome Assessment (Health Care)/mt [Methods] | Research Design | Risk Assessment | *Transcatheter Aortic Valve ReplacementInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal Article | ReviewDigital Object Identifier: https://dx.doi.org/10.1016/j.jacc.2017.02.038 (Click here) Abbreviated citation: J Am Coll Cardiol. 69(16):2067-2087, 2017 Apr 25.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007.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.Abstract: Copyright (c) 2017 American College of Cardiology Foundation and European Society of Cardiology. Published by Elsevier Inc. All rights reserved.

Powered by Koha