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

MedStar author(s):
Citation: Journal of the American College of Cardiology. 69(16):2067-2087, 2017 Apr 25PMID: 28427582Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *Aortic Valve | *Heart Valve Prosthesis/ae [Adverse Effects] | *Outcome Assessment (Health Care)/mt [Methods] | *Transcatheter Aortic Valve Replacement | Clinical Trials as Topic | Echocardiography | Humans | Research Design | Risk AssessmentYear: 2017Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007ISSN:
  • 0735-1097
Name of journal: Journal of the American College of CardiologyAbstract: Copyright (c) 2017 American College of Cardiology Foundation and European Society of Cardiology. Published by Elsevier Inc. All rights reserved.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.All authors: Berrebi A, Borer JS, Cutlip DE, Fontana G, Gerosa G, Hahn RT, Ibrahim R, Jelnin V, Jilaihawi H, Jolicoeur EM, Kliger C, Kronzon I, Leipsic J, Leon MB, Maisano F, Millan X, Nataf P, O'Gara PT, Paravalvular Leak Academic Research Consortium, Pibarot P, Ramee SR, Rihal CS, Rodes-Cabau J, Ruiz CE, Serruys PW, Sorajja P, Suri R, Swain JA, Turi ZG, Tuzcu EM, Weissman NJ, Zamorano JLFiscal year: FY2017Digital Object Identifier: Date added to catalog: 2017-05-06
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 28427582 Available 28427582

Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007

Copyright (c) 2017 American College of Cardiology Foundation and European Society of Cardiology. Published by Elsevier Inc. All rights reserved.

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.

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