期刊
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
卷 69, 期 16, 页码 2067-2087出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2017.02.038
关键词
closure devices; regurgitation; transcatheter
资金
- Medtronic
- St. Jude Medical
- Philips Healthcare
- Boston Scientific
- Edwards Lifesciences
- Sorin
- Neochord
- Artech
- Aptiva Medica
- Gada Group
- Philips
- Edwards
- Abbott
- LivaNova
- St. Jude
- Direct Flow
- Abbott Vascular
- AstraZeneca
- Biotronik
- Cardialysis
- GLG Research
- SinoMedical Sciences Technology
- Societe Europa Digital Publishing
- Stentys France
- Svelte Medical Systems
- Volcano
- Xeltis
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. (C) 2017 American College of Cardiology Foundation and European Society of Cardiology.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据