Format

Send to

Choose Destination
Eur Heart J. 2018 Apr 14;39(15):1224-1245. doi: 10.1093/eurheartj/ehx211.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis.

Author information

1
Hackensack University Medical Center, Structural and Congenital Heart Center, Hackensack, New Jersey.
2
Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York.
3
Hôpital Européen Georges Pompidou, Paris, France.
4
State University of New York Downstate Medical Center and College of Medicine, New York, New York.
5
Baim Institute for Clinical Research, Boston, Massachusetts.
6
Cedars Sinai Medical Center, Los Angeles, California.
7
Padua University Hospital, Padua, Italy.
8
Montreal Heart Institute, Montreal, Quebec, Canada.
9
NYU Langone Medical Center, New York, New York.
10
Lenox Hill Heart and Vascular Institute-North Shore LIJ Health System, New York, New York.
11
St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
12
University Hospital Zurich, Zurch, Switzerland.
13
Hospital Santa Creu i Sant Pau, Barcelona, Spain.
14
AP-HP Hôpital Bichat Service de Cardiologie, Paris, France.
15
Brigham & Women's Hospital, Boston, Massachusetts.
16
Québec Heart & Lung Institute, Quebec City, Quebec, Canada.
17
Ochsner Clinic, New Orleans, Louisiana.
18
Mayo Clinic, Rochester, Minnesota.
19
Minneapolis Heart Institute and Abbott Northwestern Hospital, Minneapolis, Minnesota.
20
Clevelend Clinic, Cleveland, Ohio.
21
Mount Sinai School of Medicine, New York, New York.
22
Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.
23
MedStar Health Research Institute, Washington, DC.
24
Hospital Clínico San Carlos, Madrid, Spain.
25
Imperial College London, London, United Kingdom.

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.

PMID:
28430909
DOI:
10.1093/eurheartj/ehx211

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center