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

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


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.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Aortic Valve / pathology
  • Aortic Valve / surgery*
  • Aortic Valve Insufficiency / complications
  • Aortic Valve Insufficiency / surgery
  • Cardiac Catheterization / methods
  • Cardiac Catheterization / standards
  • Clinical Trials as Topic / methods*
  • Clinical Trials as Topic / standards
  • Echocardiography / methods
  • Endpoint Determination
  • Heart Valve Prosthesis / adverse effects*
  • Heart Valve Prosthesis / standards
  • Humans
  • Outcome Assessment, Health Care
  • Research Design
  • Risk Assessment
  • Severity of Illness Index
  • Sutures
  • Transcatheter Aortic Valve Replacement / adverse effects*
  • Vascular Closure Devices / standards*