Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research

VARC-3 WRITING COMMITTEE:

Research output: Contribution to journalArticlepeer-review

19 Scopus citations

Abstract

Aims: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. Methods and results: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. Conclusions: Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.

Original languageEnglish (US)
Pages (from-to)2717-2746
Number of pages30
JournalJournal of the American College of Cardiology
Volume77
Issue number21
DOIs
StatePublished - Jun 1 2021

Keywords

  • Valve Academic Research Consortium
  • definitions
  • endpoints
  • surgical aortic valve replacement
  • transcatheter aortic valve implantation
  • transcatheter aortic valve replacement
  • Transcatheter Aortic Valve Replacement
  • Heart Valve Prosthesis Implantation
  • Risk Assessment
  • Heart Valve Prosthesis
  • Humans
  • Treatment Outcome
  • Cardiac Catheterization
  • Endpoint Determination
  • Aortic Valve Stenosis/surgery
  • Aortic Valve/surgery

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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