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17 Mar 2022

Joint Surgical Associations (EACTS, LACES, ASCVTS, AATS, and STS) Position Statement Regarding the VARC-3 Definitions for Aortic Valve Clinical Research

Conducting optimal clinical research is complex, resource intensive, and time consuming. A critical part of improving the evidence to guide our cardiovascular clinical practice is clinical trials' methodologic design and choices of outcomes and endpoints. The Academic Research Consortia were created to define the most critical and standardized definitions of outcome measures.
Acquired Cardiac Disease
full statement

Introduction

Conducting optimal clinical research is complex, resource intensive, and time consuming. A critical part of improving the evidence to guide our cardiovascular clinical practice is clinical trials’ methodologic design and choices of outcomes and endpoints. The Academic Research Consortia were created to define the most critical and standardized definitions of outcome measures. The Valve Academic Research Consortium (VARC) has substantially improved the quality of trials on aortic valve interventions through its multiple iterations. The latest VARC-3 definitions [1] aim to add more granularity and a patient focus to a rapidly evolving field and are particularly useful in providing a standard definition of bioprosthetic valve failure. This position statement considers the strengths and limitations of the VARC-3 document, identifies areas of concern, and proposes a way forward to further improve these definitions.