Philippe Géneréux, M.D., director of the structural heart program at Atlantic Health System’s Morristown Medical Center, is the lead author of the new VARC-3 consensus document that defines endpoints and standardizes taxonomy for aortic valve research. This document is important because it acts as a guide so all structural heart research is comparable and using the same terminology. He said this will become more important as long-term outcomes of 5 to 10 years become available and require apples-to-apples comparisons with newer valve technologies.
Key updates in VARC-3 include a new section on hospitalization or re-hospitalization, defining various levels of valve leaflet thrombosis, also known as hypo-attenuated leaflet thickening (HALT), and defining the stages of bio-prosthetic valve deterioration and valve failure.
The Valve Academic Research Consortium (VARC), founded in 2010, was intended to identify appropriate clinical endpoints and 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.
1. VARC-3 WRITING COMMITTEE: PhilippeGénéreux, Nicolo Piazza, Maria C. Aluc, Tamim Nazif, Rebecca T.Hahn, Philippe Pibarot, Jeroen J. Bax, Jonathon A.Leipsic, Philipp Blanke, Eugene H.Blackstone, Matthew T.Finn, Samir Kapadia, Axel Linke, Michael J.Mack, Raj Makkar, Roxana Mehranl, Jeffrey J. Popmam, Martin B.Leon, et al. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. Journal of the American College of Cardiology. Available online 19 April 2021. https://doi.org/10.1016/j.jacc.2021.02.038.