Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints
Rebecca T. Hahn, Matthew Lawlor, Charles J. Davidson, Vinay Badhwar, Anna Sannino, Ernest Spitzer, Philipp Lurz, Brian R. Lindman, Yan Topilsky, Suzanne J. Baron, Scott Chadderdon, Omar Khalique, Gilbert H.L. Tang, Maurizio Taramasso, Paul Grayburn, Luigi P. Badano, Jonathon Leipsic, JoAnn Lindenfeld, Stephan Windecker, Sreekanth Vemulapalli, Björn Redfors, Maria Alu, David J. Cohen, Josep Rodés‐Cabau, Gorav Ailawadi, Michael J. Mack, Ori Ben‐Yehuda, Martin B. Leon, Jörg Hausleiter, Suzanne V. Arnold, Vinayak Bapat, Natalia Berry, Philipp Blanke, Daniel Burkhoff, Megan Coylewright, Neal Duggal, Benjamin Z. Galper, Isaac George, Mayra Guerrero, Nadira Hamid, Vikrant Jagadeesan, Susheel Kodali, Mitch Krucoff, Roberto M. Lang, Mahesh V. Madhavan, Vallerie McLaughin, Roxana Mehran, François Philippon, Sanjum S. Sethi, Matheus Simonato, Robert L. Smith, Nishtha Sodhi, John A. Spertus, Thomas J. Stocker, Gregg W. Stone
Abstract
Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options.