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Review
. 2023 Oct 24;82(17):1711-1735.
doi: 10.1016/j.jacc.2023.08.008. Epub 2023 Oct 4.

Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints

Rebecca T Hahn  1 , Matthew K Lawlor  2 , Charles J Davidson  3 , Vinay Badhwar  4 , Anna Sannino  5 , Ernest Spitzer  6 , Philipp Lurz  7 , Brian R Lindman  8 , Yan Topilsky  9 , Suzanne J Baron  10 , Scott Chadderdon  11 , Omar K Khalique  12 , Gilbert H L Tang  13 , Maurizio Taramasso  14 , Paul A Grayburn  15 , Luigi Badano  16 , Jonathon Leipsic  17 , JoAnn Lindenfeld  18 , Stephan Windecker  19 , Sreekanth Vemulapalli  20 , Bjorn Redfors  21 , Maria C Alu  22 , David J Cohen  23 , Josep Rodés-Cabau  24 , Gorav Ailawadi  25 , Michael Mack  26 , Ori Ben-Yehuda  27 , Martin B Leon  28 , Jörg Hausleiter  29 ; TVARC Steering Committee
Collaborators, Affiliations
Free article
Review

Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints

Rebecca T Hahn et al. J Am Coll Cardiol. .
Free article

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.

Keywords: transcatheter; treatment; tricuspid regurgitation.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Lawlor has received grant support from Edwards Lifesciences. Dr Davidson has received research grant support from Edwards Lifesciences and Abbott; has received consulting fees from Philips Healthcare; and acts as an uncompensated consultant for Edwards Lifesciences. Dr Badhwar has received institutional research support for clinical trials from Abbott. Dr Spitzer has institutional contracts for which he receives no direct compensation with Boston Scientific, Cardiawave, Edwards Lifesciences, Medtronic, Shanghai Microport Medical Co Ltd, NVT GmBH, Pie Medical Imaging, and Siemens Healthcare GmBH. Dr Lurz has received institutional grants from Edwards Lifesciences. Dr Lindman has received investigator-initiated research grants from Edwards and Roche Diagnostics. Dr Topilsky has received consulting fees from Edwards, Mitralix, and Mitraltech. Dr Baron has received research support from Abiomed and Boston Scientific Corp; and has served as a consultant, on an advisory board, or as a paid speaker for Zoll Medical, Medtronic, Biotronik, Boston Scientific Corp, and Shockwave. Dr Chadderdon has served as a consultant for Edwards Lifesciences and Medtronic Inc. Dr Khalique has received consulting fees from Edwards Lifesciences, Abbott Structural, Cardiac Implants, Triflo, and Restore Medical. Dr Tang is a consultant for Medtronic and Abbott Structural Heart. Dr Taramasso has served as a consultant for Abbott Vascular, Edwards Lifescience, Boston Scientific, Shenqi Medical, MEDIRA, CoreMedic, Simulands, MTEX, Occlufit, Ventrimend, and Hi-D Imaging. Dr Grayburn has received research grants from Abbott Vascular, Boston Scientific, Cardiovalve, Edwards Lifesciences, W.L. Gore, Medtronic, Neochord, and 4C Medical; and has served as a consultant or on the advisory board of Abbott Vascular, Cardiovalve, Edwards Lifesciences, W.L. Gore, Medtronic, Neochord, and 4C Medical. Dr Badano has served as a member of the Speakers Bureau of GE Healthcare, Philips Medical Systems, and EsaOte SpA; has served as a member of the clinical event committee valve prosthesis trials for Edwards Lifesciences; and has received research grants from GE Healthcare, and EsaOte SpA. Dr Leipsic has served as a consultant for MVRX, CIRCLE CVI, and HeartFlow; has had an Institutional Core Lab with Edwards, Medtronic, PI Cardia, MVRX, Boston, Abbott, and NEO VASC; has received CT core laboratory grants from Edwards, Medtronic, Abbott, Boston, and PI Cardia; and has served on the Speakers Bureau for GE Healthcare and Philips. Dr Lindenfeld has received investigator-initiated research grants from AstraZeneca and Volumetrix; and has received consulting fees from AstraZeneca, Abbott, Alleviant, Boehringer Ingelheim, CVRx, Edwards Lifesciences, Merck, Medtronic, Boston Scientific, VWave, Vascular Dynamics, and Whiteswell. Dr Windecker has received research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson and Johnson, Medicure, Medtronic, Merck Sharp and Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis with payments to the institution but no personal payments; and has been a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Vemulapalli has received grants and contracts from the American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (R01 and SBIR), Abbott Vascular, Boston Scientific, Food and Drug Administration (Nest cc), and Cytokinetics; and has received advisory board/consulting fees for Medtronic, Edwards Lifesciences, American College of Physicians, and Total CME. Dr Alu has received institutional research support (no direct financial compensation) from Edwards Lifesciences and Abbott. Dr Cohen has received research grant support from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; and has received consulting fees from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Rodés-Cabau has received institutional research grants and speaker fees from Edwards Lifesciences. Dr Ailawadi has served as a consultant for Medtronic, Edwards, Abbott, Gore, Anteris, AtriCure, Cryolife, Johnson and Johnson, Philips, and Jena. Dr Mack has served as uncompensated Co-PI of the COAPT trial, funded by Abbott, Co-PI of the PARTNER trial, funded by Edwards Lifesciences, and study chair of the Apollo trial, funded by Medtronic. Dr Leon has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifescience, and Medtronic. Dr Hausleiter has received speaker honoraria from and served as a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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