Tricuspid Regurgitation: From Imaging to Clinical Trials to Resolving the Unmet Need for Treatment.

Tricuspid regurgitation (TR) is a highly prevalent and heterogeneous valvular disease, independently associated with excess mortality and high morbidity in all clinical contexts. TR is profoundly undertreated by surgery and is often discovered late in patients presenting with right-sided heart failure. To address the issue of undertreatment and poor clinical outcomes without intervention, numerous structural tricuspid interventional devices have been and are in development, a challenging process due to the unique anatomic and physiological characteristics of the tricuspid valve, and warranting well-designed clinical trials. The path from routine practice TR detection to appropriate TR evaluation, to conduction of clinical trials, to enriched therapeutic possibilities for improving TR access to treatment and outcomes in routine practice is complex. Therefore, this paper summarizes the key points and methods crucial to TR detection, quantitation, categorization, risk-scoring, intervention-monitoring, and outcomes evaluation, particularly of right-sided function, and to clinical trial development and conduct, for both interventional and surgical groups.

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Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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Funding Support and Author Disclosures Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, Polares Medical, and Medira. Dr Sorajja has served as a consultant for 4C Medical, Abbott Structural, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, Medtronic, Philips, Shifamed, Siemens, WL Gore, vDyne, and xDot. Dr Cavalcante has received consulting fees/honoraria from Abbott Structural, Anteris, AriaCV, Boston Scientific, Edwards Lifesciences, Medtronic, VDyne, WL Gore, and Xylocor; and has received research grants from Abbott Northwestern Hospital Foundation and Abbott Structural. Dr Sitges has received speaker honoraria and consultant fees for Abbott, Edwards Lifesciences, Medtronic, and General Electric. Dr Taramasso has acted as a consultant and/or received consultancy fees from Abbott, Edwards Lifescience, Boston Scientific, Medtronic, Shenqi Medical, MEDIRA, Cardiovalve, VentriMend, Simulands, MTEx, Occlufit, CoreMedic, and HeD Imaging; has received an institutional educational grant from Edwards Lifescience and Abbott; and has served on the advisory board for Abbott. Dr Messika-Zeitoun has received research grant from Edwards Lifesciences. Dr Dreyfus has served as a proctor for Abbott Dr Rudski has small holding of shares in General Electric. Dr Bax has received lecture fees from Abbott and Edwards Lifesciences; and has received unrestricted research grants from Edwards Lifesciences and Abbott. Dr Stephan von Bardeleben has received research support and trials from Abbott, Edwards Lifesciences, Jenavalve, Jenscare, Medtronic, and Neochord. Dr Redwood has served as a proctor and received speaker fees from Edwards; also served as on the international advisory board member for Medtronic. Dr Bapat has served as a consultant with Edwards Lifescienes, Medtronic, and Abbott; and has received a research grant from Atricure. Dr Nickenig has received honoraria for lectures or advisory boards from Abbott, Cardiovalve, Edwards, Medtronic, and Boston Scientific. Dr Hausleiter has received research support from Edwards Lifesciences. 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; 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 Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, and Terumo; has received consulting fees, honoraria personal and institutional from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, and Mtex; has received royalty income rights from Edwards Lifesciences; and is a shareholder (including share options) of Cardiogard, Cardiovalve, Magenta, SwissVortex, Transseptalsolutions, 4Tech, and Perifect. Dr Enriquez-Sarano has received consulting fees from Artivion, ChemImage, Edwards Lifescience, and HighLife, Corcym. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.