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

Autor:	Hahn RT; Department of Cardiology, Columbia University Irving Medical Center, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA. Electronic address: rth2@columbia.edu., Lawlor MK; Department of Cardiology, Columbia University Irving Medical Center, New York, New York, USA., Davidson CJ; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Badhwar V; Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, West Virginia, USA., Sannino A; Baylor Research Institute, The Heart Hospital Baylor Plano, Plano, Texas, USA; Department of Advanced Biomedical Sciences, Division of Cardiology, Federico II University, Naples, Italy. Electronic address: https://twitter.com/AnnaSannino198., Spitzer E; Cardialysis, Rotterdam, the Netherlands; Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands., Lurz P; Heart Center Leipzig at University of Leipzig, Leipzig, Germany., Lindman BR; Structural Heart and Valve Center, Cardiovascular Division, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Topilsky Y; Department of Cardiology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel., Baron SJ; Division of Cardiology, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA; Baim Institute of Clinical Research, Boston, Massachusetts, USA., Chadderdon S; Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon, USA. Electronic address: https://twitter.com/PDXHeartValveMD., Khalique OK; Division of Cardiology, Saint Francis Hospital and Catholic Health, Roslyn, New York, USA., Tang GHL; Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York, USA., Taramasso M; Herzzentrum Hirslanden Zürich, Zürich, Switzerland; University of Zürich, Zürich, Switzerland., Grayburn PA; Baylor Scott and White Heart and Vascular Hospital at Plano, Plano, Texas, USA., Badano L; Department of Medicine and Surgery, University of Milano Bicocca, Milan, Italy; Department of Cardiology, Istituto Auxologico Italiano, IRCCS, Milan, Italy., Leipsic J; Department of Radiology and Medicine, University of British Columbia, Vancouver, British Columbia, Canada., Lindenfeld J; Vanderbilt Heart and Vascular Institute, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Windecker S; Department of Cardiology, University Cardiovascular Center, Bern University Hospital, Inselspital, Bern, Switzerland., Vemulapalli S; Duke Clinical Research Institute, Durham, North Carolina, USA; Duke University School of Medicine, Durham, North Carolina, USA., Redfors B; Cardiovascular Research Foundation, New York, New York, USA; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden., Alu MC; Cardiovascular Research Foundation, New York, New York, USA., Cohen DJ; Cardiovascular Research Foundation, New York, New York, USA; Division of Cardiology, Saint Francis Hospital and Catholic Health, Roslyn, New York, USA., Rodés-Cabau J; Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada., Ailawadi G; Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA., Mack M; Baylor Scott and White Health, Dallas, Texas, USA., Ben-Yehuda O; Cardiovascular Research Foundation, New York, New York, USA; University of California-San Diego, San Diego, California, USA. Electronic address: https://twitter.com/oribenyehuda., Leon MB; Department of Cardiology, Columbia University Irving Medical Center, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA., Hausleiter J; Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.
Jazyk:	angličtina
Zdroj:	Journal of the American College of Cardiology [J Am Coll Cardiol] 2023 Oct 24; Vol. 82 (17), pp. 1711-1735. Date of Electronic Publication: 2023 Oct 04.
DOI:	10.1016/j.jacc.2023.08.008
Abstrakt:	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. Competing Interests: 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. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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