Original Investigation
Transcatheter Versus Medical Treatment of Patients With Symptomatic Severe Tricuspid Regurgitation

https://doi.org/10.1016/j.jacc.2019.09.028Get rights and content
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Abstract

Background

Tricuspid regurgitation is associated with increased rates of heart failure (HF) and mortality. Transcatheter tricuspid valve interventions (TTVI) are promising, but the clinical benefit is unknown.

Objectives

The purpose of this study was to investigate the potential benefit of TTVI over medical therapy in a propensity score matched population.

Methods

The TriValve (Transcatheter Tricuspid Valve Therapies) registry collected 472 patients from 22 European and North American centers who underwent TTVI from 2016 to 2018. A control cohort formed by 2 large retrospective registries enrolling medically managed patients with ≥ moderate tricuspid regurgitation in Europe and North America (n = 1,179) were propensity score 1:1 matched (distance ± 0.2 SD) using age, EuroSCORE II, and systolic pulmonary artery pressure. Survival was tested with Cox regression analysis. Primary endpoint was 1-year mortality or HF rehospitalization or the composite.

Results

After matching, 268 adequately matched pairs of patients were identified. Compared with control subjects, TTVI patients had lower 1-year mortality (23 ± 3% vs. 36 ± 3%; p = 0.001), rehospitalization (26 ± 3% vs. 47 ± 3%; p < 0.0001), and composite endpoint (32 ± 4% vs. 49 ± 3%; p = 0.0003). TTVI was associated with greater survival and freedom from HF rehospitalization (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.46 to 0.79; p = 0.003 unadjusted), which remained significant after adjusting for sex, New York Heart Association functional class, right ventricular dysfunction, and atrial fibrillation (HR: 0.39; 95% CI: 0.26 to 0.59; p < 0.0001) and after further adjustment for mitral regurgitation and pacemaker/defibrillator (HR: 0.35; 95% CI: 0.23 to 0.54; p < 0.0001).

Conclusions

In this propensity-matched case-control study, TTVI is associated with greater survival and reduced HF rehospitalization compared with medical therapy alone. Randomized trials should be performed to confirm these results.

Key Words

heart valve diseases
tricuspid regurgitation
tricuspid valve

Abbreviations and Acronyms

MR
mitral regurgitation
NYHA
New York Heart Association
RCT
randomized controlled trial
RV
right ventricular/ventricle
TR
tricuspid regurgitation
TTVI
transcatheter tricuspid valve interventions

Cited by (0)

Dr. Taramasso has served as a consultant for Abbott Vascular, Boston Scientific, 4TECH, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr. Lurz has served as a consultant for Medtronic, Edwards, and Abbott; and has received speaker fees from Abbott. Dr. Braun has received speaker honoraria and travel support from Abbott Vascular. Dr. Brochet has received speaker fees from Abbott Vascular. Dr. Connelly has received honoraria from Abbott Industry. Dr. Denti has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; has received honoraria from Abbott; and has received speaking honoraria from Edwards. Dr. Deuschl has served as a proctor and consultant for Valtech/Edwards Lifesciences and Neovasc; has received speaker honoraria from Abbott; and has received unrestricted travel grants from Boston Scientific, Abbott, Edwards Lifesciences, and Neovasc. Dr. Hausleiter has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Kodali is a consultant for Claret Medical, Abbott Vascular, Meril Lifesciences, and Admedus; and has equity in Thubrikar Aortic Valve, Inc, Dura Biotech, Biotrace Medical, and MID. Dr. Kreidel has received speaker honoraria and consulting fees from Abbott and Edwards Lifesciences. Dr. Kuck has served as a consultant for Abbott Vascular, St. Jude Medical, Biotronik, Medtronic, Biosense Webster, Boston Scientific, Edwards Lifesciences, and Mitralign; and is cofounder of Cardiac Implants. Dr. Latib has served on the advisory board for Medtronic and Abbott Vascular; has served on the Speakers Bureau for Abbott Vascular; has served on the scientific advisory board for Millipede; and has served as a consultant for 4Tech, Mitralign, and Millipede. Dr. Lauten has received research support from Abbott and Edwards Lifesciences; and has served as a consultant to Abbott, Edwards Lifesciences, and TricValve. Dr. Mehr has received a travel grant from Bristol-Myers Squibb. Dr. Nazif has served as a consultant to Edwards Lifesciences, Boston Scientific, and Medtronic. Dr. Praz has been a consultant to Edwards Lifesciences. Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences. Dr. Schäfer has received lecture fees, study honoraria, travel expenses from, and has been a member of an advisory board for Abbott. Prof. Sievert has received study honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed B.V., Contego, CVRx, Edwards, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr. Tang has served as a consultant, advisory board member, and faculty trainer for Abbott Structural Heart. Dr. Topilsky has received consultation fees and research grants from Edwards Lifesciences. Dr. Delgado has received speaker fees from Abbott Vascular. Dr. Vahanian has served as a consultant for Abbott Vascular, Edwards Lifesciences, and MitralTech; and has received speakers fees from Abbott Vascular and Edwards Lifesciences. Dr. von Bardeleben has received consulting fees from Abbott Structural Heart and Edwards Lifesciences. Dr. Webb has received research support from Edwards Lifesciences; and has served as a consultant for Abbott Vascular, Edwards Lifesciences, and St. Jude Medical. Dr. Windecker has received institutional research grants from Abbott, Amgen, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, St. Jude, and Terumo. Dr. Leon has served as a nonpaid member of the scientific advisory board of Edwards Lifesciences; and has been a consultant to Abbott Vascular and Boston Scientific. Dr. Hahn has served as a speaker for Boston Scientific and Bayliss; has served as a speaker and consultant for Abbott Structural, Edwards Lifesciences, and Philips Healthcare; has served as a consultant for Medtronic and Navigate; and is the 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. Bax has received speaker fees from Abbott Vascular and Boehringer Ingelheim. Dr. Sarano has received a research grant from Edwards Lifesciences. Dr. Maisano has served as a consultant for Abbott Vascular, Edwards Lifesciences, Cardiovalve, Valtech, and Medtronic; is cofounder of 4Tech; is founder of Occlufit, SwissVortex, transseptalsolutions, and Perifect; has received royalties from Edwards Lifesciences; and has received institutional research grants from Medtronic, Edwards, Abbott, Boston Scientific, Biotronik, and NVT. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Verghese Mathew, MD, served as Guest Editor for this paper.

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∗

Drs. Taramasso and Benfari contributed equally to this work and are joint first authors.

© 2019 by the American College of Cardiology Foundation. Published by Elsevier.