TY - JOUR
T1 - Transcatheter Versus Medical Treatment of Patients With Symptomatic Severe Tricuspid Regurgitation
AU - Taramasso, Maurizio
AU - Benfari, Giovanni
AU - van der Bijl, Pieter
AU - Alessandrini, Hannes
AU - Attinger-Toller, Adrian
AU - Biasco, Luigi
AU - Lurz, Philipp
AU - Braun, Daniel
AU - Brochet, Eric
AU - Connelly, Kim A.
AU - de Bruijn, Sabine
AU - Denti, Paolo
AU - Deuschl, Florian
AU - Estevez-Loureiro, Rodrigo
AU - Fam, Neil
AU - Frerker, Christian
AU - Gavazzoni, Mara
AU - Hausleiter, Jörg
AU - Ho, Edwin
AU - Juliard, Jean Michel
AU - Kaple, Ryan
AU - Besler, Christian
AU - Kodali, Susheel
AU - Kreidel, Felix
AU - Kuck, Karl Heinz
AU - Latib, Azeem
AU - Lauten, Alexander
AU - Monivas, Vanessa
AU - Mehr, Michael
AU - Muntané-Carol, Guillem
AU - Nazif, Tamin
AU - Nickening, Georg
AU - Pedrazzini, Giovanni
AU - Philippon, François
AU - Pozzoli, Alberto
AU - Praz, Fabien
AU - Puri, Rishi
AU - Rodés-Cabau, Josep
AU - Schäfer, Ulrich
AU - Schofer, Joachim
AU - Sievert, Horst
AU - Tang, Gilbert H.L.
AU - Thiele, Holger
AU - Topilsky, Yan
AU - Rommel, Karl Philipp
AU - Delgado, Victoria
AU - Vahanian, Alec
AU - Von Bardeleben, Ralph Stephan
AU - Webb, John G.
AU - Weber, Marcel
AU - Windecker, Stephan
AU - Winkel, Mirjam
AU - Zuber, Michel
AU - Leon, Martin B.
AU - Hahn, Rebecca T.
AU - Bax, Jeroen J.
AU - Enriquez-Sarano, Maurice
AU - Maisano, Francesco
N1 - Funding Information:
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.
Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/12/17
Y1 - 2019/12/17
N2 - 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.
AB - 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.
KW - heart valve diseases
KW - tricuspid regurgitation
KW - tricuspid valve
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U2 - 10.1016/j.jacc.2019.09.028
DO - 10.1016/j.jacc.2019.09.028
M3 - Article
C2 - 31568868
AN - SCOPUS:85074440928
SN - 0735-1097
VL - 74
SP - 2998
EP - 3008
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 24
ER -