Author + information
- Received August 18, 2019
- Revision received September 20, 2019
- Accepted September 21, 2019
- Published online December 9, 2019.
- Maurizio Taramasso, MD, PhDa,∗∗ (, )@m_taramasso,
- Giovanni Benfari, MDb,∗@GiovanniBenfari,
- Pieter van der Bijl, MDc,
- Hannes Alessandrini, MDd,
- Adrian Attinger-Toller, MDe,
- Luigi Biasco, MDf,
- Philipp Lurz, MD, PhDg,
- Daniel Braun, MDh,
- Eric Brochet, MDi,
- Kim A. Connelly, MDj,
- Sabine de Bruijn, MDk,
- Paolo Denti, MDl,
- Florian Deuschl, MDm,
- Rodrigo Estevez-Loureiro, MD, PhDn,
- Neil Fam, MDj,
- Christian Frerker, MDd,o,
- Mara Gavazzoni, MDa,
- Jörg Hausleiter, MDh,
- Edwin Ho, MDj,p,
- Jean-Michel Juliard, MDi,
- Ryan Kaple, MDq,
- Christian Besler, MDg,
- Susheel Kodali, MDr,
- Felix Kreidel, MDs,
- Karl-Heinz Kuck, MDd,
- Azeem Latib, MDp,
- Alexander Lauten, MDt,
- Vanessa Monivas, MDn,
- Michael Mehr, MDh,
- Guillem Muntané-Carol, MDu,
- Tamin Nazif, MDr,
- Georg Nickening, MDv,
- Giovanni Pedrazzini, MDf,
- François Philippon, MDu,
- Alberto Pozzoli, MDa,
- Fabien Praz, MDw,
- Rishi Puri, MDu,
- Josep Rodés-Cabau, MDu,
- Ulrich Schäfer, MDm,
- Joachim Schofer, MDx,
- Horst Sievert, MDk,
- Gilbert H.L. Tang, MD, MSc, MBAy,
- Holger Thiele, MDg,
- Yan Topilsky, MDb,z,
- Karl-Philipp Rommel, MDg,
- Victoria Delgado, MDc,
- Alec Vahanian, MDi,
- Ralph Stephan Von Bardeleben, MDs,
- John G. Webb, MDe,
- Marcel Weber, MDv,
- Stephan Windecker, MDw,
- Mirjam Winkel, MDw,
- Michel Zuber, MDa,
- Martin B. Leon, MDr,
- Rebecca T. Hahn, MDr,
- Jeroen J. Bax, MDc,
- Maurice Enriquez-Sarano, MDb and
- Francesco Maisano, MDa
- aCardiac Surgery Department, University Hospital of Zurich, Univeristy of Zurich, Switzerland
- bDivision of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota
- cDepartment of Cardiology, Leiden University Medical Center, Leiden, the Netherlands
- dAsklepios Klinik St. Georg, Hamburg, Germany
- eSt. Paul Hospital, Vancouver, British Columbia, Canada
- fCardiocentro, Lugano, Switzerland
- gHeart Center Leipzig-University Hospital, Leipzig, Germany
- hKlinikum der Universität München, Munich, Germany
- iHôpital Bichat, Université; Paris VI, Paris, France
- jToronto Heart Center, St. Michael’s Hospital, Toronto, Ontario, Canada
- kCardioVascular Center Frankfurt, Frankfurt am Main, Germany
- lSan Raffaele University Hospital, Milan, Italy
- mUniversity Heart Center Hamburg, Hamburg, Germany
- nDepartment of Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain
- oUniversity Hospital of Köln, Köln, Germany
- pMontefiore Medical Center, New York, New York
- qWestchester Medical Center, Valhalla, New York, New York
- rNew York-Presbyterian/Columbia University Medical Center, New York, New York
- sDepartment of Cardiology, University Medical Center Mainz, Mainz, Germany
- tCharité University Hospital, Berlin, Germany
- uQuebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
- vUniversitatsklinikum Bonn, Bonn, Germany
- wInselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- xAlbertinen Heart Center, Hamburg, Germany
- yMount Sinai Hospital, New York, New York
- zDepartment of Cardiology, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv, Israel
- ↵∗Address for correspondence:
Dr. Maurizio Taramasso, University Hospital of Zürich, Cardiovascular Surgery Department, Rämistrasse 100, 8091 Zurich, Switzerland.
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.
↵∗ Drs. Taramasso and Benfari contributed equally to this work and are joint first authors.
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.
- Received August 18, 2019.
- Revision received September 20, 2019.
- Accepted September 21, 2019.
- 2019 American College of Cardiology Foundation
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