Author + information
- Received December 18, 2018
- Revision received April 1, 2019
- Accepted April 12, 2019
- Published online August 5, 2019.
- Michael Mehr, MDa,b,∗,
- Maurizio Taramasso, MDc,∗,
- Christian Besler, MDd,
- Tobias Ruf, MDe,
- Kim A. Connelly, MDf,
- Marcel Weber, MDg,
- Ermela Yzeiraj, MDh,
- Davide Schiavi, MDi,
- Antonio Mangieri, MDi,
- Laura Vaskelyte, MDj,
- Hannes Alessandrini, MDk,
- Florian Deuschl, MDl,
- Nicolas Brugger, MDm,
- Hasan Ahmad, MDn,
- Luigi Biasco, MDo,
- Mathias Orban, MDa,b,
- Simon Deseive, MDa,b,
- Daniel Braun, MDa,b,
- Karl-Philipp Rommel, MDd,
- Alberto Pozzoli, MDc,
- Christian Frerker, MDk,
- Michael Näbauer, MDa,b,
- Steffen Massberg, MDa,b,
- Giovanni Pedrazzini, MDo,
- Gilbert H.L. Tang, MDn,p,
- Stephan Windecker, MDm,
- Ulrich Schäfer, MDl,
- Karl-Heinz Kuck, MDk,
- Horst Sievert, MDj,
- Paolo Denti, MDi,
- Azeem Latib, MDi,
- Joachim Schofer, MDh,
- Georg Nickenig, MDg,
- Neil Fam, MDf,
- Stephan von Bardeleben, MDe,
- Philipp Lurz, MDd,
- Francesco Maisano, MDc,† and
- Jörg Hausleiter, MDa,b,†∗ ()
- aMedizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany
- bGerman Centre for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany
- cDepartment of Cardiovascular Surgery, University Hospital of Zürich, University of Zürich, Zürich, Switzerland
- dLeipzig Heart Center, University of Leipzig, Leipzig, Germany
- eMainz University Hospital, University of Mainz, Mainz, Germany
- fDivision of Cardiology, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
- gBonn University Hospital, University of Bonn, Bonn, Germany
- hAlbertinen Heart Center, Hamburg, Germany
- iSan Raffaele University Hospital, Milan, Italy
- jCardioVascular Center, Frankfurt, Germany
- kAsklepios Klinik St. Georg, Hamburg, Germany
- lUniversity Heart Center Hamburg, University of Hamburg, Hamburg, Germany
- mInselspital, University of Bern, Bern, Switzerland
- nWestchester Medical Center, Valhalla, New York
- oCardioCentro Ticino, Lugano, Switzerland
- pMount Sinai Medical Center, New York, New York
- ↵∗Address for correspondence:
Dr. Jörg Hausleiter, Medizinische Klinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität Munich, Marchioninistrasse 15, 81377 Munich, Germany.
Objectives The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair.
Background Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse.
Methods This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed.
Results In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm.
Conclusions Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy.
↵∗ Drs. Mehr and Taramasso share first authorship.
↵† Drs. Maisano and Hausleiter share last authorship.
Dr. Mehr has received travel grants from Bristol-Myers Squibb. Dr. Taramasso is a consultant for Abbott Vascular, Boston Scientific, 4tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr. Connelly has received honoraria from Abbott; and is supported by a New Investigator award from the Canadian Institutes of Health Research and an Early Researcher award from the Ontario Ministry of Research. 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. Braun has received speaker honoraria and travel support from Abbott Vascular. Dr. Tang has served as a consultant, advisory board member, and faculty trainer for Abbott Structural Heart. Dr. Windecker has received research contracts to the institution from Abbott, Amgen, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, St. Jude, and Terumo. Dr. Schäfer has received lecture fees, study honoraria, and travel expenses from Abbott Vascular, and is a member of an advisory board for Abbott Vascular. 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. 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 Lifesciences, 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. Denti has served as a consultant for Abbott Vascular, 4tech, Neovasc, and InnovHeart; and has received honoraria from Abbott. Dr. Latib has served on the advisory board for Medtronic and Abbott Vascular; is on the Speakers Bureau for Abbott Vascular; is on the scientific advisory board for Millipede; and serves as a consultant for 4tech, Mitralign, and Millipede. Dr. Lurz has received speaker fees from Abbott. Dr. Maisano has served as a consultant for Abbott Vascular, Edwards Lifesciences, Cardiovalve, Valtech, and Medtronic; and is cofounder of 4tech. Dr. Hausleiter has received research support and speaking honoraria from Abbott Vascular and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 18, 2018.
- Revision received April 1, 2019.
- Accepted April 12, 2019.
- 2019 American College of Cardiology Foundation
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