Author + information
- Received August 15, 2018
- Revision received October 2, 2018
- Accepted October 5, 2018
- Published online December 26, 2018.
- Maurizio Taramasso, MD, PhDa,∗ (, )
- Hannes Alessandrini, MDb,
- Azeem Latib, MDc,
- Masahiko Asami, MDd,
- Adrian Attinger-Toller, MDe,
- Luigi Biasco, MDf,
- Daniel Braun, MDg,
- Eric Brochet, MDh,
- Kim A. Connelly, MDi,
- Paolo Denti, MDc,
- Florian Deuschl, MDj,
- Andrea Englmeier, MDg,
- Neil Fam, MDi,
- Christian Frerker, MDb,
- Jörg Hausleiter, MDg,
- Dominique Himbert, MDh,
- Edwin Ho, MDa,b,c,d,e,f,g,h,i,
- Jean-Michel Juliard, MDh,
- Ryan Kaple, MDk,
- Felix Kreidel, MDb,
- Karl-Heinz Kuck, MDb,
- Marco Ancona, MDc,
- Alexander Lauten, MDl,
- Philipp Lurz, MDm,
- Michael Mehr, MDg,
- Tamin Nazif, MDn,
- Georg Nickening, MDo,
- Giovanni Pedrazzini, MDf,
- Alberto Pozzoli, MDa,
- Fabien Praz, MDd,
- Rishi Puri, MDp,
- Josep Rodés-Cabau, MDp,
- Ulrich Schäfer, MDj,
- Joachim Schofer, MDq,
- Horst Sievert, MDr,
- Kolja Sievert, MDr,
- Gilbert H.L. Tang, MD, MSc, MBAs,
- Felix C. Tanner, MDa,
- Alec Vahanian, MDh,
- John G. Webb, MDe,
- Stephan Windecker, MDd,
- Ermela Yzeiray, MDq,
- Michel Zuber, MDa,
- Francesco Maisano, MDa,
- Martin B. Leon, MDn and
- Rebecca T. Hahn, MDn
- aUniversity Hospital of Zurich, University of Zurich, Zurich, Switzerland
- bAsklepios Klinik St. Georg, Hamburg, Germany
- cSan Raffaele University Hospital, Milan, Italy
- dInselSpital Bern, Bern, Switzerland
- eSt. Paul’s Hospital, Vancouver, British Columbia, Canada
- fCardiocentro Ticino, Lugano, Switzerland
- gLMU Klinikum, Munich, Germany
- hBichat Hospital, Paris, France
- iSt. Michaels Hospital, Toronto, Canada
- jUKE Hamburg, Hamburg, Germany
- kWestchester Medical Center, Valhalla, New York
- lCharité University Hospital, Berlin, Germany
- mHerzzentrum Leipzig, Leipzig, Germany
- nNew York-Presbyterian/Columbia University Medical Center, New York, New York
- oUniversity Hospital of Bonn, Bonn, Germany
- pQuebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada
- qAlbertinen Hospital, Hamburg, Germany
- rCardioVascular Center, Frankfurt, Germany
- sMount Sinai Hospital, New York, New York
- ↵∗Address for correspondence:
Dr. Maurizio Taramasso, University Hospital of Zürich, Cardiovascular Surgery Department, Rämistrasse 100, 8091 Zurich, Switzerland.
Objectives A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices.
Background TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR).
Methods The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4TECH, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (caval implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up.
Results A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm2). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved.
Conclusions TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality.
Dr. Taramasso is a consultant for Abbott Vascular, Boston Scientific, 4TECH, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr. Latib has served on the advisory board for Medtronic and Abbott Vascular; on the Speakers Bureau for Abbott Vascular; on the scientific advisory board for Millipede; and as a consultant for 4Tech, Mitralign, and Millipede. Dr. Braun has received speaker honoraria and travel support from Abbott Vascular. Dr. Brochet has received speaker fees from Abbott Vascular. Dr. Denti has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; and has received honoraria from Abbott. 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. Himbert has served as a proctor and consultant for Edwards Lifesciences. 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. Lauten has received research support from Abbott and Edwards Lifesciences; and has been a consultant to Abbott, Edwards Lifesciences, and TricValve. Dr. Lurz has received speaker fees from Abbott. Dr. Mehr has received a travel grant from Bristol-Myers Squibb. Dr. Nazif has been 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. H. 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. 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. Webb has received research support from Edwards Lifesciences; and 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. Maisano has served as a consultant for Abbott Vascular, Edwards Lifesciences, Cardiovalve, Valtech, and Medtronic; and is cofounder of 4Tech. 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 consultant for Abbott Vascular, NaviGate, and GE Healthcare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 15, 2018.
- Revision received October 2, 2018.
- Accepted October 5, 2018.
- 2019 American College of Cardiology Foundation
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