Author + information
- Received May 25, 2017
- Revision received August 3, 2017
- Accepted August 8, 2017
- Published online October 2, 2017.
- Maurizio Taramasso, MDa,∗ (, )
- Rebecca T. Hahn, MDb,
- Hannes Alessandrini, MDc,
- Azeem Latib, MDd,
- Adrian Attinger-Toller, MDe,
- Daniel Braun, MDf,
- Eric Brochet, MDg,
- Kim A. Connelly, MDh,
- Paolo Denti, MDd,
- Florian Deuschl, MDi,
- Andrea Englmaier, MDf,
- Neil Fam, MDh,
- Christian Frerker, MDc,
- Joerg Hausleiter, MDf,
- Jean-Michel Juliard, MDg,
- Ryan Kaple, MDj,
- Felix Kreidel, MDc,
- Karl Heinz Kuck, MDc,
- Shingo Kuwata, MD, PhDa,
- Marco Ancona, MDd,
- Margarita Malasa, MDk,
- Tamim Nazif, MDb,
- Georg Nickenig, MDk,
- Fabian Nietlispach, MD, PhDa,
- Alberto Pozzoli, MDa,
- Ulrich Schäfer, MDi,
- Joachim Schofer, MDl,
- Robert Schueler, MDk,
- Gilbert Tang, MDm,
- Alec Vahanian, MDg,
- John G. Webb, MDe,
- Ermela Yzeiraj, MDl,
- Francesco Maisano, MDa and
- Martin B. Leon, MDb
- aDepartment of Cardiovascular Surgery, University Hospital of Zürich, University of Zürich, Zürich, Switzerland
- bNew York-Presbyterian/Columbia University Medical Center, New York, New York
- cAsklepios Klinik St. Georg, Hamburg, Germany
- dSan Raffaele University Hospital, Milan, Italy
- eSt. Paul's Hospital, University of British Columbia, Vancouver, Canada
- fKlinikum der Universität München, Munich, Germany
- gHôpital Bichat, Université Paris VI, Paris, France
- hToronto Heart Center, St. Michael’s Hospital, Toronto, Ontario, Canada
- iUniversity Heart Center Hamburg, Hamburg, Germany
- jWestchester Medical Center, Valhalla, New York
- kUniversitatsklinikum Bonn, Bonn, Germany
- lAlbertinen Heart Center, Hamburg, Germany
- mMount Sinai Hospital, New York, New York
- ↵∗Address for correspondence:
Dr. Maurizio Taramasso, Department of Cardiovascular Surgery, University Hospital of Zürich, Rämistrasse 100, 8091 Zurich, Switzerland.
Objectives This study sought to develop a large, international registry to evaluate the diffusion of these approaches and investigate patient characteristics and initial clinical results.
Background Several transcatheter tricuspid valve therapies are emerging as therapeutic options for patients with severe symptomatic tricuspid regurgitation (TR), generally a high-risk surgical population.
Methods The TriValve (Transcatheter Tricuspid Valve Therapies) registry included 106 high-risk patients (76 ± 9 years of age; 60.4% women; European System for Cardiac Operative Risk Evaluation II 7.6 ± 5.7%) from 11 cardiac centers, with severe TR.
Results A total of 35% of the patients had prior left heart valve intervention (surgical in 29 of 106 and transcatheter in 8 of 106 patients). Right ventricular (RV) dysfunction (tricuspid annular plane systolic excursion <17 mm) was present in 56.3% of the patients; 95% of the patients were in New York Heart Association functional class III to IV. The etiology of TR was functional in 95.2%, and the mean tricuspid annulus was 45.4 ± 11 mm. In 76.9% of the patients, the main location of the regurgitant jet was central; pre-procedural systolic pulmonary artery pressure was 39.7 ± 13.8 mm Hg; and the inferior vena cava was severely dilated in most of the patients (27.4 ± 6.8 mm). Implanted devices included MitraClip (n = 58), Trialign (n = 17), TriCinch (n = 15), FORMA (n = 7), Cardioband (n = 5), and caval valve implantation (n = 3). One case had combined Trialign + MitraClip. Patients treated with the different techniques were similar in terms of European System for Cardiac Operative Risk Evaluation II and degree of RV dysfunction. In 68% of the cases the tricuspid intervention was performed as an isolated procedure. Procedural success was achieved in 62% of cases. At 30-day follow-up, all-cause mortality was 3.7%, with an overall incidence of major adverse cardiac and cerebrovascular events of 26%; 58% of the patients were New York Heart Association functional class I or II at 30 days.
Conclusions Patients currently undergoing transcatheter tricuspid valve therapy are mostly high risk, with a functional etiology and very severe central regurgitation, and do not have severely impaired RV function. Initial results suggest that transcatheter tricuspid valve therapy is feasible with different techniques, but clinical efficacy requires further investigation.
Dr. Taramasso has served as a consultant for Abbott Vascular and 4Tech. Dr. Hahn has served as a consultant for Abbott Vascular and GE Healthcare. Dr. Latib has served on the advisory board for Medtronic; 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 from Abbott Vascular. Dr. Brochet has received speaker fees from Abbott Vascular. Dr. Denti has served as a consultant for Abbott Vascular, 4Tech, and InnovHeart. Dr. Deuschl has served as a proctor and consultant for Valtech/Edwards (Cardioband). Dr. Hausleiter has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Kuck has served as a consultant for Abbott Vascular, St. Jude Medical, Biotronik, Medtronic, Edwards Lifesciences, and Mitralign; and is cofounder of Cardiac Implants. Dr. Nietlispach has served as a consultant for Abbott Vascular, Medtronic, and Edwards Lifesciences; and owns stock in Edwards Lifesciences. Dr. Schäfer has received lecture fees, study honoraria, travel expenses from, and is member of the advisory board of Abbott. 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 Mitral Tech. Dr. Webb has received research support from Edwards Lifesciences; and served as a consultant for Abbott Vascular, Edwards Lifesciences, and St. Jude Medical. Dr. Maisano has served as a consultant for Abbott Vascular, Edwards Lifesciences, and Medtronic; and is cofounder of 4Tech. Dr. Leon has served as a nonpaid member of the Scientific Advisory Board of Edwards Lifesciences and consultant for Abbott Vascular and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper. Drs. Taramasso and Hahn contributed equally this work.
- Received May 25, 2017.
- Revision received August 3, 2017.
- Accepted August 8, 2017.
- 2017 American College of Cardiology Foundation