Author + information
- Michael Mehra,b,
- Nicole Karama,c,
- Maurizio Taramassod,
- Taoufik Ouarrake,
- Steffen Schneidere,
- Philipp Lurzf,
- Ralph Stephan von Bardelebeng,
- Neil Famh,
- Alberto Pozzolid,
- Edith Lubosi,
- Peter Boekstegersj,
- Wolfgang Schillingerk,
- Björn Plichtl,
- Holger Eggebrechtm,
- Stephan Baldusn,
- Jochen Sengese,
- Francesco Maisanod,
- Jörg Hausleitera,b,∗ (, )
- for the TriValve and TRAMI Investigators
- 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
- cEuropean Hospital Georges Pompidou (Cardiology Department) and Paris Cardiovascular Research Center (INSERMU970), Paris, France
- dDepartment of Cardiovascular Surgery, University Hospital of Zurich, University of Zurich, Zurich, Switzerland
- eStiftung für Herzinfarktforschung, Ludwigshafen, Germany
- fLeipzig Heart Center, University of Leipzig, Leipzig, Germany
- gHeart Valve Center Mainz, Center of Cardiology University Medical Center, Mainz, Germany
- hDivision of Cardiology, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
- iUniversity Heart Center Hamburg, University of Hamburg, Hamburg, Germany
- jKlinikum Siegburg, Siegburg, Germany
- kHelios Albert-Schweitzer-Klinik, Northeim, Germany
- lKlinikum Westfalen, Dortmund, Germany
- mCardioangiologisches Centrum Bethanien, Frankfurt am Main, Germany
- nCologne University Hospital, Cologne, Germany
- ↵∗Address for correspondence:
Prof. Dr. med. Jörg Hausleiter, Medizinische Klinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität Munich, Marchioninistrasse 15, 81377 Munich, Germany.
Objectives The aim of this study was to retrospectively compare the characteristics, procedural courses, and outcomes of patients presenting with concomitant mitral regurgitation (MR) and tricuspid regurgitation (TR) in the TriValve (Transcatheter Tricuspid Valve Therapies) and TRAMI (Transcatheter Mitral Valve Interventions) registries.
Background Transcatheter mitral edge-to-edge valve repair (TMVR) has been shown to be successful in patients with severe MR. Lately, edge-to-edge repair has also emerged as a possible treatment for severe TR in patients at high risk for cardiac surgery. In patients with both severe MR and TR, the yield of concomitant transcatheter mitral and tricuspid valve repair (TMTVR) for patients at high surgical risk is unknown.
Methods The characteristics, procedural data, and 1-year outcomes of all patients in the international multicenter TriValve registry and the German multicenter TRAMI registry, who presented with both severe MR and TR, were retrospectively compared. Patients in TRAMI (n = 106) underwent isolated TMVR, while those in TriValve (n = 122) additionally underwent concurrent TMTVR in compassionate and/or off-label use.
Results All 228 patients (mean age 77 ± 8 years, 44.3% women) presented with significant dyspnea at baseline (New York Heart Association functional class III or IV in 93.9%), without any differences in the rates of pulmonary hypertension and chronic pulmonary disease. The proportion of patients with left ventricular ejection fraction <30% was higher in the TMVR group (34.9% vs. 18.0%; p < 0.001), while patients in the TMTVR group had lower glomerular filtration rates. At discharge, MR was comparably reduced in both groups. At 1 year, overall all-cause mortality was 34.0% in the TMVR group and 16.4% in the TMTVR group (p = 0.035, Cox regression). On multivariate analysis, TMTVR was associated with a 2-fold lower mortality rate (hazard ratio: 0.52; p = 0.02). The rate of patients in New York Heart Association functional class ≤II at 1 year did not differ (69.4% vs. 67.0%; p = 0.54).
Conclusions Concurrent TMTVR was associated with a higher 1-year survival rate compared with isolated TMVR in patients with both MR and TR. Further randomized trials are needed to confirm these results.
The statistical analysis for this manuscript was supported by an unrestricted grant from Abbott Medical. The TRAMI registry received support from Abbott Vascular. The TriValve registry was not supported by external funding. Dr. Karam has received consulting fees from Abbott Vascular. Dr. Taramasso is a consultant for Abbott Vascular, Boston Scientific, 4tech, and CoreMedic; and has received speaking honoraria from Edwards Lifesciences. Dr. Lurz has received speaking fees from Abbott Vascular. Dr. von Bardeleben has received speaking fees from Abbott Vascular and Edwards Lifesciences. Dr. Lubos has received research support and speaking honoraria from Abbott Vascular. Dr. Schillinger has received consulting and lecture fees and travel expenses from Abbott Vascular. Dr. Maisano has served as a consultant for Abbott Vascular, Edwards Lifesciences, Cardiovalve, Valtech, and Medtronic; and is a 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 June 28, 2019.
- Revision received September 19, 2019.
- Accepted October 8, 2019.
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