Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 64, Issue 9, Pages 875-884Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2014.06.1166
Keywords
MitraClip; mitral regurgitation; percutaneous mitral valve repair; registry
Categories
Funding
- Abbott Vascular
- Abbott
- Access Closure
- AGA
- Angiomed
- Aptus
- Atrium
- Avinger
- Bard
- Boston Scientific
- Bridgepoint
- Carag
- Cardiac Dimensions
- CardioKinetix
- CardioMEMS
- Cardiox
- Celonova
- CGuard
- Coherex
- Contego
- Covidien
- CSI
- CVRx
- EndoCross
- ev3
- FlowCardia
- Gardia
- Gore
- Guided Delivery Systems
- Hemoteq
- InSeal Medical
- Lumen Biomedical
- HLT
- Lifetech
- Lutonix
- Maya Medical
- Medtronic
- NDC
- Occlutech
- Osprey
- Ostial
- PendraCare
- SquareOne
- Svelte Medical Systems
- Trireme
- Trivascular
- Vascular Dynamics
- Venus Medical
- Veryan
- Vessix
- Cook and St. Jude Medical
- Edwards Lifesciences
- Gold-Abbott Vascular
- Bristol-Myers Squibb
- Pfizer Inc.
- Boehringer Ingelheim
- Daiichi-Sankyo Europe
- Menarini International Operations
- Novartis Pharma
- Sanofi-Aventis
- Servier International
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BACKGROUND The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited. OBJECTIVES The aim of this multinational registry is to present a real-world overview of TMVR use in Europe. METHODS The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data. RESULTS A total of 628 patients (mean age 74.2 +/- 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 +/- 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation). CONCLUSIONS This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms. (C) 2014 by the American College of Cardiology Foundation.
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