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Multicenter Study
. 2014 Sep 2;64(9):875-84.
doi: 10.1016/j.jacc.2014.06.1166.

Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry

Georg Nickenig  1 , Rodrigo Estevez-Loureiro  2 , Olaf Franzen  3 , Corrado Tamburino  4 , Marc Vanderheyden  5 , Thomas F Lüscher  6 , Neil Moat  7 , Susanna Price  8 , Gianni Dall'Ara  2 , Reidar Winter  9 , Roberto Corti  6 , Carmelo Grasso  4 , Thomas M Snow  2 , Raban Jeger  10 , Stefan Blankenberg  11 , Magnus Settergren  9 , Klaus Tiroch  12 , Jan Balzer  13 , Anna Sonia Petronio  14 , Heinz-Joachim Büttner  15 , Federica Ettori  16 , Horst Sievert  17 , Maria Giovanna Fiorino  18 , Marc Claeys  19 , Gian Paolo Ussia  20 , Helmut Baumgartner  21 , Salvatore Scandura  4 , Farqad Alamgir  22 , Freidoon Keshavarzi  22 , Antonio Colombo  23 , Francesco Maisano  24 , Henning Ebelt  25 , Patrizia Aruta  4 , Edith Lubos  11 , Björn Plicht  26 , Robert Schueler  1 , Michele Pighi  2 , Carlo Di Mario  27 ; Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Society of Cardiology
Collaborators, Affiliations
Free article
Multicenter Study

Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry

Georg Nickenig et al. J Am Coll Cardiol. .
Free article

Abstract

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.

Keywords: MitraClip; mitral regurgitation; percutaneous mitral valve repair; registry.

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Comment in

  • Snake eyes.
    Holmes DR Jr, Rihal CS. Holmes DR Jr, et al. J Am Coll Cardiol. 2014 Sep 2;64(9):885-6. doi: 10.1016/j.jacc.2014.05.055. J Am Coll Cardiol. 2014. PMID: 25169172 No abstract available.

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