title: 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.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine and Cardiology/Pneumology, University of Bonn, Bonn, Germany.
authors.forename: Georg
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authors.lastname: Nickenig
authors.affiliation: Department of Cardiology, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Estevez-Loureiro
authors.affiliation: Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Olaf
authors.initials: O
authors.lastname: Franzen
authors.affiliation: Department of Cardiology, Ferrarotto Hospital, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: Department of Cardiology, OLV Ziekenhuis, Aalst, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Vanderheyden
authors.affiliation: Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland.
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Lüscher
authors.affiliation: Cardiac Surgery Department, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom.
authors.forename: Neil
authors.initials: N
authors.lastname: Moat
authors.affiliation: Intensive Care Unit, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom.
authors.forename: Susanna
authors.initials: S
authors.lastname: Price
authors.affiliation: Department of Cardiology, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom.
authors.forename: Gianni
authors.initials: G
authors.lastname: Dall'Ara
authors.affiliation: Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Reidar
authors.initials: R
authors.lastname: Winter
authors.affiliation: Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland.
authors.forename: Roberto
authors.initials: R
authors.lastname: Corti
authors.affiliation: Department of Cardiology, Ferrarotto Hospital, Catania, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Grasso
authors.affiliation: Department of Cardiology, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Snow
authors.affiliation: Department of Cardiology, University Hospital Basel, Basel, Switzerland.
authors.forename: Raban
authors.initials: R
authors.lastname: Jeger
authors.affiliation: Department of General and Interventional Cardiology, Universitäres Herzzentrum Hamburg, Hamburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Blankenberg
authors.affiliation: Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Magnus
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authors.lastname: Settergren
authors.affiliation: Department of Cardiology, Helios Klinikum Wuppertal, Wuppertal, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Tiroch
authors.affiliation: Department of Cardiology, Universitätsklinikum Düsseldorf, Düsseldorf, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Balzer
authors.affiliation: Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
authors.forename: Anna Sonia
authors.initials: AS
authors.lastname: Petronio
authors.affiliation: Department of Cardiology and Angiology II, Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany.
authors.forename: Heinz-Joachim
authors.initials: HJ
authors.lastname: Büttner
authors.affiliation: Cardiothoracic Department, Spedali Civili Brescia, Brescia, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Ettori
authors.affiliation: Department of Cardiology and Vascular Medicine, CardioVasculäres Centrum Frankfurt, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Department of Cardiology, Ospedale Civico ARNAS, Palermo, Italy.
authors.forename: Maria Giovanna
authors.initials: MG
authors.lastname: Fiorino
authors.affiliation: Department of Cardiology, University Hospital Antwerpen, Edegem, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Claeys
authors.affiliation: Department of Cardiology, Policlinico Tor Vergata, Roma, Italy.
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Ussia
authors.affiliation: Department of Cardiology and Angiology, Universitätsklinikum Münster, Münster, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Baumgartner
authors.affiliation: Department of Cardiology, Ferrarotto Hospital, Catania, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Scandura
authors.affiliation: Department of Cardiology, Castle Hill Hospital, Cottingham, United Kingdom.
authors.forename: Farqad
authors.initials: F
authors.lastname: Alamgir
authors.affiliation: Department of Cardiology, Castle Hill Hospital, Cottingham, United Kingdom.
authors.forename: Freidoon
authors.initials: F
authors.lastname: Keshavarzi
authors.affiliation: Department of Cardiology, Università degli Studi San Raffaele, Milano, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Department of Cardiovascular Surgery, Università degli Studi San Raffaele, Milano, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Department of Cardiology, Universitätsklinikum Halle/Saale, Halle/Saale, Germany.
authors.forename: Henning
authors.initials: H
authors.lastname: Ebelt
authors.affiliation: Department of Cardiology, Ferrarotto Hospital, Catania, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Aruta
authors.affiliation: Department of General and Interventional Cardiology, Universitäres Herzzentrum Hamburg, Hamburg, Germany.
authors.forename: Edith
authors.initials: E
authors.lastname: Lubos
authors.affiliation: Department of Cardiology, University Clinic Essen, Essen, Germany.
authors.forename: Björn
authors.initials: B
authors.lastname: Plicht
authors.affiliation: Department of Internal Medicine and Cardiology/Pneumology, University of Bonn, Bonn, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Schueler
authors.affiliation: Department of Cardiology, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom.
authors.forename: Michele
authors.initials: M
authors.lastname: Pighi
authors.affiliation: Department of Cardiology, NIHR Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom. Electronic address: c.dimario@rbht.nhs.uk.
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
mesh_terms: D000368:Aged; D002404:Catheterization; D004452:Echocardiography; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D010865:Pilot Projects; D011446:Prospective Studies; D012042:Registries; D013997:Time Factors; D016896:Treatment Outcome
keywords: MitraClip; mitral regurgitation; percutaneous mitral valve repair; registry