title: Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe.
abstract: OBJECTIVE
  The purpose of this article is to report early and mid-term outcomes of the ACCESS-EU study (ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe), a European prospective, multicenter, nonrandomized post-approval study of MitraClip therapy (Abbott Vascular, Inc., Santa Clara, California).
  
  
  BACKGROUND
  MitraClip has been increasingly performed in Europe after approval; the ACCESS-EU registry provides a snapshot of the real-world clinical demographic data and outcomes.
  
  
  METHODS
  A total of 567 patients with significant mitral valve regurgitation (MR) underwent MitraClip therapy at 14 European sites. Mean logistic European System for Cardiac Operative Risk Evaluation at baseline was 23.0 ± 18.3; 84.9% patients were in New York Heart Association functional class III or IV, and 52.7% of patients had an ejection fraction ≤40%.
  
  
  RESULTS
  The MitraClip implant rate was 99.6%. A total of 19 patients (3.4%) died within 30 days after the MitraClip procedure. The Kaplan-Meier survival at 1 year was 81.8%. Intensive care unit and hospital length of stay was 2.5 ± 6.5 days and 7.7 ± 8.2 days, respectively. Single leaflet device attachment was reported in 27 patients (4.8%). There were no MitraClip device embolizations. Thirty-six subjects (6.3%) required mitral valve surgery within 12 months after the MitraClip implant procedure. There was improvement in the severity of MR at 12 months, compared with baseline (p < 0.0001), with 78.9% of patients free from MR, severity of >2+ at 12 months. At 12 months, 71.4% of patients had New York Heart Association functional class II or class I. Six-min-walk-test improved 59.5 ± 112.4 m, and Minnesota-living-with-heart-failure score improved 13.5 ± 20.5 points.
  
  
  CONCLUSIONS
  In the real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are high-risk, elderly patients, mainly affected by functional MR. In this patient population, the MitraClip procedure is effective with low rates of hospital mortality and adverse events.
authors.affiliation: Scientific Institute San Raffaele, Milan, Italy. Electronic address: francesco.maisano@hsr.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Olaf
authors.initials: O
authors.lastname: Franzen
authors.affiliation: Department of General and Interventional Cardiology, University Heart Centre, Hamburg, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Baldus
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schäfer
authors.affiliation: Deutsches Herzzentrum München, Munich, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.affiliation: Heart Centre Brandenburg, Bernau/Berlin, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Butter
authors.affiliation: Interventional Structural and Congenital Heart Disease Programme, Invasive Cardiology Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Ussia
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel and Hamburg), Bad Segeberg, Germany.
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.affiliation: Medizinische Hochschule, Hannover, Germany.
authors.forename: Julian D
authors.initials: JD
authors.lastname: Widder
authors.affiliation: Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.
authors.forename: Tiziano
authors.initials: T
authors.lastname: Moccetti
authors.affiliation: Heart Centre, Georg-August University, Göttingen, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schillinger
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: 6-min walk test; 6MWT; CI; DMR; EF; EuroSCORE; European System for Cardiac Operative Risk Evaluation; FMR; MLHFQ; MR; Minnesota Living with Heart Failure quality of life questionnaire; MitraClip; NYHA; New York Heart Association; SLDA; confidence interval; degenerative mitral valve regurgitation; double orifice repair; ejection fraction; functional mitral valve regurgitation; mitral regurgitation; mitral valve; mitral valve regurgitation; percutaneous mitral valve repair; single leaflet device attachment