title: Impact of Preprocedural Left Ventricular Ejection Fraction on 1-Year Outcomes After MitraClip Implantation (from the ACCESS-EU Phase I, a Prospective, Multicenter, Nonrandomized Postapproval Study of the MitraClip Therapy in Europe).
abstract: This report describes the 12-month outcomes of the a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe (ACCESS-EU postapproval study of MitraClip therapy) with respect to preprocedural left ventricular ejection fraction (LVEF). Transcatheter deployment of the MitraClip device may be considered for patients who are not suitable for conventional surgery. A total of 567 patients with significant mitral regurgitation (MR) underwent MitraClip therapy. Of those, 393 had functional MR (FMR) and were subdivided by preprocedural LVEF (A: 10% to 20%, B: >20% to 30%, C: >30% to 40%, D: >40%). Procedural safety and efficacy and treatment outcomes including MR grade, New York Heart Association (NYHA) functional class, 6-minute walk test, and the Minnesota Living with Heart Failure Questionnaire were analyzed at baseline, 30 days, and 12 months. Baseline mean logistic EuroSCORE was 25 ± 19; 87% of patients were in NYHA classes III or IV (A: 96%, B: 83%, C: 90%, D: 86%). There was no incidence of death or stroke intraprocedurally. Eleven patients died within 30 days with no differences among subgroups. Kaplan-Meier survival at 12 months was 81.8% (A: 71%, B: 79%, C: 87%, D: 86%). There was a significant improvement in MR severity at 30 days and 12 months (p <0.0001). At 12 months, all subgroups experienced similar improvements in NYHA class, 6-minute walk test, and Minnesota Living with Heart Failure Questionnaire. This real-world registry reports promising results of MitraClip therapy in patients with FMR. In conclusion, the low rates of hospital mortality and adverse events in patients with FMR-even in patients with severely reduced LVEF-provide additional evidence of substantial benefits after MitraClip implantation.
authors: Department of General and Interventional Cardiology, University Heart Centre, Hamburg, Germany. Electronic address: u.schaefer@uke.de.
authors: Ulrich
authors: U
authors: Schäfer
authors: Department of Cardiovascular Surgery, University Hospital Zurich, Zurich, Switzerland.
authors: Francesco
authors: F
authors: Maisano
authors: Department of Cardiology, Heart Centre Brandenburg, Bernau, Germany.
authors: Christian
authors: C
authors: Butter
authors: Department of Cardiology, Klinik im Park, Zürich, Switzerland.
authors: Olaf
authors: O
authors: Franzen
authors: Department of Cardiology, University Heart Centre, Cologne, Germany.
authors: Stephan
authors: S
authors: Baldus
authors: Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany.
authors: Jörg
authors: J
authors: Hausleiter
authors: Department of Cardiology, University of Rome "Tor Vergata", Rome, Italy.
authors: Gian Paolo
authors: GP
authors: Ussia
authors: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors: Horst
authors: H
authors: Sievert
authors: Department of Cardiology, Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel and Hamburg), Bad Segeberg, Germany.
authors: Volker
authors: V
authors: Geist
authors: Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
authors: Julian Daniel
authors: JD
authors: Widder
authors: Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.
authors: Tiziano
authors: T
authors: Moccetti
authors: HELIOS Albert-Schweitzer-Klinik Northeim, Innere Medizin I, Northeim, Germany.
authors: Wolfgang
authors: W
authors: Schillinger
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization; D016022:Case-Control Studies; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058386:Mitral Valve Annuloplasty; D008944:Mitral Valve Insufficiency / Q000503:physiopathology / Q000601:surgery*; D009026:Mortality; D011379:Prognosis; D012042:Registries; D012720:Severity of Illness Index; D013318:Stroke Volume; D013525:Surgical Instruments; D016896:Treatment Outcome; D000070857:Walk Test