Impact of Pre-Procedural Left Ventricular Ejection Fraction on One-Year Outcomes after MitraClip Implantation (From the ACCESS-EU Phase I, A Prospective, Multicenter, Non-Randomized Post-Approval Study of the MitraClip® Therapy in Europe)

• Published in: The American journal of cardiology
• Main Authors: Schäfer, Ulrich, MD, Maisano, Francesco, MD, Butter, Christian, MD, Franzen, Olaf, MD, Baldus, Stephan, MD, Hausleiter, Jörg, MD, Ussia, Gian Paolo, MD, Sievert, Horst, MD, Geist, Volker, MD, Widder, Julian Daniel, MD, Moccetti, Tiziano, MD, Schillinger, Wolfgang, MD
• Format: Journal Article
• Language: English
• Published: 2016
• Subjects: Cardiovascular; MitraClip; mitral regurgitation; percutaneous mitral valve repair; Double orifice repair; mitral valve
• ISSN: 0002-9149
• DOI: 10.1016/j.amjcard.2016.06.036

Abstract This report describes the 12-month outcomes of the ACCESS-EU post-approval study of MitraClip therapy (Abbott Vascular, Inc., Santa Clara, CA) with respect to pre-procedural 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 valve regurgitation (MR) underwent MitraClip therapy. Of those, 393 had functional MR (FMR) and were subdivided by pre-procedural LVEF (A: 10-20%, B: >20-30%, C: >30-40%, D: >40%). Procedural safety and efficacy, and treatment outcomes including MR grade, New York Heart Association (NYHA) functional class, 6-minute walk test (6MWT), and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) were analyzed at baseline, 30 days and 12 months. Baseline mean logistic EUROscore was 25±19; 87% of patients were in NYHA class III/IV (A: 96%, B: 83%, C: 90%, D: 86%). There was no incidence of death or stroke intra-procedurally. 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 at 12 months (p<0.0001). At 12 months, all subgroups experienced similar improvements in NYHA class, 6MWT and MLHFQ. 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.