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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

Journal of the American College of Cardiology, 2013-09, Vol.62 (12), p.1052-1061 [Peer Reviewed Journal]

2014 INIST-CNRS ;Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. ;ISSN: 0735-1097 ;EISSN: 1558-3597 ;DOI: 10.1016/j.jacc.2013.02.094 ;PMID: 23747789 ;CODEN: JACCDI

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  • 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
  • Author: MAISANO, Francesco ; FRANZEN, Olaf ; MOCCETTI, Tiziano ; SCHILLINGER, Wolfgang ; BALDUS, Stephan ; SCHÄFER, Ulrich ; HAUSLEITER, Jörg ; BUTTER, Christian ; PAOLO USSIA, Gian ; SIEVERT, Horst ; RICHARDT, Gert ; WIDDER, Julian D
  • Subjects: Aged ; Aged, 80 and over ; Biological and medical sciences ; Cardiology. Vascular system ; Europe - epidemiology ; Female ; Heart ; Humans ; Male ; Medical sciences ; Mitral Valve Insufficiency - surgery ; Percutaneous Coronary Intervention - instrumentation ; Percutaneous Coronary Intervention - mortality ; Prospective Studies ; Treatment Outcome
  • Is Part Of: Journal of the American College of Cardiology, 2013-09, Vol.62 (12), p.1052-1061
  • Description: 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). 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. 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%. 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. 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.
  • Publisher: New York, NY: Elsevier
  • Language: English
  • Identifier: ISSN: 0735-1097
    EISSN: 1558-3597
    DOI: 10.1016/j.jacc.2013.02.094
    PMID: 23747789
    CODEN: JACCDI
  • Source: GFMER Free Medical Journals
    MEDLINE
    Alma/SFX Local Collection
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