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.
| Autor: | Maisano F; Scientific Institute San Raffaele, Milan, Italy. Electronic address: francesco.maisano@hsr.it., Franzen O; Department of Cardiology, Rigshospitalet, Copenhagen, Denmark., Baldus S; Department of General and Interventional Cardiology, University Heart Centre, Hamburg, Germany., Schäfer U; Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany., Hausleiter J; Deutsches Herzzentrum München, Munich, Germany., Butter C; Heart Centre Brandenburg, Bernau/Berlin, Germany., Ussia GP; Interventional Structural and Congenital Heart Disease Programme, Invasive Cardiology Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy., Sievert H; CardioVascular Center Frankfurt, Frankfurt, Germany., Richardt G; Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel and Hamburg), Bad Segeberg, Germany., Widder JD; Medizinische Hochschule, Hannover, Germany., Moccetti T; Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland., Schillinger W; Heart Centre, Georg-August University, Göttingen, Germany. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | Journal of the American College of Cardiology [J Am Coll Cardiol] 2013 Sep 17; Vol. 62 (12), pp. 1052-1061. Date of Electronic Publication: 2013 Jun 07. |
| DOI: | 10.1016/j.jacc.2013.02.094 |
| Abstrakt: | Objectives: 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. (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.) |
| Databáze: | MEDLINE |
| Externí odkaz: |
|