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, Franzen, O, Baldus, S, Schafer, U, Hausleiter, J, Butter, C, Ussia, Gp, Sievert, H, Richardt, G, Widder, J, Moccetti, T, Schillinger, W |
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| Přispěvatelé: | Maisano, F, Franzen, O, Baldus, S, Schafer, U, Hausleiter, J, Butter, C, Ussia, Gp, Sievert, H, Richardt, G, Widder, Jd, Moccetti, T, Schillinger, W, University of Zurich, Maisano, Francesco |
| Rok vydání: | 2013 |
| Předmět: |
Male
mitral valve Minnesota Living with Heart Failure quality of life questionnaire functional mitral valve regurgitation Settore MED/11 - Malattie dell'Apparato Cardiovascolare 610 Medicine & health 6-min walk test 6MWT CI DMR EF EuroSCORE European System for Cardiac Operative Risk Evaluation FMR MLHFQ MR MitraClip NYHA New York Heart Association SLDA confidence interval degenerative mitral valve regurgitation double orifice repair ejection fraction mitral regurgitation mitral valve regurgitation percutaneous mitral valve repair single leaflet device attachment Aged Aged 80 and over Europe Female Humans Mitral Valve Insufficiency Percutaneous Coronary Intervention Prospective Studies Treatment Outcome 11171 Cardiocentro Ticino 2705 Cardiology and Cardiovascular Medicine 80 and over |
| Popis: | ObjectivesThe 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).BackgroundMitraClip has been increasingly performed in Europe after approval; the ACCESS-EU registry provides a snapshot of the real-world clinical demographic data and outcomes.MethodsA 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%.ResultsThe 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.ConclusionsIn 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. |
| Databáze: | OpenAIRE |
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