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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.
J Am Coll Cardiol. 2013 Sep 17; 62(12):1052-1061.JACC

Abstract

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.

Authors+Show Affiliations

Scientific Institute San Raffaele, Milan, Italy. Electronic address: francesco.maisano@hsr.it.Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.Department of General and Interventional Cardiology, University Heart Centre, Hamburg, Germany.Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.Deutsches Herzzentrum München, Munich, Germany.Heart Centre Brandenburg, Bernau/Berlin, Germany.Interventional Structural and Congenital Heart Disease Programme, Invasive Cardiology Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.CardioVascular Center Frankfurt, Frankfurt, Germany.Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel and Hamburg), Bad Segeberg, Germany.Medizinische Hochschule, Hannover, Germany.Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.Heart Centre, Georg-August University, Göttingen, Germany.

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23747789

Citation

Maisano, Francesco, et al. "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, vol. 62, no. 12, 2013, pp. 1052-1061.
Maisano F, Franzen O, Baldus S, et al. 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. J Am Coll Cardiol. 2013;62(12):1052-1061.
Maisano, F., Franzen, O., Baldus, S., Schäfer, U., Hausleiter, J., Butter, C., Ussia, G. P., Sievert, H., Richardt, G., Widder, J. D., Moccetti, T., & Schillinger, W. (2013). 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, 62(12), 1052-1061. https://doi.org/10.1016/j.jacc.2013.02.094
Maisano F, et al. 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. J Am Coll Cardiol. 2013 Sep 17;62(12):1052-1061. PubMed PMID: 23747789.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Maisano,Francesco, AU - Franzen,Olaf, AU - Baldus,Stephan, AU - Schäfer,Ulrich, AU - Hausleiter,Jörg, AU - Butter,Christian, AU - Ussia,Gian Paolo, AU - Sievert,Horst, AU - Richardt,Gert, AU - Widder,Julian D, AU - Moccetti,Tiziano, AU - Schillinger,Wolfgang, Y1 - 2013/06/07/ PY - 2012/10/08/received PY - 2013/02/07/revised PY - 2013/02/14/accepted PY - 2013/6/11/entrez PY - 2013/6/12/pubmed PY - 2013/11/14/medline KW - 6-min walk test KW - 6MWT KW - CI KW - DMR KW - EF KW - EuroSCORE KW - European System for Cardiac Operative Risk Evaluation KW - FMR KW - MLHFQ KW - MR KW - Minnesota Living with Heart Failure quality of life questionnaire KW - MitraClip KW - NYHA KW - New York Heart Association KW - SLDA KW - confidence interval KW - degenerative mitral valve regurgitation KW - double orifice repair KW - ejection fraction KW - functional mitral valve regurgitation KW - mitral regurgitation KW - mitral valve KW - mitral valve regurgitation KW - percutaneous mitral valve repair KW - single leaflet device attachment SP - 1052 EP - 1061 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 62 IS - 12 N2 - 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. SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/23747789/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(13)02179-7 DB - PRIME DP - Unbound Medicine ER -