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J Am Coll Cardiol. 2013 Sep 17;62(12):1052-1061. doi: 10.1016/j.jacc.2013.02.094. Epub 2013 Jun 7.

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 information

1
Scientific Institute San Raffaele, Milan, Italy. Electronic address: francesco.maisano@hsr.it.
2
Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.
3
Department of General and Interventional Cardiology, University Heart Centre, Hamburg, Germany.
4
Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
5
Deutsches Herzzentrum München, Munich, Germany.
6
Heart Centre Brandenburg, Bernau/Berlin, Germany.
7
Interventional Structural and Congenital Heart Disease Programme, Invasive Cardiology Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.
8
CardioVascular Center Frankfurt, Frankfurt, Germany.
9
Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel and Hamburg), Bad Segeberg, Germany.
10
Medizinische Hochschule, Hannover, Germany.
11
Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.
12
Heart Centre, Georg-August University, Göttingen, Germany.

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.

KEYWORDS:

6-min walk test; 6MWT; CI; DMR; EF; EuroSCORE; European System for Cardiac Operative Risk Evaluation; FMR; MLHFQ; MR; Minnesota Living with Heart Failure quality of life questionnaire; MitraClip; NYHA; New York Heart Association; SLDA; confidence interval; degenerative mitral valve regurgitation; double orifice repair; ejection fraction; functional mitral valve regurgitation; mitral regurgitation; mitral valve; mitral valve regurgitation; percutaneous mitral valve repair; single leaflet device attachment

PMID:
23747789
DOI:
10.1016/j.jacc.2013.02.094
[Indexed for MEDLINE]
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