In a real-world European registry of high-risk patients with significant mitral regurgitation, MitraClip therapy achieved 81.8% 1-year survival and left 78.9% free from MR >2+ at 12 months.
Observational (n=567)
Yes
p-value: p=<0.0001
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 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.
“The major deficiency, which precludes a rigorous assessment of the appropriateness of performing MitraClip procedures in any specific population, is the lack of a control group of any kind, much less randomization of the procedure versus no procedure in similar patients.”
Maisano et al. (2013) conducted an observational in significant mitral valve regurgitation (n=567). MitraClip therapy was evaluated on freedom from MR severity >2+ at 12 months (p=<0.0001). In a real-world European registry of high-risk patients with significant mitral regurgitation, MitraClip therapy achieved 81.8% 1-year survival and left 78.9% free from MR >2+ at 12 months.