One-Year Results Published From the ACCESS-EU European Postapproval Registry of Abbott Vascular's MitraClip

September 9, 2013—Francesco Maisano, MD, et al published early and midterm outcomes of the two-phase observational ACCESS-EU study in the Journal of the American College of Cardiology (JACC) (2013;62:1052–1061). ACCESS-EU is a European prospective, multicenter, nonrandomized postapproval study of the MitraClip system (Abbott Vascular, Santa Clara, CA). These data were first presented in August 2012 at the European Society of Cardiology’s Congress 2012 in Munich, Germany.

According to the investigators, the ACCESS-EU registry provides a snapshot of the real-world clinical demographic data and outcomes of MitraClip procedures, which have been increasingly performed in Europe since the device was approved.

As summarized in JACC, 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 ± 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%.

The investigators reported that 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 patients (6.3%) required mitral valve surgery within 12 months after the MitraClip implantation procedure.

There was improvement in the severity of MR at 12 months compared with baseline (P < .0001), with 78.9% of patients free from MR, severity of > 2+ at 12 months. At 12 months, 71.4% of patients were New York Heart Association functional class II or I. Six-minute walk test scores improved by 59.5 ± 112.4 minutes, and Minnesota Living With Heart Failure scores improved 13.5 ± 20.5 points.

The ACCESS-EU investigators concluded that in the real-world, postapproval experience in Europe, patients undergoing 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.