Percutaneous Mitral Valve Interventions in the Real World: Early and One Year Results From the ACCESS-EU, a Prospective, Multicenter, Non-Randomized Post-Approval Study of the MitraClip® Therapy in Europe

OBJECTIVES: To report early and mid-term outcomes of the ACCESS-EU Study, a European prospective, multicenter, non-randomized post-approval study of MitraClip therapy.BACKGROUND: Following approval, MitraClip is increasingly performed in Europe, the ACCESS-EU registry provides a snapshot of the real-world clinical demographics and outcomes.METHODS: A total of 567 patients with significant MR underwent MitraClip therapy at 14 European sites. Mean logistic EuroSCORE at baseline was 23.0±18.3; 84.9% patients were in NYHA Class III or IV, and 52.7% patients had an EF≤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 embolization. Thirty-six subjects (6.3%) required mitral valve surgery within 12 months post the MitraClip implant procedure. There was improvement in the severity of MR at 12 months compared to 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 NYHA Functional Class II or Class I. Six-minutes-walk-test improved 59.5±112.4 meters 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