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

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• 作者：Francesco Maisano ; Olaf Franzen ; Stephan Baldus ; Ulrich Sch?fer ; J?rg Hausleiter ; Christian Butter ; Gian Paolo Ussia ; Horst Sievert ; Gert Richardt ; Julian D. Widder ; Tiziano Moccetti ; Wolfgang Schillinger
• 关键词：double orifice repair ; MitraClip ; mitral regurgitation ; mitral valve ; percutaneous mitral valve repair
• 刊名：Journal of the American College of Cardiology
• 出版年：2013
• 出版时间：17 September, 2013
• 年：2013
• 卷：62
• 期：12
• 页码：1052-1061
• 全文大小：892 K

文摘

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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 ¡À 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?¡Ü40 % .

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?¡À?6.5 days and 7.7 ¡À 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 ¡À 112.4 m, and Minnesota-living-with-heart-failure score improved 13.5 ¡À 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.