Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II

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• 作者：Ted Feldman ; MD^&lowast ; ; ^{tfeldman@tfeldman.org" class="auth_mail" title="E-mail the corresponding author} ; Saibal Kar ; MD^&dagger ; ; Sammy Elmariah ; MD ; MPH^&Dagger ; ; ^§ ; ; Steven C. Smart ; MD^&lowast ; ; Alfredo Trento ; MD^‖ ; Robert J. Siegel ; MD^&dagger ; ; Patricia Apruzzese ; MS^§ ; ; Peter Fail ; MD^¶ ; ; Michael J. Rinaldi ; MD^# ; Richard W. Smalling ; MD ; PhD^&lowast ; &lowast ; ; James B. Hermiller ; MD^&dagger ; &dagger ; ; David Heimansohn ; MD^&Dagger ; &Dagger ; ; William A. Gray ; MD^§ ; § ; ; Paul A. Grayburn ; MD^‖‖ ; Michael J. Mack ; MD^¶ ; ¶ ; ; D. Scott Lim ; MD^## ; Gorav Ailawadi ; MD^&lowast ; &lowast ; &lowast ; ; Howard C. Herrmann ; MD^&dagger ; &dagger ; &dagger ; ; Michael A. Acker ; MD^&Dagger ; &Dagger ; &Dagger ; ; Frank E. Silvestry ; MD^&dagger ; &dagger ; &dagger ; ; Elyse Foster ; MD^§ ; § ; § ; ; Andrew Wang ; MD^‖‖‖ ; Donald D. Glower ; MD^¶ ; ¶ ; ¶ ; ; Laura Mauri ; MD^§ ; ; ^### ; for the EVEREST II Investigators
• 关键词：mitral insufficiency ; regurgitant lesion ; valve therapy
• 刊名：Journal of the American College of Cardiology
• 出版年：2015
• 出版时间：29 December 2015
• 年：2015
• 卷：66
• 期：25
• 页码：2844-2854
• 全文大小：1129 K

文摘

In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, but less effective reduction in MR at 1 year.

Objectives

This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery.

Methods

Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up.

Results

At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival.

Conclusions

Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274)