EVEREST II randomized clinical trial: Predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure

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• 作者：Donald Glower ; MD^a ; ^{Glowe001@mc.duke.edu} ; Gorav Ailawadi ; MD^b ; Michael Argenziano ; MD^c ; Michael Mack ; MD^d ; Alfredo Trento ; MD^e ; Andrew Wang ; MD^a ; D. Scott Lim ; MD^b ; William Gray ; MD^c ; Paul Grayburn ; MD^d ; John Dent ; MD^b ; Linda Gillam ; MD^c ; Barathi Sethuraman ; MD^f ; Ted Feldman ; MD^g ; Elyse Foster ; MD^h ; Laura Mauri ; MDⁱ ; Irving Kron ; MD^b ; EVEREST II Investigators
• 关键词：28.1 ; 35 ; 35.4
• 刊名：The Journal of Thoracic and Cardiovascular Surgery
• 出版年：2012
• 出版时间：April, 2012
• 年：2012
• 卷：143
• 期：4_supp_S
• 页码：S60-S63
• 全文大小：229 K

文摘

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Objective

The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement.

Methods

Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group.

Results

The rate of percutaneous or surgical MV repair at 1 year was 89 % (158/178) in patients initially receiving the MitraClip device versus 84 % (67/80) in the surgical patients (P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54 % ) of 37patients (P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5 % ) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure.

Conclusions

These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.