- 作者：Laura Mauri ; Elyse Foster ; Donald D. Glower ; Patricia Apruzzese ; Joseph M. Massaro ; Howard C. Herrmann ; James Hermiller ; William Gray ; Andrew Wang ; Wesley R. Pedersen ; Tanvir Bajwa ; John Lasala ; Reginald Low ; Paul Grayburn ; Ted Feldman ; EVEREST II Investigators
- 关键词：mitral regurgitation ; mitral repair ; percutaneous valve therapy
- 刊名：Journal of the American College of Cardiology
- 出版年：2013
- 出版时间：23 July, 2013
- 年：2013
- 卷：62
- 期：4
- 页码：317-328
- 全文大小：2109 K
Objectives
This study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation.Background
Transcatheter therapies are being developed to treat valvular heart disease. In the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at 1 year overall. We report the 4-year outcomes from the EVEREST II trial.
Methods
Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the MitraClip (Abbott, Menlo Park, California) device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients prospectively consented to 5 years of follow-up.
Results
At 4 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the intention-to-treat population was 39.8 % versus 53.4 % in the percutaneous repair group and surgical groups, respectively (p?=?0.070). Rates of death were 17.4 % versus 17.8 % (p?= 0.914), and 3+ or 4+ MR was present in?21.7 % versus 24.7 % (p?= 0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4 % versus 2.2 % (p?< 0.001) at 1 year and 24.8 % versus 5.5 % (p?< 0.001) at 4 years.
Conclusions
Patients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at 4 years. (Endovascular Valve Edge-to-Edge Repair Study [EVEREST II]; )