Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 62, Issue 4, Pages 317-328Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2013.04.030
Keywords
mitral regurgitation; mitral repair; percutaneous valve therapy
Categories
Funding
- Abbott Vascular
- Abbott
- Boston Scientific
- Cordis
- Medtronic
- Eli Lilly
- Daiichi Sankyo
- Bristol-Myers Squibb
- Sanofi-Aventis
- Edwards Life-sciences
- Gilead Sciences
- American Heart Association (Mid-Atlantic Affiliate)
- Baxter
- ValTech Cardio
- Guided Delivery Systems
- Tendyne
- Bracco Diagnostics
- Edwards
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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]; NCT00209274) (C) 2013 by the American College of Cardiology Foundation
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