• J. Am. Coll. Cardiol. · Jul 2013

    Randomized Controlled Trial Multicenter Study

    4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation.

    • 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, and EVEREST II Investigators.
    • Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115, USA. lmauri1@partners.org
    • J. Am. Coll. Cardiol. 2013 Jul 23; 62 (4): 317-28.

    ObjectivesThis study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation.BackgroundTranscatheter 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.MethodsPatients 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.ResultsAt 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.ConclusionsPatients 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).Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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