4-Year Results of a Randomized Controlled Trial of Percutaneous Repair Versus Surgery for Mitral Regurgitation

• Published in: Journal of the American College of Cardiology Vol. 62; no. 4; pp. 317 - 328
• Main Authors: Mauri, Laura, MD, Foster, Elyse, MD, Glower, Donald D., MD, Apruzzese, Patricia, MS, Massaro, Joseph M., PhD, Herrmann, Howard C., MD, Hermiller, James, MD, Gray, William, MD, Wang, Andrew, MD, Pedersen, Wesley R., MD, Bajwa, Tanvir, MD, Lasala, John, MD, PhD, Low, Reginald, MD, Grayburn, Paul, MD, Feldman, Ted, MD
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 23-07-2013; Elsevier; Elsevier Limited
• Subjects: Biological and medical sciences; Cardiology; Cardiology. Vascular system; Cardiovascular; Catheters; Confidence intervals; Endocardial and cardiac valvular diseases; Follow-Up Studies; Heart; Humans; Internal Medicine; Laboratories; Medical sciences; mitral regurgitation; mitral repair; Mitral Valve Insufficiency - diagnosis; Mitral Valve Insufficiency - mortality; Mitral Valve Insufficiency - surgery; Patients; Percutaneous Coronary Intervention - methods; Percutaneous Coronary Intervention - mortality; Percutaneous Coronary Intervention - standards; percutaneous valve therapy; Prospective Studies; Surgery; Survival Rate - trends; Treatment Outcome; NYHA; New York Heart Association; percutaneous valve therapy; mitral repair; left ventricular internal diameter diastolic; mitral regurgitation; MR; LVEF; LVIDd; left ventricular ejection fraction; Corrective surgery; Mitral valve; Prognosis; Cardiovascular disease; Long term; Randomized controlled trial; Percutaneous route; Randomization; Treatment; Cardiac valvular disease; Mitral regurgitation; Clinical trial; Circulatory system; Cardiology; Repair; Comparative study
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2013.04.030

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 )