TY - JOUR
T1 - 4-Year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation
AU - Mauri, Laura
AU - Foster, Elyse
AU - Glower, Donald D.
AU - Apruzzese, Patricia
AU - Massaro, Joseph M.
AU - Herrmann, Howard C.
AU - Hermiller, James
AU - Gray, William
AU - Wang, Andrew
AU - Pedersen, Wesley R.
AU - Bajwa, Tanvir
AU - Lasala, John
AU - Low, Reginald
AU - Grayburn, Paul
AU - Feldman, Ted
N1 - Funding Information:
Dr. Mauri's institution has received research grants from Abbott , Boston Scientific , Cordis , Medtronic , Eli Lilly , Daiichi Sankyo , Bristol-Myers Squibb , and Sanofi-Aventis ; and she is a consultant to St. Jude Medical. Dr. Foster has received research grants from Abbott Vascular . Patricia Apruzzese has received research grants to employer from Abbott . Dr. Massaro is a consultant to Abbott. Dr. Herrmann has received grants from Abbott . Dr. Hermiller is a consultant to Abbott, Boston Scientific, Medtronic, and St. Jude Medical. Dr. Gray is a consultant to Abbott, Boston Scientific, Cordis Endovascular, Terumo Medical, WL Gore, Medtronic, and Medrad, and has equity ownership in Amaranth Medical, CoAptus Inc., and Silk Road. Dr. Wang has received research grants from Abbott , Edwards Lifesciences , Gilead Sciences , and the American Heart Association (Mid-Atlantic Affiliate). Dr. Low has received grants from Abbott . Dr. Grayburn has received grants from Abbott Vascular , Medtronic , Baxter , ValTech Cardio , and Guided Delivery Systems , and consulting fees/honoraria from Abbott Vascular, Tendyne, and Bracco Diagnostics. Dr. Feldman is a consultant for and has received honoraria/institutional research support from Abbott, Boston Scientific, Edwards, and WL Gore. The other authors have reported they have no relationships relevant to the contents of this paper to disclose.
PY - 2013/7/23
Y1 - 2013/7/23
N2 - 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)
AB - 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)
KW - mitral regurgitation
KW - mitral repair
KW - percutaneous valve therapy
UR - http://www.scopus.com/inward/record.url?scp=84880320907&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2013.04.030
DO - 10.1016/j.jacc.2013.04.030
M3 - Article
C2 - 23665364
AN - SCOPUS:84880320907
SN - 0735-1097
VL - 62
SP - 317
EP - 328
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 4
ER -