Faculty Collaboration Database

4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol 2013 Jul 23;62(4):317-28

Date

05/15/2013

Pubmed ID

23665364

DOI

10.1016/j.jacc.2013.04.030

Scopus ID

2-s2.0-84880320907 (requires institutional sign-in at Scopus site)   359 Citations

Abstract

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).

Author List

Mauri L, Foster E, Glower DD, Apruzzese P, Massaro JM, Herrmann HC, Hermiller J, Gray W, Wang A, Pedersen WR, Bajwa T, Lasala J, Low R, Grayburn P, Feldman T, EVEREST II Investigators

Author

Paul Joseph Pearson MD, PhD Chief, Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Follow-Up Studies
Humans
Mitral Valve Insufficiency
Percutaneous Coronary Intervention
Prospective Studies
Survival Rate
Treatment Outcome