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

Published

Journal Article

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).

Full Text

Duke Authors

Cited Authors

  • 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,

Published Date

  • July 23, 2013

Published In

Volume / Issue

  • 62 / 4

Start / End Page

  • 317 - 328

PubMed ID

  • 23665364

Pubmed Central ID

  • 23665364

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2013.04.030

Language

  • eng

Conference Location

  • United States