Percutaneous repair or surgery for mitral regurgitation.

Published

Journal Article

BACKGROUND: Mitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet. METHODS: We randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days. RESULTS: At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P=0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both groups had improved left ventricular size, New York Heart Association functional class, and quality-of-life measures, as compared with baseline. CONCLUSIONS: Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov number, NCT00209274.).

Full Text

Duke Authors

Cited Authors

  • Feldman, T; Foster, E; Glower, DD; Kar, S; Rinaldi, MJ; Fail, PS; Smalling, RW; Siegel, R; Rose, GA; Engeron, E; Loghin, C; Trento, A; Skipper, ER; Fudge, T; Letsou, GV; Massaro, JM; Mauri, L; EVEREST II Investigators,

Published Date

  • April 14, 2011

Published In

Volume / Issue

  • 364 / 15

Start / End Page

  • 1395 - 1406

PubMed ID

  • 21463154

Pubmed Central ID

  • 21463154

Electronic International Standard Serial Number (EISSN)

  • 1533-4406

Digital Object Identifier (DOI)

  • 10.1056/NEJMoa1009355

Language

  • eng

Conference Location

  • United States