title: Percutaneous repair or surgery for mitral regurgitation.
abstract: 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.).
authors.affiliation: Evanston Hospital, NorthShore University Health System, Evanston, IL 60201, USA. tfeldman@northshore.org
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
authors.forename: Elyse
authors.initials: E
authors.lastname: Foster
authors.forename: Donald D
authors.initials: DD
authors.lastname: Glower
authors.forename: Donald G
authors.initials: DG
authors.lastname: Glower
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Rinaldi
authors.forename: Peter S
authors.initials: PS
authors.lastname: Fail
authors.forename: Richard W
authors.initials: RW
authors.lastname: Smalling
authors.forename: Robert
authors.initials: R
authors.lastname: Siegel
authors.forename: Geoffrey A
authors.initials: GA
authors.lastname: Rose
authors.forename: Eric
authors.initials: E
authors.lastname: Engeron
authors.forename: Catalin
authors.initials: C
authors.lastname: Loghin
authors.forename: Alfredo
authors.initials: A
authors.lastname: Trento
authors.forename: Eric R
authors.initials: ER
authors.lastname: Skipper
authors.forename: Tommy
authors.initials: T
authors.lastname: Fudge
authors.forename: George V
authors.initials: GV
authors.lastname: Letsou
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
mesh_terms: D000368:Aged; D005260:Female; D006333:Heart Failure / Q000453:epidemiology; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures; D008943:Mitral Valve / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000145:classification / Q000401:mortality / Q000601:surgery* / Q000628:therapy*; D011183:Postoperative Complications; D011474:Prosthesis Design; D011788:Quality of Life; D019233:Retreatment; D016896:Treatment Outcome