title: EVEREST II randomized clinical trial: predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure.
abstract: OBJECTIVE
  The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement.
  
  
  METHODS
  Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group.
  
  
  RESULTS
  The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37 patients (P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure.
  
  
  CONCLUSIONS
  These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.
authors.affiliation: Duke University Medical Center, Durham, NC 27710, USA. Glowe001@mc.duke.edu
authors.forename: Donald
authors.initials: D
authors.lastname: Glower
authors.forename: Gorav
authors.initials: G
authors.lastname: Ailawadi
authors.forename: Michael
authors.initials: M
authors.lastname: Argenziano
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.forename: Alfredo
authors.initials: A
authors.lastname: Trento
authors.forename: Andrew
authors.initials: A
authors.lastname: Wang
authors.forename: D Scott
authors.initials: DS
authors.lastname: Lim
authors.forename: William
authors.initials: W
authors.lastname: Gray
authors.forename: Paul
authors.initials: P
authors.lastname: Grayburn
authors.forename: John
authors.initials: J
authors.lastname: Dent
authors.forename: Linda
authors.initials: L
authors.lastname: Gillam
authors.forename: Barathi
authors.initials: B
authors.lastname: Sethuraman
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
authors.forename: Elyse
authors.initials: E
authors.lastname: Foster
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.forename: Irving
authors.initials: I
authors.lastname: Kron
mesh_terms: D006348:Cardiac Surgical Procedures / Q000009:adverse effects; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects; D006801:Humans; D016015:Logistic Models; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000601:surgery*; D008945:Mitral Valve Prolapse / Q000000981:diagnostic imaging / Q000601:surgery*; D009656:North America; D011446:Prospective Studies; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D013525:Surgical Instruments; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography