title: Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II.
abstract: BACKGROUND
  In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, but less effective reduction in MR at 1 year.
  
  
  OBJECTIVE
  This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery.
  
  
  METHODS
  Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up.
  
  
  RESULTS
  At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival.
  
  
  CONCLUSIONS
  Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274).
authors.affiliation: Department of Medicine, Division of Cardiology, Evanston Hospital, Evanston, Illinois. Electronic address: tfeldman@tfeldman.org.
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
authors.affiliation: Department of Medicine, Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.affiliation: Department of Medicine, Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts; Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Sammy
authors.initials: S
authors.lastname: Elmariah
authors.affiliation: Department of Medicine, Division of Cardiology, Evanston Hospital, Evanston, Illinois.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Smart
authors.affiliation: Department of Surgery, Division of Cardiovascular Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Trento
authors.affiliation: Department of Medicine, Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Siegel
authors.affiliation: Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Patricia
authors.initials: P
authors.lastname: Apruzzese
authors.affiliation: Department of Medicine, Division of Cardiology, Terrebonne General Medical Center, Houma, Louisiana.
authors.forename: Peter
authors.initials: P
authors.lastname: Fail
authors.affiliation: Department of Medicine, Division of Cardiology, Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Rinaldi
authors.affiliation: Department of Medicine, Division of Cardiology, The Memorial Hermann Heart and Vascular Institute, Houston, Texas.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Smalling
authors.affiliation: Department of Medicine, Division of Cardiology, St. Vincent Medical Group, Indianapolis, Indiana.
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.affiliation: Department of Surgery, Division of Cardiovascular Surgery, St. Vincent Medical Group, Indianapolis, Indiana.
authors.forename: David
authors.initials: D
authors.lastname: Heimansohn
authors.affiliation: Department of Medicine, Division of Cardiology, Columbia University Medical Center, New York, New York.
authors.forename: William A
authors.initials: WA
authors.lastname: Gray
authors.affiliation: Department of Medicine, Division of Cardiology, Baylor University, Dallas, Texas.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Grayburn
authors.affiliation: Department of Surgery, Division of Cardiovascular Surgery, Baylor University, Dallas, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.affiliation: Department of Medicine, Division of Cardiology, University of Virginia, Charlottesville, Virginia.
authors.forename: D Scott
authors.initials: DS
authors.lastname: Lim
authors.affiliation: Department of Surgery, Division of Cardiovascular Surgery, University of Virginia, Charlottesville, Virginia.
authors.forename: Gorav
authors.initials: G
authors.lastname: Ailawadi
authors.affiliation: Department of Medicine, Division of Cardiology, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.affiliation: Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Acker
authors.affiliation: Department of Medicine, Division of Cardiology, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Frank E
authors.initials: FE
authors.lastname: Silvestry
authors.affiliation: Department of Medicine, Division of Cardiology, University of California, San Francisco, California.
authors.forename: Elyse
authors.initials: E
authors.lastname: Foster
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Andrew
authors.initials: A
authors.lastname: Wang
authors.affiliation: Department of Surgery, Division of Cardiovascular Surgery, Duke University Medical Center, Durham, North Carolina.
authors.forename: Donald D
authors.initials: DD
authors.lastname: Glower
authors.affiliation: Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute, Boston, Massachusetts; Department of Medicine, Division of Cardiology, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization / Q000379:methods*; D017548:Echocardiography, Transesophageal; D005260:Female; D005471:Fluoroscopy; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D011446:Prospective Studies; D012720:Severity of Illness Index; D025321:Surgery, Computer-Assisted / Q000379:methods*; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: mitral insufficiency; regurgitant lesion; valve therapy