title: Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study.
abstract: BACKGROUND
  The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States.
  
  
  OBJECTIVE
  The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair.
  
  
  METHODS
  Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled.
  
  
  RESULTS
  In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%.
  
  
  CONCLUSIONS
  The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).
authors.affiliation: Duke University Medical Center, Durham, North Carolina. Electronic address: d.glower@duke.edu.
authors.forename: Donald D
authors.initials: DD
authors.lastname: Glower
authors.affiliation: Heart Institute, Cedars Sinai Medical Center, Los Angeles, California.
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.affiliation: Heart Institute, Cedars Sinai Medical Center, Los Angeles, California.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Trento
authors.affiliation: Division of Pediatric Cardiology, University of Virginia, Charlottesville, Virginia.
authors.forename: D Scott
authors.initials: DS
authors.lastname: Lim
authors.affiliation: Aurora Cardiovascular Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Milwaukee, Wisconsin; University of Wisconsin School of Medicine and Public Health, Milwaukee, Wisconsin.
authors.forename: Tanvir
authors.initials: T
authors.lastname: Bajwa
authors.affiliation: Baptist Hospital of Miami, Miami, Florida.
authors.forename: Ramon
authors.initials: R
authors.lastname: Quesada
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Patrick L
authors.initials: PL
authors.lastname: Whitlow
authors.affiliation: Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Rinaldi
authors.affiliation: Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas.
authors.forename: Paul
authors.initials: P
authors.lastname: Grayburn
authors.affiliation: Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.affiliation: Brigham and Women's Hospital, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.affiliation: Division of Cardiac Surgery, Northwestern University, Chicago, Illinois.
authors.forename: Patrick M
authors.initials: PM
authors.lastname: McCarthy
authors.affiliation: Northshore University Health System, Chicago, Illinois.
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization / Q000379:methods* / Q000401:mortality; D017548:Echocardiography, Transesophageal; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality; D006801:Humans; D015994:Incidence; D019028:Magnetic Resonance Imaging, Cine; D008297:Male; D008944:Mitral Valve Insufficiency / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology*; D011446:Prospective Studies; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D012720:Severity of Illness Index; D015996:Survival Rate / Q000639:trends; D014481:United States / Q000453:epidemiology
keywords: high surgical risk; mitral valve insufficiency; percutaneous