title: Effects of atrial fibrillation on treatment of mitral regurgitation in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized trial.
abstract: OBJECTIVE
  The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using the MitraClip device (Abbott Vascular, Abbott Park, Illinois) and compare the results with surgery in this population.
  
  
  BACKGROUND
  The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair.
  
  
  METHODS
  The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses.
  
  
  RESULTS
  Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AF patients (64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF.
  
  
  CONCLUSIONS
  Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF.
authors.affiliation: Interventional Cardiology and Cardiac Catheterization Labs, Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104-4283, USA. howard.herrmann@uphs.upenn.edu
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.forename: Zachary M
authors.initials: ZM
authors.lastname: Gertz
authors.forename: Frank E
authors.initials: FE
authors.lastname: Silvestry
authors.forename: Susan E
authors.initials: SE
authors.lastname: Wiegers
authors.forename: Y Joseph
authors.initials: YJ
authors.lastname: Woo
authors.forename: James
authors.initials: J
authors.lastname: Hermiller
authors.forename: Douglas
authors.initials: D
authors.lastname: Segar
authors.forename: David
authors.initials: D
authors.lastname: Heimansohn
authors.forename: William
authors.initials: W
authors.lastname: Gray
authors.forename: Shunichi
authors.initials: S
authors.lastname: Homma
authors.forename: Michael
authors.initials: M
authors.lastname: Argenziano
authors.forename: Andrew
authors.initials: A
authors.lastname: Wang
authors.forename: James
authors.initials: J
authors.lastname: Jollis
authors.forename: Mark B
authors.initials: MB
authors.lastname: Lampert
authors.forename: John
authors.initials: J
authors.lastname: Alexander
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.forename: Elyse
authors.initials: E
authors.lastname: Foster
authors.forename: Donald
authors.initials: D
authors.lastname: Glower
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000295:instrumentation* / Q000379:methods; D001281:Atrial Fibrillation / Q000150:complications* / Q000175:diagnosis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D015150:Echocardiography, Doppler / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D008944:Mitral Valve Insufficiency / Q000150:complications* / Q000000981:diagnostic imaging / Q000628:therapy*; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D013525:Surgical Instruments; D013997:Time Factors; D016896:Treatment Outcome