title: Clinical outcomes and economic impact of transcatheter mitral leaflet repair in heart failure patients.
abstract: BACKGROUND
  Mitral regurgitation (MR) is a common valvular heart disorder requiring intervention once it becomes severe. Transcatheter mitral repair with the MitraClip device is a safe and effective therapy for selected patients denied surgery. The authors sought to evaluate the clinical outcomes and economic impact of this therapy compared to medical management in heart-failure patients with symptomatic mitral regurgitation.
  
  
  RESULTS
  The study was comprised of two phases; an observational study of patients with heart failure and mitral regurgitation treated with either medical therapy or the MitraClip, and an economic model. Results of the observational study were used to estimate parameters for the decision model, which estimated costs, and benefits in a hypothetical cohort of patients with heart failure and moderate-to-severe mitral regurgitation treated with either standard medical therapy or MitraClip. The cohort of patients treated with the MitraClip was propensity matched to a population of heart failure patients, and their outcomes compared. At a mean follow-up of 22 months, all-cause mortality was 21% in the MitraClip cohort and 42% in the medical management cohort (p = .007). The decision model demonstrated that MitraClip increased life expectancy from 1.87-3.60 years and quality-adjusted life years (QALY) from 1.13-2.76 years. The incremental cost was $52,500 Canadian dollars, corresponding to an incremental cost-effectiveness ratio (ICER) of $32,300.00 per QALY gained. Results were sensitive to the survival benefit.
  
  
  CONCLUSIONS
  In heart failure patients with symptomatic moderate-severe mitral regurgitation, therapy with the MitraClip is associated with superior survival and is cost-effective compared to medical therapy.
authors.affiliation: a Department of Cardiology , Montreal Heart Institute , Montreal , Canada.
authors.forename: Anita W
authors.initials: AW
authors.lastname: Asgar
authors.affiliation: a Department of Cardiology , Montreal Heart Institute , Montreal , Canada.
authors.forename: Paul
authors.initials: P
authors.lastname: Khairy
authors.affiliation: b Montreal Heart Institute Coordinating Centre , Montreal , Canada.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Guertin
authors.affiliation: b Montreal Heart Institute Coordinating Centre , Montreal , Canada.
authors.forename: Daniel
authors.initials: D
authors.lastname: Cournoyer
authors.affiliation: a Department of Cardiology , Montreal Heart Institute , Montreal , Canada.
authors.forename: Anique
authors.initials: A
authors.lastname: Ducharme
authors.affiliation: a Department of Cardiology , Montreal Heart Institute , Montreal , Canada.
authors.forename: Raoul
authors.initials: R
authors.lastname: Bonan
authors.affiliation: a Department of Cardiology , Montreal Heart Institute , Montreal , Canada.
authors.forename: Arsene
authors.initials: A
authors.lastname: Basmadjian
authors.affiliation: a Department of Cardiology , Montreal Heart Institute , Montreal , Canada.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Tardif
authors.affiliation: c Department of Cardiology , Saint Luke's Mid America Heart Institute , Kansas City , MO , USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
mesh_terms: D000368:Aged; D002170:Canada; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data; D006333:Heart Failure / Q000191:economics / Q000601:surgery*; D019918:Heart Valve Prosthesis Implantation / Q000191:economics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D018803:Models, Economic; D011446:Prospective Studies; D019057:Quality-Adjusted Life Years; D016896:Treatment Outcome
keywords: Cost-effectiveness; Heart failure; Mitral regurgitation; Transcatheter mitral repair