title: Cost-effectiveness of primary prevention implantable cardioverter defibrillator treatment: data from a large clinical registry.
abstract: BACKGROUND
  Although randomized trials have shown the beneficial effect on survival of an implantable cardioverter defibrillator (ICD) as primary prevention therapy in selected patients, data concerning the cost-effectiveness in routine clinical practice remain scarce. Accordingly, the purpose of this study was to assess the cost-effectiveness of primary prevention ICD implantation in the real world.
  
  
  METHODS
  Patients receiving primary prevention single-chamber or dual-chamber ICD implantation at the Leiden University Medical Center were included in the study. Using a Markov model, lifetime cost, life years (LYs), and gained quality-adjusted life years (QALYs) were estimated for device recipients and control patients. Data on mortality, complication rates, and device longevity were retrieved from our center and entered into the Markov model. To account for model assumptions, one-way deterministic and probabilistic sensitivity analyses were performed. Importantly, calculations for the estimated incremental cost-effectiveness rate (ICER) per QALY gained are based on several numbers of assumptions, and accordingly findings may have over- or underestimated the cost-effectiveness of ICD therapy.
  
  
  RESULTS
  Primary prevention ICD implantation adds an estimated mean of 2.07 LYs and 1.73 QALYs. Increased lifetime cost for single-chamber and dual-chamber ICD recipients were estimated at €60,788 and €64,216, respectively. This resulted for single-chamber ICD recipients, in an estimated ICER of €35,154 per QALY gained. In dual-chamber ICD recipients, an estimated ICER of €37,111 per QALY gained was calculated. According to the probabilistic sensitivity analysis, estimated cost per QALY gained are €35,837 (95% confidence interval [CI]: €28,368-€44,460) for single-chamber and €37,756 (95% CI: €29,055-€46,050) for dual-chamber ICDs.
  
  
  CONCLUSIONS
  On the basis of data and detailed costs, derived from routine clinical practice, ICD therapy in selected patients with a reduced left ventricular ejection fraction appears to be cost-effective.
authors.affiliation: Department of Cardiology.
authors.forename: Joep
authors.initials: J
authors.lastname: Thijssen
authors.forename: M Elske
authors.initials: ME
authors.lastname: van den Akker van Marle
authors.forename: C Jan Willem
authors.initials: CJ
authors.lastname: Borleffs
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Rees
authors.forename: Mihály K
authors.initials: MK
authors.lastname: de Bie
authors.forename: Enno T
authors.initials: ET
authors.lastname: van der Velde
authors.forename: Lieselot
authors.initials: L
authors.lastname: van Erven
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Schalij
mesh_terms: D003362:Cost-Benefit Analysis / Q000191:economics; D017147:Defibrillators, Implantable / Q000191:economics*; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006333:Heart Failure / Q000191:economics* / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D015995:Prevalence; D011322:Primary Prevention / Q000191:economics*; D012042:Registries; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome
keywords: cost-benefit analysis; implantable cardioverter defibrillator; left ventricular ejection fraction; primary prevention