title: Cost-effectiveness of the implantable HeartMate II left ventricular assist device for patients awaiting heart transplantation.
abstract: BACKGROUND
  Left ventricular assist devices (LVADs) are being proposed as a life-saving therapeutic alternative to conventional medical management for people with end-stage heart failure awaiting transplantation. However, cost-effectiveness assessments of first-generation LVADs have not been encouraging. The cost-effectiveness of the enhanced second-generation LVAD HeartMate II (Thoratec, Pleasanton, CA) is estimated here.
  
  
  METHODS
  A probabilistic Markov model was developed to extrapolate survival, utility, and resource use over the total lifetime of a hypothetic cohort of patients with end-stage heart failure under the 2 competing therapeutic strategies, using the most robust and recently published evidence about their performance. Cost data are based on UK activity to consider reimbursement in the UK National Health Service setting.
  
  
  RESULTS
  HeartMate II had a mean cost per quality-adjusted life-year (QALY) of £258,922 ($414,275). The sensitivity analysis showed that 2 factors mainly explain why HeartMate II is not a cost-effectiveness strategy as a bridge-to-transplant: (1) the survival of heart transplant candidates treated conventionally while on the waiting list has significantly improved in recent years, and (2) the high acquisition cost of the device, £94,200 ($150,720).
  
  
  CONCLUSIONS
  Although HeartMate II LVAD implantation significantly increases survival compared with conventional medical management, it does not provide good value for the money spent according to established thresholds of cost-effectiveness in the UK. HeartMate II is unlikely to become cost-effective unless the additional survival gained by its use raises and/or the device is given free of charge. Therefore, its implantation to transplant candidates lacks justification in terms of cost-effectiveness.
authors: Department of Evaluation of Innovation & New Technologies, Fundació Clínic, Barcelona, Spain. sgmoreno@clinic.ub.es
authors: Santiago G
authors: SG
authors: Moreno
authors: Nicola
authors: N
authors: Novielli
authors: Nicola J
authors: NJ
authors: Cooper
mesh_terms: D003362:Cost-Benefit Analysis; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000191:economics*; D006801:Humans; D008390:Markov Chains; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D012042:Registries; D015996:Survival Rate; D006113:United Kingdom; D014850:Waiting Lists