title: The cost-effectiveness of a new percutaneous ventricular assist device for high-risk PCI patients: mid-stage evaluation from the European perspective.
abstract: OBJECTIVE
  A new and smaller percutaneous ventricular assist device (pVAD, Impella, Abiomed, Danvers, MA) has been developed to provide circulatory support in hemodynamically unstable patients and to prevent hemodynamic collapse during high-risk percutaneous coronary interventions (PCI). The objective of the study was to assess the cost-effectiveness of this specific device compared to the intra-aortic balloon pump (IABP) from the European perspective. Additional analysis on extracorporeal membrane oxygenation was conducted for observational purposes only, given its use in some European countries.
  
  
  METHODS
  A combination of a decision tree and Markov model was developed to assess the cost-effectiveness of the small, pVAD. The short-term (30-day) effectiveness and safety (early survival, risk of bleeding, and stroke) were modeled, as well as long-term risk of major adverse cardiovascular events (recurrent myocardial infarction, stroke, and heart failure). The short-term effectiveness and safety data for the device were obtained from two registries (the Europella and USpella), both of which are large multi-center studies in high-risk patient groups. Probabilities of long-term major adverse cardiovascular events were obtained from various published clinical studies. The economic analysis was conducted from a German statutory health insurance perspective and only direct medical costs were included. Cost-effectiveness was estimated over a 10-year time horizon.
  
  
  RESULTS
  Compared with IABP, the pVAD generated an incremental quality-adjusted life-year (QALY) of 0.22 (with Euro-registry data) and 0.27 (with US-registry data). The incremental cost-effectiveness ratio (ICER) of the device varied between €38,069 (with Euro-registry data) and €31,727 (with US-registry data) per QALY compared with IABP.
  
  
  CONCLUSIONS
  Unadjusted, indirect comparisons of short-term effectiveness and safety between the interventions were used in the model. Cost and utility data were retrieved from various sources. Therefore, differences in patient populations may bias the estimated cost-effectiveness.
  
  
  CONCLUSIONS
  Compared with IABP, the pVAD is a cost-effective intervention for high-risk PCI patients, with ICERs well-below the conventional cost-effectiveness threshold.
authors.affiliation: Synergus AB, Stockholm, Sweden. johanna.roos@synergus.com
authors.forename: Johanna B
authors.initials: JB
authors.lastname: Roos
authors.forename: Sagar N
authors.initials: SN
authors.lastname: Doshi
authors.forename: Thomas
authors.initials: T
authors.lastname: Konorza
authors.forename: Igor
authors.initials: I
authors.lastname: Palacios
authors.forename: Ted
authors.initials: T
authors.lastname: Schreiber
authors.forename: Oleg V
authors.initials: OV
authors.lastname: Borisenko
authors.forename: Jose P S
authors.initials: JP
authors.lastname: Henriques
mesh_terms: D003362:Cost-Benefit Analysis; D005060:Europe; D006295:Health Resources / Q000706:statistics & numerical data; D006353:Heart-Assist Devices / Q000191:economics*; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000191:economics / Q000295:instrumentation; D008390:Markov Chains; D009203:Myocardial Infarction / Q000628:therapy; D062645:Percutaneous Coronary Intervention; D015203:Reproducibility of Results; D016019:Survival Analysis