title: The cost-utility of left ventricular assist devices for end-stage heart failure patients ineligible for cardiac transplantation: a systematic review and critical appraisal of economic evaluations.
abstract: BACKGROUND
  A health technology assessment (HTA) of left ventricular assist devices (LVADs) as destination therapy in patients with end-stage heart failure was commissioned by the Dutch Health Care Insurance Board [College voor Zorgverzekeringen (CVZ)]. In this context, a systematic review of the economic literature was performed to assess the procedure's value for money.
  
  
  METHODS
  A systematic search (updated in December 2013) for economic evaluations was performed by consulting various databases: the HTA database produced by the Centre for Reviews and Dissemination (CRD HTA), websites of HTA institutes, CRD's National Health Service Economic Evaluation Database (NHS EED), Medline (OVID) and EMBASE. No time or language restrictions were imposed and pre-defined selection criteria were used. The two-step selection procedure was performed by two people. References of the selected studies were checked for additional relevant citations.
  
  
  RESULTS
  Six relevant studies were selected. Four economic evaluations relied on the results of the REMATCH trial to compare a pulsatile-flow LVAD with optimal medical therapy (OMT). These evaluations were performed before the publication of the HeartMate II (HM-II) Destination Therapy Trial which compared a pulsatile-flow with a continuous-flow LVAD. Two more recent economic evaluations combined the results of both trials to make an indirect comparison of a continuous-flow LVAD with OMT. In all studies, the largest part of the incremental cost was due to the reimplantation cost of an LVAD, with a device cost of €58,000-€75,000 and about €55,000 for the surgical procedure. The survival gain was highest with a continuous-flow LVAD, up to about three life-years gained (LYG) versus OMT in the most optimistic study. Quality of life (QoL) was improved but measures with a generic utility instrument were lacking, making estimates on quality-adjusted life-years (QALYs) gained more uncertain. Incremental cost-effectiveness ratios of the two most recent studies were on average €107,600 and $198,184 (ca.€145,800) per QALY gained.
  
  
  CONCLUSIONS
  Although LVAD destination therapy improves survival and QoL, it remains questionable as to whether it offers value for money. This conclusion may alter if the price of the device/procedure decreases sufficiently, in combination with further improved outcomes for mortality, adverse events and QoL.
authors.affiliation: 1 ME-TA, Medical Evaluation and Technology Assessment, Belgium ; 2 Independent researcher, the Netherlands ; 3 Department of Cardiology, University Medical Centre Utrecht, Utrecht, the Netherlands.
authors.forename: Mattias
authors.initials: M
authors.lastname: Neyt
authors.affiliation: 1 ME-TA, Medical Evaluation and Technology Assessment, Belgium ; 2 Independent researcher, the Netherlands ; 3 Department of Cardiology, University Medical Centre Utrecht, Utrecht, the Netherlands.
authors.forename: Ann
authors.initials: A
authors.lastname: Van den Bruel
authors.affiliation: 1 ME-TA, Medical Evaluation and Technology Assessment, Belgium ; 2 Independent researcher, the Netherlands ; 3 Department of Cardiology, University Medical Centre Utrecht, Utrecht, the Netherlands.
authors.forename: Yolba
authors.initials: Y
authors.lastname: Smit
authors.affiliation: 1 ME-TA, Medical Evaluation and Technology Assessment, Belgium ; 2 Independent researcher, the Netherlands ; 3 Department of Cardiology, University Medical Centre Utrecht, Utrecht, the Netherlands.
authors.forename: Nicolaas
authors.initials: N
authors.lastname: De Jonge
authors.affiliation: 1 ME-TA, Medical Evaluation and Technology Assessment, Belgium ; 2 Independent researcher, the Netherlands ; 3 Department of Cardiology, University Medical Centre Utrecht, Utrecht, the Netherlands.
authors.forename: Joan
authors.initials: J
authors.lastname: Vlayen
keywords: Heart-assist devices; cost-benefit analysis; left ventricular assist devices (LVADs); review