title: Comparative cost-effectiveness of the HeartWare versus HeartMate II left ventricular assist devices used in the United Kingdom National Health Service bridge-to-transplant program for patients with heart failure.
abstract: BACKGROUND
  Patients with advanced heart failure may receive a left ventricular assist device (LVAD) as part of a bridge-to-transplant (BTT) strategy. The United Kingdom National Health Service (UK NHS) has financed a BTT program in which the predominant LVADs used have been the HeartMate II (HM II; Thoratec, Pleasanton, CA) and HeartWare (HW; HeartWare International, Inc. Framingham, MA). We aimed to compare the cost-effectiveness of the use of these within the NHS program.
  
  
  METHODS
  Individual patient data from the UK NHS Blood and Transplant Data Base were analyzed with Kaplan-Meier and competing outcomes methodologies. Outcomes were time to death, time to heart transplant (HT), and cumulative incidences of HT, death on LVAD support, and LVAD explantation. A semi-Markov multistate economic model was built to assess cost-effectiveness. The perspective was from the NHS, discount rates were 3.5%. Outcomes were quality-adjusted life-years (QALYs) and incremental cost (2011 prices in GB£) per QALY (ICER) for HW vs HM II.
  
  
  RESULTS
  Survival was better with HW support than with HM II. Cumulative incidence of HT was low for both groups (11% at ~2 years). HW patients accrued 4.99 lifetime QALYs costing £258,913 ($410,970), HM II patients accrued 3.84 QALYs costing £231,871 ($368,048); deterministic and probabilistic ICERs for HW vs HM II were £23,530 ($37,349) and £20,799 ($33,014), respectively.
  
  
  CONCLUSIONS
  Patients In the UK BTT program who received the HW LVAD had a better clinical outcome than those who received the HM II, and the HW was more cost-effective. This result needs to be reassessed in a randomized controlled trial comparing the 2 devices.
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry.
authors.forename: Ruth
authors.initials: R
authors.lastname: Pulikottil-Jacob
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry.
authors.forename: Gaurav
authors.initials: G
authors.lastname: Suri
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry.
authors.forename: Martin
authors.initials: M
authors.lastname: Connock
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry.
authors.forename: Ngianga-Bakwin
authors.initials: NB
authors.lastname: Kandala
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry.
authors.forename: Paul
authors.initials: P
authors.lastname: Sutcliffe
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry.
authors.forename: Hendramoorthy
authors.initials: H
authors.lastname: Maheswaran
authors.affiliation: Heart Failure Care Group, Royal Brompton and Harefield NHS Foundation Trust, London, and Institute of Cardiovascular Medicine and Science, National Heart and Lung Institute, Imperial College, London, and Clinical Effectiveness Unit, Royal College of Surgeons of London.
authors.forename: Nicholas R
authors.initials: NR
authors.lastname: Banner
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry. Electronic address: aileen.clarke@warwick.ac.uk.
authors.forename: Aileen
authors.initials: A
authors.lastname: Clarke
mesh_terms: D000328:Adult; D003362:Cost-Benefit Analysis / Q000191:economics; D005260:Female; D006333:Heart Failure / Q000191:economics* / Q000401:mortality / Q000628:therapy*; D016027:Heart Transplantation / Q000191:economics*; D006353:Heart-Assist Devices / Q000191:economics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D011474:Prosthesis Design; D019057:Quality-Adjusted Life Years; D013222:State Medicine / Q000191:economics*; D016019:Survival Analysis; D006113:United Kingdom
keywords: bridge to transplant; clinical effectiveness; cost-effectiveness analysis; economic model; heart failure; left ventricular assist device