Abstract
ObjectiveThe objective of this study was to evaluate the cost effectiveness of tissue engineered bovine tissue pericardium scaffold (CardioCel) for the repair of congenital heart defects in comparison with surgery using xenogeneic, autologous, and synthetic patches over a 40-year time horizon from the perspective of the UK National Health Service.MethodsA six-state Markov state-transition model to model natural history of disease and difference in the interventional effect of surgeries depending on patch type implanted. Patches differed regarding their probability of re-operation due to patch calcification, based on a systematic literature review. Transition probabilities were based on the published literature, other clinical inputs were based on UK registry data, and cost data were based on UK sources and the published literature. Incremental cost-effectiveness ratio (ICER) was determined as incremental costs per quality adjusted life years (QALY) gained. We used a 40-year analytic time-horizon and adopted the payer perspective. Comprehensive sensitivity analyses were performed.ResultsAccording to the model predictions, CardioCel was associated with reduced incidence of re-operation, increased QALY, and costs savings compared to all other patches. Cost savings were greatest compared to synthetic patches. Estimated cost savings associated with CardioCel were greatest within atrioventricular septal defect repair and lowest for ventricular septal defect repair. Based on our model, CardioCel relative risk for re-operations is 0.938, 0.956and 0.902 relative to xenogeneic, autologous, and synthetic patches, respectively.ConclusionCardioCel was estimated to increase health benefits and save cost when used during surgery for congenital heart defects instead of other patches.
Highlights
Congenital heart defects (CHD) are associated with considerable morbidity and mortality globally, with an incidence ranging from 8 to 13 per 1000 live births [1–3]
According to the model predictions, CardioCel was associated with reduced incidence of reoperation, increased quality adjusted life years (QALY), and costs savings compared to all other patches
CardioCel was estimated to increase health benefits and save cost when used during surgery for congenital heart defects instead of other patches
Summary
Congenital heart defects (CHD) are associated with considerable morbidity and mortality globally, with an incidence ranging from 8 to 13 per 1000 live births [1–3]. Of the $2.6 billion USD in hospital costs associated with birth defects in the United States during 2004, $1.4 billion (54%) was directly associated with the management and treatment of structural cardiovascular defects [2]. The costs of identifying critical congenital heart defects in neonates have previously been reported at just over $20,000 USD per newborn detected [4, 5] whilst median palliation costs have been reported at up to $99,000 USD [6]. A diverse range of cardiovascular patches for the correction of congenital defects in neonates and pediatric patients have been tested in clinical trials including the use of synthetic, autologous, and biological material [7–12]. Whilst the complication rate associated with such procedures is relatively moderate [13], calcification of patches with subsequent dehiscence and failure is a known risk of biologics [14], in addition to infection, inflammation, and bleeding [15]
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