Congenital heart defect repair with ADAPT tissue engineered pericardium scaffold: An early-stage health economic model

OBJECTIVE: The 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. METHODS: A 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. RESULTS: According 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. CONCLUSION: CardioCel was estimated to increase health benefits and save cost when used during surgery for congenital heart defects instead of other patches.