What is the potential of tissue-engineered pulmonary valves in children?

BACKGROUND: As a living heart valve substitute with growth potential and improved durability, tissue-engineered heart valves (TEHV) may prevent re-interventions that are currently often needed in children with congenital heart disease. We performed early Health Technology Assessment to assess the potential cost-effectiveness of TEHV in children requiring right ventricular outflow tract reconstruction (RVOTR).
METHODS: A systematic review and meta-analysis was conducted of studies reporting clinical outcome after RVOTR with existing heart valve substitutes in children published between 1/1/2000-2/5/2018. Using a patient-level simulation model, costs and effects of RVOTR with TEHV compared to existing heart valve substitutes were assessed from a healthcare perspective applying a 10-year time horizon. Improvements in performance of TEHV, divided in durability, thrombogenicity, and infection resistance, were explored to estimate quality-adjusted life years (QALY) gain, cost reduction, headroom, and budget impact associated with TEHV.
RESULTS: Five-year freedom from re-intervention after RVOTR with existing heart valve substitutes was 46.1% in patients ≤2 years old and 81.1% in patients >2 years old. Improvements in durability had the highest impact on QALYs and costs. In the ‘improved TEHV performance’ scenario (durability≥5 years and -50% other valve-related events), QALY gain was 0.074 and cost reduction was €10,378 per patient, translating to maximum additional costs of €11,856 per TEHV compared to existing heart valve substitutes.
CONCLUSIONS: This study showed that there is room for improvement in clinical outcomes in children requiring RVOTR. If TEHV result in improved clinical outcomes, they are expected to be costeffective compared to existing heart valve substitutes.