OBJECTIVES: Tissue-engineered heart valves (TEHV) are foreseen to have important advantages over currently used heart valve substitutes. In elderly patients, these include reduction of reinterventions due to degeneration of biological heart valve substitutes. Our objective was to perform early Health Technology Assessment of TEHV in elderly patients (≥70 years) requiring aortic valve replacement.

METHODS: Using a patient-level simulation model, the cost-effectiveness of TEHV compared to surgical (SAVR) or transcatheter aortic valve replacement (TAVI) with currently used heart valve substitutes was assessed from a societal perspective. Clinical input parameters were derived from registries or meta-analyses. Health-related quality of life was expressed in utilities obtained from patient-reported EQ-5D-5L-questionnaires corrected for utilities during events based on literature. Costs included healthcare costs extracted from health insurance claims databases, and costs of informal care and productivity loss of unpaid work based on patient-reported questionnaires. Improvements in long-term performance of TEHV, divided in durability, thrombogenicity, and infection resistance, were explored separately and combined in scenario analyses to estimate the maximum QALY gain, cost reduction and headroom.

RESULTS: Durability of TEHV had the highest impact on QALY gain and costs. Perfect(no prosthetic valve-related events)/improved(50% of current prosthetic valve-related events) TEHV performance resulted in a maximum lifetime QALY gain of 0.098/0.055 QALYs compared to SAVR and 0.028/0.019 QALYs compared to TAVI, a maximum cost reduction of €412/446 compared to SAVR and €1,730/939 compared to TAVI, translating to a headroom of €2,382/1,548 compared to SAVR and €3,125/1,874 compared to TAVI. When the durability of TEHV was 50% less, but thrombogenicity and infection resistance were 50% improved, the QALY loss was 0.035/0.062 and cost increase was €2,935/2,541 compared to SAVR or TAVI, respectively.

CONCLUSIONS: Considering the high impact on lifetime QALYs and costs, the focus of TEHV developers to create durable, lifelong lasting valves is crucial to further improve current heart valve substitutes.