Key result
Hypothetical tissue-engineered heart valves with 50% fewer valve-related events are predicted to yield lifetime QALY gains of 0.131 and 0.043 and cost reductions of €639 and €368 compared to surgical and transcatheter bioprostheses, respectively.
Why the study?
Tissue-engineered heart valves may offer advantages over bioprostheses by reducing valve degeneration and re-interventions, prompting an early assessment of their potential cost-effectiveness to inform future development decisions in elderly patients.
Are hypothetical tissue-engineered heart valves cost-effective compared to bioprostheses in elderly patients requiring aortic valve replacement?
Are hypothetical tissue-engineered heart valves cost-effective compared to bioprostheses in elderly patients requiring aortic valve replacement?
Hypothetical tissue-engineered heart valves are predicted to be cost-effective and result in national cost savings compared to bioprostheses in elderly patients, provided improvements in durability and infection resistance are realized.
OBJECTIVES: Aortic valve disease is the most frequent indication for heart valve replacement with the highest prevalence in elderly. Tissue-engineered heart valves (TEHV) are foreseen to have important advantages over currently used bioprosthetic heart valve substitutes, most importantly reducing valve degeneration with subsequent reduction of re-intervention. We performed early Health Technology Assessment of hypothetical TEHV in elderly patients (≥ 70 years) requiring surgical (SAVR) or transcatheter aortic valve implantation (TAVI) to assess the potential of TEHV and to inform future development decisions. METHODS: Using a patient-level simulation model, the potential cost-effectiveness of TEHV compared with bioprostheses was predicted from a societal perspective. Anticipated, but currently hypothetical improvements in performance of TEHV, divided in durability, thrombogenicity, and infection resistance, were explored in scenario analyses to estimate quality-adjusted life-year (QALY) gain, cost reduction, headroom, and budget impact. RESULTS: Durability of TEHV had the highest impact on QALY gain and costs, followed by infection resistance. Improved TEHV performance (- 50% prosthetic valve-related events) resulted in lifetime QALY gains of 0.131 and 0.043, lifetime cost reductions of €639 and €368, translating to headrooms of €3255 and €2498 per hypothetical TEHV compared to SAVR and TAVI, respectively. National savings in the first decade after implementation varied between €2.8 and €11.2 million (SAVR) and €3.2-€12.8 million (TAVI) for TEHV substitution rates of 25-100%. CONCLUSIONS: Despite the relatively short life expectancy of elderly patients undergoing SAVR/TAVI, hypothetical TEHV are predicted to be cost-effective compared to bioprostheses, commercially viable and result in national cost savings when biomedical engineers succeed in realising improved durability and/or infection resistance of TEHV.
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Huygens et al. (2020) studied Aortic valve disease (n=25,000). Tissue-engineered heart valves (TEHV) vs. Bioprostheses (SAVR or TAVI) was evaluated on Lifetime QALY gain and cost reduction (QALY gains of 0.131 and 0.043). Hypothetical tissue-engineered heart valves with 50% fewer valve-related events are predicted to yield lifetime QALY gains of 0.131 and 0.043 and cost reductions of €639 and €368 compared to surgical and transcatheter bioprostheses, respectively.
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