One of the most promising developments to limit or eliminate the disadvantages of existing heart valve prostheses is the creation of a living heart valve. In situ tissue-engineering provides a promising method where a synthetic biodegradable scaffold in the shape of a valve will be implanted in the patient. The scaffold recruits endogenous cells from the bloodstream and surrounding tissues, the cells form new tissue and gradually transform into a valve. Tissue-engineered heart valves (TEHV) are in the development phase and not used in clinical practice yet. This thesis describes the early Health Technology Assessment (HTA) of TEHV. The conceptual model of the decision-analytic model used for the early HTA was based on a systematic review of model-based economic evaluations of heart valve implantations and a Delphi panel. The input parameters were based on systematic reviews and meta-analyses, results from a patient-reported questionnaire, and cost-analysis of health insurance claims database, reported in this thesis. The early cost-effectiveness of TEHV was assessed in elderly patients in need of aortic valve implantation and children in need of pulmonary valve implantations. The results can inform various stakeholders. First, it informs biomedical companies developing TEHV about minimum performance requirements and maximum additional costs of TEHV in different target populations, which can guide priority setting of further research initiatives. Developers of TEHV should especially focus on improving durability of TEHV compared to existing heart valve substitutes, since this was the largest driver of quality adjusted life year gains and cost savings. However, it was noted that the potential improvement in thrombogenicity of TEHV compared to existing heart valve substitutes is expected to result in larger benefits in other patient populations than discussed in this thesis (i.e. young adults or middle aged patients eligible for mechanical heart valve substitutes). Moreover, the headroom was sufficiently large for TEHV to be economically viable. Second, it provides patients and clinicians with the first estimates of potential improvements in clinical outcomes with TEHV, which may result in faster adoption of TEHV in clinical practice. Finally, it informs healthcare payers about the possible entrance of TEHV to the market, the promising potential cost-effectiveness of TEHV and the expected large cost savings for the national healthcare budget, which may result in more timely decisions about reimbursement.

Additional Metadata
Keywords Health Technology Assessment, cost-effectiveness analysis, tissue-engineered heart valves, heart valve replacement.
Promotor M.P.M.H. Rutten-van Mölken (Maureen) , J.J.M. Takkenberg (Hanneke)
Publisher Erasmus University Rotterdam
Sponsor The research described in this dissertation was supported by a grant of the Dutch Heart Foundation (DHF 2012B001)
ISBN 978-94-6380-217-8
Persistent URL hdl.handle.net/1765/115131
Citation
Huygens, S.A. (2019, February 20). Early Health Technology Assessment of Tissue-Engineered Heart Valves. Erasmus University Rotterdam. Retrieved from http://hdl.handle.net/1765/115131