The Heart Valve Society

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What is the Potential Cost-Effectiveness of Tissue-Engineered Heart Valves?
Simone A. Huygens1, Maureen P.M.H. Rutten-van Mφlken2, Anahita Noruzi1, Jonathan R.G. Etnel1, Isaac Corro Ramos3, Carlijn V.C. Bouten4, Jolanda Kluin5, Johanna J.M. Takkenberg1.
1Erasmus MC, Rotterdam, Netherlands, 2Erasmus School of Health Policy & Management, Rotterdam, Netherlands, 3Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, Netherlands, 4Eindhoven University of Technology, Eindhoven, Netherlands, 5Amsterdam Medical Centre, Amsterdam, Netherlands.

OBJECTIVE: As a living heart valve substitute with growth potential, tissue-engineered heart valves (TEHV) may reduce the occurrence of valve-related events and subsequent re-interventions that are currently often needed in patients with structural heart disease. In this study, we assessed the potential cost-effectiveness of TEHV in two patient populations. METHODS: Using a patient-level simulation model, costs and effects of right ventricular outflow tract reconstruction (RVOTR) in children and surgical/transcatheter aortic valve implantation (SAVR/TAVI) in elderly patients using TEHV or existing heart valve substitutes were compared. TEHV costs were assumed equal to existing heart valve substitutes. Improvements in TEHV performance, defined by 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 costs and effects, followed by infection resistance. In children undergoing RVOTR, improved TEHV performance (durability≥5 years and -50% other valve-related events) resulted in a QALY gain of 0.074 and healthcare cost reduction of €10,378 per patient in the first decade after RVOTR. Improved TEHV performance (-50% prosthetic valve-related events) in elderly patients undergoing SAVR/TAVI resulted in lifetime QALY gains and societal cost reductions of 0.131 QALY and €639 per SAVR patient and 0.043 QALY and €368 per TAVI patient versus bioprostheses. National savings in the first decade after implementation, varied from €1.9-€7.5 million (RVOTR), €2.8-€11.2 million (SAVR) and €3.2-€12.8 million (TAVI) for TEHV substitution rates of 25% or 100%. The costs of TEHV may be €11,856(RVOTR), €639(SAVR), or €368(TAVI) higher than existing heart valve substitutes, while remaining cost-effective. CONCLUSIONS: The potential cost-effectiveness of TEHV is promising. Furthermore, despite the relatively small number of children requiring RVOTR and the short life expectancy of elderly patients undergoing aortic valve implantation, TEHV may result in large national cost savings.


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