Early cost-utility analysis of tissue-engineered heart valves compared to bioprostheses in the aortic position in elderly patients.

Abstract

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.

• Authors: Simone A Huygens, Isaac Corro Ramos, Carlijn V C Bouten, Jolanda Kluin, Shih Ting Chiu, Gary L Grunkemeier, Johanna J M Takkenberg, Maureen P M H Rutten-van Mölken
• Journal: The European journal of health economics : HEPAC : health economics in prevention and care (Eur J Health Econ) Vol. 21 Issue 4 Pg. 557-572 (Jun 2020) ISSN: 1618-7601 [Electronic] Germany
• PMID: 31982976 (Publication Type: Journal Article)

Topics

• Aged
• Aged, 80 and over
• Bioprosthesis (adverse effects, economics)
• Cost-Benefit Analysis
• Female
• Health Expenditures (statistics & numerical data)
• Heart Valve Prosthesis (adverse effects, economics)
• Heart Valve Prosthesis Implantation (adverse effects, economics, methods)
• Humans
• Male
• Models, Econometric
• Quality-Adjusted Life Years
• Technology Assessment, Biomedical
• Tissue Engineering (economics)