Abstract
ObjectivesAortic 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.MethodsUsing 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.ResultsDurability 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%.ConclusionsDespite 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.
Highlights
Aortic valve disease is the most frequent indication for heart valve surgery [1]
Based on expert opinion and aspects on which the ongoing development of Tissue-engineered heart valves (TEHV) focuses, we investigated three types of improvements that influence the occurrence of late events: (1) Improved durability due to lower rates of prosthetic valve dysfunction (SVD and non-structural valve dysfunction; including calcification, structural and residual leak, and thickening of the prosthetic valve) resulting in longer time to re-intervention; (2) Reduced thrombogenicity, the tendency of heart valve substitutes in contact with blood to produce a thrombus or clot, resulting in lower rates of prosthetic valve thrombosis and reduced need for anticoagulation treatment; (3) Improved infection resistance resulting in lower rates of endocarditis and subsequent hospitalisation and/or re-intervention
There were discrepancies between cumulative incidence functions of events; the number of events in the model was higher than observed in Portland (Supplement 9). This early Health Technology Assessment (HTA) study showed that hypothetical TEHV are likely to be cost-effective when used in elderly patients with aortic valve disease, under the current assumptions about improvements, compared to bioprostheses [2]
Summary
Prevalence of aortic valve disease is the highest in elderly patients (stenosis 2.8%; regurgitation 2.0%), due to degeneration of the native aortic valve [2]. The average annual number of patients undergoing surgical aortic valve replacement (SAVR) in 2007–2015 in The Netherlands was 1931 (Adult Cardiac Surgery Database [ACSD]). In addition to SAVR, transcatheter aortic valve implantation (TAVI) is a less invasive alternative to replace the aortic valve for patients who are deemed inoperable or at high operable risk because of comorbidities [3]. Due to the ageing population and improvements in healthcare, the number of aortic valve implantations is only expected to increase further, especially in elderly patients [2, 6]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
