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 qualityadjusted 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.

Aortic Valve Replacement in Adult Patients with Decellularized Homografts: A Single-Center Experience

“…Due to limited durability of bioprostheses, repeat procedures (re-SAVR or valve-invalve TAVR and TAVR-in-TAVR) are inevitable for young adults throughout their life, so that the initially attractive cost-effectiveness of bio-SAVR may be diminished by the costs incurred for readmission, reintervention, and new prostheses needed by the patient. It has been demonstrated that even in elderly patients, decellularized homografts are more costeffective than SAVR and TAVR due to reduced adverse events rates [54]. Also, being sold at a higher price than bioprostheses, decellularized homografts remain not only cost-effective, but, most importantly, demonstrate a quality-of-life gain for the patients.…”

Computer Model-Driven Design in Cardiovascular Regenerative Medicine

“… 32 , 50 , 69 By contrast, TEHVs are living tissues having regenerative capacity, which thereby have the potential to become superior valve replacements compared to contemporary valve replacements. 42 , 43 To enable this transition, the regeneration and adaptation of TEHVs should be understood and well controlled such that proper, ideally native-like, valve function is established during tissue development and maintained over long periods through tissue adaptation and repair.…”