目的:主动脉瓣疾病是心脏瓣膜置换术最常见的指征,在老年人中患病率最高。预计组织工程心脏瓣膜(TEHV)比目前使用的生物人工心脏瓣膜替代品具有重要优势。最重要的是减少瓣膜变性,随后减少再干预。我们对需要手术(SAVR)或经导管主动脉瓣植入(TAVI)的老年患者(≥70岁)进行了假设的TEHV的早期健康技术评估,以评估TEHV的潜力并为未来的发展决策提供信息。
方法:使用患者水平的模拟模型,从社会角度预测了TEHV与生物假体相比的潜在成本效益。预期,但目前假设TEHV性能的改善,分为耐久性,血栓形成性,和抗感染,在情景分析中进行了探索,以估计质量调整寿命年(QALY)增益,降低成本,净空,和预算影响。
结果:TEHV的耐久性对QALY收益和成本的影响最大,其次是抗感染。与SAVR和TAVI相比,TEHV性能的提高(-50%的人工瓣膜相关事件)导致寿命QALY增加0.131和0.043,寿命成本降低639欧元和368欧元,相当于每个假设TEHV的净空3255欧元和2498欧元,分别。实施后的第一个十年的国民储蓄在2.8欧元至1120万欧元(SAVR)和3.2欧元至1280万欧元(TAVI)之间,TEHV替代率为25-100%。
结论:尽管接受SAVR/TAVI的老年患者的预期寿命相对较短,与生物假体相比,假设的TEHV预计具有成本效益,商业上可行,并在生物医学工程师成功实现TEHV的耐用性和/或抗感染能力时节省了国家成本。
OBJECTIVE: 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.