Peng Jin, Zheng Xinglong, Jiang Minghuan, Yao Xuelin, Ma Yue, Fu Mao, Ma Tao, Shang Xiaolong, Yan Yang, Thourani Vinod H, Fang Yu
Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy (J.P., M.J., X.Y., Y.M., M.F., Y.F.), Xi'an Jiaotong University, China.
Center for Drug Safety and Policy Research (J.P., M.J., X.Y., Y.M., M.F., Y.F.), Xi'an Jiaotong University, China.
Circ Cardiovasc Qual Outcomes. 2025 Apr;18(4):e010858. doi: 10.1161/CIRCOUTCOMES.124.010858. Epub 2025 Mar 18.
Transcatheter aortic valve replacement (TAVR) remains debated as an alternative to surgical aortic valve replacement (SAVR). We aimed to evaluate the cost-effectiveness of aortic valve replacement strategies in low- and intermediate-risk patients with severe aortic stenosis in China.
A decision-analytic model combining decision tree and Markov model was developed to compare outcomes of universal SAVR, universal TAVR, and a risk-based strategy (SAVR in low-risk patients and TAVR in intermediate-risk patients) in a hypothetical cohort of 75-year-old patients with aortic stenosis within the perspective of the Chinese health care system. A meta-analysis was performed to derive the clinical inputs; the 2019 to 2021 claims data from Shaanxi Province were used for cost analysis, and quality of life was measured using EuroQoL-5D. One-way and probabilistic (10 000 Monte Carlo simulations) sensitivity analyses were conducted to examine the robustness of model results. Primary outcomes included total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER).
Universal TAVR gained the most QALYs (6.76 QALYs) with the highest costs (USD 58 949). Compared with universal SAVR, the risk-based strategy gained 0.12 additional QALYs at higher costs (USD 14 046); the ICER (117 048 USD/QALY) exceeded the willingness-to-pay threshold (37 657 USD/QALY, 3-fold gross domestic product per capita in China). The ICER of universal TAVR versus universal SAVR (80 526 USD/QALY) also exceeded the willingness-to-pay threshold. Sensitivity analysis showed that universal TAVR would be cost-effective if TAVR valve costs were <USD 21 477 (>44.23% cost reduction). Subgroup analysis showed that universal TAVR and risk-based strategy remained not cost-effective compared with universal SAVR in both low-risk (ICER of 64 414 USD/QALY) and intermediate-risk (ICER of 124 851 USD/QALY) patients. In 10 000 Monte Carlo simulations, the probabilities of being cost-effective for universal SAVR, universal TAVR, and risk-based strategy were 89.81%, 10.14%, and 0.05%, respectively.
The risk-based strategy and universal TAVR appeared not to be cost-effective versus universal SAVR in low- and intermediate-risk patients with severe aortic stenosis in China.
经导管主动脉瓣置换术（TAVR）作为外科主动脉瓣置换术（SAVR）的替代方案仍存在争议。我们旨在评估中国中低风险重度主动脉瓣狭窄患者主动脉瓣置换策略的成本效益。
建立了一个结合决策树和马尔可夫模型的决策分析模型，在中国医疗保健系统的视角下，比较75岁主动脉瓣狭窄假设队列中普遍SAVR、普遍TAVR和基于风险的策略（低风险患者采用SAVR，中风险患者采用TAVR）的结果。进行荟萃分析以得出临床数据；使用陕西省2019年至2021年的理赔数据进行成本分析，并使用欧洲五维健康量表（EuroQoL-5D）测量生活质量。进行单向和概率性（10000次蒙特卡洛模拟）敏感性分析，以检验模型结果的稳健性。主要结局包括总成本、质量调整生命年（QALY）和增量成本效益比（ICER）。
普遍TAVR获得的QALY最多（6.76个QALY），但成本最高（58949美元）。与普遍SAVR相比，基于风险的策略在成本更高（14046美元）的情况下多获得0.12个QALY；ICER（117048美元/QALY）超过了支付意愿阈值（37657美元/QALY，中国人均国内生产总值的3倍）。普遍TAVR与普遍SAVR相比的ICER（80526美元/QALY）也超过了支付意愿阈值。敏感性分析表明，如果TAVR瓣膜成本低于21477美元（成本降低超过44.23%），普遍TAVR将具有成本效益。亚组分析表明，在低风险（ICER为64414美元/QALY）和中风险（ICER为124851美元/QALY）患者中，与普遍SAVR相比，普遍TAVR和基于风险的策略仍然不具有成本效益。在10000次蒙特卡洛模拟中，普遍SAVR、普遍TAVR和基于风险的策略具有成本效益的概率分别为89.81%、10.14%和0.05%。
在中国中低风险重度主动脉瓣狭窄患者中，与普遍SAVR相比，基于风险的策略和普遍TAVR似乎不具有成本效益。
