Ascaso María, Pérez Daniel, Montero Lourdes, Deckert Jens, White Andrea, González Paloma, Mengual Marta, Lorenzo-Herrero Seila, Crespo Carlos, Cánovas Sergio
Hospital Clínic de Barcelona, Barcelona, Spain.
Hospital Universitario Clínico San Carlos, Madrid, Spain.
Pharmacoecon Open. 2025 May 31. doi: 10.1007/s41669-025-00582-2.
Limited information is available regarding the impact of valve choice for patients with aortic stenosis (AS) undergoing surgical aortic valve replacement (SAVR) in Spain. Herein, we aimed to explore the potential cost-effectiveness of a new bioprosthetic valve with RESILIA tissue versus mechanical alternatives from a Spanish healthcare perspective.
Health outcomes, including quality-adjusted life years (QALYs), adverse events, and costs were estimated for two cohorts of patients with severe AS (aged ≥ 65 or 55-64 years) over a lifetime horizon employing a UK cost-effectiveness model adapted to Spanish clinical practice to compare a novel bioprosthesis versus mechanical alternatives. This model included a decision tree to describe short-term outcomes and a partitioned survival model to evaluate mortality and long-term outcomes. A panel of clinical experts validated the model methodology, including parameters and assumptions considered. Sensitivity analyses were performed to account for uncertainty.
The novel bioprosthetic valve led to cost savings for both cohorts (€6209/patient for age ≥ 65 years; €8289/patient for ages 55-64 years). These were mainly driven by a reduction in anticoagulation- and adverse event-associated resources, outweighing the costs derived from more reoperations estimated with the novel bioprosthetic valve. An observable increase in QALYs was detected in both age groups (0.0051 and 0.0191, respectively). Hence, the novel bioprosthetic valve is expected to be a dominant alternative for patients 55 years or older who are eligible for SAVR. It remained cost-effective in > 98% of sensitivity analyses.
Our exploratory study indicates the novel RESILIA bioprosthetic valve as a potential alternative to mechanical valves for SAVR in patients 55 years or older can lead to budgetary cost savings and improved health outcomes in Spain.
在西班牙，关于接受外科主动脉瓣置换术（SAVR）的主动脉瓣狭窄（AS）患者瓣膜选择的影响，可获取的信息有限。在此，我们旨在从西班牙医疗保健的角度探讨一种采用RESILIA组织的新型生物瓣膜相对于机械瓣膜替代品的潜在成本效益。
采用适用于西班牙临床实践的英国成本效益模型，对两组重度AS患者（年龄≥65岁或55 - 64岁）的一生健康结局进行估计，包括质量调整生命年（QALYs）、不良事件和成本，以比较新型生物瓣膜与机械瓣膜替代品。该模型包括一个描述短期结局的决策树和一个评估死亡率及长期结局的分段生存模型。一组临床专家对模型方法进行了验证，包括所考虑的参数和假设。进行敏感性分析以应对不确定性。
新型生物瓣膜使两组患者均节省了成本（年龄≥65岁的患者为6209欧元/例；55 - 64岁的患者为8289欧元/例）。这主要是由于抗凝和不良事件相关资源的减少，超过了新型生物瓣膜估计的更多再次手术所产生的成本。在两个年龄组中均检测到QALYs有明显增加（分别为0.0051和0.0191）。因此，对于符合SAVR条件的55岁及以上患者，新型生物瓣膜预计将是一种占优选择。在超过98%的敏感性分析中，它仍然具有成本效益。
我们的探索性研究表明，对于55岁及以上的患者，新型RESILIA生物瓣膜作为SAVR中机械瓣膜的潜在替代品，可在西班牙节省预算成本并改善健康结局。
