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荷兰低手术死亡风险的严重主动脉瓣狭窄患者中,经导管主动脉瓣植入术(TAVI)与外科手术的成本效用分析。

Cost-utility analysis of TAVI compared with surgery in patients with severe aortic stenosis at low risk of surgical mortality in the Netherlands.

作者信息

Eerdekens Rob, Kats Suzanne, Grutters Janneke Pc, Green Michelle, Shore Judith, Candolfi Pascal, Oortwijn Wija, Harst Pim Van Der, Tonino Pim

机构信息

Heart Center, Catharina Hospital, Eindhoven, The Netherlands.

Maastricht University Medical Center, Maastricht, The Netherlands.

出版信息

Cost Eff Resour Alloc. 2024 Mar 26;22(1):24. doi: 10.1186/s12962-024-00531-6.

Abstract

BACKGROUND

There is growing evidence to support the benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (sSAS) who are at high- or intermediate-risk of surgical mortality. The PARTNER 3 trial showed clinical benefits with SAPIEN 3 TAVI compared with SAVR in patients at low risk of surgical mortality. Whether TAVI is also cost-effective compared with SAVR for low-risk patients in the Dutch healthcare system remains uncertain. This article presents an analysis using PARTNER 3 outcomes and costs data from the Netherlands to inform a cost-utility model and examine cost implications of TAVI over SAVR in a Dutch low-risk population.

METHODS

A two-stage cost-utility analysis was performed using a published and validated health economic model based on adverse events with both TAVI and SAVR interventions from a published randomized low risk trial dataset, and a Markov model that captured lifetime healthcare costs and patient outcomes post-intervention. The model was adapted using Netherlands-specific cost data to assess the cost-effectiveness of TAVI and SAVR. Uncertainty was addressed using deterministic and probabilistic sensitivity analyses.

RESULTS

TAVI generated 0.89 additional quality-adjusted life years (QALYs) at a €4742 increase in costs per patient compared with SAVR over a lifetime time horizon, representing an incremental cost-effectiveness ratio (ICER) of €5346 per QALY gained. Sensitivity analyses confirm robust results, with TAVI remaining cost-effective across several sensitivity analyses.

CONCLUSIONS

Based on the model results, compared with SAVR, TAVI with SAPIEN 3 appears cost-effective for the treatment of Dutch patients with sSAS who are at low risk of surgical mortality. Qualitative data suggest broader societal benefits are likely and these findings could be used to optimize appropriate intervention selection for this patient population.

摘要

背景

越来越多的证据支持,对于有症状的严重主动脉瓣狭窄(sSAS)且手术死亡风险高或中等的患者,经导管主动脉瓣植入术(TAVI)优于外科主动脉瓣置换术(SAVR)。PARTNER 3试验表明,对于手术死亡风险低的患者,与SAVR相比,SAPIEN 3 TAVI具有临床益处。在荷兰医疗保健系统中,对于低风险患者,TAVI与SAVR相比是否具有成本效益仍不确定。本文利用荷兰的PARTNER 3结果和成本数据进行分析,以建立成本效用模型,并研究在荷兰低风险人群中TAVI相对于SAVR的成本影响。

方法

采用已发表并经验证的健康经济模型进行两阶段成本效用分析,该模型基于已发表的随机低风险试验数据集中TAVI和SAVR干预的不良事件,以及一个马尔可夫模型,该模型记录了干预后的终身医疗成本和患者结局。使用荷兰特定的成本数据对模型进行调整,以评估TAVI和SAVR的成本效益。通过确定性和概率敏感性分析来处理不确定性。

结果

在终身时间范围内,与SAVR相比,TAVI每位患者的成本增加4742欧元,产生了0.89个额外的质量调整生命年(QALY),每获得一个QALY的增量成本效益比(ICER)为5346欧元。敏感性分析证实了稳健的结果,在多项敏感性分析中TAVI仍然具有成本效益。

结论

基于模型结果,与SAVR相比,使用SAPIEN 3的TAVI对于治疗手术死亡风险低的荷兰sSAS患者似乎具有成本效益。定性数据表明可能有更广泛的社会效益,这些发现可用于优化该患者群体的适当干预选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e99/10964658/9c88e4634723/12962_2024_531_Fig1_HTML.jpg

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