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复杂完整型主动脉瘤腔内分支型覆膜支架修复术的成本效果分析的基本原理和证据的范围综述。

A scoping review of the rationale and evidence for cost-effectiveness analysis of fenestrated-branched endovascular repair for intact complex aortic aneurysms.

机构信息

Division of Vascular and Endovascular Surgery, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden; Division of Vascular and Endovascular Surgery, Cardiovascular Department, University Hospital of Cattinara ASUIGI, Trieste, Italy; Division of Vascular and Endovascular Surgery, Gonda Vascular Center, Mayo Clinic, Rochester, Minn.

Division of Vascular and Endovascular Surgery, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.

出版信息

J Vasc Surg. 2020 Nov;72(5):1772-1782. doi: 10.1016/j.jvs.2020.05.037. Epub 2020 May 27.

DOI:10.1016/j.jvs.2020.05.037
PMID:32473347
Abstract

BACKGROUND

Cost-effectiveness analysis of new interventions is increasingly required by policymakers. For intact complex aortic aneurysms (CAAs), fenestrated-branched endovascular aneurysm repair (F/B-EVAR) offers a minimally invasive alternative option for patients who are physically ineligible for open surgical repair (OSR). Thus, F/B-EVAR is increasingly used, but whether it represents a cost-effective treatment option remains unknown.

METHODS

A scoping review of the literature was conducted from the PubMed, Ovid Embase, and Scopus databases. They were searched to identify relevant English-language articles published from inception to December 31, 2019. All costs in the identified literature were transformed to U.S. dollar values by the following exchange rate: 1 GBP = 1.3 USD; 1 EUR = 1.1 USD.

RESULTS

At this literature search, no randomized clinical trials assessing cost-effectiveness of F/B-EVAR vs OSR for intact CAAs were found. Also, no health economic evaluation studies were found regarding use of F/B-EVAR in patients unfit for OSR. A Markov model analysis based on seven observational center- or registry-based studies published from 2006 to 2014 found that the incremental cost-effectiveness ratio for F/B-EVAR vs OSR was $96,954/quality-adjusted life-year. In the multicenter French Medical and Economical Evaluation of Fenestrated and Branched Stent-grafts to Treat Complex Aortic Aneurysms (WINDOW) registry (2010-2012), F/B-EVAR had a higher cost than OSR for a similar clinical outcome and was therefore economically dominated. At 2 years, costs were higher with F/B-EVAR for juxtarenal/pararenal aneurysms and infradiaphragmatic thoracoabdominal aneurysms but similar for supradiaphragmatic thoracoabdominal aneurysms. The higher costs were related to a $24,278 cost difference of the initial admission (95% of the difference at 2 years) due to stent graft costs. Both these studies, however, included a highly varying center experience with complex endovascular aortic repair, and their retrospective design is subject to selection bias for chosen treatment, which could affect the studied outcome. In contrast, in a more recent U.S. database analysis (879 thoracoabdominal aortic aneurysm repairs, 45% OSRs), the unadjusted total hospitalization cost of OSR was significantly higher compared with F/B-EVAR (median, $44,355 vs $36,612; P = .004). In-hospital mortality as well as major complications were two to three times higher after OSR, indicating that endovascular repair might be the economically dominant strategy.

CONCLUSIONS

The literature regarding cost-effectiveness analysis of F/B-EVAR for intact CAAs is scarce and ambiguous. Based on the limited nonrandomized available evidence, stent grafts are the main driver for F/B-EVAR expenses, whereas cost-effectiveness in relation to OSR may vary by health care setting and selection of patients.

摘要

背景

新干预措施的成本效益分析越来越受到政策制定者的要求。对于完整的复杂主动脉瘤(CAAs),分支型腔内血管修复术(F/B-EVAR)为身体不适合开放手术修复(OSR)的患者提供了一种微创的替代选择。因此,F/B-EVAR 的应用越来越多,但它是否代表一种具有成本效益的治疗选择尚不清楚。

方法

对 PubMed、Ovid Embase 和 Scopus 数据库进行文献范围的综述。检索这些数据库以确定从成立到 2019 年 12 月 31 日发表的相关英文文章。通过以下汇率将确定文献中的所有成本转换为美元值:1 GBP=1.3 美元;1 欧元=1.1 美元。

结果

在本次文献检索中,未发现评估完整 CAAs 的 F/B-EVAR 与 OSR 成本效益的随机临床试验。此外,也未发现关于不适合 OSR 的患者使用 F/B-EVAR 的健康经济评估研究。基于 2006 年至 2014 年发表的七项观察性中心或注册中心研究的马克姆模型分析发现,F/B-EVAR 与 OSR 的增量成本效益比为 96954 美元/质量调整生命年。在多中心法国医学和 Fenestrated 和分支支架治疗复杂主动脉瘤的经济评估(WINDOW)登记处(2010-2012 年)中,F/B-EVAR 的成本高于 OSR,但其临床结果相似,因此在经济上处于劣势。在 2 年时,对于肾周/肾旁动脉瘤和膈下胸腹主动脉瘤,F/B-EVAR 的成本更高,但对于膈上胸腹主动脉瘤,其成本相似。更高的成本与初始入院时支架移植物成本的 24278 美元差异有关(2 年时差异的 95%)。然而,这两项研究都包含了复杂的腔内主动脉修复的高度变化的中心经验,并且其回顾性设计易受到所选治疗的选择偏倚的影响,这可能会影响研究结果。相比之下,在美国最近的一项数据库分析(879 例胸腹主动脉瘤修复,45%OSR)中,OSR 的未调整总住院费用明显高于 F/B-EVAR(中位数,44355 美元比 36612 美元;P=0.004)。OSR 后院内死亡率和主要并发症的发生率是 F/B-EVAR 的两到三倍,表明血管内修复可能是具有成本效益的主要策略。

结论

关于完整 CAAs 的 F/B-EVAR 成本效益分析的文献很少且存在歧义。基于有限的非随机可用证据,支架移植物是 F/B-EVAR 费用的主要驱动因素,而与 OSR 的成本效益可能因医疗保健环境和患者选择而异。

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