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.

中文翻译：

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范围审查的理由和证据的完整复杂的主动脉瘤的有孔分支血管内修复的成本效益分析。

背景

决策者越来越需要对新干预措施进行成本效益分析。对于完整的复杂主动脉瘤（CAA），有孔分支分支血管内动脉瘤修复（F / B-EVAR）为身体不适合开放手术修复（OSR）的患者提供了微创替代选择。因此，F / B-EVAR越来越多地被使用，但是它是否代表一种具有成本效益的治疗方案仍然未知。

方法

从PubMed，Ovid Embase和Scopus数据库中对文献进行了范围界定的回顾。搜索它们以识别从开始到2019年12月31日发表的相关英语文章。通过以下汇率将标识出的文献中的所有成本转换为美元价值：1英镑= 1.3美元；1欧元= 1.1美元。

结果

在本文献检索中，未发现评估F / B-EVAR与OSR对完整CAA的成本效益的随机临床试验。此外，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。根据2006年至2014年发布的七项基于观察中心或注册表的研究进行的马尔可夫模型分析，F / B-EVAR与OSR的成本效益比/质量调整生命年为96,954美元。在法国有中心和分支支架移植物治疗复杂主动脉瘤的多中心医学和经济评估中（WINDOW）注册（2010-2012），F / B-EVAR的成本比OSR高，具有相似的临床疗效，因此在经济上占主导地位。2岁时 F / B-EVAR的费用较高，用于下睑下/肾旁动脉瘤和dia下胸腹动脉瘤，但对于sup下胸腹腹动脉瘤相似。较高的费用与初次入院时由于支架移植物费用造成的费用差异$ 24,278（2年时差异的95％）有关。然而，这两项研究都包括复杂的血管内主动脉修复的中心经验，并且其回顾性设计受选择治疗的选择偏见的影响，这可能会影响研究结果。相比之下，在最近的美国数据库分析中（胸腹主动脉瘤修复879例，OSR占45％），未经调整的OSR住院总费用明显高于F / B-EVAR（中位数为$ 44,355 vs $ 36,612；然而，这两项研究都包括复杂的血管内主动脉修复的中心经验，并且其回顾性设计受选择治疗的选择偏见的影响，这可能会影响研究结果。相比之下，在最近的美国数据库分析中（胸腹主动脉瘤修复879例，OSR占45％），未经调整的OSR住院总费用明显高于F / B-EVAR（中位数为$ 44,355 vs $ 36,612；然而，这两项研究都包括复杂的血管内主动脉修复的中心经验，并且其回顾性设计受选择治疗的选择偏见的影响，这可能会影响研究结果。相比之下，在最近的美国数据库分析中（胸腹主动脉瘤修复879例，OSR占45％），未经调整的OSR住院总费用明显高于F / B-EVAR（中位数为$ 44,355 vs $ 36,612；P  = .004）。OSR后住院死亡率和主要并发症高出两到三倍，这表明血管内修复可能是经济上占主导地位的策略。

结论

有关F / B-EVAR用于完整CAA的成本效益分析的文献稀少且模棱两可。基于有限的非随机可用证据，支架植入物是F / B-EVAR费用的主要驱动因素，而与OSR相关的成本效益可能因医疗机构和患者选择而异。