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