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高刻意练习量中心腹主动脉瘤破裂血管内修复与开放修复的Q-TWiST及成本效益分析

Q-TWiST and Cost-Effectiveness Analysis of Endovascular versus Open Repair for Ruptured Abdominal Aortic Aneurysms in a High Deliberate Practice Volume Center.

作者信息

Canning Patrick, Tawfick Wael, Kamel Khaled, Hynes Niamh, Sultan Sherif

机构信息

School of Medicine, National University of Ireland, Galway, Ireland.

School of Medicine, National University of Ireland, Galway, Ireland; Western Vascular Institute, University College Hospital, Galway, Ireland.

出版信息

Ann Vasc Surg. 2019 Apr;56:163-174. doi: 10.1016/j.avsg.2018.08.091. Epub 2018 Nov 23.

Abstract

BACKGROUND

The objective of the study was to compare the cost-effectiveness of endovascular aortic repair (rEVAR) versus open surgical repair (rOSR) for ruptured abdominal aortic aneurysm (rAAA), where rEVAR is regularly performed outside of instructions for use (IFUs) (shorter and more angulated necks). Primary end point is incremental cost-effectiveness ratio (ICER) of rEVAR versus rOSR and aneurysm-related mortality. Secondary end points are cost per quality-adjusted life years (QALYs), perioperative morbidity and mortality, reintervention, and all-cause mortality.

METHODS

All rAAA repairs performed between 2002 and 2016 in a single center were scrutinized. Between 2002 and 2007, most rAAAs were repaired using rOSR. From 2007 to 2016, we implemented a rEVAR with an anatomically possible protocol. During this time, severe angulation was rarely seen as a contraindication to rEVAR, and rEVAR was performed on aneurysms with an infrarenal aortic neck cranial to the aneurysm with a diameter of 20-33 mm and a length of at least 5 mm. Demographics and outcomes were reported according to the Society for Vascular Surgery guidelines. QALY was measured based on quality of time spent without symptoms of disease or toxicity of treatment (Q-TWiST) assessment.

RESULTS

Eight hundred aneurysm surgeries were performed; of these, 135 were emergency surgeries of which 88 were for rAAA; (42 rEVARs and 46 rOSRs). Primary technical success (rEVAR 89.1% vs. rOSR 87.8%; P = 0.1), perioperative morbidity (rEVAR 56.5% vs. rOSR 64.3%; P = 0.457), and mortality (rEVAR 26.1% vs. rOSR 28.6%; P = 0.794) were nonsignificantly favorable in rEVAR patients. Freedom from reintervention was significantly lower in rEVAR patients at 3 years (rEVAR 74% vs. rOSR 90%; P = 0.038). Three-year aneurysm-related survival (rEVAR 65% vs. rOSR 62%; P = 0.848) and all-cause survival (rEVAR 56% vs. rOSR 51%; P = 0.577) were higher in rEVAR patients. At 3 years, rEVAR patients had a higher QALY of 1.671 versus OSR of 1.549 (P = 0.502). Operating room (P = 0.001) and total accommodation costs (P = 0.139) were lower in rEVAR patients, while equipment (P < 0.001), surveillance, and reintervention (P < 0.001) costs were higher. Median cost of rEVAR at 3 years was €23,352 vs. €20,494 for OSR (P < 0.084) (power>80%). Median cost per QALY of rEVAR at 3 years was €13,974 vs. €13,230 for rOSR (P = 0.296). ICER for rEVAR versus rOSR was €23,426 (95% confidence interval [CI] < €0 to > €30,000). At 3 years, the area under the curve and 95% CI for Q-TWiST was higher in rEVAR compared with OSR (rEVAR 500.819 vs. rOSR 437.838).

CONCLUSIONS

There is no significant difference in cost or QALYs between rEVAR and rOSR even when rEVAR is performed on complex cases outside of IFU (shorter and more angulated necks). There is a significantly higher freedom from secondary intervention in rOSR patients compared with rEVAR patients at 3 years.

摘要

背景

本研究的目的是比较血管腔内主动脉修复术(rEVAR)与开放手术修复术(rOSR)治疗破裂性腹主动脉瘤(rAAA)的成本效益,其中rEVAR常在超出使用说明(IFU)(较短且更成角的颈部)的情况下进行。主要终点是rEVAR与rOSR的增量成本效益比(ICER)以及与动脉瘤相关的死亡率。次要终点是每质量调整生命年(QALY)的成本、围手术期发病率和死亡率、再次干预以及全因死亡率。

方法

对2002年至2016年在单一中心进行的所有rAAA修复手术进行审查。2002年至2007年,大多数rAAA采用rOSR修复。从2007年到2016年,我们实施了符合解剖学可能方案的rEVAR。在此期间,严重成角很少被视为rEVAR的禁忌症,rEVAR用于肾下主动脉颈部位于动脉瘤上方、直径为20 - 33毫米且长度至少为5毫米的动脉瘤。根据血管外科学会指南报告人口统计学和结果。QALY基于无疾病症状或治疗毒性的时间质量(Q - TWiST)评估进行测量。

结果

共进行了800例动脉瘤手术;其中,135例为急诊手术,其中88例为rAAA手术(42例rEVAR和46例rOSR)。rEVAR组的主要技术成功率(89.1%对rOSR组的87.8%;P = 0.1)、围手术期发病率(rEVAR组56.5%对rOSR组64.3%;P = 0.457)和死亡率(rEVAR组26.1%对rOSR组28.6%;P = 0.794)在rEVAR患者中虽有优势但无统计学意义。rEVAR患者3年时再次干预的自由度显著较低(rEVAR组74%对rOSR组90%;P = 0.038)。rEVAR患者的3年动脉瘤相关生存率(rEVAR组65%对rOSR组62%;P = 0.848)和全因生存率(rEVAR组56%对rOSR组51%;P = 0.577)较高。3年时,rEVAR患者的QALY为1.671,高于OSR组的1.549(P = 0.502)。rEVAR患者的手术室成本(P = 0.001)和总住院成本(P = 0.139)较低,而设备成本(P < 0.001)、监测和再次干预成本(P < 0.001)较高。rEVAR组3年的中位数成本为23,352欧元,而OSR组为20,494欧元(P < 0.084)(检验效能>80%)。rEVAR组3年每QALY的中位数成本为13,974欧元,rOSR组为 €13,230(P = 0.296)。rEVAR与rOSR的ICER为23,426欧元(95%置信区间[CI]< €0至> €30,000)。3年时,rEVAR组Q - TWiST的曲线下面积和95%CI高于OSR组(rEVAR组500.819对rOSR组437.838)。

结论

即使rEVAR在超出IFU(较短且更成角的颈部)的复杂病例中进行,rEVAR与rOSR在成本或QALY方面也没有显著差异。与rEVAR患者相比,rOSR患者在3年时二次干预的自由度显著更高。

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