Department of Outcomes Research, St George's Vascular Institute, St George's Healthcare NHS Trust, London, UK.
Br J Surg. 2012 Dec;99(12):1657-64. doi: 10.1002/bjs.8938. Epub 2012 Sep 28.
Long-term concerns about the durability of endovascular aortic aneurysm repair (EVAR) remain after the publication of controlled trials. Increased expertise in endograft technology, case selection and postoperative reintervention has created a need for reappraisal of the longer-term efficacy of EVAR using contemporary data.
Patients undergoing infrarenal EVAR between 2004 and 2010 were studied prospectively. Morphological compliance with manufacturers' instructions for use (IFU) was established using three-dimensional computed tomography. The primary outcome measures were all-cause and aneurysm-related mortality, postoperative rupture, reintervention and sac expansion. These adverse events were reported using Kaplan-Meier survival analysis, with comparison within, or outside IFU by the log rank test.
Some 478 patients of median age 76 years had a median aneurysm diameter of 62·9 mm. Median follow-up was 44 (range 11-94) months; 198 (41·4 per cent) were compliant with IFU. The 30-day mortality rate was 2·1 per cent (10 of 478 patients): nine (2·0 per cent) of 455 patients who had elective and one (4 per cent) of 23 patients who had non-elective surgery. Aneurysm-related mortality was 0·897 deaths per 100 person-years, and all-cause mortality was 8·558 deaths per 100 person-years, with significantly lower survival outside IFU (P = 0·012). Two patients had a late rupture (0·138 per 100 person-years), of whom one died. There were 6·120 reinterventions per 100 person-years, with no difference for aneurysms treated outside IFU (P = 0·136). Primary sac expansion occurred in 6·721 per 100 person-years and secondary sac expansion in 4·142 per 100 person-years.
In this series EVAR had a lower aneurysm-related mortality rate than demonstrated in early controlled trials, and with lower sac expansion rates than reported from image repositories. Data from earlier studies should be applied to current practice with caution.
在对照试验公布后,关于血管内主动脉瘤修复术(EVAR)长期耐久性的担忧仍然存在。腔内移植物技术、病例选择和术后再干预方面的专业知识的提高,使得有必要使用当代数据重新评估 EVAR 的长期疗效。
前瞻性研究了 2004 年至 2010 年间接受肾下 EVAR 的患者。使用三维计算机断层扫描来确定形态与制造商使用说明(IFU)的符合程度。主要结局指标为全因死亡率和动脉瘤相关死亡率、术后破裂、再干预和瘤腔扩张。使用 Kaplan-Meier 生存分析报告这些不良事件,并通过对数秩检验在 IFU 内或 IFU 外进行比较。
478 名患者的中位年龄为 76 岁,中位动脉瘤直径为 62.9mm。中位随访时间为 44(11-94)个月;455 例患者中有 198 例(41.4%)符合 IFU。30 天死亡率为 2.1%(478 例患者中有 10 例):9 例(2.0%)择期手术患者和 1 例(4%)非择期手术患者。动脉瘤相关死亡率为每 100 人年 0.897 例死亡,全因死亡率为每 100 人年 8.558 例死亡,IFU 外的生存率显著降低(P=0.012)。2 例患者发生迟发性破裂(每 100 人年 0.138 例),其中 1 例死亡。再干预率为每 100 人年 6.120 例,IFU 外治疗的动脉瘤无差异(P=0.136)。原发瘤腔扩张率为每 100 人年 6.721 例,继发瘤腔扩张率为每 100 人年 4.142 例。
在本系列中,EVAR 的动脉瘤相关死亡率低于早期对照试验,瘤腔扩张率低于图像存储库报道。应谨慎将早期研究的数据应用于当前实践。