Objective

Limb graft occlusion (LGO) is a serious complication after endovascular aneurysm repair (EVAR) and while device development enables treatment of increasingly complex aortic anatomy, little is known about how endograft type affects the risk of occlusion. This observational study aimed to explore the incidence of LGO after EVAR for three major endograft systems.

Methods

All patients with standard EVAR as the primary intervention for infrarenal abdominal aortic aneurysm (AAA), between January 2012 and December 2018, at five Swedish vascular surgery centres, were included in this multicentre retrospective cohort study. LGO was defined as a total limb occlusion regardless of symptoms, or a treated significant stenosis. A nested case control (NCC) design with incidence density sampling of 1:3 was used for analysis of potential per-operative and morphological risk factors. Conditional logistic regression was used to estimate multivariable odds ratios (OR) with 95% confidence intervals (CI)

Results

A total of 924 patients were included. The majority were male (84%), the mean age was 76 years (± 7.5 SD), and median AAA diameter was 59 mm (IQR 55, 67). Patients were treated with Zenith Alpha (n = 315, ZISL limbs), Excluder (n = 152, PLC/PXC limbs), and Endurant (n = 457, ETLW/ ETEW limbs). During median follow up of 37 months (IQR 21, 62), 55 occlusions occurred (5.9%); 39 with Zenith Alpha (12.4%), one with Excluder (0.7%), and 15 with Endurant (3.3%). In the NCC analysis, the Zenith Alpha device (OR 5.31, 95% CI 1.97 – 14.3), external iliac artery (EIA) landing (OR 5.91, 95% CI 1.30 – 26.7), and EIA diameter < 10 mm (OR 4.99, 95% CI 1.46 – 16.9) were associated with an increased risk of LGO.

Conclusion

Endograft device type is an independent risk factor for LGO after EVAR. Specifically, the Zenith Alpha demonstrated an increased risk of LGO compared with the Endurant and Excluder devices. In addition, a narrow EIA and landing zone in EIA are also risk factors for LGO.

中文翻译：

---

使用 Zenith Alpha、Excluder 和 Endurant 装置对肾下腹主动脉瘤进行血管内动脉瘤修复后的肢体移植物闭塞：一项多中心队列研究

客观的

肢体移植物闭塞 (LGO) 是血管内动脉瘤修复 (EVAR) 后的严重并发症，虽然设备开发能够治疗日益复杂的主动脉解剖结构，但对内移植物类型如何影响闭塞风险知之甚少。这项观察性研究旨在探讨三种主要内移植系统在 EVAR 后 LGO 的发生率。

方法

这项多中心回顾性队列研究纳入了 2012 年 1 月至 2018 年 12 月期间在瑞典五个血管外科中心采用标准 EVAR 作为肾下腹主动脉瘤 (AAA) 主要干预措施的所有患者。LGO 被定义为肢体完全闭塞，无论症状如何，或经治疗的显着狭窄。使用 1:3 的发病率密度抽样的嵌套病例对照 (NCC) 设计来分析潜在的手术和形态学风险因素。条件逻辑回归用于估计具有 95% 置信区间 (CI) 的多变量优势比 (OR)

结果

共纳入 924 名患者。大多数为男性 (84%)，平均年龄为 76 岁 (± 7.5 SD)，中位 AAA 直径为 59 mm (IQR 55, 67)。患者接受 Zenith Alpha（n  = 315，ZISL 肢体）、Excluder（n  = 152，PLC/PXC 肢体）和 Endurant（n  = 457，ETLW/ETEW 肢体）治疗。在 37 个月的中位随访期间 (IQR 21, 62)，发生了 55 次闭塞 (5.9%)；Zenith Alpha 39 个（12.4%），Excluder 1 个（0.7%），Endurant 15 个（3.3%）。在 NCC 分析中，Zenith Alpha 装置（OR 5.31，95% CI 1.97 – 14.3），髂外动脉（EIA）着陆（OR 5.91，95% CI 1.30 – 26.7）和 EIA 直径 < 10 mm（OR 4.99， 95% CI 1.46 – 16.9) 与 LGO 风险增加有关。

结论

内移植物装置类型是 EVAR 后 LGO 的独立危险因素。具体而言，与 Endurant 和 Excluder 设备相比，Zenith Alpha 显示出 LGO 风险增加。此外，环评狭窄和环评着陆区也是LGO的危险因素。