Objective

The Gore Excluder Iliac Branch Endoprosthesis (IBE) was developed to preserve perfusion in the hypogastric artery after endovascular repair of aorto-iliac aneurysms. This study reports the 12 month technical and clinical outcomes of treatment with this device.

Methods

This study was a physician initiated international multicentre, prospective cohort study. The primary endpoint was primary patency of the hypogastric branch at 12 months. Secondary endpoints included technical and clinical outcomes. Patients with an indication for elective treatment with the Gore Excluder IBE were enrolled between March 2015 and August 2018. Baseline and procedural characteristics, imaging data, physical examinations and questionnaire data (Walking Impairment Questionnaire [WIQ], EuroQol-5-Dimensions [EQ5D], International Index of Erectile Function 5 [IIEF-5]) were collected through 12 month follow up.

Results

One hundred patients were enrolled of which 97% were male, with a median age of 70.0 years (interquartile range [IQR] 64.5 – 75.5 years). An abdominal aortic aneurysm (AAA) above threshold for treatment was found in 42.7% and in the remaining patients the iliac artery diameter was the indication for treatment. The maximum common iliac artery (CIA) diameter on the Gore Excluder IBE treated side was 35.5 mm (IQR 30.8 – 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 – 193 minutes) with a median hospital stay of four days (IQR 3 – 5 days). Primary patency of the IBE at 12 month follow up was 91.3%. Primary patency for patients treated inside and outside the instructions for use were 91.8% and 85.7%, respectively (p = .059). Freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively. CIA and AAA diameters decreased significantly through 12 months. IIEF-5 and EQ5D scores remained stable through follow up. Patency of the contralateral internal iliac artery led to better IIEF-5 outcomes. WIQ scores decreased at 30 days and returned to baseline values through 12 months.

Conclusion

Use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms shows a satisfactory primary patency through 12 months, with significant decrease of diameters, a low re-intervention rate, and favourable clinical outcomes.

中文翻译：

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Gore Excluder 髂动脉内支架治疗主髂动脉瘤的国际多中心前瞻性队列研究的一年结果

客观的

Gore Excluder Iliac Branch Endoprosthesis (IBE) 的开发目的是在主髂动脉瘤血管内修复后保持下腹动脉的灌注。本研究报告了使用该设备进行治疗的 12 个月技术和临床结果。

方法

这项研究是医生发起的国际多中心、前瞻性队列研究。主要终点是 12 个月时下腹分支的主要通畅率。次要终点包括技术和临床结果。在 2015 年 3 月至 2018 年 8 月期间招募了具有 Gore Excluder IBE 选择性治疗指征的患者。 基线和程序特征、影像学数据、体检和问卷数据（步行障碍问卷 [WIQ]、EuroQol-5-Dimensions [EQ5D] , 国际勃起功能指数 5 [IIEF-5]) 通过 12 个月的随访收集。

结果

招募了 100 名患者，其中 97% 为男性，中位年龄为 70.0 岁（四分位距 [IQR] 64.5 – 75.5 岁）。42.7% 的患者发现腹主动脉瘤 (AAA) 高于治疗阈值，其余患者的髂动脉直径是治疗指征。Gore Excluder IBE 治疗侧的最大髂总动脉 (CIA) 直径为 35.5 mm (IQR 30.8 – 42.0) mm。22 名患者接受了双侧治疗，7 名患者接受了孤立性 IBE。中位手术时间为 151 分钟（IQR 117 – 193 分钟），中位住院时间为 4 天（IQR 3 – 5 天）。12 个月随访时 IBE 的主要通畅率为 91.3%。在使用说明内外治疗的患者的主要通畅率分别为 91.8% 和 85.7%（p = .059）。在 30 天和 12 个月时，没有二级干预的比例分别为 98% 和 97%。CIA 和 AAA 直径在 12 个月内显着下降。IIEF-5 和 EQ5D 分数在随访期间保持稳定。对侧髂内动脉的通畅导致更好的 IIEF-5 结果。WIQ 分数在 30 天时下降，并在 12 个月内恢复到基线值。

结论

使用 Gore Excluder IBE 治疗主髂动脉瘤在 12 个月内显示出令人满意的主要通畅性，直径显着减小，再干预率低，临床结果良好。