Ogawa Yukihisa, Fujimura Naoki, Yamaguchi Masato, Banno Hiroshi, Furuyama Tadashi, Yamaoka Terutoshi, Sumi Makoto, Fukuda Tetsuya, Morikage Noriyasu, Sohgawa Etsuji, Onitsuka Seiji, Nishimaki Hiroshi, Ichihashi Shigeo
Department of Radiology, St. Marianna University School of Medicine, Kawasaki, Japan.
Division of Vascular Surgery, Saiseikai Central Hospital, Tokyo, Japan.
J Endovasc Ther. 2024 Feb;31(1):55-61. doi: 10.1177/15266028221109477. Epub 2022 Jul 11.
To evaluate the clinical utility of the Gore Excluder iliac branch endoprosthesis (IBE) for Japanese patients with aortoiliac aneurysms.
This was a multicenter retrospective cohort study (J-Preserve Registry). Patients undergoing endovascular aortic repair using the Gore Excluder IBE for aortoiliac aneurysms between August 2017 and June 2020 were enrolled. Data pertaining to the baseline and anatomical characteristics, technical details, and clinical outcomes were collected from each institution. The primary endpoints were technical success, IBE-related complications, and reinterventions. Secondary endpoints were mortality, aneurysm size change, and reintervention during follow-up. Technical success was defined as accurate deployment of the IBE without type Ib, Ic, or III endoleaks on the IBE sides on completion angiography. A change in aneurysm size of 5 mm or more was taken to be a significant change.
We included 141 patients with 151 IBE implantations. Sixty-five IBE implantations (43.0%) had at least one instruction for use violation. Twenty-two patients (15.6%) required internal iliac artery (IIA) embolization for external iliac artery extension on the contralateral side. Of 151 IBE implantations, 19 exhibited IIA branch landing zones due to IIA aneurysms. Mean maximum and proximal common iliac artery (CIA) diameters were 32.9±9.9 mm and 20.5±6.9 mm, respectively. The mean CIA length was 59.1±17.1 mm. The IIA landing diameter and length were 9.0±2.3 mm and 33.8±14.6 mm. The overall technical success rate was 96.7%. There were no significant differences in IBE-related complications (2.3% vs 5.3%, =0.86) or IBE-related reinterventions (1.5% vs 5.3%, =0.33) between the IIA trunk and IIA branch landing groups. The mean follow-up period was 635±341 days. The all-cause mortality rate was 5.0%. There were no aneurysm-related deaths or ruptures during the follow-up. Most patients (95.7%) had sac stability or shrinkage.
The Gore Excluder IBE was safe and effective for Japanese patients in the midterm. Extending the IIA device into the distal branches of the IIA was acceptable, which may permit extending indications for endovascular aortic aneurysm repair of aortoiliac aneurysms to more complex lesions.
This study suggests clinical benefits of the Gore Excluder IBE for Japanese patients, despite 43% of the IBE implantations having at least one IFU violation.
评估戈尔髂支血管内修复装置（IBE）对日本主髂动脉瘤患者的临床应用价值。
这是一项多中心回顾性队列研究（J-Preserve注册研究）。纳入2017年8月至2020年6月间使用戈尔IBE对主髂动脉瘤进行血管腔内主动脉修复的患者。从各机构收集有关基线和解剖特征、技术细节及临床结果的数据。主要终点为技术成功、与IBE相关的并发症及再次干预。次要终点为死亡率、动脉瘤大小变化及随访期间的再次干预。技术成功定义为IBE在完成血管造影时准确植入，且IBE侧无Ib型、Ic型或III型内漏。动脉瘤大小变化5mm或更多被视为有显著变化。
我们纳入了141例患者，共植入151枚IBE。65枚IBE植入（43.0%）至少有一项使用说明违规情况。22例患者（15.6%）因对侧髂外动脉延伸而需要栓塞髂内动脉（IIA）。在151枚IBE植入中，19枚因IIA动脉瘤出现IIA分支着陆区。髂总动脉（CIA）平均最大直径和近端直径分别为32.9±9.9mm和20.5±6.9mm。CIA平均长度为59.1±17.1mm。IIA着陆直径和长度分别为9.0±2.3mm和33.8±14.6mm。总体技术成功率为96.7%。IIA主干组和IIA分支着陆组在与IBE相关的并发症（2.3%对5.3%，P=0.86）或与IBE相关的再次干预（1.5%对5.3%，P=0.33）方面无显著差异。平均随访期为635±341天。全因死亡率为5.0%。随访期间无动脉瘤相关死亡或破裂。大多数患者（95.7%）的瘤腔稳定或缩小。
中期来看，戈尔IBE对日本患者安全有效。将IIA装置延伸至IIA远端分支是可行的，这可能使主髂动脉瘤血管腔内修复的适应证扩展至更复杂病变。
本研究提示了戈尔IBE对日本患者的临床益处，尽管43%的IBE植入至少有一项使用说明违规情况。
