Department of Vascular Surgery, Ludwig Maximilian University Hospital, Munich, Germany.
Department of Vascular Surgery, Ludwig Maximilian University Hospital, Munich, Germany; Vascular Surgery Department, University of Bologna, IRCCS Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
J Vasc Surg. 2022 Sep;76(3):724-732. doi: 10.1016/j.jvs.2022.02.056. Epub 2022 Mar 10.
The aim of this cross-sectional, single-center study was to analyze the feasibility of different commercially available iliac branch devices in Europe in a cohort of patients with aorto-iliac aneurysms.
All patients with aorto-iliac or iliac aneurysms that required iliac aneurysm repair, between 2017 and 2021, were included. Morphologic data was analyzed using computed tomography angiograms. The main outcome was the feasibility of each endoprosthesis (Cook ZBIS, Gore Iliac Branch Endoprosthesis [IBE], and JOTEC E-Iliac) according to the manufacturer's instructions for use. Secondary outcomes were feasibility in all three devices, in any device, and with adjunctive procedures (liberal criteria). Additionally, a comparative analysis of all three grafts was performed to analyze differences in feasibility.
Overall, 119 iliac aneurysms in 101 patients were included. The mean age was 71 ± 11 years, and 91.6% were male. Feasibility was 52.9% for Cook ZBIS, 33.6% for Gore IBE, and 26.9% for the JOTEC E-Iliac device. A total of 65.5% of patients were feasible with at least one device, whereas only 10.1% complied with all three devices. The main reasons for lack of feasibility were a short common iliac artery length (Cook ZBIS), a narrow common iliac artery diameter (Gore IBE), and a >50° angulation between the external and internal iliac arteries (JOTEC E-Iliac). There was a significant difference between the feasibility of the three devices (P < .001). Cook ZBIS was the graft with the higher feasibility, with 3.3 and 4.4 higher odds when compared with Gore IBE and JOTEC E-Iliac devices, respectively. There was no significant difference between the Gore IBE and the JOTEC E-Iliac. By using liberal criteria, the overall feasibility increased to 95.8%.
We found that only 65.5% of patients were feasible with one of the available devices according to the manufacturer's instructions for use. The Cook ZBIS was the device with the overall highest feasibility. Extending the use of these devices with adjunctive measures and a more liberal approach increased feasibility to 95.8%.
本横断面单中心研究旨在分析 2017 年至 2021 年间患有主髂动脉瘤的患者队列中，不同市售髂分支装置的可行性。
所有需要进行髂动脉瘤修复的主髂或髂动脉瘤患者均被纳入研究。采用计算机断层血管造影术分析形态学数据。主要结局是根据制造商的使用说明评估每种血管内移植物（Cook ZBIS、戈尔髂分支内支架 [IBE] 和 JOTEC E-Iliac）的可行性。次要结局是所有三种装置的可行性、任何一种装置的可行性和辅助治疗的可行性（宽松标准）。此外，还对所有三种移植物进行了对比分析，以分析可行性方面的差异。
共纳入 101 例患者的 119 个髂动脉瘤。平均年龄为 71±11 岁，91.6%为男性。Cook ZBIS 的可行性为 52.9%，Gore IBE 为 33.6%，JOTEC E-Iliac 为 26.9%。共有 65.5%的患者至少有一种装置可行，而只有 10.1%的患者符合所有三种装置的要求。缺乏可行性的主要原因是髂总动脉长度较短（Cook ZBIS）、髂总动脉直径较窄（Gore IBE）以及髂外动脉和髂内动脉之间的夹角>50°（JOTEC E-Iliac）。三种装置的可行性有显著差异（P<.001）。与 Gore IBE 和 JOTEC E-Iliac 装置相比，Cook ZBIS 的可行性分别高出 3.3 和 4.4 倍，是可行性较高的移植物。Gore IBE 和 JOTEC E-Iliac 之间无显著差异。采用宽松标准后，总体可行性提高到 95.8%。
我们发现，根据制造商的使用说明，只有 65.5%的患者有一种可用的装置可行。Cook ZBIS 是整体可行性最高的装置。通过辅助措施和更宽松的方法扩展这些装置的使用范围，可以将可行性提高到 95.8%。
