Division of Vascular Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisc.
Division of Vascular Surgery, Department of Surgery, University of Washington, Valley Medical Center, Seattle, Wash.
J Vasc Surg. 2021 Nov;74(5):1558-1564.e1. doi: 10.1016/j.jvs.2021.05.026. Epub 2021 Jun 1.
The GORE EXCLUDER iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Ariz) is designed to preserve internal iliac artery (IIA) patency during endovascular treatment of aneurysms involving the common iliac artery. The device is intended to conform to iliac tortuosity, which may decrease adverse iliac events (AIE). The objective of this study was to evaluate risk factors for AIE after IBE implantation.
This was a post hoc analysis of the prospective, multicenter GORE 12-04 IBE pivotal trial. Patients with preoperative and postoperative axial imaging were included, with analysis based on each treated iliac system. An independent core laboratory performed all scan measurements, including iliac diameters, lengths, and tortuosity. Conformability was analyzed by the changes in tortuosity after IBE deployment, with less change indicating greater conformation. The end point was AIE, defined as ipsilateral radiographic or clinical complications. Critical nonconformation was defined as a threshold change in tortuosity associated with a significant increase in AIE.
We included 98 patients with 101 treated iliac systems. There were eight AIE (8%; six IIA component occlusions, one iliac branch component occlusion, and one EIA dissection requiring reintervention). Patients with AIE had smaller IIA diameters and less IBE conformability. After multivariable logistic regression analysis, an IIA diameter of less than 10 mm and a change in total iliac tortuosity beyond -15% were independently associated with AIE (odds ratio, 12 [interquartile range, 1.4-110] and odds ratio, 8.2 [interquartile range, 1.5-46], respectively), and the latter was used to define critical nonconformation. Critical nonconformation occurred in 11% of treated systems, and was associated with a high rate of AIE (36% vs 4%; P = .004).
Endograft conformation is a novel device property and technical outcome that, along with a larger IIA diameter, is associated with freedom from AIE after IBE deployment. An evaluation of these risk factors may better inform the management of patients with iliac aneurysmal disease. Further research on endograft conformation and patient outcomes is warranted, particularly for those with challenging anatomy undergoing complex procedures.
戈尔髂分支覆膜支架（IBE；W.L.戈尔及同仁公司，Flagstaff，Ariz）旨在维持血管内治疗累及髂总动脉的动脉瘤时髂内动脉（IIA）通畅。该装置旨在顺应髂内动脉迂曲，这可能会降低不良髂内动脉事件（AIE）的发生风险。本研究旨在评估 IBE 植入后 AIE 的危险因素。
这是前瞻性、多中心 GORE 12-04 IBE 关键试验的事后分析。纳入了术前和术后轴向成像的患者，根据每个治疗的髂内系统进行分析。一个独立的核心实验室进行了所有的扫描测量，包括髂内动脉直径、长度和迂曲度。顺应性通过 IBE 放置后的迂曲度变化来分析，变化越小表明顺应性越好。终点为 AIE，定义为同侧放射学或临床并发症。临界非顺应性定义为与 AIE 显著增加相关的迂曲度的阈值变化。
我们纳入了 98 例患者的 101 个治疗的髂内系统。有 8 例发生 AIE（8%；6 例 IIA 分支闭塞，1 例髂内分支闭塞，1 例 EIA 夹层需要再次介入治疗）。发生 AIE 的患者 IIA 直径较小，IBE 顺应性较差。多变量逻辑回归分析后，IIA 直径小于 10mm 和总髂内动脉迂曲度变化超过-15%与 AIE 独立相关（比值比，12[四分位间距，1.4-110]和比值比，8.2[四分位间距，1.5-46]），后者用于定义临界非顺应性。临界非顺应性发生在 11%的治疗系统中，与 AIE 发生率高相关（36%比 4%；P=0.004）。
移植物顺应性是一种新的装置特性和技术结果，与 IBE 植入后无 AIE 发生相关，同时 IIA 直径较大。对这些危险因素的评估可能会更好地为髂动脉瘤疾病患者的管理提供信息。需要进一步研究移植物顺应性和患者结局，特别是对于那些接受复杂手术的具有挑战性解剖结构的患者。
