Division of Vascular and Endovascular Surgery, Gonda Vascular Center, Mayo Clinic, Rochester, MN, USA.
J Endovasc Ther. 2020 Apr;27(2):316-327. doi: 10.1177/1526602820905583. Epub 2020 Feb 18.
To evaluate the outcomes of the Gore Excluder Iliac Branch Endoprosthesis (IBE) using division branches of the internal iliac artery (IIA) as distal landing zones. Between January 1, 2014, and December 31, 2018, 74 patients (mean age 74±7 years; 72 men) treated for aortoiliac or common iliac artery aneurysms had an IBE deployed with distal landing of the side branch within the main trunk (n=60) of the internal iliac artery (IIA) vs within a division branch (n=25). Thirteen (17%) patients received bilateral IBE implantations for a total of 85 vessels evaluated. Early endpoints were technical success, 30-day mortality, 30-day major adverse events (MAEs), and 30-day major access complications. Late endpoints were survival, primary and secondary IIA patency, freedom from IIA branch instability, freedom from new-onset buttock claudication, and aneurysm sac diameter changes. Time-dependent outcomes were reported as Kaplan-Meier curves with differences assessed using the log-rank test. Estimates are presented with the 95% confidence interval (CI). The overall technical success rate was 97%, with 1 technical failure per group (p=0.43). Two patients, one from each group, died within 30 days (p=0.43). No significant differences were seen in the rates of 30-day MAEs (7% vs 17%, p=0.35) or major access complications (9% vs 11%, p>0.99) for patients receiving distal landing in the main trunk vs a division branch, respectively. The mean follow-up for the entire cohort was 19±12 months. The overall 1-year survival rate was 94% (95% CI 74% to 99%). The primary and secondary patency rates at 1 year were 98% (95% CI 88% to 99%) vs 95% (95% CI 72% to 99%, p=0.72) and 98% (95% CI 88% to 99%) vs 100% (p=0.41) for the main trunk vs division branch groups, respectively. Freedom from IIA branch instability estimates were also similar at 1-year follow-up [93% (95% CI 82% to 97%) vs 90% (95% CI 66% to 97%), p=0.29], as were the freedom from new-onset buttock claudication estimates [98% (95% CI 86% to 99%) and 94% (95% CI 67% to 99%), respectively; p=0.62]. Mean sac diameter change was 5.4±5.3 mm, not significantly different between the groups (p=0.85). Use of the posterior or anterior division of the IIA as a distal landing zone for the Gore Excluder IBE was safe and efficacious in the midterm. This technique may permit extending indications for endovascular repair of aortoiliac aneurysms to cases with unsuitable anatomy within the IIA main trunk. Long-term assessment is needed to affirm the efficacy of this technique.
评估 Gore Excluder 髂动脉分支覆膜支架(IBE)使用髂内动脉(IIA)分支作为远端着陆区的效果。2014 年 1 月 1 日至 2018 年 12 月 31 日,74 例接受腹主动脉瘤或髂总动脉瘤治疗的患者(平均年龄 74±7 岁;72 例男性)采用 IBE 治疗,其中 60 例患者的分支内(主支)内髂内动脉(IIA)的分支远端有侧支,25 例患者在分支内(主支)有分支(n=25)。13 例(17%)患者因双侧 IBE 植入术共评估 85 支血管。早期终点为技术成功率、30 天死亡率、30 天主要不良事件(MAE)和 30 天主要入路并发症。晚期终点为生存率、主支和 IIA 二级通畅率、IIA 分支稳定性、新发臀肌跛行、瘤囊直径变化。时间依赖性结果以 Kaplan-Meier 曲线报告,使用对数秩检验评估差异。结果以 95%置信区间(CI)表示。总的技术成功率为 97%,每组各有 1 例技术失败(p=0.43)。两组各有 1 例患者(每组 1 例)在 30 天内死亡(p=0.43)。接受主支远端着陆的患者与接受分支远端着陆的患者相比,30 天 MAE(7% vs. 17%,p=0.35)或主要入路并发症(9% vs. 11%,p>0.99)的发生率无显著差异。整个队列的平均随访时间为 19±12 个月。整个队列的 1 年生存率为 94%(95%CI 74%至 99%)。1 年时主支与分支组的一级和二级通畅率分别为 98%(95%CI 88%至 99%)与 95%(95%CI 72%至 99%,p=0.72)和 98%(95%CI 88%至 99%)与 100%(p=0.41)。1 年时 IIA 分支稳定性的估计值也相似[93%(95%CI 82%至 97%)与 90%(95%CI 66%至 97%,p=0.29)],新发臀肌跛行的估计值也相似[98%(95%CI 86%至 99%)和 94%(95%CI 67%至 99%,p=0.62)]。瘤囊直径变化的平均值为 5.4±5.3mm,两组间无显著差异(p=0.85)。Gore Excluder IBE 将 IIA 的后支或前支作为远端着陆区是安全有效的,在中期结果中。该技术可能将腹主动脉瘤腔内修复术的适应证扩大到 IIA 主支内解剖结构不合适的病例。需要进行长期评估以确认该技术的疗效。