Division of Vascular and Endovascular Surgery, Mayo Clinic, Jacksonville, FL, USA.
Division of Vascular and Endovascular Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Cardiovasc Intervent Radiol. 2020 Aug;43(8):1143-1147. doi: 10.1007/s00270-020-02489-3. Epub 2020 May 14.
To evaluate the impact of compliance with anatomical guidelines on outcomes of endovascular aortic aneurysm repair using "bell-bottom" stent grafts (BBSGs).
This is a retrospective review from January 1999 to May 2012 of patients who underwent endovascular infrarenal abdominal aneurysm repair and whose iliac limbs were greater than 18 mm in diameter. Computed tomography angiography was utilized for compliance with anatomical guidelines as stated in manufacturer's instructions for use (IFU). The primary outcome observed was iliac limb events. The secondary outcome observed was the need for re-intervention due to BBSG failure.
Of the 376 BBSGs, 55 (15%) in 27 patients met IFU. Aneurysm exclusion was achieved in all patients. The mean follow-up was 44 ± 30 months. Twenty-eight patients (11%) had 29 iliac limb events (12 type 1b endoleaks, 4 aneurysm sac growth, 4 stenosis/kink, 4 retrograde migrations, 2 component separations, 2 ruptures and 1 limb occlusion); all among patients treated outside of IFU (p < 0.04). The rate of aneurysm sac enlargement was similar between both groups, at 56%, respectively, between those treated within and those treated outside of IFU. On multivariate regression analysis, larger common iliac artery (CIA) (HR 1.088, 95% CI 1.016-1.166, p = 0.016), greater CIA tortuosity (HR 2.352, 95% CI 1.004-5.509, p = 0.048) and limbs with more than two characteristics that did not meet IFU criteria (HR 3.84, 95% CI 1.15-12.83, p = 0.03) were associated with higher rates of BBSG events and re-interventions.
BBSGs effectively seal ectatic CIAs. But rates of iliac limb events and re-interventions are higher among patients who do not meet IFU criteria. The larger CIA diameter, the greater CIA tortuosity and more than two criteria not met by IFU were associated with BBSG failure and re-intervention.
评估“喇叭裤”支架移植物（BBSG）血管内主动脉瘤修复中符合解剖学指南对结局的影响。
这是一项回顾性研究，纳入了 1999 年 1 月至 2012 年 5 月期间接受血管内肾下腹部动脉瘤修复且髂支直径大于 18mm 的患者。采用计算机断层血管造影术（computed tomography angiography）来评估是否符合制造商使用说明书（IFU）中规定的解剖学指南。主要观察结局为髂支事件。次要观察结局为因 BBSG 失败而需要再次干预的情况。
在 376 个 BBSG 中，有 27 名患者的 55 个（15%）符合 IFU。所有患者均实现了动脉瘤隔绝。平均随访时间为 44±30 个月。28 名患者（11%）出现 29 个髂支事件（12 例 1b 型内漏、4 例瘤囊生长、4 例狭窄/扭曲、4 例逆行迁移、2 例部件分离、2 例破裂和 1 例支闭塞）；所有这些患者均在 IFU 之外接受治疗（p<0.04）。两组的瘤囊扩大率相似，分别为 56%，其中在 IFU 内治疗的患者和在 IFU 外治疗的患者的瘤囊扩大率相似。多变量回归分析显示，更大的髂总动脉（CIA）（HR 1.088，95%CI 1.016-1.166，p=0.016）、更大的 CIA 迂曲（HR 2.352，95%CI 1.004-5.509，p=0.048）和有超过两个不符合 IFU 标准的特征的支（HR 3.84，95%CI 1.15-12.83，p=0.03）与 BBSG 事件和再干预的发生率较高相关。
BBSG 可有效封闭扩张的 CIA。但不符合 IFU 标准的患者髂支事件和再干预的发生率更高。更大的 CIA 直径、更大的 CIA 迂曲和超过两个不符合 IFU 标准的特征与 BBSG 失败和再干预有关。
