Department of Cardiothoracic & Vascular Surgery, Advanced Aortic Research Program at the University of Texas Health Science Center at Houston, McGovern Medical School, Houston, Tex.
Division of Vascular Surgery, Department of Surgery, University of North Carolina, Chapel Hill, NC.
J Vasc Surg. 2021 Apr;73(4):1128-1138.e2. doi: 10.1016/j.jvs.2020.08.128. Epub 2020 Sep 3.
To report 5-year results of the prospective, multicenter study designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (William A. Cook Australia, Brisbane, Australia) for juxtarenal abdominal aortic aneurysms (AAAs).
Sixty-seven patients (54 male, mean age 74 ± 8 years) were prospectively enrolled at 14 U.S. centers from 2005 to 2012. Fenestrated stent grafts were used in patients with infrarenal aortic neck lengths of 4 to 14 mm to target 178 renal-mesenteric arteries with a mean of 2.7 vessels per patient. At 5 years, 42 of the 67 patients completed the final study follow-up, with clinical examination obtained in 41 and computed tomography imaging in 39. Outcomes adjudicated by a clinical events committee included all-cause and aneurysm-related mortality, major adverse events, renal stent occlusion/stenosis, renal function changes and renal infarcts, aneurysm sac enlargement (>5 mm), device migration (≥10 mm), type I/III endoleak, and secondary interventions.
Median follow-up was 59.8 months (range, 0.1-67.5 months). There were seven deaths, including one (1.5%) within 30 days (procedure-related) and six beyond 30 days (not procedure-related in five, indeterminate in one). At 5 years, freedom from all-cause mortality was 88.8 ± 4.2% and freedom from aneurysm-related mortality was 96.8 ± 2.3%. There were no aneurysm ruptures or conversions to open surgery. Of the 129 renal arteries targeted by fenestrations, five (4%) occluded and 14 (11%) developed in-stent stenosis. Treatment included redo stenting/angioplasty in 13 vessels, renal artery bypass in 2 vessels, and failed thrombectomy in 1 vessel. Primary and secondary renal target patency was 82.7 ± 4.1% and 95.7 ± 2.1% at 5 years, respectively. Dialysis was required in one patient who had pre-existing chronic kidney disease. During the 5 years, there was 1 type IA endoleak (1.5%), 1 type IB endoleak (1.5%), 2 device migrations (3%), and 4 aneurysm sac enlargements (6%). Overall, 81% of patients had sac shrinkage at 5 years. Of 20 patients who underwent secondary interventions, 12 were for renal in-stent stenosis or occlusion, 7 were for endoleak, and 1 was for both indications. Freedom from secondary intervention was 63.5 ± 7.2% at 5 years.
These 5-year results confirm the safety and effectiveness of the Zenith Fenestrated AAA stent graft with no late graft- or aneurysm-related deaths. In-stent stenosis of bare metal renal stents was the most frequent indication for secondary intervention. The low rate of type IA endoleak, sac enlargement, and device migration support its use in patients with juxtarenal AAAs.
报告前瞻性、多中心研究的 5 年结果，该研究旨在评估 Zenith Fenestrated AAA 血管内移植物（William A. Cook Australia，澳大利亚布里斯班）在肾下腹主动脉瘤（AAA）中的应用。
2005 年至 2012 年期间，在美国 14 个中心前瞻性纳入 67 例患者（54 例男性，平均年龄 74 ± 8 岁）。对肾下主动脉颈长度为 4 至 14mm 的患者使用分体式支架移植物，目标为 178 个肾肠系膜动脉，平均每个患者 2.7 个血管。5 年后，67 例患者中有 42 例完成了最终的研究随访，其中 41 例进行了临床检查，39 例进行了计算机断层扫描成像。由临床事件委员会裁定的结果包括全因死亡率和动脉瘤相关死亡率、主要不良事件、肾支架闭塞/狭窄、肾功能变化和肾梗死、瘤囊扩大（＞5mm）、移植物迁移（≥10mm）、I/III 型内漏和二次干预。
中位随访时间为 59.8 个月（范围 0.1-67.5 个月）。共有 7 例死亡，其中 1 例（1.5%）发生在 30 天内（与手术相关），6 例发生在 30 天之后（与手术无关，5 例，1 例无法确定）。5 年时，全因死亡率的无事件生存率为 88.8 ± 4.2%，动脉瘤相关死亡率的无事件生存率为 96.8 ± 2.3%。无动脉瘤破裂或转为开放手术。129 个肾动脉目标中有 5 个（4%）闭塞，14 个（11%）出现支架内狭窄。治疗包括 13 个血管的再次支架置入/血管成形术、2 个血管的肾动脉旁路术和 1 个血管的失败血栓切除术。5 年后，主要和次要的肾目标通畅率分别为 82.7 ± 4.1%和 95.7 ± 2.1%。1 例已有慢性肾脏病的患者需要透析。5 年内，发生 1 例 I 型内漏（1.5%）、1 例 IB 型内漏（1.5%）、2 例移植物迁移（3%）和 4 例瘤囊扩大（6%）。总体而言，5 年后有 81%的患者瘤囊缩小。在接受二次干预的 20 例患者中，12 例为肾支架内狭窄或闭塞，7 例为内漏，1 例为两者兼有。5 年后，二次干预的无事件生存率为 63.5 ± 7.2%。
这些 5 年的结果证实了 Zenith Fenestrated AAA 支架移植物的安全性和有效性，没有与移植物或动脉瘤相关的晚期死亡。裸金属肾支架内狭窄是二次干预最常见的指征。IA 型内漏、瘤囊扩大和移植物迁移的发生率较低，支持其在肾下 AAA 患者中的应用。
