University of Texas South Western, Dallas, TX, USA.
Mayo Clinic, Rochester, MN, USA.
Eur J Vasc Endovasc Surg. 2021 Feb;61(2):219-226. doi: 10.1016/j.ejvs.2020.11.001. Epub 2020 Nov 28.
The aim of this study was to report the expanded use of preloaded catheters and wires of fenestrations and directional branches to facilitate access to renal and mesenteric target arteries during endovascular repair of complex aortic aneurysms.
This was an observational retrospective cohort multicentre study. Prospectively collected data from six physician sponsored investigational device exemption studies at US centres were analysed. Patients were treated with fenestrated and branched aortic endografts for pararenal and thoraco-abdominal aortic aneurysms (TAAAs) between 2012 and 2017. Technical success was defined as successful intra-operative catheterisation and stenting of all intended target visceral arteries. Univariable and stratified analyses were performed to identify differences in outcomes between repairs using preloaded and standard devices.
There were 564 patients (73% men, mean age 73 ± 8 years) treated for 168 pararenal aortic aneurysms (29.8%), 216 type IV TAAAs (38.3%), and 180 type I - III TAAAs (31.9%). Preloaded grafts (PGs) were used in 387 (68.6%) patients and standard grafts (SGs) in 177 (31.4%). PGs were used preferentially for type IV TAAAs (45% vs. 24%; p < .001), whereas standard devices were used more frequently among patients with type I - III TAAAs (24% vs. 49%; p < .001). The majority of custom made devices were preloaded (95% vs. 21%; p < .001). A total of 2 157 target arteries were incorporated (mean 3.9/patient) utilising 1 469 fenestrations (68.1%), 603 directional branches (27.9%), and 85 double wide scallops (3.9%). Most PGs included fenestrations (80% vs. 43%; p < .001), whereas directional branches were more frequent in standard devices (17% vs. 53%; p < .001). Contrast volume, fluoroscopy time, radiation dose, and operative time were not significantly different between preloaded and standard devices. Upper extremity access was more frequent for PGs (87% vs. 72%; p < .001). Overall technical success was 98.8% and comparable for both preloaded and standard grafts (99.5% vs. 97.2%; p = .022). The 30 day stroke rate was similar for PGs and SGs (2.3% and 1.7%%, respectively). The 30 day mortality rate was 1.9%, and low for both PGs and SGs (0.8% vs. 4.5%; p = .003).
Endovascular repair of complex aortic aneurysms is safe and effective. The expanded use of preloaded catheters and wires of fenestrations and directional branches for target artery incorporation is associated with a high technical success and low early mortality.
本研究旨在报告预装载的导管和分支导丝在血管内修复复杂主动脉瘤中的扩展应用，以促进对肾和肠系膜靶动脉的进入。
这是一项观察性回顾性队列多中心研究。对美国中心的 6 项医生赞助的研究设备豁免研究中前瞻性收集的数据进行了分析。2012 年至 2017 年间，对肾周和胸腹主动脉瘤（TAAA）患者使用开窗和分支主动脉内移植物进行治疗。技术成功定义为所有预期的内脏靶动脉的术中导管插入和支架置入均成功。采用单变量和分层分析来确定使用预装载和标准设备修复之间的结果差异。
共有 564 名（73%为男性，平均年龄 73±8 岁）患者接受了 168 例肾周主动脉瘤（29.8%）、216 例 IV 型 TAAA（38.3%）和 180 例 I-III 型 TAAA（31.9%）的治疗。387 名（68.6%）患者使用了预装载移植物（PG），177 名（31.4%）患者使用了标准移植物（SG）。PG 优先用于 IV 型 TAAA（45%比 24%；p<0.001），而标准设备在 I-III 型 TAAA 患者中更常使用（24%比 49%；p<0.001）。定制设备主要是预装载（95%比 21%；p<0.001）。共纳入 2157 个靶动脉（平均每个患者 3.9 个），使用了 1469 个开窗（68.1%）、603 个定向分支（27.9%）和 85 个双宽扇贝（3.9%）。大多数 PG 包括开窗（80%比 43%；p<0.001），而标准设备中定向分支更常见（17%比 53%；p<0.001）。预装载和标准设备之间的对比剂体积、透视时间、辐射剂量和手术时间无显著差异。PG 的上肢通路更频繁（87%比 72%；p<0.001）。总体技术成功率为 98.8%，PG 和 SG 之间相似（99.5%比 97.2%；p=0.022）。PG 和 SG 的 30 天卒中率相似（分别为 2.3%和 1.7%）。30 天死亡率为 1.9%，PG 和 SG 均较低（0.8%比 4.5%；p=0.003）。
复杂主动脉瘤的血管内修复是安全有效的。预装载的导管和分支导丝在开窗和定向分支的靶动脉置入中的扩展应用与高技术成功率和低早期死亡率相关。
