Division of Vascular and Surgery, University of North Carolina, Chapel Hill, NC.
Division of Vascular Surgery, University of Colorado School of Medicine, Aurora, CO.
J Vasc Surg. 2024 Nov;80(5):1326-1335.e4. doi: 10.1016/j.jvs.2024.05.020. Epub 2024 Jun 20.
This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair.
This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines.
The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m. Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor.
Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure.
本研究报告了 GORE EXCLUDER 胸主动脉分支覆膜支架（TAMBE）用于复杂腹主动脉瘤修复的主要研究分支的 30 天结果。
这项 TAMBE 装置的多中心、非随机、前瞻性研究纳入了主要研究分支中 extent IV 胸腹主动脉瘤和肾周动脉瘤患者。根据血管外科学会的指南，分析了技术成功率和主要不良事件。
在接受 TAMBE 装置血管内修复的 102 例主要研究分支患者中，平均年龄为 73 ± 6.4 岁（范围，58-82 岁），84 例（84.2%）为男性。平均体重指数为 28.3 ± 5.0 kg/m。59 例（57.8%）患者接受 extent IV 治疗，43 例（42.2%）患者接受肾周动脉瘤治疗；动脉瘤的最大直径平均为 59.4 ± 7.8mm。10 例（9.8%）患者预防性使用了脑脊髓液引流管。99%的患者达到了技术成功，唯一的失败是由于左肾动脉的导管插入不成功。平均手术时间为 315 ± 103 分钟（范围，163-944 分钟），估计失血量为 300 ± 296mL（范围，10-2000mL），造影剂用量为 153.6 ± 73.5mL（范围，16-420mL）。重症监护病房的住院时间为 58.7 ± 52.7 小时（范围，1-288 小时）。在 28 例（27.5%）患者中，总共部署了 32 个额外的血管内组件来处理手术并发症，包括主动脉和靶血管夹层以及与入路无关的损伤。支架移植物用于覆盖 407 个靶血管（平均每支血管 1.6 个；范围，1-4）。14 例患者（13.7%）术后需要输血。7 例患者（6.9%）在 30 天内发生了主要不良事件。事件包括呼吸衰竭（n=2）、致残性中风（n=1）、新出现的需要透析的肾功能衰竭（n=2）和截瘫（n=2）。在 30 天内，有 1 例患者术中破裂；没有严重的肠缺血或与病变相关/所有原因的死亡率报告。通过 30 天的随访，核心实验室报告的主动脉、肠系膜上动脉和腹腔动脉通畅率为 100%，左肾分支和右肾分支通畅率分别为 95.9%和 99.0%。在 30 天内进行了 9 例（9.4%）的再干预，均为次要再干预。
早期 TAMBE 装置的结果表明，技术成功率高，无 30 天病变相关死亡率，指数手术后 30 天内安全性事件发生率低。
