Department of Medical Imaging, University of Arizona Health System, Tuscon, Ariz.
Department of Cardiothoracic Surgery, Stanford University Hospitals, Palo Alto, Calif.
J Vasc Surg. 2021 Nov;74(5):1483-1490.e2. doi: 10.1016/j.jvs.2021.04.025. Epub 2021 Apr 30.
Thoracic endovascular aortic repair has radically transformed the treatment of descending thoracic aortic aneurysms. However, when aneurysms involve the aortic arch in the region of the left subclavian artery, branch vessel preservation must be considered. Branched aortic endografts have provided a new option to maintain branch patency.
Six investigative sites enrolled 31 patients in a nonrandomized, prospective investigational device exemption feasibility trial of a single branched aortic endograft for the management of aneurysms that include the distal aortic arch. The Gore TAG thoracic branch endoprosthesis (W. L. Gore & Associates, Inc, Flagstaff, Ariz), an investigational device, allows for graft placement proximal to the left subclavian artery and incorporates a single side branch for left subclavian perfusion.
All 31 patients (100%) had undergone successful implantation of the investigational device in landing zone 2. Men slightly outnumbered women (51.6%). Their average age was 74.1 ± 10.4 years. The aneurysm morphology was fusiform in 12 and saccular in 19 patients, with a mean maximum aortic diameter of 54.8 ± 10.9 mm. The mean follow-up period for the cohort was 25.2 ± 11.1 months. We have reported the patient outcomes at 1 month and 1 year. At 1 month, the side branch patency was 100% and the freedom from core laboratory-reported device-related endoleak (types I and III) was 96.7%, without 30-day death or permanent paraplegia. One patient experienced a procedure-related stroke. Through 1 year, five patients had died; none of the deaths were related to the device or procedure (clinical endpoint committee adjudicated). One thoracic reintervention was required. No conversions were required, and no aneurysm growth (core laboratory) was reported. One case of the loss of side branch patency was diagnosed in the left subclavian artery in an asymptomatic individual from computed tomography at 6 months, with no reported subsequent adverse events due to loss of patency. Endoleaks were reported by the core laboratory in five patients at 12 months (two, type II; and three, indeterminate).
The present investigational device exemption feasibility study has reported the preliminary results of the use of a single side branch endograft to treat patients with proximal descending thoracic aortic aneurysms.
胸主动脉腔内修复术彻底改变了降主动脉瘤的治疗方法。然而，当动脉瘤累及主动脉弓位于左锁骨下动脉区域时，必须考虑保留分支血管。分支主动脉覆膜支架为保持分支通畅提供了一种新的选择。
6 个研究点在一项非随机、前瞻性的研究性器械豁免可行性试验中招募了 31 名患者，该试验使用单个分支主动脉覆膜支架治疗包括远端主动脉弓在内的动脉瘤。戈尔 TAG 胸部分支覆膜支架（戈尔公司，亚利桑那州弗拉格斯塔夫）是一种研究性器械，可在左锁骨下动脉近端放置移植物，并包含一个用于左锁骨下动脉灌注的单一侧支。
所有 31 名患者（100%）均成功植入了研究性器械，植入部位为 2 区。男性略多于女性（51.6%）。他们的平均年龄为 74.1±10.4 岁。12 名患者的动脉瘤形态为梭形，19 名患者为囊状，最大主动脉直径平均为 54.8±10.9mm。该队列的平均随访时间为 25.2±11.1 个月。我们已经报告了 1 个月和 1 年的患者结果。1 个月时，侧支通畅率为 100%，核心实验室报告的器械相关内漏（1 型和 3 型）无复发率为 96.7%，无 30 天内死亡或永久性截瘫。1 名患者发生手术相关卒中。1 年后，5 名患者死亡；无死亡与器械或手术相关（临床终点委员会裁定）。1 例需要再次胸主动脉干预。无转换，无动脉瘤生长（核心实验室）。1 例在 6 个月时无症状个体的左锁骨下动脉出现侧支通畅丧失，通过 CT 诊断，但由于通畅丧失未报告随后发生的不良事件。核心实验室在 12 个月时报告了 5 例内漏（2 例为 2 型，3 例为不确定型）。
本研究性器械豁免可行性研究报告了使用单个侧支覆膜支架治疗近端降主动脉瘤患者的初步结果。
