Division of Vascular Surgery, University of Pittsburgh Medical Centre, Pittsburgh, PA, USA.
Department of Medical Imaging, University of Arizona Health System, Tucson, AZ, USA.
Eur J Vasc Endovasc Surg. 2022 Dec;64(6):639-645. doi: 10.1016/j.ejvs.2022.08.003. Epub 2022 Aug 13.
Aortic aneurysms involving aortic arch vessels are anatomically unsuitable for standard thoracic endovascular repair (TEVAR) without cervical debranching of the arch vessels. Three year outcomes of a single branched thoracic endograft following previous publication of peri-operative and one year outcomes are reported.
This was a multicentre feasibility trial of the GORE TAG Thoracic Branch Endoprosthesis (TBE), a thoracic endovascular graft incorporating a single retrograde branch for aortic arch vessel perfusion. The first study arm enrolled patients with an intact descending thoracic aortic aneurysm extending to the distal arch with left subclavian artery (LSA) incorporation (zone 2). The second arm enrolled patients with arch aneurysms requiring incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularisation of the remaining aortic arch vessels. Outcomes at three years are reported.
The cohort comprised 40 patients (31 zone 2, nine zone 0/1). The majority were male (52%). Mean follow up was 1 408 ± 552 days in the zone 2 and 1 187 ± 766 days in the zone 0/1 cohort. During three year follow up there was no device migration, fracture, or aortic rupture in either arm. In the zone 2 arm, freedom from re-intervention was 97% at one and three years but there were two side branch occlusions. Two patients had aneurysm enlargement > 5 mm without documented endoleak or re-intervention. Freedom from death at one and three years was 90% and 84%. In the zone 0/1 arm there were no re-interventions, loss of branch patency, or aneurysm enlargement at three years. Cerebrovascular events occurred in three patients during follow up: two unrelated to the device or procedure, and one of unknown relationship. Two patients in this arm died during the follow up period, both unrelated to the procedure or the aneurysm.
Initial three year results of the TBE device for endovascular repair of arch aneurysms show favourable patency and durability with low rates of graft related complications.
主动脉弓血管受累的主动脉瘤在解剖学上不适合进行标准的胸主动脉腔内修复术(TEVAR),除非对弓血管进行颈侧分支部。现将先前报道的围手术期和 1 年结果之后,该单一分支胸主动脉腔内移植物的 3 年结果报道如下。
这是戈尔 TAG 胸主动脉分支覆膜支架(TBE)的多中心可行性试验,TBE 是一种胸主动脉腔内移植物,包含一个用于弓血管灌注的逆行分支。第一研究臂纳入降主动脉瘤延伸至远端弓且包含左锁骨下动脉(LSA)的患者(区域 2)。第二臂纳入需要包含左颈总动脉或无名动脉(区域 0/1)且需要对剩余主动脉弓血管进行外解剖再血管化的弓部动脉瘤患者。报道了 3 年的结果。
该队列包括 40 名患者(31 名区域 2,9 名区域 0/1)。大多数为男性(52%)。区域 2 的中位随访时间为 1408 ± 552 天,区域 0/1 组为 1187 ± 766 天。在 3 年的随访期间,两个组均未出现器械迁移、断裂或主动脉破裂。在区域 2 组,1 年和 3 年的免于再次干预率分别为 97%,但有 2 例分支闭塞。2 例患者出现动脉瘤增大>5mm,无内漏或再次干预。1 年和 3 年的免于死亡率分别为 90%和 84%。在区域 0/1 组,3 年内无再次干预、分支闭塞或动脉瘤增大。3 名患者在随访期间发生脑血管事件:2 例与器械或手术无关,1 例与两者均无关。该组有 2 名患者在随访期间死亡,均与手术或动脉瘤无关。
TBE 装置用于治疗弓部动脉瘤的初步 3 年结果显示通畅性和耐用性良好,且移植物相关并发症发生率低。