Department of Medical Imaging, University of Arizona Health System, Tucson, AZ.
The Heart Hospital Baylor Scott and White, Plano, TX.
J Vasc Surg. 2022 Nov;76(5):1141-1149.e3. doi: 10.1016/j.jvs.2022.05.014. Epub 2022 Jun 14.
Thoracic endovascular aortic repair has emerged as the dominant paradigm for treatment of patients with descending thoracic aortic aneurysms. For aneurysms involving the aortic arch in the region of the left subclavian artery (LSA), branch vessel preservation to maintain blood flow to the LSA is recommended. Branched aortic endografts are an alternative to surgical revascularization of the LSA.
Across 34 investigative sites, 84 patients with zone 2 aneurysms were enrolled in a nonrandomized, prospective study of a single branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for left subclavian perfusion.
More than one-half of the patients were male (63%). Their average age was 70 ± 11 years. The aneurysm morphology was fusiform in 43 and saccular in 41 patients. The mean aneurysm diameter at screening was 56.2 mm. The mean follow-up was 30 months (range, 2.6-50.7 months). Reported here are the patient outcomes at 1 and 12 months. Predefined technical success with implantation of the device in landing zone 2 was achieved in 92% of patients (n = 77). There were no cases of aortic rupture, lesion-related mortality, or new-onset renal failure. There was no perioperative (30-day) mortality. A single case each of permanent paraplegia and paraparesis occurred. Three patients experienced a procedure-related stroke. Through 12 months, four patients died; none of the deaths were adjudicated as related to the device or procedure. One aortic reintervention was required. A single case of aortic enlargement (core laboratory) was reported at 6 months. Type I (n = 3) and III (n = 5) endoleaks occurred in 9.8% of patients, of which one (type III) required reintervention.
Results from this device study in patients with zone 2 aneurysms demonstrate that early safety and efficacy outcomes are maintained up to 12 months after the endovascular procedure with low mortality and reintervention rates and an acceptable frequency of procedural complications, including neurologic complications.
胸主动脉腔内修复术已成为治疗降主动脉瘤患者的主要方法。对于累及左锁骨下动脉（LSA）区域主动脉弓的动脉瘤，建议保留分支血管以维持 LSA 的血流。分支型主动脉覆膜支架是 LSA 外科血运重建的替代方法。
在 34 个研究地点，84 例 2 区动脉瘤患者参与了一项单分支型主动脉覆膜支架的非随机前瞻性研究。胸部分支覆膜支架装置允许在 LSA 近端放置移植物，并包含一个用于左锁骨下灌注的单侧分支。
超过一半的患者为男性（63%）。他们的平均年龄为 70±11 岁。43 例动脉瘤形态为梭形，41 例为囊状。筛查时的平均动脉瘤直径为 56.2mm。平均随访 30 个月（范围 2.6-50.7 个月）。这里报告的是 1 个月和 12 个月时的患者结果。92%（n=77）的患者实现了装置植入 2 区的预设技术成功。无主动脉破裂、与病变相关的死亡率或新发肾功能衰竭。无围手术期（30 天）死亡率。各有 1 例永久性截瘫和不全截瘫发生。3 例患者发生与手术相关的卒中。12 个月时，4 例患者死亡；无死亡被判定与装置或手术相关。需要进行 1 次主动脉再干预。6 个月时报告了 1 例主动脉扩大（核心实验室）。9.8%的患者发生了Ⅰ型（n=3）和Ⅲ型（n=5）内漏，其中 1 例（Ⅲ型）需要再次干预。
这项 2 区动脉瘤患者装置研究的结果表明，在血管内手术后 12 个月内，早期安全性和疗效结果得以维持，死亡率和再干预率较低，且手术相关并发症（包括神经并发症）的发生率可接受。
