1.中国医学科学院阜外医院 血管外科，北京 100037;2.中南大学湘雅二医院 血管外科，湖南 长沙 410011;3.中南大学血管病研究所，湖南 长沙 410011
1.Department of Vascular Surgery, Fuwai Hospital, Chinese Academy of Medical Science, Beijing 100037, China;2.Department of Vascular Surgery, the Second Xiangya Hospital, Central South University, Changsha 410011, China;3.Institute of Vascular Diseases, Central South University, Changsha 410011, China
背景与目的 胸主动脉腔内修复术（TEVAR）目前已广泛应用于胸主动脉疾病的治疗，但主动脉弓部疾病由于其治疗难度大，风险高，是TEVAR的难点和研究方向之一。特别是如何用微创的方式重建主动脉弓部三分支，是目前血管外科面临的一大挑战。虽然目前有杂交技术、烟囱技术、带分支支架技术、开窗技术等新的方法用于主动脉弓部疾病的腔内治疗，但这些技术都有其局限性。本文总结一种新型一体式三分支支架系统（Concave Supra-arch branched stent-graft系统，简称CS系统）用于主动脉弓部病变腔内治疗的first-in-man（FIM）研究结果，探讨其安全性和有效性。 方法 回顾性分析2022年8月—2023年4月在中南大学湘雅二医院和中国医学科学院阜外医院采用CS系统治疗主动脉弓部疾病的5例患者的临床资料。观察CS系统的技术成功率、血管通畅率、内漏发生率和近期临床效果。 结果 5例患者包括缺乏近端锚定区的主动脉弓部动脉瘤患者4例，Stanford B型主动脉夹层1例；男性4例，女性1例；年龄51~79岁。其中2例患者合并高血压，2例合并冠心病，1例合并糖尿病，3例存在脂代谢异常。全部5例患者手术中均顺利置入CS系统。无血管破裂、死亡等严重并发症。平均介入时间（72.4±16.9）min，平均总手术时间（169.4±19.6）min，平均造影剂使用量为（79.0±6.5）mL。术毕造影均显示瘤体隔绝完整，夹层破口封堵完全，未见内漏且分支支架形态良好，无狭窄闭塞。术后入住ICU时间（24.2±3.2）h。围手术期均无严重并发症，存活率100%。术后2周5例患者均顺利出院。出院复查CTA检查均显示三分支支架系统位置满意，无内漏，弓上三分支血管无狭窄闭塞。5例患者随访一般情况良好，无心脑相关事件，存活率100%，其中最长随访时间已达6个月。随访期间未发现支架移位，内漏，亦无二次介入情况。 结论 CS系统为一款带有凹槽结构的一体化支架系统。该系统从设计上优化了主动脉弓部全腔内修复的脑保护策略，在治疗缺乏锚定区的主动脉弓部病变同时能有效保留弓部分支血管，一体化的设计也使其具有较好的稳定性。CS系统用于主动脉弓部病变腔内三分支重建，其手术成功率较高，近期效果满意，具有较好的临床应用前景。
Background and Aims Thoracic endovascular aneurysm repair (TEVAR) has been widely used in treating thoracic aortic diseases. However, aortic arch disease remains one of tough parts and research directions of TEVAR due to its treatment difficulties and high risk. In particular, how to reconstruct the three branches of aortic arch in a minimally invasive way is a major challenge for vascular surgery. Although there are new methods for the endovascular treatment of aortic arch diseases, such as hybrid technique, chimney technique, branched stent technique and fenestration technique, these techniques have their limitations. This study was performed to present the results of the first-in-man (FIM) study of applying a novel integrated supra-arch branched stent-graft system (Concave Supra-arch branched stent-graft system, CS system) for the endovascular treatment of aortic arch diseases, to assess its safety and effectiveness. Methods The clinical data of 5 patients with aortic arch disease treated by CS system in the Second Xiangya Hospital of Central South University and Fuwai Hospital of Chinese Academy of Medical Sciences from August 2022 to April 2023 were retrospectively analyzed. The technical success rate, branch patency rate, endo-leak rate and short-term clinical efficacy of the CS system were evaluated. Results The 5 patients included 4 patients with aortic arch aneurysm and 1 patient with Stanford type B aortic dissection. There were 4 males and 1 female, aged from 51 to 79 years. Among them, 2 patients had hypertension, 2 patients had coronary heart disease, 1 patient had diabetes, and 3 patients had abnormal lipid profiles. The CS system was successfully implanted in all 5 patients. There were no serious complications such as vascular rupture and death. The mean interventional time was (72.4±16.9) min, the mean total procedure time was (169.4±19.6) min, and the mean volume of contrast agent used was (79.0±6.5) mL. Intraoperative angiography showed that the aneurysms were completely isolated and the primary dissection tear was completely excluded. No endoleak was observed, and the branch stents were in good shape without stenosis or occlusion. Postoperative ICU stay time was (24.2±3.2) h. There were no serious complications during the perioperative period, and the survival rate was 100%. All 5 patients were discharged from hospital 2 weeks after operation. The CTA examination before discharge showed that the position of the three-branch stent system was satisfactory, there was no endoleak, and there was no stenosis or occlusion of the three-branch vessels in the arch. Five patients were in good general condition during follow-up, with no cardio-cerebral events. The survival rate was 100%, and the longest follow-up period reached 6 months. No stent migration and endoleak were observed or secondary interventions were required during the follow-up period. Conclusion The CS system is an integrated stent system with a concave structure. The design of this system optimates the brain protection strategy of total endovascular repair of aortic arch and can effectively preserve the arch branches while treating aortic arch lesions without sufficient proximal landing zone. The integrated design also provides excellent stability. Using the CS system for endovascular three-branch reconstruction of aortic arch lesions has a high success rate of operation and satisfactory short-term outcome, indicating promising prospects for clinical application.