Abstract: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.