Concave Triple Branched Stent Graft System for Aortic Arch Pathologies: A First in Man Prospective Cohort Study.

Objective: Endovascular aortic arch repair with supra-aortic trunk (SAT) reconstruction is an alternative to surgical replacement, but the ideal stent graft is still under investigation. This study describes the first experience and one year results of a novel, off the shelf, concave supra-arch triple branched stent graft system (CS system) for aortic arch diseases.

Methods: This was a prospective cohort study conducted in three hospitals, enrolling patients from March 2022 to June 2023, to evaluate use of the CS system for aortic arch pathologies. An interdisciplinary board assessed patients pre-operatively. All patients were treated using the CS system to cover the aortic arch pathologies and reconstruct all SATs. Follow up assessments were conducted with computed tomography scans at two weeks and six and 12 months.

Results: Ten patients (eight men) were treated using the CS system. The mean age was 65.3 years. Conditions included thoracic aortic aneurysm, non-A-non-B aortic dissection, and penetrating aortic arch ulcer. Technical success was achieved in all patients, with one type III endoleak during the procedure. The mean procedure time was 160 ± 23 minutes and the mean fluoroscopy time was 63 ± 20 minutes. The in hospital mortality and stroke rates were both 0%. The mean follow up duration was 456.9 ± 93.6 days. All patients recovered well without complications. The CS system completely covered the aortic pathologies, and all reconstructed branches remained patent. The single endoleak sealed spontaneously within six months. Mild to moderate in stent stenosis was observed in three left common carotid arteries. No other morphological abnormalities were observed, and secondary interventions were unnecessary.

Conclusion: The CS system for endovascular treatment of aortic arch pathologies demonstrated promising safety and efficacy in this study with no occurrences of death, stroke, retrograde type A aortic dissection, re-intervention, or significant endoleak during one year follow up. Stenosis of the reconstructed SATs should be closely monitored.