Preliminary experience of the isolate left subclavian artery in-situ fenestration during "zone 2" thoracic endovascular aortic repair

Objectives: To evaluate the results of isolate left subclavian artery (LSA) in-situ fenestration (ISF) during "zone 2" thoracic endovascular aortic repair (TEVAR) using a new adjustable needle puncturing device system. Methods: It is a multicentre, retrospective, physician-initiated cohort study of patients treated from July 28th 2021 to April 3rd 2024. Inclusion criteria were isolate LSA revascularization for elective or urgent/emergent "zone 2" TEVAR. The primary outcome was technical success and freedom from ISF TEVAR-related reintervention or endoleak. Results: We treated 50 patients: 28 (56.0%) atherosclerotic thoracic aneurysms, 12 (24.0%) type B aortic dissection, and 10 (20.0%) penetrating aortic ulcers. Elective intervention was carried out in 46 (92.0%) cases. ISF was successful in all cases, with a procedural primary technical success in 47 (94.0%) cases. Median time of intervention was 184 min (IQR, 135-220) with a median fenestration time of 20 min (IQR, 13-35). Operative mortality did not occur. We observed 1 case of spinal cord ischaemia, and 2 cases of bilateral posterior non-disabling stroke. Mortality at 30 days occurred in 1 (2.0%) patient (not aorta-related). The median follow-up median follow-up of 4 months (IQR, 1-12.25). Bridging stent graft patency was 100% with no ISF-related endoleak. In-situ fenestration-related reintervention was never required. Conclusions: ISF TEVAR using the Ankura™-II device with the self-centering adjustable needle system showed high technical success, promising stability, and stable aortic-related outcomes. Owing to these results, it represents a safe and effective alternative for standard "zone 2" TEVAR.