Objectives: To evaluate the results of isolated left subclavian artery 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 28 July 2021 to 3 April 2024. Inclusion criteria were isolate left subclavian artery 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. The median time of intervention was 184 min (interquartile range 135-220) with a median fenestration time of 20 min (interquartile range 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 was 4 months (interquartile range 1-12.25). Bridging stent graft patency was 100% with no ISF-related endoleak. ISF-related reintervention was never required.
Conclusions: ISF TEVAR using the Ankura™-II device with the self-centring 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.
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