Objectives: To evaluate the feasibility of thoracic endovascular aortic repair (TEVAR) using the Ankura™ device (Lifetech Scientific, Shenzhen, China) with left subclavian artery (LSA) in-situ fenestration (ISF) using an adjustable puncture device system.
Methods: It is a single center, retrospective, financially unsupported cohort study of TEVAR performed from 16 February 2007 to 10 January 2023. Inclusion criteria were isolate LSA revascularization for elective or urgent/emergent "zone 2" TEVAR, and the availability of the preoperative computed tomography angiography.
Results: Post-hoc analysis identified 52 TEVARs. There were 39 (75.0%) males, and 13 (25.0%) females: median age was 74.5 years (IQR, 65.5-78). Index TEVAR was performed for atherosclerotic aneurysm in 27 (51.9%) cases, dissection-related diseases in 18 (34.6%), penetrating aortic ulcer in 5 (9.6%), and blunt traumatic aortic injury in 2 (3.8%). Access-vessel feasibility rate of TEVAR using the Ankura™ device would have been 98.1% (51/52). Considering the morphology of the aortic arch, ISF TEVAR feasibility would have been 61.5% (32/52). Binary logistic regression analysis identified LSA angulation (OR: 1.1, 95%CI: 1.03-1.14, p = 0.003) to be associated with ISF feasibility using this endograft and a self-centering adjustable needle-based puncture device.
Conclusions: Potential feasibility of TEVAR using the Ankura™ endograft with ISF using a self-centering adjustable needle system was 61.5%. Left subclavian artery angulation seems to be the most important and limiting anatomical constraint.
Keywords: adjustable needle; in-situ fenestration; left subclavian artery fenestration; “zone 2” TEVAR.