Key result
Novel adjustable pre-fenestrated TEVAR graft achieves 100% procedural success in preclinical testing.
Why the study?
In-vivo or in-situ fenestration techniques for TEVAR require stent-graft structure modification, which may affect long-term stability, motivating the design of an adjustable pre-fenestration aortic stent-graft.
Does a newly designed adjustable pre-fenestration aortic stent-graft provide feasible and safe f-TEVAR in a canine model?
Does a newly designed adjustable pre-fenestration aortic stent-graft provide feasible and safe f-TEVAR in a canine model?
A novel adjustable pre-fenestration aortic stent-graft is feasible and safe in a canine model, maintaining branch artery patency without migration up to 12 weeks.
Pre-fenestrated adjustable stent-graft preserves branch patency in animals; leaves open human TEVAR feasibility pending clinical trials.
OBJECTIVES: To isolate aortic arch pathologies and keep the branches superior in arch patent, it always need physicians to do in-vivo fenestration or in-situ fenestration when performing the thoracic endovascular aortic repair (TEVAR). However, both of those fenestration techniques need structure modification of the stent-graft, which may affect their long-term stability. We designed an adjustable pre-fenestration aortic stent-graft to treat pathologies in this area and obtained a patent branch arteries. This study used this new designed stent-graft to perform fenestrated-TEVAR (f-TEVAR) in canine aorta. This study aims to identify its feasibility and safety through animal experiments, which might provide preliminary data for potential human implantation. METHODS: A total of 8 Labrador Retrievers were underwent f-TEVAR by using the new devices. Digital subtraction angiography was performed before and after f-TEVAR to evaluate the success of the procedures. All the canines were divided into a 4-week group (feeding for 4 weeks after operation) and a 12-week group (feeding for 12 weeks after operation). Computed tomography angiography (CTA) were performed before euthanasia. RESULTS: The success rate of operation was 100%. During the operation, there was no accident of major bleeding or failure to be released by fenestration. Adjustable fenestration worked well. No stent-graft migration was found in CTA at 4 weeks and 12 weeks after the operation. All branch arteries kept by the adjustable fenestration were patent. CONCLUSIONS: The result of feasibility and safety of the new designed adjustable pre-fenestration aortic stent-graft in f-TEVAR of canine is acceptable. This study provides a reference for further optimization of this stent and human f-TEVAR implantation involving aortic arch lesions.
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Li et al. (2022) studied Aortic arch pathologies (canine model) (n=8). Adjustable pre-fenestration aortic stent-graft was evaluated on Success rate of operation. In a canine model, fenestrated-TEVAR using a newly designed adjustable pre-fenestration aortic stent-graft achieved a 100% procedural success rate with no stent-graft migration at 12 weeks.
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