PURPOSE: A conventional fenestrated, branched aortic stent graft had been introduced to overcome such limitation of the anatomical location when disease involves the aortic arch.But due to high blood pressure in that region, it was still difficult to perform exact access to the branch arteries of aortic arch. To overcome such limitation, author have attempted to develop a novel, fenestrated aortic arch stent graft(FASG) with a preloading catheter to save branch arteries and have achieved good result in an experimental study in a swine model. METHODS: This FASG is a self-expandable nitinol-PTEF stent graft with round shape fenestration and preloading catheter placed inside the stent graft that is designed to access carotid, left subclavian artery safely(Fig A). After FASG is partially deployed, 035 inch guidewire is placed into the carotid artery, assembling round shape fenestration into carotid artery, and then stent graft is fully deployed(Fig B). Following seperate stent graft for carotid artery is deployed. CT is checked at 4 weeks. Accessibility of the caorotid artery, protection of blood flow to the brain, and 8 weeks safety of FASG were evaluated in 6 anesthetized domestic swine weighing 70 to 80 kg.
RESULTS: Attempted FASGs using a retrograde transiliac access were successful in all 6 pigs. The FASGs were positioned and deployed exactly in the intended aortic arch. We could select the carotid artery easily and deploy another stent graft into that carotid artery. Mean selection time of carotid artery was 4.83±1.17 minutes. There were no endoleak or any deformity of FASGs in all 6 pigs. Six pigs were kept alive for 8 week, and postmortem examination showed good arrangement of FASGs and stent grafts in the carotid artery. CONCLUSION: This initial feasibility study demonstrates the ability of exact deployment, the easy accessibility of branch artery and safety of this novel FASG in experimental pigs. Clinical evaluation of the device is planned in the near future after approval of Korean Food and Drug Association.
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