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KMID : 0368120170470020215
Korean Circulation Journal
2017 Volume.47 No. 2 p.215 ~ p.221
Safety and Efficacy of an Aortic Arch Stent Graft with Window-Shaped Fenestration for Supra-Aortic Arch Vessels: an Experimental Study in Swine
Park Jong-Ha

Lee Han-Cheol
Choe Jeong-Cheon
Kim Sang-Pil
Park Tae-Sik
Ahn Jin-Hee
Park Jin-Sup
Lee Hye-Won
Oh Jun-hyok
Choi Jung-Hyun
Cha Kwang-Soo
Abstract
Background and Objectives: Thoracic endovascular aortic repair exhibits limitations in cases where the aortic pathology involves the aortic arch. We had already developed a fenestrated aortic stent graft (FASG) with a preloaded catheter for aortic pathology involving the aortic arch. FASG was suitable for elective cases.

Materials and Methods: An aortic arch stent graft with a window-shaped fenestration (FASG-W) for supra-aortic arch vessels is suitable for emergent cases. This study aims to test a FASG-W for supra-aortic arch vessels and to perform a preclinical study in swine to evaluate the safety and efficacy of this device. Six FASG-Ws with 1 preloaded catheter were advanced through the iliac artery in 6 swine. The presence of endoleak and the patency and deformity of the grafts were examined with computed tomography (CT) at 4 weeks postoperatively. A postmortem examination was performed at 8 weeks. The mean procedure time for FASG-W was 27.15¡¾4.02 minutes. The mean time for the selection of the right carotid artery was 5.72¡¾0.72 minutes.

Results: Major adverse events were not observed in any of the 6 pigs who survived for 8 weeks. For the FASG-W, no endoleaks, no disconnection, and no occlusion of the stent grafts were observed in the CT findings or the postmortem gross findings.

Conclusion: The procedure with the FASG-W was able to be performed safely in a relatively short procedure time and involved an easy technique. The FASG-W was found to be safe and convenient for use in this preclinical study of swine.
KEYWORD
Stents, Aneurysm, thoracic aortic, Aortic diseases, Animal experimentation
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