Korean Circ J.  2017 Mar;47(2):215-221. 10.4070/kcj.2016.0286.

Safety and Efficacy of an Aortic Arch Stent Graft with Window-Shaped Fenestration for Supra-Aortic Arch Vessels: an Experimental Study in Swine

Affiliations
  • 1Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea. glaraone@hanmail.net
  • 2Department of Thoracic Surgery, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.

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±4.02 minutes. The mean time for the selection of the right carotid artery was 5.72±0.72 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

MeSH Terms

Animal Experimentation
Aorta, Thoracic*
Aortic Aneurysm, Thoracic
Aortic Diseases
Autopsy
Blood Vessel Prosthesis*
Carotid Arteries
Catheters
Congenital Abnormalities
Endoleak
Iliac Artery
Pathology
Stents*
Swine*
Transplants
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