title: Safety and Efficacy of an Aortic Arch Stent Graft with Window-Shaped Fenestration for Supra-Aortic Arch Vessels: an Experimental Study in Swine.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Jong Ha
authors.initials: JH
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Han Cheol
authors.initials: HC
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Jeong Cheon
authors.initials: JC
authors.lastname: Choe
authors.affiliation: Department of Thoracic Surgery, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Sang-Pil
authors.initials: SP
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Tae Sik
authors.initials: TS
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Jinhee
authors.initials: J
authors.lastname: Ahn
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Jin Sup
authors.initials: JS
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Hye Won
authors.initials: HW
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Jun-Hyok
authors.initials: JH
authors.lastname: Oh
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Jung Hyun
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Korea.
authors.forename: Kwang Soo
authors.initials: KS
authors.lastname: Cha
keywords: Aneurysm, thoracic aortic; Animal experimentation; Aortic diseases; Stents