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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 (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Lee, Han Cheol (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Choe, Jeong Cheon (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Kim, Sang-Pil (Department of Thoracic Surgery, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Park, Tae Sik (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Ahn, Jinhee (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Park, Jin Sup (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Lee, Hye Won (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Oh, Jun-Hyok (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Choi, Jung Hyun (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Cha, Kwang Soo (Division of Cardiology, Department of Internal Medicine, Medical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine)
  • Received : 2016.08.04
  • Accepted : 2016.11.22
  • Published : 2017.03.31

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 $27.15{\pm}4.02minutes$. The mean time for the selection of the right carotid artery was $5.72{\pm}0.72minutes$. 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.

Keywords

References

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