title: Safety and efficacy of a novel, fenestrated aortic arch stent graft with a preloaded catheter for supraaortic arch vessels: an experimental study in Swine.
abstract: Thoracic endovascular aortic repair (TEVAR) shows limitations in cases in which the aortic pathology involves the aortic arch. The study aims were to test a fenestrated aortic arch stent graft (FASG) with a preloaded catheter for the supraaortic arch vessels and to perform a preclinical study in swine to evaluate the safety and efficacy of this device. Six FASGs with 1 preloaded catheter and 5 FASGs with 2 preloaded catheters were advanced through the iliac artery in 11 swines. The presence of endoleaks 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 the one and two FASG groups was 30.2 (27.9-34.5) min and 43.1 (39.2-53.7) min. The mean time for the selection of the carotid artery was 4.8 (4.2-5.5) min and 6.2 (4.6-9.4) min. Major adverse event was observed in one of 11 pigs. One pig died at 4 weeks likely because of the effects of the high dose of ketamine, while the remaining 10 pigs survived 8-week. For both the one and two FASG groups, no endoleaks, no disconnection, no occlusion of the stent grafts were observed in the CT findings and the postmortem gross findings. The procedure with the FASG could be performed safely in a relatively short procedure time and involved an easy technique. The FASG is found to be safe and convenient in this preclinical study with swine.
authors.affiliation: Department of Thoracic Surgery, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Sang-Pil
authors.identifier: 0000-0001-8110-8432
authors.initials: SP
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Han Cheol
authors.identifier: 0000-0002-7236-4204
authors.initials: HC
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Tae Sik
authors.initials: TS
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Jin Hee
authors.initials: JH
authors.lastname: Ahn
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Hye-Won
authors.initials: HW
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Jong-Ha
authors.initials: JH
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Junhyok
authors.initials: J
authors.lastname: Oh
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Jung Hyun
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors.forename: Kwang Soo
authors.initials: KS
authors.lastname: Cha
mesh_terms: D000818:Animals; D001013:Aorta, Thoracic / Q000601:surgery*; D057785:Catheters; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D015607:Stents; D013552:Swine; D014057:Tomography, X-Ray Computed
keywords: Animal Experimentation; Aortic Aneurysm; Aortic Diseases; Stents
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