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

• Park JH
• Lee HC
• Choe JC
• Kim SP
• Park TS
• Ahn J
• Park JS
• Lee HW
• Oh JH
• Choi JH
• Cha KS

• KMID: 2377462
• DOI: http://doi.org/10.4070/kcj.2016.0286

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

Figure

• 

  Fig. 1 The FASG-W has a preloaded catheter (1.14 mm in diameter) inside the main delivery system for selection of the right carotid artery (red arrow). The preloaded catheter links to a window-shaped fenestration (red arrow), and the distal port of the preloaded catheter protrudes from the distal portion of the deployment section of the main delivery system. A 0.035-inch guidewire can reach the right carotid artery through the preloaded catheter. The size of the FASG-W is 18 French, including the preloaded catheter. FASG-W: fenestrated aortic stent graft window-shaped fenestration.

• 

  Fig. 2 The framework of the FASG-W is composed of 0.234-mm nitinol. The graft of the FASG is made of polytetrafluoroethylene. The FASG-W is 34 mm and 150 mm in diameter and length, respectively. The bare area of the FASG-W is 30 mm in length from the proximal end of the graft, with an oversized diameter of 38 mm to prevent migration. (A) The proximal end of the FASG-W is tied up at 2 points to allow for movement when the FASG-W is deployed partially and is able to be untied at the end of stent graft deployment. (A-D) The fenestration is indicated with a window-shaped gold mark, and the opposite side of the fenestration is indicated with a straight gold mark for easy identification. FASG-W: fenestrated aortic stent graft window-shaped fenestration.

• 

  Fig. 3 The FASG-W was advanced into the aortic arch, and the window-shaped fenestration (A) faced the carotid artery. We then partially deployed the FASG-W to the proximal portion of the fenestration (B) and selected the right carotid artery with the 0.035-inch hydrophilic guidewires (C). We pushed the FASG-W up to fit the window-shaped fenestration into the carotid arteries (D) and completely deployed the FASG-W (E, F). The delivery sheath of the FASG was removed from the aorta, but the guidewire for the right carotid artery was maintained. We then advanced and deployed the stent graft for the right carotid artery (G, H). Aortography was conducted to examine the flow of the carotid arteries and to detect endoleaks (I). FASG-W: fenestrated aortic stent graft window-shaped fenestration, FASG: fenestrated aortic stent graft.

• 

  Fig. 4 CT findings at 4 weeks. (A, B) The blood flow of the carotid arteries was preserved through the window-shaped fenestration. (C) Stent graft for the right carotid artery was connected to the aorta and was patent. (D-F) The main stent graft of FASG-W was in the aorta. There was no endoleak, disconnection, or dissection. CT: computed tomography, FASG-W: fenestrated aortic stent graft window-shaped fenestration.

• 

  Fig. 5 Postmortem gross findings. (A-D) There was no disconnection or tearing of the stent graft, no fractures in the stent graft, and no occlusion of the stent graft for the right carotid artery. (C, D) The blood of both carotid arteries was preserved through the window-shaped fenestration.

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