J Korean Med Sci.  2015 Apr;30(4):426-434. 10.3346/jkms.2015.30.4.426.

Safety and Efficacy of a Novel, Fenestrated Aortic Arch Stent Graft with a Preloaded Catheter for Supraaortic Arch Vessels: An Experimental Study in Swine

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

• KMID: 2164450
• DOI: http://doi.org/10.3346/jkms.2015.30.4.426

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.

Keyword

Stents; Aortic Aneurysm; Aortic Diseases; Animal Experimentation

MeSH Terms

Animals
Aorta, Thoracic/*surgery
Catheters
Endovascular Procedures/adverse effects/*instrumentation
*Stents
Swine
Tomography, X-Ray Computed

Figure

• 

  Fig. 1 The fenestrated aortic stent graft (FASG) has a preloaded catheter (1.14 mm in diameter) inside the main delivery system for selection of the carotid artery, innominate artery, and subclavian artery (red arrow). The preloaded catheter links to a distal side hole (red arrow) 8 mm in diameter, 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 carotid and subclavian arteries through the preloaded catheter. The size of the FASG is 18 French, including the preloaded catheter.

• 

  Fig. 2 The framework of the FASG is composed of 0.234-mm nitinol. The graft of the FASG is made of polytetrafluoroethylene. The FASG is 34 and 110 mm in diameter and length, respectively. The bare area of the FASG is 30 mm in length from the proximal end of the graft and oversized at 38 mm in diameter to prevent migration of the FASG. The proximal end of the FASG is tied up at 2 points to be movable when the FASG is deployed partially and when the FASG is deployed completely at the end of the stent graft deployment (A, B). The side hole is indicated with a circular gold mark, and either side of it is indicated with a straight gold mark to identify the side hole easily (C-E).

• 

  Fig. 3 Test of the deployment in vitro. We partially deployed the FASG up to the fenestration side holes (A) and then simulated the selection of carotid arteries using the guidewires. We then fully deployed the FASG (B) and finally untied the proximal end of the FASG (C, D).

• 

  Fig. 4 The FASG was advanced into the aortic arch, and the fenestration side hole was kept facing the carotid artery. We then partially deployed the FASG up to the fenestration side holes (A, B) and selected carotid arteries with the 0.035-inch hydrophilic guidewires (C, D). We pushed the FASG up to fit the fenestration side holes into the carotid arteries (E) and deployed the FASG completely (F). The delivery sheath of the FASG was removed from the aorta, but the guidewires for the carotid arteries were maintained. We then advanced the stent grafts for the carotid arteries (G). Percutaneous transluminal balloons were then inflated to create good connections between the main FASG and stent grafts for the carotid arteries (H). Aortography was conducted to examine the flow of the carotid arteries and to detect endoleaks (I).

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  Fig. 5 CT findings at 4 weeks. One-branch (A) and 2-branch (B) FASG.

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  Fig. 6 Postmortem gross findings. There were no disconnections or tearing of the stent grafts, no fractures in the stent grafts, and no occlusion of the stent graft for the carotid arteries (A) for 1-branch (B) and 2-branch (C) FASG.

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