Safety and efficacy of a new microporous stent-graft for reconstructing porcine supra-aortic arch branches and excluding thoracic aortic aneurysm.

Abstract

Objective: To evaluate the safety and efficacy of a new microporous stent-graft for reconstructing porcine supra-aortic arch branches and excluding porcine thoracic aortic aneurysm.

Methods: Aneurysm models were established in the descending aorta of six ternary large white pigs; simultaneously, microporous stent-grafts were placed to exclude the aneurysms. Digital subtraction angiography (DSA) was performed 7 ± 1 days postoperatively to assess the aneurysms. Microporous stent-grafts were placed in the aortic arch, and the supra-aortic arch branches were reconstructed in an additional 6 ternary large white pigs. The time required to reconstruct the supra-aortic arch branches was recorded. The peak systolic velocity (PSV) in the right internal carotid artery was measured before and after stent placement using color Doppler ultrasound.

Results: The aneurysms were noted to fade on DSA immediately after placement of microporous stent-grafts. Follow-up DSA at 6-8 days postoperatively showed no visualization of the aneurysms. The PSV in the right internal carotid artery was 81.5 ± 7.3 cm/s before stenting and 65.1 ± 7.6 cm/s after stenting, a mean decrease of 20% (p < 0.0001). The time required to reconstruct a single and double branch was 4.5 ± 0.5 min and 11.5 ± 1.9 min, respectively. During the follow-up period, all 12 pigs showed no infection, lameness, paraplegia, cerebral infarction, or death. DSA showed that all the stent-grafts were patent; further, there was no endo-leak, or fracture/migration of the stents.

Conclusion: The microporous stent-graft allows complete thrombosis of the aortic aneurysm by altering its hemodynamics, and the micropores maintain the blood supply to the supra-aortic arch branches for a safe period. Enlarging the micropores of the stent-graft allows rapid reconstruction of the supra-aortic arch branches; moreover, the procedure is easy to perform and the technology is easily accessible.