Safety and Efficacy of a New Microporous Stent-Graft for Reconstructing Porcine Supra-Aortic Arch Branches and Excluding Thoracic Aortic Aneurysm.

BACKGROUND

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 6 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 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 peak systolic velocity in the right internal carotid artery was 81.5 ± 7.3 cm/sec before stenting and 65.1 ± 7.6 cm/sec 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; furthermore, there was no endoleak 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.