Abstract Body: Background: Endovascular treatment of aortoiliac occlusive disease is currently limited to kissing iliac stents with poor long-term outcomes. We developed an AortoIliac Fenestrated (AIFEN) balloon-expandable covered stent for managing this condition, and evaluated its feasibility and preliminary efficacy in first-in-animal trials.
Methods: AIFEN stents were fabricated by cutting 7 mm fenestrations into from 10×55 mm balloon-expandable covered stents, suturing on radiopaque markers, and re-crimping using a 3D-printed crimper (Figure 1). In vivo feasibility was assessed in 3 anesthetized pigs (two non-survival, one 10-week survival). Right femoral access obtained with a 12 Fr sheath enabled AIFEN deployment from aorta to proximal right common iliac. A 7 Fr sheath in the left femoral artery enabled delivery of a 7×15 mm balloon-expandable covered stent into the left common iliac artery and AIFEN fenestration. The survival pig received daily dual antiplatelet therapy and underwent weekly femoral artery duplex ultrasounds for patency assessment.
Results: AIFEN stent deployment was successful in all three pigs, with demonstrated patency through both AIFEN and contralateral iliac artery stents (Figure 2). Explant analysis showed the AIFEN device and left iliac stent remained in situ without retroperitoneal bleeding or injury (Figure 3). In the survival pig, serial femoral ultrasounds confirmed device patency through week 4, with stable arterial peak systolic velocities (right femoral: 84-90 cm/s; left femoral: 81-90 cm/s).
Conclusions: This first-in-animal study demonstrated successful fabrication, deployment, and preliminary patency of the AIFEN stent system in the aortoiliac bifurcation. The system offers significant advantages over traditional kissing stents, potentially reducing known complications such as thrombosis and restenosis by preserving natural bifurcation anatomy. 10-week survival data, supported by consistent ultrasound velocities and clean explant findings, suggest biocompatibility and maintained patency. While long-term studies are needed, initial results suggest promise for treating aortoiliac occlusive disease, addressing the limitations of current therapeutic options. The simplified deployment technique and anatomically-oriented design may translate to improved clinical outcomes and expanded treatment options for patients with complex aortoiliac disease.