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OBJECTIVES:
Although uncommon, graft limb occlusion continues to plague endovascular abdominal aortic aneurysm repair. Endograft kinking, tortuous anatomy and occlusive burden have been identified as risk factors. This study reports outcomes from a prospective multicenter registry describing physician experience with the Zenith® Spiral-Z® AAA Iliac Leg Graft.
METHODS:
The Spiral-Z® Registry is a prospective, non-randomized registry that is designed to collect up to 600 consecutive patients at up to 30 sites in North America. Clinical outcomes were assessed at two time intervals, short-term (1-6 months based on the site’s standard of care) and longer-term (12 months). Main study outcomes include limb occlusion, secondary intervention, endoleak, component separation, and stent fracture related to the Spiral-Z® graft.
RESULTS:
Between March 2012 and August 2014, the registry prospectively collected procedural results on 389 patients (mean age 74±8.6 years, range 48-93 years; 87% male), with Spiral-Z® grafts implanted in 752 limbs. Aneurysms were aortic in 286 (74%) and aortoiliac in 103 patients (26%). Moderate to severe occlusive disease, calcification, and vessel tortuosity were present in 13%, 22%, and 33% of iliac arteries, respectively.
Follow-up data were available for 250 patients in the short-term and for 72 patients in the longer-term. Unilateral limb occlusion was observed in 2 patients (occurring on days 0 and 1 post-procedure); in 1 patient, pre-procedure severe iliac tortuosity and difficulty deploying the main body were noted. Both patients underwent secondary interventions (thrombectomy in one and fem-fem bypass in one). Also, 4 patients underwent secondary interventions in 4 additional limbs for kink, partial thrombosis and/or compression of iliac leg component, and 1 patient received placement of bilateral leg extensions to extend the original leg components which were considered too short. No Spiral-Z®-related endoleak, migration, component separation, or stent fractures have been reported. Twelve deaths were reported; none were related to limb occlusion.
CONCLUSIONS:
The Spiral-Z® leg graft is associated with excellent early patency rates. While data collection is ongoing, preliminary registry results support the performance of the Spiral-Z® leg graft in real-world practice, with a low limb occlusion rate and no migration, component separation, and stent fractures within 12 months.