Purpose: To present performance data on the use of the Aorfix stent-graft in patients with hostile infrarenal abdominal aortic aneurysm (AAA) anatomy.
Methods: A study protocol was designed to examine the safety and efficacy of the Aorfix endovascular stent-graft in AAA patients who had a proximal neck diameter between 18 and 30 mm, neck angulation between 60 degrees and 90 degrees , and/or severe iliac artery angulation/tortuosity. Between September 2005 and April 2009, 20 men (mean age 72.4+/-7.7 years, range 55-89) were enrolled in the study. The mean AAA diameter was 61.8+/-14.9 mm (range 45.5-102). The mean angulation of the proximal neck was 61.9 degrees +/-16.5 degrees (range 30 degrees -90 degrees ); in the iliac arteries, the angulation was 59.9 degrees +/-16.3 degrees (range 30 degrees -85 degrees ) for the left and 60.9 degrees +/-17.6 degrees (range 28 degrees -90 degrees ) on the right. Fourteen (70%) patients had >60 degrees proximal neck angulation. Outcome measures were analyzed using life-table analysis.
Results: The graft was successfully implanted in all but 1 patient (technical success 95%); failure to cannulate the contralateral iliac limb resulted in conversion to aortomonoiliac stent-graft placement. In 1 patient, bilateral renal artery stent rescue was performed due to severe procedure-related stenosis. Occlusion of an internal iliac artery was noted in 2 patients. Mean follow-up was 26.9 months (range 4.5-43.5). No aneurysm-related rupture or death occurred. Two endoleaks were observed: 1 type I without migration at 3 years and 1 type II at 13 months. Freedom from any type of endoleak was 91.6% at 1 year and 75.9% at 2 years. Freedom from any early or late intervention was 88.8% at 1 year and 76.0% at 2 years. Aneurysm sac shrinkage (>5 mm) was evident in 79% (11/14) of the cases reaching 12-month follow-up.
Conclusion: The Aorfix device seems to be safe and reliable in purely complex infrarenal AAA anatomy, demonstrating good short and midterm clinical outcomes. Further larger or multicenter studies are needed to confirm the suitability of the Aorfix stent-graft in hostile infrarenal AAA anatomy.