Endovascular Abdominal Aortic Aneurysm Repair Using an Anatomical Fixation Technique and Concomitant Suprarenal Orientation: Results of a Prospective, Multicenter Trial

Background: Endovascular repair of abdominal aortic aneurysms with the Endologix Powerlink System has been shown to be a safe and effective alternative to open surgery in patients having an aortic neck diameter of up to 26 mm. Wereport the mid-term outcomes of an endovascular repair approach wherein the infrarenal bifurcated stent graft was placed at the aortoiliac bifurcation, with concomitant placement of a proximal extension having suprarenal orientation for proximal sealing. Methods: Between 2006 and 2008, eight US sites enrolled 44 consecutive eligible patients presenting with abdominal aortic aneurysm in a prospective, single arm pivotal trial approved by the Food and Drug Administration. Each patient received a Powerlink infrarenal bifurcated stent graft through anatomical fixation at the aortoiliac bifurcation and a suprarenal extension to achieve proximal sealing. Analysis of the primary endpoint (proximal type I endoleak) was evaluated using contrast-enhanced computed tomography scans at 30 days, with on-going long-term follow-up for safety and treatment effectiveness. Results: Patients (89% male) presented at a mean age of 70 +/- 10 years with mean maximal aneurysm sac diameter of 5.5 cm. Challenging infrarenal aortic neck anatomy was present in 93% of patients. Technical success was 100% over a mean procedure time of 129 minutes. No aneurysm-related deaths, conversions, ruptures, migrations, or type III or IV endoleaks have been observed. The majority of endoleaks (80%) observed to date are type II. Currently, the primary clinical success rate is 93%. Two endovascular secondary procedures have been performed for resolution of type IA or type IB endoleak, and one surgical intervention was performed for resolution of limb occlusion. Significant reduction in sac diameter is observed to up to 2 years. Conclusions: The combination of an anatomically-fixed Powerlink infrarenal bifurcated stent graft and a suprarenal proximal extension safely and effectively excludes aneurysms in eligible patients. Longer term follow-up will determine the durability of these findings.