• Vascular Annual Meeting
• General Information
• Call for Abstracts
• Exhibitor Information
• Future Meeting Dates
• Past Meeting Information
• Contact Us

The Powerlink Multicenter Trial: 5-Year Results

Jeffrey P Carpenter, Endologix Investigators.
University of Pennsylvania, Philadelphia, PA.

OBJECTIVES: To assess the results of open AAA repair versus EVAR using the Powerlink device.

METHODS: In a non-randomized Pivotal trial 258 patients were enrolled (192 Powerlink and 66 open surgical control patients) and followed (mean 42mo, range 0.03-69mo). CTA was obtained at 1, 6, and 12 months and annually.

RESULTS: Powerlink and Control patients were comparable with respect to demographics and comorbidity except that Powerlink patients were older (73 vs 69yo, P=0.0008). Technical success was achieved in 97.9% of patients. There was a significant difference in operative and perioperative outcomes favoring EVAR (table).

Over the long-term, however, the survival and adverse event benefit of EVAR was not sustained (figures). Freedom from AAA-related mortality with EVAR was 97.9%. Secondary procedures were performed for 26 patients, chiefly for treatment of endoleak. Endoleak-free survival was 77%. Type II endoleaks predominated (1 type I, no type III or IV). Migration occurred in 6 (3.1%) patients, one resulting in an endoleak. No migrations have been observed in patients for whom “anatomic fixation” technique (graft placement on the aortic bifurcation) was employed. Sac regression was noted in 82% of patients and endotension in 2 (1%). Significant reduction in mean AAA diameter and volume was noted over every interval. There have been no ruptures, fabric defects or wire fractures.

CONCLUSIONS: There is a perioperative benefit in survival and adverse events with EVAR compared with open AAA repair, but this benefit is not sustained. The Powerlink system safely and effectively protects patients from AAA rupture. The graft materials are durable.