Treatment of Large Neck Aortic Aneurysms with the Powerlink System

O. William Brown, MD
Vascular Surgery, William Beaumont Hospital, Bingham Farms, MI

Objectives: To present the clinical trial design for treating aneurysms with large aortic necks with the Powerlink System.
Methods: A prospective, controlled, multicenter IDE trial of the Powerlink 34mm Infrarenal Cuff used with the Powerlink 28mm Bifurcated Stent Graft is being conducted at seven sites in the US. Enrollment is going at the sites. CT-based aneurysm measurements were obtained using criteria for the aortic neck of 23-32mm. All repairs are being performed in the operating room through one surgically exposed femoral artery and a contralateral 9 French sheath.
Results: All patients have met the anatomical requirements for the Powerlink 28mm Infrarenal Bifurcated Stent Graft. After initial placement of the stent graft, a 34mm Infrarenal Cuff is placed. Patients are being followed with CT evaluation at 1 month, 6 months, 12 months post-implant and annually.
Four year clinical data on the Powerlink System include 192 patients enrolled between July 2000 and March 2003. Mean follow-up is 36.14 months (0-62 mos). Survival at 4 years (all cause and aneurysm-related) was 82.1% and 97.9%. Freedom from device-related secondary procedures at 4 years was 88.6%. Freedom from device-related endoleak was 96.1%. Infrarenal cuffs (89) were used in 78 patients (4 did not receive the endograft). The current trial requires use of a 34mm Infrarenal Cuff with a 28mm Bifurcated Stent Graft in every patient enrolled in the trial.
Conclusions: The Powerlink System appears to be safe and effective in protecting patients from AAA rupture over the follow-up period. The low rate of device-related endoleaks appears to enhance its effectiveness. Results of the 34mm cuff/28mm stent graft will address the effectiveness of treating larger aortic neck anatomy.
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