Objective: We compared the results of endovascular repair using the Powerlink endovascular graft with conventional open abdominal aortic aneurysm repair through a 6-year follow-up period.
Methods: Two hundred fifty-eight patients with abdominal aortic aneurysms were prospectively enrolled in a multicenter trial and underwent endovascular repair (N = 192) or conventional open surgery (N = 66). All endovascular repairs were approached through a surgically exposed femoral artery and a percutaneously accessed femoral artery. Study endpoints included all-cause mortality and morbidity. Follow-up imaging consisted of contrast-enhanced CT scans and plain abdominal x-rays at 1, 6, 12 months, and annually postoperatively.
Results: Technical success was achieved in 97.9% of test patients, with four failed insertions (three early conversions because of deployment issues, one access failure). Mean follow-up was 4.1 +/- 1.7 years (test group) and 3.1 +/- 1.9 years (control group). Perioperative morbidity and mortality were significantly reduced in the test group compared with the control group (P < .05). At 6 years, all-cause mortality and morbidity was no different in the Powerlink group compared with the open repair group. There were no reported stent fractures, graft disruptions, or aneurysm ruptures. Core laboratory-reported endoleaks included proximal or distal type I (n = 1) and type I/II (n = 3), with no type III or type IV endoleaks. One explant (0.5%) was undertaken to resolve a refractory type I endoleak. A total of 37 secondary procedures were performed in 26 patients to treat site-reported endoleak (n = 26; 7 for type I and 19 for type II), graft limb occlusion (n = 7), native artery occlusion (n = 3), or endograft migration (n = 1). A reduction in mean aneurysm sac diameters and volumes has been noted at every follow-up interval.
Conclusion: Consistent with other reports, perioperative morbidity and mortality were significantly reduced in the endovascular group compared with the open repair group. Six-year follow-up of patients treated with the Powerlink system demonstrates the continued safety and efficacy of its treatment of abdominal aortic aneurysm.