Objective: To assess the long-term performance of the bifurcated Zenith stent graft.
Methods: A total of 325 patients (300 men and 25 women) underwent elective endovascular abdominal aortic aneurysm repair with bifurcated Zenith stent grafts between October 1998 and December 2005. Follow-up included routine contrast-enhanced computed tomography and multiview abdominal radiographs at 1, 6, and 12 months and yearly thereafter. Data on late-occurring (>30 days after stent-graft implantation) complications and interventions were collected prospectively.
Results: Of the original 325 patients, 92 have since died, resulting in a mean follow-up of 2.3 years (range, 1 month to 7.0 years). Nine (2.8%) of 325 patients required reintervention to treat or prevent endoleak (type I or III) or graft occlusion at an average of 1.4 years after stent-graft placement (range, 40 days to 4.0 years). Three (0.9%) of these patients died from causes related to malfunction of the stent graft: one each from aneurysm rupture, stent-graft infection, and infection of a femoral-femoral bypass graft placed after limb occlusion. Nineteen additional patients (5.8%) required treatment for type II endoleak, for a total reintervention rate of 8.6%.
Conclusions: Late failures of Zenith stent-graft attachment, structure, or function are rare. In the absence of known endoleak, routine follow-up imaging plays a limited role in the identification and prevention of impending failure.