Purpose: To evaluate the efficacy and midterm results of the Zenith stent-graft in the treatment of abdominal aortic aneurysms (AAA).
Methods: Since March 1994, 364 patients have undergone endovascular repair of infrarenal AAA. Of the 94 who were treated with the Zenith stent-graft from 1996 to 2002, 88 patients (82 men; mean age 72.6 +/- 6.5 years, range 47-88) with at least 6-month follow-up were analyzed. Sixty-one (69.3%) patients were considered at high risk for intervention; 7 ruptured AAAs were treated emergently. In all, 68 (77.3%) bifurcated stent-grafts (including 18 TriFab systems) and 20 aortomonoiliac configurations were used. Cumulative data on endoleak, migration, secondary procedures, and survival were evaluated with Kaplan-Meier analyses.
Results: Implantation success was 97.7%; 2 (2.3%) access-related failures were converted to open repair (1 immediate, 1 at 3 months). There were 3 (3.4%) graft limb thromboses (2 immediate, 1 late), 3 (3.4%) cases of colon ischemia due to embolization in 1 and hypogastric artery occlusion in 2, and 1 (1.1%) renal infarction due to embolism. Three (3.4%) patients died within 30 days. Eleven (12.5%) endoleaks and 1 (1.1%) late endograft migration were recorded. The 5-year cumulative endoleak and migration rates were 15% and 7%, respectively. Sixty-three (71.6%) patients did not present any complication related to the repair during a mean follow-up of 20.6 +/- 14.9 months (range 6-68); notably, no complications were associated with the 18 TriFab systems. Six (6.8%) secondary procedures were performed (31% 5-year cumulative secondary procedural rate). All 6 (6.8%) aneurysm-related deaths (the 3 perioperative, 2 from late AAA rupture, and 1 during a secondary procedure) and 14 of 18 (20.4%) non-aneurysm-related deaths occurred in high-risk patients; the 5-year cumulative survival rates were 57% for any death and 92% for aneurysm-related deaths.
Conclusions: The Zenith stent-graft appears both safe and effective in terms of midterm outcome of endovascular aortic aneurysm repair.