Purpose: The purpose of this study was to assess the short-term and mid-term results of endovascular aneurysm repair with the Zenith stent graft in a single-center prospective study.
Method: Between October 1998 and July 2001, we used the Zenith stent graft for elective endovascular aneurysm repair in 116 patients, six of whom were women. The mean age was 75 years, and the mean aneurysm diameter was 60.3 +/- 8.8 mm. Stent grafts were oversized 10% to 20% relative to computed tomographic (CT) scan-based diameter measurements. All repairs were performed in the operating room through surgically exposed femoral arteries. The results were assessed before discharge with three-phase, contrast-enhanced CT scan and plain abdominal radiograph. These studies were repeated at 1, 6, 12, and 24 months after operation. Follow-up periods ranged from 1 to 34 months.
Results: No failed insertions and no conversions to open surgery occurred. The diameter of the main body of the stent graft was 28 mm or more in 73 patients (63%). Additional stents were inserted during surgery to treat kinking in eight patients (6.9%) and renal artery encroachment in two patients (1.7%). Mean fluoroscopy time was 35.1 +/- 18.3 minutes, contrast load was 146 +/- 53 mL (350 mg/mL), and estimated blood loss was 249 +/- 407 mL. The major complication rate was 9.5%, and the minor complication rate was 10.3%. The perioperative complications were myocardial infarction in four patients, arrythmia in four patients, and pulmonary embolism, renal failure, stroke, small bowel obstruction, femoral stenosis, digital embolism, and graft limb thrombosis in one patient each. All 116 patients went home from the hospital, but one patient died 2 weeks later of a combination of pulmonary embolism and myocardial infarction. Endoleak was seen on the first CT scan in 16 patients (15%); 15 were type II, and one was type III. No endoleaks of type I or IV were seen. Additional interventions were performed for each of the following conditions: type II endoleak (n = 4), type III endoleak (n = 1), femoral clamp injury (n = 1), renal artery stenosis (n = 1), and graft limb occlusion (n = 1). One patient had acute aneurysm dilatation and rupture caused by a type II endoleak through the inferior mesenteric artery 6 months after stent graft implantation. No cases were seen of late graft occlusion, stent graft migration, stent fracture, barb fracture, or secondary endoleak.
Conclusion: The Zenith device is safe, versatile, and effective in the short to medium term. Most patients need wide stent grafts (>or=28 mm proximally and >or=16 mm distally) to achieve 10% to 20% oversizing to prevent type I endoleak.