Experience with the Stentor endograft at four Italian centers.

Abstract

Purpose: To report the outcome of an Italian multicenter trial of endovascular abdominal aortic aneurysm (AAA) exclusion using the Stentor device.

Methods: Between April 1995 and July 1996, 66 patients (63 men; average age 69 years, range 53 to 84) with infrarenal AAAs meeting the inclusion criteria were enrolled. The average diameter of the aneurysm was 4.6 cm (range 4.2 to 7). Three (4.5%) of the 66 AAAs were anastomotic aneurysms.

Results: Sixteen (25%) tubular and 50 (76%) bifurcated endograft procedures were attempted; 4 (6.1%) were converted and 1 terminated owing to technical faults with the bifurcated graft's second limb. One tube graft was too short and failed to exclude an anastomotic aneurysm. Sixty (91%) endograft procedures were completed successfully. Six (9.1%) vascular complications occurred, three in one patient who subsequently died of pulmonary embolism 72 hours postoperatively (1.5% mortality). There were four (6.1%) proximal endoleaks; two sealed spontaneously in < 1 month, and a third was converted (7.6% conversion rate). The fourth is being observed. Clinical success (aneurysm exclusion with no death or endoleak) at 30 days was 86.3% (57/66). In the 23-month follow-up of 57 eligible patients, 2 patients died of unrelated causes and 1 graft limb thrombosed, requiring a crossover femoral bypass. One patient was converted to surgical repair at 5 months postoperatively when increasing aneurysm size signaled an undisclosed endoleak (1.8% late conversion rate). Five other secondary endoleaks were treated with endovascular techniques.

Conclusions: The Stentor was technically feasible in 10% to 40% of AAA candidates in this study, although deployment of the second limb was problematic in the bifurcated device. Introduction of the second-generation Vanguard endograft brought this study to an end.