EXPERIENCE WITH THE STENTER ENDOGRAFT AT 4 ITALIAN CENTERS

Purpose: To report the outcome of an Italian multicenter trial of endo vascular abdominal aortic aneurysm (AAA) exclusion using the Stenter d evice. Methods: Between April 1995 and July 1996, 66 patients (63 men; average age 69 years, range 53 to 84) with infrarenal AAAs meeting th e inclusion criteria were enrolled. The average diameter of the aneury sm was 4.6 cm (range 4.2 to 7). Three (4.5%) of the 66 AAAs were anast omotic aneurysms. Results: Sixteen (25%) tubular and 50 (76%) bifurcat ed endograft procedures were attempted; 4 (6.1%) were converted and 1 terminated owing to technical faults with the bifurcated graft's secon d limb. One tube graft was too short and failed to exclude an anastomo tic aneurysm. Sixty (91%) endograft procedures were completed successf ully. Six (9.1%) vascular com plications occurred, th ree in one patie nt who subsequently died of pulmonary embolism 72 hours postoperativel y (1.5% mortality). There were four (6.1%) proximal endoleaks; two sea led spontaneously in < 1 month, and a third was converted (7.6% conver sion rate). The fourth is being observed. Clinical success (aneurysm e xclusion with no death or endoleak) at 30 days was 86.3% (57/66). In t he 23-month follow-up of 57 eligible patients, 2 patients died of unre lated causes and 1 graft limb thrombosed, requiring a crossover femora l bypass. One patient was converted to surgical repair at 5 months pos toperatively when increasing aneurysm size signaled an undisclosed end oleak (1.8% late conversion rate). Five other secondary endoleaks were treated with endovascular techniques. Conclusions: The Stenter was te chnically feasible in 10% to 40% of AAA candidates in this study, alth ough deployment of the second limb was problematic in the bifurcated d evice. Introduction of the second-generation Vanguard endograft brough t this study to an end.