THE ITALIAN TRIAL OF ENDOVASCULAR AAA EXCLUSION USING THE PARODI ENDOGRAFT

Purpose: To report the outcome of the prospective Ii-center Italian Pa rodi Trial using straight and tapered endografts for the endovascular exclusion of abdominal aortic aneurysms (AAA). Methods: From April 199 4 to July 1995, 27 patients were evaluated and selected for endovascul ar AAA exclusion. The Parodi devices were delivered through femoral ar teriotomies using 18 to 22F introducers and deployed by balloon expans ion of the terminal stents. Results: Of 27 cases attempted, 24 endogra fts (15 tube, 9 aortomonoiliac) were implanted (1 deployment and 2 acc ess failures [11.1%] were converted). Th ree endoleaks (12.5%) were tr eated intraoperatively with covered stents, two successfully, and the third sealed within 30 days. Three (12.5%) of the 24 treated patients died in-hospital of device- (n = 2) and procedure-related (n = 1) caus es; the remaining 21 patients were discharged within 8 days. Of the 8 aortomonoiliac grafts in follow-up, only 1 (12.5%) failed in the mean 23-month (range 18 to 30) follow-up; however, 4 (31%,) Of 13 tube graf t patients were converted to surgery within 18 months. Of the 16 (66.7 %) surviving endografts at 2 years, 6 (38%) showed no change in the AA A diameter, while 10 (62%) had shrunk. Conclusions: The tube graft was applicable in only about 5% of cases, and accurate endograft sizing a nd distal fixation were problematic. The aortomonoiliac design was not appealing to surgeons but fared better in the long term. Given the ad vent of newer endograft models, the Italian Parodi Trial has been term inated.