The Italian trial of endovascular AAA exclusion using the Parodi endograft.
PURPOSE: To report the outcome of the prospective 11-center Italian Parodi Trial using straight and tapered endografts for the endovascular exclusion of abdominal aortic aneurysms (AAA). METHODS: From April 1994 to July 1995, 27 patients were evaluated and selected for endovascular AAA exclusion. The Parodi devices were delivered through femoral arteriotomies using 18 to 22F introducers and deployed by balloon expansion of the terminal stents. RESULTS: Of 27 cases attempted, 24 endografts (15 tube, 9 aortomonoiliac) were implanted (1 deployment and 2 access failures [11.1%] were converted). Three endoleaks (12.5%) were treated 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) causes; 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 graft 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 AAA diameter, while 10 (62%) had shrunk. CONCLUSIONS: The tube graft was applicable in only about 5% of cases, and accurate endograft sizing and distal fixation were problematic. The aortomonoiliac design was not appealing to surgeons but fared better in the long term. Given the advent of newer endograft models, the Italian Parodi Trial has been terminated.