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12. A comparative trial of open versus stent graft repair of descending thoracic aneurysms.
R. Scott Mitchell, Michel S. Makaroun, Gregario Sicard, Richard P Cambria, David Williams, Joseph Bavaria; Stanford, CA; Pittsburgh, PA; St. Louis, MO; Boston, MA; Ann Arbor, MI; Philadelphia, PA

Objective: To compare the results of open versus endovascular repair of descending thoracic aortic aneurysms.
Methods: A multicenter, prospective, nonrandomized phase II trial of the Gore TAG endoprosthesis (W.L.Gore & Associates, Flagstaff, AZ) was conducted at 17 U.S. centers. Between September 1999 and May 2001, 236 patients were enrolled, and prospectively evaluated with aortography and spiral computed tomography of the chest abdomen and pelvis. Follow-up x-rays and CT scans were performed at 1,6, and 12 month intervals, and annually thereafter. Assessment included operative variables(operative time, blood loss, complications, ICU stay and hospital stay) and acturarial event free survival, and aneurysm-related and overall survival out to three years.
Results: Endovascular repair was successful for 142 of 145 patients.. Inadequate arterial access was responsible for the three failures. Mean age for open and endograft patients was similar, and mean aneurysm size xxx cm versus xxx cm. Males were more prevalent in both groups: 59% vs 57.7%. Procedure time(149 vs 306 minutes), operative blood loss (507 vs 2120 ml), ICU stay (3 vs 6 days) and total hospital length of stay (6 vs 13 days) was significantly less for the endograft group. Within 30 days, stent graft patients also experienced fewer adverse events (38 vs. 63%) and improved 30 day survival (99+2 vs. 94+5%).
At 24 months follow-up, in the stent graft group, endoleaks had developed in 6 pts.: migration at the proximal fixation site and inter-component migration had occurred in 3 and 4 pts respectively. 11 pts experienced aneurysm sac enlargement >5mm, but endovascular revision was necessary in only 1 pt. One pt required open conversion. There were no late ruptures. By Kaplan-Meier analysis, freedom from all mortality and aneurysm related mortality at 2 years was 75% and 97% respectively.
Conclusion: For patients with suitable anatomy, the Gore TAG thoracic endoprosthesis provides a satisfactory alternative for the repair of descending thoracic aortic aneurysms with significantly decreased operative mortality and morbidity compared with open repair. Overall survival at two years is similar.

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