Aorto-uni-iliac endograft for complex aortoiliac aneurysms compared with tube/bifurcation endografts: Results of the EVT/Guidant trials

Objective: Our objective was to present the results of the multicenter EVT/Guidant aorto-uni-iliac trial and to compare them with the tube, bifurcated graft, and open control series in regard to patient demographics, medical comorbidity, 30-day morbidity/mortality, and outcome at 1 year. Methods: One hundred twenty-one patients not eligible for tube or bifurcated endografts were entered into the aorto-uni-iliac trial (A-I). These were compared with 153 patients in a tube (T) group, 268 patients in a bifurcated endograft (BI) group, and 111 patients in an open control (C) group. Al data were audited and independently analyzed for presentation to the Food and Drug Administration. Results: Group demographics were similar with the following exceptions. Aneurysm diameter was significantly less in the T group (51.2 mm) but similar for the A-I (57 mm), BI (54.6 mm), and C (55.6 mm) groups (P < .001). There were more male patients in all endograft groups (A-I 92.6%, BI 89.5%, T 85.6% vs 76.6% for C, P = .002). Peripheral arterial occlusion was present more frequently in the A-I group (25.6% vs 13.8% BI, 10.5% T, and 10.8% C, P = .003). However, no differences were found in mean age, incidence of coronary artery disease, and American Society of Anesthesiologists III/IV classification. Implantation was achieved in 94.2% of the A-I group, 90.3% of the BI group, and 92% of the T group. No significant difference was seen in the operative mortality rate (4.2% A-I, 2.6% BI, 0% T, 2.7% C). Postoperative cardiac complications were similar for the A-I (22%) and C (20.7%) groups but significantly less for the BI and T groups (13.4% and 10.5%, P = .019), whereas pulmonary problems were significantly reduced in all endogaft groups (A-I 11.9%, BI 10.1%, and T 7.2% vs 22.5% for C, P = .002). Transient renal dysfunction occurred in 6.8% of the A-I group and 8.2% of the BI group but in only 3.3% of the T group and 1.8% of the C group (P = .028), Operating time was significantly longer for the A-I group than for the BI, T, or C groups (258 minutes vs 156, 179, and 174 minutes). Median blood loss, intensive care unit use, and hospital stays were markedly and significantly reduced in all endograft groups compared with the control group. The incidences of type I endoleak at 1 year were 2.4% A-I, 2.3% BI, and 3.8% T, and no ruptures occurred in any of the patients treated with endografts. No femoral-femoral graft thromboses occurred in the A-I group. Conclusion: Despite the fact that patients with combined aortic and iliac aneurysms have a more complex repair requirement and have an increased rate of comorbidity, the results are competitive with endovascular repair of aortic aneurysm by tube and bifurcated graft systems and are associated with a lower morbidity than open operation.