European Experience With a System for Bifurcated Stent-Graft Insertion

Abstract
To test an endovascular aneurysm exclusion system in the presence of a wide range of challenging anatomic features. Bifurcated endovascular stent-grafts were inserted in 52 patients and followed with serial computed tomography for up to 3 years. The device underwent several modifications during this time, the most significant of which represent the difference between the homemade (n = 42) and industry-made (n = 10) versions. The initial procedural success rate was 92% in the homemade group and 100% in the industry-made group. In the 3 years of follow-up, the long-term success rate was 64% in the homemade group and 90% in the industry-made group. The primary reasons for failure in the homemade group were graft thrombosis due to kinking early in the series and proximal stent migration later in our experience. All cases of migration occurred when the neck was < 15 mm in length, the neck was lined with thrombus, or the stent was implanted > 15 mm from the renal arteries. Kinking was subsequently overcome by implanting Wallstents throughout the graft limbs. The sole failure in the industry-made group was a case in which collateral perfusion reached the aneurysm through patent lumbar arteries. The fruits of this experience are a better technique, a better device, and, most importantly, a better understanding of the system's limits, as reflected in the current selection criteria.