Midterm pivotal trial results of the Talent Low Profile System for repair of abdominal aortic aneurysm: Analysis of complicated versus uncomplicated aortic necks

This study was undertaken to determine whether a complicated aortic neck is associated with unfavorable outcome after abdominal aortic aneurysm (AAA) endografting. In a prospective pivotal clinical trial, 237 consecutive patients underwent implantation of the bifurcated Talent Low Profile System. Patients were divided into 2 groups, those with complicated aortic necks (short, 28 mm; angulated, >45 degrees; calcified; and thrombus-lined) versus those with uncomplicated neck anatomy. Major outcome parameters included procedure time, operative blood loss, transfusion requirements, volume of contrast medium used during the implant procedure, endoleaks, migration, limb patency, AAA regression, conversion to open repair, morbidity, and mortality. Mean follow-up was 620.5 days. Overall, 32% of aortic necks were short, 19% were very short, 20% were dilated, 18% were calcified, 8.5% were thrombus-lined, and 19.9% were angulated. Thirty percent and 70% of patients, respectively, were stratified to the uncomplicated and complicated groups ( P < .01. Procedure time, operative blood loss, transfusions, volume of contrast medium used in the implant procedure, migration, endograft patency, AAA sac regression, conversion to open repair, and mortality were not significantly different in necks with complicated versus uncomplicated anatomy. At 21 months, sacs were regressing or stable in 98% (complicated) versus 96% (uncomplicated). Primary graft limb patency was 100% in both groups. The endoleak rate was 4.3% (complicated) versus 17% (uncomplicated) at 18 months, but this difference was not statistically significant. Adverse renal events, however, occurred in 27.5% (complicated) versus 13.6% (uncomplicated; P = .04). Complicated aortic neck is not associated with unfavorable outcome at midterm follow-up after AAA endografting. However, statistically more adverse renal events occur in patients with complicated neck anatomy.