Variable sac behavior after endovascular repair of abdominal aortic aneurysm: Analysis of core laboratory data

Objectives: The behavior of the aneurysm sac after endovascular grafting has been the subject of significant speculation. The importance of sac behavior is manifested by the correlation between aneurysm size or size change and risk for rupture, and potentially further extrapolated to define the need for secondary intervention. This study was undertaken to define graft-specific differences and the effect of endoleak on sac remodeling. Methods: Core laboratory data were obtained for three US Phase 11 clinical trials. Patients were included if they met anatomic inclusion criteria and underwent placement of the latest version of a bifurcated endovascular prosthesis. Unsupported Dacron (Ancure), supported Dacron (Zenith), and expanded polytetrafluoroethylene (Excluder) grafts were evaluated. Digitized images were electronically assessed for aneurysm size (area, maximum, minimum diameter) with National Institutes of Health Image software. Two blinded reviewers analyzed each radiographic study to ensure accurate image selection and establish the presence or absence of endoleak. A third reviewer adjudicated discrepancies. X 2 analysis and mixed nonlinear modeling were used to analyze the results. Results: Of 1506 patients evaluated, 723 (227 Ancure, 343 Excluder, 153 Zenith) met inclusion criteria for the study. Mean follow-up was 23.2 months (Ancure, 31.3 months; Excluder, 19.6 months; Zenith, 19.3 months). The incidence of any endoleak was 39.1% (Ancure, 58.1%; Excluder, 34.7%; Zenith, 20.9%; P < .001). Type of prosthesis, presence or absence of endoleak, and baseline size were determinants of rate of aneurysm shrinkage. Reduction in sac size was greatest with the Zenith graft, followed by the Ancure and Excluder grafts. Presence of endoleak had a moderating effect on rate of sac shrinkage with the Zenith and Ancure grafts; however, sac size increased in the presence of endoleak with the Excluder graft. Finally, baseline size was positively correlated with rate of aneurysm shrinkage. Conclusions: The behavior of the aneurysm sac depends on the type of prosthesis, presence or absence of endoleak, and baseline size of the sac. Differential sac behavior must be considered when determining the need for secondary interventions, timing follow-up studies, and assessing success or failure of endovascular repair.