Possible implications of device-specific variability in post-endovascular aneurysm repair sac regression and endoleaks for surveillance categorization

Abstract

<p>Objective: Significant sac regression during early surveillance has been shown to best predict reintervention-free long-term surveillance after endovascular aneurysm repair (EVAR). Furthermore, a persistent endoleak has been related to a worse outcome. Individualized surveillance algorithms based on these findings have been suggested. There are no studies comparing the performance of different stent grafts regarding sac regression, the presence of type II endoleaks, and their possible implications for individualized surveillance. The objective of this study was to evaluate device-specific differences and how these may affect patient categorization for surveillance. Methods: Patients were treated electively with standard EVAR between 2005 and 2015 using three different devices (Zenith by Cook, Excluder by Gore, and Endurant by Medtronic). The data were reviewed retrospectively until 2020. Patients’ computed tomography angiographies (CTAs) at 30 days and at 2 years were analyzed for freedom from endoleaks and for sac regression of ≥5 mm. Reinterventions during long-term surveillance were counted. Patients were categorized according to the presence of any endoleak and sac regression at 30 days and 2 years, and the probability of reintervention-free long-term surveillance was evaluated based on these findings. Results: A total of 435 patients were treated for an abdominal aortic aneurysm with EVAR during the study period. At 30 days, 80.0% (n = 339) of the patients were free from endoleaks, and at 2 years, 78.9% (n = 273) were free from endoleaks. There was a significant difference in endoleak rate at 30 days and 2 years between the devices (P < .001 and P = .001). There was no significant difference in sac regression between the devices at 2 years (P = .096). The categorization at 30 days based on endoleak status had a sensitivity of 44.9%, specificity of 87.4%, and negative predictive value of 84.1% for finding a reintervention-requiring complication during long-term follow-up. The corresponding figures at 2 years were 63.3%, 91.4%, and 89.4%, respectively. The combination of freedom from endoleaks and sac regression of ≥5 mm in the 2-year CTA best predicted an uneventful long-term surveillance. Patients who met this criterion had a 95.6% probability (negative predictive value) of having a reintervention-free long-term surveillance. Conclusions: There are significant differences in the prevalence of endoleaks between devices at 30 days and 2 years, but there is no difference in sac regression. Patients with sac regression of ≥5 mm and no endoleaks in the 2-year CTA can be safely categorized for infrequent surveillance regardless of the stent graft model that has initially been used.</p>