Background: To evaluate the real-world safety and mid-term clinical performance of the Ankura™ AAA Stent Graft System in patients undergoing endovascular aneurysm repair (EVAR). Materials and Methods: This prospective, multicenter PMCF study analyzed 100 patients with abdominal aortic aneurysms (AAAs). Patients were monitored for a mean duration of 2.26 years. Primary endpoints included 30-day major adverse events and 24-month treatment success. Statistical evaluation of risk factors for reintervention was performed using univariate logistic regression. Results: The study cohort was predominantly male (97%), with a mean age of 72.01 years. Hypertension (90%) and smoking (89%) were the most prevalent comorbidities. Regarding the primary endpoints, the 30-day MAE rate was 2%. During the overall follow-up (mean 2.26 years), the primary patency rate was 97%, demonstrating high structural integrity and sustained patency. However, the overall freedom from reintervention rate was 74%, corresponding to a 26% reintervention requirement and a 27% incidence of endoleak. Reinterventions were almost exclusively driven by these post-procedural morphological complications; specifically, 26 of the 27 patients with endoleaks required a secondary procedure. No preoperative clinical or anatomical parameters were identified as significant independent predictors of reintervention in the univariate analysis (p > 0.05). The overall mortality rate was 12%, with 0% aneurysm-related mortality. Conclusions: Mid-term success and reintervention after EVAR with the Ankura™ system are primarily driven by postoperative morphological complications, such as endoleaks, rather than baseline patient risk profiles. These findings underscore the critical importance of rigorous, lifelong radiological surveillance regardless of preoperative anatomical challenges.
Ozsar et al. (Thu,) studied this question.