The aim of this study is to determine Previous publications have documented high rates of delayed endoleaks in the Endologix (Irvine, Calif) AFX1 (Strata) grafts. In a safety communication from October 2019, the Food and Drug Administration recommended “benefit-risk determination for each individual patient … to assess the need for additional procedures related to the risk of developing type III endoleaks.” The goal of this study was to assess long-term outcomes of AFX1 grafts to develop more specific recommendations for the follow-up and management of patients with this device. A retrospective review was performed of a single tertiary center’s experience comparing AFX1 grafts (n = 122) with a control cohort (Medtronic, Gore, Cook; n = 101) placed between December 2012 and April 2019. AFX1 was the favored graft in the early experience. The primary study end point was freedom from any abdominal aortic aneurysm (AAA)-related major complication (non-type II endoleak, graft relining, or graft explantation). Secondary end points were 5-year survival, freedom from any endoleak, and freedom from any reintervention. Event rates were calculated by Kaplan-Meier and life-table analysis.
Patient demographics, average AAA diameter, and proportion of elective procedures were comparable between cohorts. Median follow-up was longer for the AFX1 compared with the control cohort.
Reference link- https://www.jvascsurg.org/article/S0741-5214(20)31452-X/fulltext
