Mid-term outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system.

Abstract Background Endologix issued important safety updates for the AFX® Endovascular AAA System in 2016 and 2018 due to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe mid-term outcomes for a large cohort of patients who received an Endologix AFX® or AFX2® device. Study Design Data from an integrated healthcare system’s implant registry, which prospectively monitors all patients after endovascular aortic repair (EVAR), was used for this descriptive study. Patients undergoing EVAR with three AFX System variations (Strata [AFX-S], DuraplyTM [AFX-D], and AFX®2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (type I and type III), major reintervention, conversion to open, rupture, and mortality (aneurysm-related and all-cause) were estimated. Results Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range=2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI]=6.3-12.3), 12.0% (95% CI=9.1-15.9), and 8.8% (95% CI=6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI=4.8-13.0), 10.6% (95% CI=6.9-16.1), and 9.7% (95% CI=6.3-14.7); for AFX2 they were 14.1% (95% CI=4.7-38.2), 16.2% (95% CI=6.4-37.7), and 21.2% (95% CI=10.7-39.4). Conclusion Mid-term outcomes of a large US patient cohort with an Endologix AFX or AFX®2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events.