Long-term Incidence And Management Of Type III Endoleaks In Early Generation Endologix Stent Grafts
Alexandra Forsyth, BA1, Daniel Alfson, MD1, Sarah Carlson, MD2, Michelle Martin, MD2, Joseph Raffetto, MD2, James McPhee2.
1Boston University School of Medicine, Boston, MA, USA, 2Veteran Affairs Boston Healthcare System, West Roxbury, MA, USA.
OBJECTIVES: Early generation Endologix AFX devices are at increased risk of developing Type 3a (intercomponent/overlap-related, T3a) as well as Type 3b (fabric tear, T3b) endoleaks over time. The purpose of this study was to examine the incidence and management of Type 3 Endoleaks (T3) associated with these devices over a long-termfollow-up period. METHODS: A retrospective single institution cohort analysis of all aortic Endologix devices implanted 3/2011-3/2016 was performed. Patient characteristics, imaging, and follow-up were obtained via chart review. T3s were characterized based on angiogram and/or operative findings and confirmed by 2 surgeons. Statistical Analysis was performed with SAS v9.4.
RESULTS: 60 patients underwent AFX stent graft implantation with Strata fabric for aneurysmal disease. Baseline characteristics are included in the Table.
|Median age at surgery in years, range||73.4, 58-90|
|History of Smoking||53 (88.3%)|
|Coronary artery disease||32 (53.3%)|
|Chronicobstructive pulmonary disease||20 (33.3%)|
|Chronic kidney disease (Cr>1.5)||5 (8.3%)|
|Taking anti-platelet therapy||46 (76.7%)|
|Taking anti-coagulation therapy||10 (16.7%)|
Longest patient follow-up was 8.6 years (median 5.2). Most AAAs(91.7%) were fusiform with initial median diameter 5.7cm. Initial 30-day mortality was 0%. Overall, 14(23.3%) T3 endoleaks were detected, of which 8(57.1%) were T3a and 6(42.9%) were T3b. Median time to T3 endoleak discovery was 4.8 years (range 10.8 months-7.2 years) and similar for T3a vs. T3b, p=0.39. Four patients(28.6%) had undergone prior sac coiling for Type 2 endoleaks with enlargement. Patients with T3 endoleaks had average sac growth of 1.3cm compared to a net decrease for non-T3 endoleaks, p<.0001. Of the 14 patients with T3 endoleaks, 12(85.7%) underwent reintervention, while 2(14.3%) refused. Nine patients(75%) underwent endovascular relining, 8(88.9%) were fully relined with Medtronic(55.5%), and Gore(33.3%) endografts. Three patients(25%) underwent graft explantation via retroperitoneal incision(66.6%) with suprarenal-crossclamp(100%). Reintervention 30-day mortality was 0% for all approaches. CONCLUSIONS: Early generation Endologix aortic stent-grafts with Strata have a high rate of T3Es (>20%). Most are not detected until several years (>4.5) after initial implantation, beyond the range of most validation studies. Long-term imaging surveillance is critical and a low threshold for complete relining or explantation should be considered with ongoing sac enlargement, even if endoleak is not readily demonstrated.
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