Five-year outcomes of the Bi- versus Trimodular EndurantTM stent-graft in 100 patients with infrarenal abdominal aortic repair.

Abstract

BACKGROUND Recent studies on the Endurant™ endografts mainly compared outcomes of the bimodular stent graft to other manufacturer's endografts or reported results for cases outside manufacturer's instructions for use (IFU), while data on the experience of standard endovascular aortic repair (EVAR) of infrarenal abdominal aortic aneurysms (AAA) inside manufacturer's IFU comparing the bi- with the trimodular device is limited. METHODS Inclusion criteria were 1) infrarenal aneurysms (>50 mm diameter) treated by EndurantTM II (END II) or EndurantTM IIs (END IIs) stent graft inside manufacturer's IFU 2) available CTA with 1 mm reconstruction of the entire aorta prior to intervention. Endpoints comparing the devices included technical success, 30d mortality, rate of complications (bleeding with conversion to open repair, stent graft stenosis/occlusion, acute distal embolism, infection or postprocedural necessity of dialysis), endoleaks and re-interventions (5-year follow-up). Aneurysm sac diameters were compared between baseline pre-interventional CTA and last post-interventional CTA. RESULTS 100 patients (90% male, mean age 74y.) treated with END II (n=66) or END IIs (n=34) were included. Technical success was 99%. One procedure-related active bleeding occurred ending up in surgical conversion (END II n=1). 30d mortality was 0%. No initial type I/III endoleaks were present. Re-interventions were required in 19/100 (19%) of patients (END II n=10; END IIs n=9, p= 0.17). The outcome of EVAR including technical success, 30d mortality, rate of complications, endoleaks and re-interventions showed no significant differences comparing END II/IIs. CONCLUSIONS Five-year outcomes of EVAR show consistently safe and effective results for either END II or IIs device.