OBJECTIVE: Several studies have confirmed the excellent early performance of the Endurant (Medtronic Endovascular, Santa Rosa, Calif) endoprosthesis to treat abdominal aortic aneurysms (AAAs). However, data about the long-term durability of the device are still lacking. We conducted this prospective two-center single-arm study to assess the late outcomes of the endograft in patients undergoing AAA repair. METHODS: An intention-to-treat analysis was performed for all comers with AAAs who were implanted with an Endurant endograft between November 2007 and December 2010. Clinical and radiologic data were prospectively collected and analyzed. The primary end point was any AAA-related reintervention. Secondary end points were overall mortality, aneurysm shrinkage, all types of endoleak, and device-related complications. RESULTS: During the study period, 273 patients underwent implantation of the Endurant stent graft. The median follow-up time for the primary end point was 42 months (interquartile range, 30.7-50.7). AAA-related reinterventions were required in 26 patients (10%), resulting in a reintervention-free probability of 93%, 90%, and 87% at 3, 4, and 5 years, respectively. The leading cause for reintervention was iliac limb occlusion (n = 10). Only one AAA-related death (0.3%) was reported within an overall mortality of 29% (n = 78). The median aneurysm shrinkage was 9 mm (interquartile range, 3-15). Five type I (2%) and one type III (0.4%) endoleaks were identified. No proximal and two distal limb migrations (1%) were observed. CONCLUSIONS: Our study confirms late durability of the Endurant endoprosthesis for AAA repair, with very encouraging freedom from reintervention rates and overall outcomes.
OBJECTIVE: Several studies have confirmed the excellent early performance of the Endurant (Medtronic Endovascular, Santa Rosa, Calif) endoprosthesis to treat abdominal aortic aneurysms (AAAs). However, data about the long-term durability of the device are still lacking. We conducted this prospective two-center single-arm study to assess the late outcomes of the endograft in patients undergoing AAA repair. METHODS: An intention-to-treat analysis was performed for all comers with AAAs who were implanted with an Endurant endograft between November 2007 and December 2010. Clinical and radiologic data were prospectively collected and analyzed. The primary end point was any AAA-related reintervention. Secondary end points were overall mortality, aneurysm shrinkage, all types of endoleak, and device-related complications. RESULTS: During the study period, 273 patients underwent implantation of the Endurant stent graft. The median follow-up time for the primary end point was 42 months (interquartile range, 30.7-50.7). AAA-related reinterventions were required in 26 patients (10%), resulting in a reintervention-free probability of 93%, 90%, and 87% at 3, 4, and 5 years, respectively. The leading cause for reintervention was iliac limb occlusion (n = 10). Only one AAA-related death (0.3%) was reported within an overall mortality of 29% (n = 78). The median aneurysm shrinkage was 9 mm (interquartile range, 3-15). Five type I (2%) and one type III (0.4%) endoleaks were identified. No proximal and two distal limb migrations (1%) were observed. CONCLUSIONS: Our study confirms late durability of the Endurant endoprosthesis for AAA repair, with very encouraging freedom from reintervention rates and overall outcomes.