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Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Early results from a Canadian multicenter prospective registry of the Endurant stent graft for endovascular treatment of abdominal aortic aneurysms.
Journal of Endovascular Therapy 2012 Februrary
PURPOSE: To report the early results of a multicenter registry of endovascular aneurysm repair (EVAR) using the Endurant stent-graft.
METHODS: Patients having elective treatment of infrarenal abdominal aortic aneurysm (AAA) with the Endurant stent-graft at 3 Canadian centers were enrolled in a prospective registry between September 2008 and January 2010. In the 16-month period, 111 patients (90 men; mean age 75 years, range 53-93) were registered. Thirty-seven (33.3%) patients had challenging anatomy: short proximal aortic necks (n=17), large diameter (>28 mm) aortic necks (n=4), angulated (>60°) necks (n=3), and small (<15 mm) external iliac arteries (n=21). Outcomes evaluated included survival, endoleak, aneurysm expansion >5 mm, secondary intervention, stent-graft migration, and graft thrombosis.
RESULTS: The overall technical success rate was 100%. Nineteen (17.1%) patients experienced perioperative complications. After a mean follow-up of 6 months (range 0.1-16), mortality in the series was 4.5%: 1 perioperative death (multisystem organ failure) and 4 (3.6%) late deaths (3 cardiac, 1 cancer). Clinical and imaging follow-up past the perioperative period were available in 107 (96.4%) and 99 (89.2%) patients, respectively. Among the latter, 9 (9.1%) had a type II endoleak on the first scan; 4 resolved spontaneously. Three (3.0%) patients developed graft limb thrombosis in follow-up; one required an intervention. There was no graft migration, aneurysm expansion, secondary intervention for endoleak, aneurysm rupture, or conversion.
CONCLUSION: Early results from this prospective multicenter registry indicate that the Endurant stent-graft is a safe option for elective EVAR in selected AAA patients. Longer follow-up is required to determine the durability of these outcomes.
METHODS: Patients having elective treatment of infrarenal abdominal aortic aneurysm (AAA) with the Endurant stent-graft at 3 Canadian centers were enrolled in a prospective registry between September 2008 and January 2010. In the 16-month period, 111 patients (90 men; mean age 75 years, range 53-93) were registered. Thirty-seven (33.3%) patients had challenging anatomy: short proximal aortic necks (n=17), large diameter (>28 mm) aortic necks (n=4), angulated (>60°) necks (n=3), and small (<15 mm) external iliac arteries (n=21). Outcomes evaluated included survival, endoleak, aneurysm expansion >5 mm, secondary intervention, stent-graft migration, and graft thrombosis.
RESULTS: The overall technical success rate was 100%. Nineteen (17.1%) patients experienced perioperative complications. After a mean follow-up of 6 months (range 0.1-16), mortality in the series was 4.5%: 1 perioperative death (multisystem organ failure) and 4 (3.6%) late deaths (3 cardiac, 1 cancer). Clinical and imaging follow-up past the perioperative period were available in 107 (96.4%) and 99 (89.2%) patients, respectively. Among the latter, 9 (9.1%) had a type II endoleak on the first scan; 4 resolved spontaneously. Three (3.0%) patients developed graft limb thrombosis in follow-up; one required an intervention. There was no graft migration, aneurysm expansion, secondary intervention for endoleak, aneurysm rupture, or conversion.
CONCLUSION: Early results from this prospective multicenter registry indicate that the Endurant stent-graft is a safe option for elective EVAR in selected AAA patients. Longer follow-up is required to determine the durability of these outcomes.
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