ITalian Excluder Registry and results of Gore Excluder endograft for the treatment of elective infrarenal abdominal aortic aneurysms.

Abstract BACKGROUND: To report the midterm results of elective endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAAs) in a multicenter, clinical unsponsored registry using the Gore Excluder endograft. METHODS: This study is a retrospective analysis of a multicenter, prospective registry that involved nine centers in Italy. Periodic clinical and radiographic follow-up with computed tomography scans were performed at 1, 6, and 12 months after the procedure, and on a yearly basis thereafter. RESULTS: A total of 872 patients underwent elective EVAR. Primary technical success was 97.5%, and hospital mortality was 1.0% (9/872). At least 816 (93.6%) patients underwent a follow-up control. Freedom from all-cause death was estimated to be 97.9% at 1 year, 93.4% at 3 years, and 88.5% at 5 years. Aneurysm-related mortality was 1.6% (n = 13) with only two late AAA-related deaths observed at 21 and 36 months. Significant predictors of all-cause mortality included age (P < .001) and AAA maximum diameter (P = .027). Overall conversion rate was 2.3% (n = 19). Mean elapsed time from initial intervention to surgical conversion was 23 ± 18 months (range, 0-52 months). Late rupture was detected in four (0.5%) cases: two of these patients died after conversion. The rate of any reintervention was 9.4% (n = 77); most of them were required within the first 24 months. The leading cause of reintervention was endoleak (n = 41; 5.0%). Limb thrombosis occurred in nine (1.1%) cases. Freedom from reintervention at 1, 3, and 5 years of follow-up were 98.6%, 94.6%, and 86.5%. CONCLUSIONS: The ITalian Gore Excluder Registry is the largest clinical unsponsored registry using a single device, with the longest follow-up period so far. The present experience confirms the effectiveness of EVAR using the Gore Excluder with low rates of mortality, migration, reintervention, and limb thrombosis.