Ten-year outcome analysis of the Italian Excluder Registry with the Gore Excluder endograft for infrarenal abdominal aortic aneurysms

OBJECTIVE: The objective of this study was to report the 10-year outcomes of the multicenter Italian Excluder Registry for elective endovascular aneurysm repair (EVAR). METHODS: A retrospective analysis of all patients who underwent elective EVAR using the Gore Excluder (W. L. Gore & Associates, Flagstaff, Ariz) endograft (EG) at four Italian centers between 1998 and 2006 was carried out. Follow-up consisted of duplex ultrasound scan and computed tomography performed at 1 month, 6 months, and 12 months and yearly thereafter. Long-term outcomes were evaluated according to a life-table analysis. RESULTS: The Excluder EG was used in 461 patients (425 men; mean age, 72.9 ± 9.2 years) with abdominal aortic aneurysm (mean diameter, 52.2 ± 11.9 mm) who underwent elective EVAR. The 10-year cumulative survival was 62.5% ± 3.5% (95% confidence interval [CI], 55.5%-69.1%). During the follow-up, 14 (3.03%) patients were lost to follow-up. Estimated freedom from EG-related complication was 90.5% ± 1.5% (95% CI, 87.4%-92.9%) at 5 years, 89.2% ± 1.6% (95% CI, 85.6%-91.9%) at 7 years, and 88.4% ± 1.8% (95% CI, 84.4%-91.5%) at 10 years. Freedom from reintervention at 5, 7, and 10 years was 87.7% ± 1.8% (95% CI, 83.7%-90.8%), 82.4% ± 2.4% (95% CI, 77.2%-86.6%), and 80.6% ± 2.6% (95% CI, 75.5%-84.9%), respectively. On multivariable analysis, we did not find independent predictors of a higher rate of reintervention. There were 127 (27.5%) endoleaks detected during the follow-up. Only one type I endoleak was identified beyond 5-year follow-up. Cumulative freedom from endoleak rate was significantly different between the two different follow-up intervals (0-5 years, 2.6%; 6-10 years, 0.8%; P < .001). Estimated freedom from aorta-related mortality was 97.2% ± 0.8% (95% CI, 49.7%-99.9%) at 10 years. CONCLUSIONS: The Italian Excluder Registry outcomes confirmed sustained EVAR effectiveness at 10-year follow-up using the Gore Excluder EG. Freedom from EG-related complications, endoleaks, and reinterventions was satisfactory and remained acceptable beyond 5 years of follow-up, supporting a reasonable long-term durability of this device