Italian Registry Data Support Gore Excluder for Elective AAA Repair

December 30, 2013—Midterm results from the Italian Excluder Registry (ITER) were published by Carlo Pratesi, MD, et al in the Journal of Vascular Surgery (2014;59:52–57). ITER is evaluating elective endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) in an unsponsored, multicenter, clinical registry using the Gore Excluder endograft (Gore & Associates, Flagstaff, AZ).

According to the investigators, ITER is the largest unsponsored clinical registry using a single device and has the longest follow-up period thus far. This study is a retrospective analysis of a multicenter, prospective registry that involved nine centers in Italy. Periodic clinical and radiographic follow-up with CT scans were performed at 1, 6, and 12 months after the procedure and on a yearly basis thereafter.

As summarized in the Journal of Vascular Surgery, a total of 872 patients underwent elective EVAR. Primary technical success was 97.5%, and hospital mortality was 1% (nine of 872). At least 816 patients (93.6%) 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 two late AAA-related deaths observed at 21 and 36 months, respectively. Significant predictors of all-cause mortality included age (P < .001) and AAA maximum diameter (P = .027). The 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 cases (0.5%); two of these patients died after conversion. The rate of any reintervention was 9.4% (n = 77), and most were required within the first 24 months. The leading cause of reintervention was endoleak (n = 41; 5%). Limb thrombosis occurred in nine cases (1.1%). Freedom from reintervention rates at 1, 3, and 5 years of follow-up were 98.6%, 94.6%, and 86.5%, respectively, reported the ITER investigators.

The present experience confirms the effectiveness of elective EVAR for AAA using the Gore Excluder, with low rates of mortality, migration, reintervention, and limb thrombosis, concluded the investigators.