Results of the multicenter pELVIS Registry for isolated common iliac aneurysms treated by the iliac branch device.

OBJECTIVE: We evaluated the short- and long-term results of off-label use of iliac branch devices (IBDs) in isolated common iliac artery aneurysms compared with the manufacturer-recommended configuration with additional extension in the infrarenal aorta based on the pELVIS Registry (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation). METHODS: Between January 2005 and April 2017, 804 patients underwent endovascular aneurysm repair with 910 IBDs owing to aneurysmal involvement of the iliac bifurcation in nine high-volume European vascular centers. Among this cohort, 231 IBDs were implanted in 207 patients to treat an isolated common iliac aneurysm; 91 IBDs (group 1) were implanted without proximal aortic extension in the infrarenal aorta, and in the remaining cases (n = 140; group 2) an aortic bifurcated stent graft was deployed proximally as stated in the instructions for use. Primary outcomes were IBD and target hypogastric artery occlusions, type I and III endoleaks, procedure-related reinterventions, and aneurysm-related deaths. RESULTS: Technical success was achieved in 90 cases (98.9%) in group 1 versus 137 cases (97.8%) in group 2 (P = .55). The overall aneurysm-related early reintervention rate for the two groups was 4.4% (4 of 91) and 2.1% (3 of 140), respectively (P = .33). The 30-day mortality was 1.1% in group 1 (n = 1), and 0% in group 2 (P = .21). The median postoperative follow-up in groups 1 and 2 were 34.1 months (range, 1-108 months) and 17.5 months (range, 1-90 months), respectively. The estimated rates of freedom from IBD occlusion at 60 months were 86% in group 1 and 83% in group 2 (P = .69). The estimated rates of freedom from target hypogastric artery occlusion at 60 months were 98.3% in group 1 and 91.3% in group 2 (P = .45). The estimated freedom from reintervention rates at 60 months for types I, types III, and IBD stenosis-occlusion were 78.2% in group 1 and 79.9% in group 2 (P = .79). The estimated freedom from all cause reintervention at 60 months was 64.5% in group 1 and 66.1% in group 2 (P = .44). The estimated freedom from aneurysm-related death at 60 months was 97.9% in group 1 and 100% in group 2 (P = .83). CONCLUSIONS: Single IBD placement for isolated common iliac artery aneurysms seems to be a safe and effective treatment option, when a proper anatomic patient selection is provided. Major benefits are represented by the decrease in X ray exposure, overall procedural time, and use of contrast medium, without affecting perioperative and long-term results in comparison with more extensive procedures.