Aaron T Fargion1, Fabrizio Masciello2, Carlo Pratesi2, Giovanni Pratesi3, Giovanni Torsello4, Konstantinos P Donas4. 1. Department of Vascular Surgery, University of Florence, Florence, Italy. Electronic address: aaronthomas.fargion@unifi.it. 2. Department of Vascular Surgery, University of Florence, Florence, Italy. 3. Department of Vascular Surgery, University of Rome Tor Vergata, Rome, Italy. 4. Clinic of Vascular and Endovascular Surgery, University of Münster and Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany.
Abstract
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.
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.