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 owingto aneurysmal involvement of the iliac bifurcationinnine high-volumeEuropeanvascular centers. Amongthis 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.

Fargion, A.t., Masciello, F., Pratesi, C., Pratesi, G., Torsello, G., Donas, K.p., et al. (2018). Results of the multicenter pELVIS Registry for isolated common iliac aneurysms treated by the iliac branch device. JOURNAL OF VASCULAR SURGERY, 68(5), 1367-1373.e1 [10.1016/j.jvs.2018.02.032].

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

Pratesi G.;Ippoliti A.;Barbante M.;
2018-01-01

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 owingto aneurysmal involvement of the iliac bifurcationinnine high-volumeEuropeanvascular centers. Amongthis 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.
2018
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/22 - CHIRURGIA VASCOLARE
English
Endovascular aortic aneurysm repair; Endovascular iliac aneurysm repair; Iliac branch devices; Occlusion; Reintervention; Aged; Aged, 80 and over; Blood Vessel Prosthesis Implantation; Computed Tomography Angiography; Endovascular Procedures; Europe; Female; Humans; Iliac Aneurysm; Male; Middle Aged; Operative Time; Postoperative Complications; Product Surveillance, Postmarketing; Progression-Free Survival; Prosthesis Design; Registries; Reoperation; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Blood Vessel Prosthesis; Stents
Fargion, A.t., Masciello, F., Pratesi, C., Pratesi, G., Torsello, G., Donas, K.p., et al. (2018). Results of the multicenter pELVIS Registry for isolated common iliac aneurysms treated by the iliac branch device. JOURNAL OF VASCULAR SURGERY, 68(5), 1367-1373.e1 [10.1016/j.jvs.2018.02.032].
Fargion, At; Masciello, F; Pratesi, C; Pratesi, G; Torsello, G; Donas, Kp; Austermann, M; Weiss, K; Bosiers, M; Dorigo, W; Cao, P; Ferrer, C; Ippoliti, A; Barbante, M; Pitoulias, Ga; Verzini, F; Parlani, G; Simonte, G; Kolbel, T; Tsilimparis, N; Haulon, S; Branzan, D; Schmidt, A
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/233991
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