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WHAT THIS PAPER ADDSThe IceBERG study has included 100 patients treated with the Gore Excluder Iliac Branch Endoprosthesis for aorto-iliac aneurysms. Besides a satisfactory primary patency of the hypogastric branch and successful aneurysm exclusion, clinical outcomes were studied. Occlusions of the hypogastric branch occurred mostly during the first month after treatment but are not related to either buttock claudication, erectile function, walking ability or health status. However, a concomitant contralateral hypogastric occlusion is related to more erectile dysfunction.Objective: The Gore Excluder Iliac Branch Endoprosthesis (IBE) was developed to preserve perfusion in the hypogastric artery after endovascular repair of aorto-iliac aneurysms. This study reports the 12 month technical and clinical outcomes of treatment with this device. Methods: This study was a physician initiated international multicentre, prospective cohort study. The primary endpoint was primary patency of the hypogastric branch at 12 months. Secondary endpoints included technical and clinical outcomes. Patients with an indication for elective treatment with the Gore Excluder IBE were enrolled between March 2015 and August 2018. Baseline and procedural characteristics, imaging data, physical examinations and questionnaire data (Walking Impairment Questionnaire [WIQ], EuroQol-5-Dimensions [EQ5D], International Index of Erectile Function 5 [IIEF-5]) were collected through 12 month follow up. Results: One hundred patients were enrolled of which 97% were male, with a median age of 70.0 years (interquartile range [IQR] 64.5 e 75.5 years). An abdominal aortic aneurysm (AAA) above threshold for treatment was found in 42.7% and in the remaining patients the iliac artery diameter was the indication for treatment. The maximum common iliac artery (CIA) diameter on the Gore Excluder IBE treated side was 35.5 mm (IQR 30.8 e 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 e 193 minutes) with a median hospital stay of four days (IQR 3 e 5 days). Primary patency of the IBE at 12 month follow up was 91.3%. Primary patency for patients treated inside and outside the instructions for use were 91.8% and 85.7%, respectively (p ¼ .059). Freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively. CIA and AAA diameters decreased significantly through 12 months. IIEF-5 and EQ5D scores remained stable through follow up. Patency of the contralateral internal iliac artery led to better IIEF-5 outcomes. WIQ scores decreased at 30 days and returned to baseline values through 12 months. Conclusion: Use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms shows a satisfactory primary patency through 12 months, with significant decrease of diameters, a low re-intervention rate, and favourable clinical outcomes.

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After publication of a few such cases with the older Zenith device, the union between the suprarenal stent and main body was reinforced in 2002 to prevent this complication. Since modification of the device, this sequela had not been described. The reappearance of this complication underscores the need for continued surveillance, considering that these late events may require a reintervention to maintain the clinical success of the procedure.

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