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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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Background: The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction is an endovascular technique, developed to reconstruct the aortic bifurcation in the most optimal anatomical and physiological manner. Short-term data were promising, but long-term data are still lacking. The objective was to report the long-term outcomes of CERAB for extensive aorto-iliac occlusive disease and to identify predictors for loss of primary patency. Methods: Consecutive electively treated patients with CERAB for aorto-iliac occlusive disease in a single hospital were identified and analyzed. Baseline and procedural data and follow-up were collected at 6-weeks, 6 months, 12 months, and annually thereafter. Technical success, procedural, and 30-day complications were evaluated, as well as overall survival. Patency and freedom from target lesion revascularization rates were analyzed using Kaplan Meier curves. Uni- and multivariate analysis were performed to identify possible predictors of failure. Results: One hundred and sixty patients were included (79 male). Indication for treatment was intermittent claudication for 121 patients (75.6%) and 133 patients (83.1%) had a TASC-II D lesion. Technical success was obtained in 95.6% of patients and the 30-day mortality rate was 1.3%. The 5-year primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization (CD-TLR) rate of 84.4%. The strongest predictor of loss of primary patency of CERAB was a previous aorto-iliac intervention (odds ratio [OR]=5.36 (95% confidence interval [CI]: 1.30; 22.07), p=0.020). In patients not previously treated in the aorto-iliac tract, 5-year primary, primary assisted, and secondary patency rates were 85.1%, 94.4%, and 96.9%, respectively. At 5-year follow-up, an improved Rutherford was found in 97.9% of patients and the freedom from major amputation rate was 100%. Conclusion: The CERAB technique is related to good long-term outcomes, particularly in primary cases. In patients that had prior treatment for aorto-iliac occlusive disease, there were more reinterventions and therefore surveillance should likely be more intense. Clinical Impact The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction was designed to improve outcomes of endovascular treatment of extensive aorto-iliac occlusive disease. At 5-year follow-up clinical improvement was found in 97.9% of patients without major amputations. The 5-year overall primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization rate of 84.4%. Significantly better patency rates were observed for patients that were never treated before in the target area. The data implicate that CERAB are a valid treatment option for patients with extensive aorto-iliac occlusive disease. For patients previously treated in the target area, other treatment options might be considered, or more intensive follow-up surveillance is warranted.

Background: Accurate determination of probable surgical outcomes is fundamental in decision-making regarding appropriate abdominal aortic aneurysm treatment. These outcomes depend, among other factors, on patient-related factors such as physical fitness. The primary aim of this study was to evaluate the correlation between physical fitness, measured by the metabolic equivalent of task (MET) score and the five-factor Modified Frailty Index (MFI-5), and all-cause mortality.Methods: Four hundred twenty-nine patients undergoing elective endovascular treatment of an infrarenal aortic aneurysm (EVAR) from January 2011 to September 2018 were identified in an existing local abdominal aortic aneurysm database. Physical fitness was measured by the MFI-5 and the METs as registered during preoperative screening. The primary end point was 1-year all-cause mortality and secondary end points included 5-year all-cause mortality, freedom from aneurysm-related mortality and aneurysm-related reinterventions. Correlations were analyzed using Spearman's rho and survival was analyzed using Kaplan-Meier analyses. The effect of physical fitness on mortality was assessed by binary logistics regression analyses.Results: There was a positive correlation between the MFI-5 and 1-year all-cause mortality (Rho ¼ 0.163; P ¼ .001), but not between the METs and 1-year all-cause mortality (Rho ¼ e0.083; P ¼ .124). A significant correlation between both MFI-5 and METs and 5-year all-cause mortality was observed (Rho ¼ 0.255; P < .001 and Rho ¼ e0.154; P ¼ .004). When stratified by the MFI-5, the 1-and 5-year follow-up survival rates were 95.1% and 85.9%, respectively, in the group with the lowest MFI-5 and 74.5% and 33.1% in the group with the highest MFI-5 score (P ¼ .007 and P < .001). When stratified by METs categories for 1-year follow-up, no significant differences in survival between the groups were observed (P ¼ .090). The 5year follow-up survival rate was 39.4% in the lowest METs category and 76.3% in the highest METs category (P ¼ .039). Logistic regression analysis, assessing the impact of age, sex, METs, and the MFI-5 on the risk of all-cause mortality, showed that only age and the MFI-5 made a significant contribution. Conclusions:There is a significant positive association between the MFI-5 and both the 1-and 5-year all-cause mortality rates after EVAR; METs only correlated with the 5-year all-cause mortality. Only age and the MFI-5 contributed to predicting overall survival after EVAR; therefore, it could be recommended to add the MFI-5 for guidance in preoperative counselling.