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Objective: We present the 5-year results of a prospective regulatory study of the INCRAFT device, a low-profile endovascular stent graft system for repair of abdominal aortic aneurysms., Methods: This was an open-label prospective nonrandomized single-arm study enrolling in centers in the United States and Japan. The primary effectiveness outcome was successful aneurysm treatment and the primary safety outcome was the incidence of major adverse events at 30 days after the procedure. Major long-term outcomes were mortality, reintervention, adverse limb outcomes, and suprarenal stent fracture., Results: One hundred and ninety patients (mean age, 73.8 ± 7.6 years; 90% male; 69% white and 30% Asian) were enrolled from 32 centers throughout the United States and Japan. Minimal access vessel size was less than 7 mm on both sides in 43.9% of the study cohort. Thirty-day major adverse events occurred in 3.2% of patients (6/190). Periprocedural technical success was 94.1% (176/187). Successful aneurysm treatment was 100% at 30 days and 87.9% at 1 year. Two patients required open conversion for thromboembolic complications, 3 developed new type I or III endoleaks, and 7 experienced graft or limb occlusion. Freedom from graft occlusion was 96 ± 2% at 1 year and 94 ± 2% at 5 years. Freedom from stent fracture was 97 ± 1% at 1 year and 87 ± 3% at 5 years. Freedom from aneurysm-related mortality was 99 ± 1% at 1 and 5 years., Conclusions: This study demonstrates good efficacy and safety and a very low rate of aneurysm related deaths with the INCRAFT device in a population with a high proportion of challenging anatomy., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter arterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). The purpose of this study was to investigate incidence and risk factors of contrast-induced nephropathy (CIN) after TACE in patients with HCC., Methods: In this single-center retrospective study, we examined 461 consecutive TACE sessions in 260 patients between January 2003 and October 2015. CIN was defined as an increase in serum creatinine levels by ≥ 0.5 mg/dl or ≥ 25% from baseline within 72 h after TACE. We calculated incidence rate of CIN and tried to identify its risk factors by logistic regression analysis., Results: Twenty-one cases of CIN (5%) were observed in 461 TACE sessions. One patient required subsequent hemodialysis transiently. In univariate analysis, tumor size > 5 cm [odds ratio (OR) 5.76, 95% confidence interval (CI) 2.34-14.14, p < 0.001], chronic kidney disease (OR 2.54, 95% CI 1.05-6.14, p = 0.04), serum hemoglobin level [OR 0.79 (per 1 g/dl increase), 95% CI 0.64-0.98, p = 0.03] and serum albumin level [OR 0.44 (per 1 g/dl increase), 95% CI 0.19-1.02, p = 0.05] were associated with the development of CIN. Stepwise logistic regression methods showed that tumor size > 5 cm (OR 7.81, 95% CI 2.99-20.46, p < 0.001) and serum albumin [OR 0.29 (per 1 g/dl increase), 95% CI 0.11-0.75, p = 0.01] were risk factors of CIN., Conclusions: In this study, HCC tumor size and lower serum albumin level were independent predictors of CIN after TACE.

Objective: We aimed to retrospectively analyze incidence, risk factors, and management of postoperative stent graft (SG) infection after endovascular aneurysm repair (EVAR)., Methods: We evaluated patients who underwent EVAR for infrarenal abdominal aortic aneurysm at our institution between July 2006 and December 2014. The primary end point was SG infection. We compared patients' demographics between the infection (group I) and noninfection (group NI) groups and reviewed management and outcomes in group I. A risk factor for SG infection was assessed by multivariable logistic regression. Patients without aortoenteric fistula (AEF) were treated with conservative therapy for SG infection., Results: A total of 1202 patients underwent EVAR for infrarenal abdominal aortic aneurysm. During a mean follow-up of 43.9 ± 30.4 months, SG infection occurred in 15 cases (incidence, 3.5/1000 person-years). The median time between initial EVAR and detection of infection was 30 months (range, 14 days-86 months). Freedom from SG infection at 1 year, 3 years, and 5 years was 99.5%, 99.2%, and 98.2%, respectively. There were no differences in age, sex, comorbidities, and SG type between the groups. Coil embolization of the hypogastric artery was more frequent in group I (60% vs 31%). During follow-up before infection, type II endoleak (47% vs 24%), sac enlargement (40% vs 16%), and multiple reinterventions (13% vs 2%) were significantly higher in group I; however, after multivariate analysis, only coil embolization of the hypogastric artery (odds ratio, 3.22; 95% confidence interval, 1.12-9.24; P = .029) remained a significant predictor. Among the 15 patients, four had AEF and six bacteriologic species were detected in five patients (33%). Twelve patients (80%) were treated with conservative therapy; three underwent surgical therapy (two patients with SG resection, omentum patching, and extra-anatomic bypass with fistula closure or partial duodenectomy and one patient with graft preservation, irrigation, omentum patching, and aneurysmorrhaphy). In-hospital mortality occurred in three cases; two cases were due to sepsis after conservative therapy, and one case was due to aortic stump rupture after surgical therapy. Excluding in-hospital mortality cases, during a median follow-up of 31 (range, 2-76) months, five patients were lost because of cancer or senility. There was no aneurysm-related death or recurrence of SG infection., Conclusions: Concomitant coil embolization was a risk factor for SG infection. For patients with AEF, surgical therapy remains the first-line treatment of SG infection after EVAR; however, conservative therapy is a viable option for SG infection in patients without AEF, particularly considering patients' comorbidities and limited life expectancy., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)