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The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry. DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year. From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion. At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence. This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up. [Display omitted] [ABSTRACT FROM AUTHOR]

This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice. When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems. From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates. Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%. This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up. [ABSTRACT FROM AUTHOR]

Abstract Background Aim of this study was to evaluate peri-procedural incidence of new diffusion-weighted-magnetic-resonance-imaging (DWMRI) brain lesions in CAS patients treated by carotid mesh stent (CGuard™) or closed-cell stent (Wallstent™). Methods Consecutive patients with asymptomatic carotid stenosis ≥ 70% were submitted to preoperative DW-MRI scan, to exclude the presence of preoperative silent cerebral lesions. Patients were randomized to CGuard or Wallstent. DWMRI was performed immediately after the intervention and at 72-hour postoperatively. Moreover, pre and postoperative Mini-Mental-State-Examination Test (MMSE) and a Montreal-Cognitive-Assessment (MoCA) test were conducted, and S100β and NSE neurobiomarkers were measured at 5-time points (preoperatively, 2, 12, 24, and 48 h postoperatively). Results From January 2015 to October 2016, sixty-one consecutive eligible patients were submitted to preoperative DWMRI scan. Three patients were excluded because of preoperative silent cerebral lesions. In 29 CGuard patients, 1 developed a minor stroke and 8 silent new lesions were observed in the 72 h-DWMRI (31%): 4 lesions were ipsilateral, and 4 lesions were contra or bilateral. In 29 Wallstent patients, 7 clinically-silent new lesions were found in the 72 h-DWMRI (24.1%; p = 0.38). In 4 cases lesions were ipsilateral and in 3 cases contra or bilateral. S100B values doubled at 48 h in 24 patients, and among them 12 presented new DWMRI lesions. 48-h S100B increase was significantly related to 72-h DWMRI lesions (p = 0.012). Conclusions In our experience both stents showed an acceptable rate of subclinical neurological events with no significant differences at 72-hour DWMRI between groups. Bilateral/contralateral lesions suggest that periprocedural neurological damage may have extra-carotid sources. Highlights • 3PCAS RCT compared microembolism rate after CGuard and Wallstent implantation. • Acceptable rates were detected by 72-h DWMRI in both treatment groups. • New 72-h DWMRI lesions' presence correlates positively with NPTs postop scores variation. • New 72-h DWMRI lesions' presence correlates positively with 48-h S100B increase. • A not-negligible rate of bilateral or contralateral lesions were detected at DWMRI. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the impact of two-dimensional and three-dimensional preoperative morphologic features analyzed on computed tomography (CT) angiography on midterm outcome in patients with abdominal aortic aneurysms (AAAs) treated with endovascular aneurysm repair (EVAR).Materials and Methods: A retrospective analysis was conducted using a prospectively collected database. Morphologic features considered as potentially influencing outcomes were maximum aortic diameter, thrombus area, overall aneurysm volume, and intrasac thrombus volume. Outcome measures were all perioperative and midterm AAA-related reinterventions and all-cause mortality.Results: Investigators reviewed 191 preoperative CT angiography scans. Mean maximum aortic diameter was 58 mm; thrombus area, 49.6%; aortic volume, 159.36 cm(3); and thrombus volume, 58.6%. Technical success was achieved in all cases. No reintervention was required in the perioperative period, and there was no perioperative mortality. At a mean follow-up of 32 months ± 16.8 (range, 3-66 mo), mortality rate was 9.4%, AAA-related death was 0, and reintervention rate was 8.9%. Causes of reintervention included type I endoleak (n = 3 [1.6%]), type II endoleak (n = 7 [3.7%]), type III endoleak (n = 1 [0.5%]), endograft limb thrombosis (n = 4 [2.1%]), and access vessel thrombosis (n = 2; 1%). Greater thrombus area (> 60%) and thrombus volume (> 59%) were predictors for reintervention (P = .005 and P = .0034). Greater maximum aortic diameter (> 59 mm) and aortic volume (> 159 cm(3)) were related to higher reintervention rate without statistical significance (P = .62 and P = .12). Aortic volume was a predictor of any adverse event, reintervention, and all-cause mortality after EVAR (P = .03).Conclusions: Thrombus area and volume are related to higher rates of reintervention. Maximum aortic diameter was related to a higher reintervention rate, but this was not significant. [ABSTRACT FROM AUTHOR]

Objective: Surgical arterial thromboembolectomy (TE) is an efficient treatment for acute arterial thromboemboli of lower limbs, especially if a single large artery is involved. Unfortunately, residual thrombus, propagation of thrombi, chronic atherosclerotic disease, and vessel injuries secondary to balloon catheter passage may limit the clinical success rate. Intraoperative angiography can identify any arterial imperfection after TE, which may be corrected simultaneously by endovascular techniques (so-called “hybrid procedures,” HP). The aim of this study is to compare outcomes of surgical TE vs HP in patients with acute lower limb ischemia (ALLI). Methods: From 2006 to 2012, 322 patients with ALLI were admitted to our department. Patients received urgent surgical treatment using only a Fogarty balloon catheter (TE group = 112) or in conjunction with endovascular completion (HP group = 210). In-hospital complications, 30-day mortality, primary and secondary patency, reintervention rate, limb salvage, and overall survival rates were calculated using the Kaplan-Meier method and compared by log-rank test. Results: HPs (n = 210) following surgical TE consisted of angioplasty (PTA) ± stenting in 90 cases, catheter-directed intra-arterial thrombolysis + PTA ± stenting in 24, thrombus fragmentation and aspiration by large guiding catheter + PTA ± stenting in 67, vacuum-based accelerated thromboaspiration by mechanical devices in 9, and primary covered stenting in 12. Estimated primary patency was 90.4% vs 70.4% at 2-year and 87.1% vs 66.3% at 5-year follow-up, respectively, for HP and TE patients (hazard ratio, 3.1; 95% confidence interval, 1.78-5.41; P < .01). A hazard ratio of 2.1 for limb salvage was noted for the HP group (95% confidence interval, 1.01-4.34; P = .03). Estimated freedom from reintervention at 1 year was 94.4% for HP vs 82.1% for TE patients, and 89% vs 73.7% at 5 years, respectively (P = .04). Conclusions: HPs for ALLI may represent the tools that, when applied to specific clinical scenarios, hold the potential to reduce the morbidity previously associated with acute arterial occlusion. [Copyright &y& Elsevier]