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Background: Stent-assisted carotid artery revascularization employing surgical cutdown for transcervical access and dynamic flow reversal (TCAR) is gaining popularity. TCAR, despite maximized intra-procedural cerebral protection, shows a marked excess of 30-day neurologic complications in symptomatic vs. asymptomatic stenoses. The TCAR conventional single-layer stent (free-cell area 5.89mm 2 ) inability to seal embologenic lesions may be particularly relevant after the flow reversal neuroprotection is terminated., Methods: We evaluated peri-procedural and 30-day major adverse cerebral and cardiac events (MACCE) of TCAR (ENROUTE, SilkRoad Medical) paired with MicroNET-covered neuroprotective stent (CGuard, InspireMD) in consecutive patients at elevated risk of complications with transfemoral/transradial filter-protected stenting (increased lesion-related and/or access-related risk). CGuard (MicroNET free cell area ≈0.02-0.03 mm 2 ) has level-1 evidence for reducing intra- and abolishing post-procedural lesion-related cerebral embolism., Results: One hundred and six increased-risk patients (age 72 [61-76] years, median [Q1-Q3]; 60.4% symptomatic, 49.1% diabetic, 36.8% women, 61.3% left-sided index lesion) were enrolled in three vascular surgery centers. Angiographic stenosis severity was 81 (75-91)%, lesion length 21 (15-26)mm, increased-risk lesional characteristics 87.7%. Study stent use was 100% (no other stent types). 74.5% lesions were predilated; post-dilatation rate was 90.6%. Flow reversal duration was 8 (5-11)min. One stroke (0.9%) occurred in an asymptomatic patient prior to establishing neuroprotection (index lesion disruption with the sheath insertion wire); there were no other peri-procedural MACCE. No further adverse events occurred by 30-days. 30-day stent patency was 100% with normal velocities and absence of any in-stent material by Duplex Doppler., Conclusions: Despite a high proportion of increased-risk lesions and clinically symptomatic patients in this study, TCAR employing the MicroNET-covered anti-embolic stent showed 30-day MACCE rate <1%. This suggests a clinical role for combining maximized intra-procedural prevention of cerebral embolism by dynamic flow reversal with anti-embolic stent prevention of peri- and post-procedural cerebral embolism (TOPGUARD NCT04547387).

Optimal management of patients with internal carotid artery (ICA) stenosis concurrent with severe cardiac disease remains undefined. The aim of this study is to evaluate the safety and feasibility of the one-day, sequential approach by carotid artery stenting (CAS) immediately followed by cardiac surgery. The study included 70 consecutive patients with symptomatic > 50% or ⩾ 80% asymptomatic ICA stenosis coexisting with severe coronary/valve disease, who underwent one-day, sequential CAS + cardiac surgery. The majority of patients (85.7%) had CSS class III or IV angina and 10% had non-ST elevation myocardial infarction. The EuroSCORE II risk was 2.4% (IQR 1.69-3.19%). All CAS procedures were performed according to the 'tailored' algorithm with a substantial use of proximal neuroprotection devices of 44.3%. Closed-cell (75.7%) and mesh-covered (18.6%) stents were implanted in most cases. The majority of patients underwent isolated coronary artery bypass grafting (88.6%) or isolated valve replacement (7.1%). No major adverse cardiac and cerebrovascular events (MACCE) occurred at the CAS stage. There were three (4.3%) perioperative MACCE: one myocardial infarction and two deaths. All MACCE were related to cardiac surgery and were due to the high surgical risk profile of the patients. Up to 30 days, no further MACCE were observed. No perioperative or 30-day neurological complications occurred. In this patient series, one-day, sequential CAS and cardiac surgery was relatively safe and did not result in neurological complications. Thus, a strategy of preoperative CAS could be considered for patients with severe or symptomatic ICA stenosis who require urgent cardiac surgery.

Objectives: To assess safety and efficacy of carotid artery stenting (CAS) according to "tailored-CAS" algorithm in the elderly (≥75 years) in relation to younger patients., Background: Although CAS has grown as an alternative to carotid endarterectomy the data on safety of CAS in the very elderly are inconsistent., Material and Methods: 1,139 patients with significant carotid stenosis underwent 1,252 CAS procedures in one high-volume center between years 2001-2011. CAS procedures were performed with lesion and patient dependent selection of neuroprotection type ("tailored-CAS"). There were 193 subjects ≥75-years-old (17%) and 946 <75-years-old. No major differences in atherosclerosis risk factors and comorbidities between groups were noted. In both groups the majority of patients were male (70.4% vs. 68.6%, P = NS) and half of the patients were symptomatic (50.2% vs. 55.2%, P = NS). Bilateral carotid stenosis was present in 25% of patients from CAS ≥75 group and 22% from CAS< 75 group, P = NS. Proximal neuroprotection devices use for high risk or symptomatic lesions accounted for 31% in CAS≥ 75 group and 32% in CAS<75 group, P = NS., Results: In symptomatic patients aged ≥75 years 30-day stroke and death rate was 7% versus 1.9% in symptomatic patients aged <75; P = 0.01 and vs. 1.8% in asymptomatic elderly, P = 0.09. No myocardial infarcts were noted., Conclusions: Symptomatic elderly is a group of highest CAS risk and the use of "tailored CAS" algorithm does not equalize CAS risk in this patients' group. "Tailored CAS" remains a safe procedure for asymptomatic elderly as well as symptomatic and asymptomatic young patients., (Copyright © 2013 Wiley Periodicals, Inc.)

Background: The rate of early complications of carotid artery stenting (CAS) should not exceed 3% in asymptomatic and 6% in symptomatic patients. However, some recent studies/registries failed to reach this threshold, fueling a debate on the role of CAS in the treatment of patients with carotid artery stenosis., Aim: To evaluate 30-day safety of CAS using different embolic protection devices and different stent types according to the tailored-CAS algorithm and to identify risk factors for complications., Methods: Between 2002 and 2010, we performed 1176 CAS procedures in 1081 patients (age 38-86 years, mean 66.3 ± 8.4 years, 51.5% symptomatic) according to the tailored-CAS algorithm that included extracranial ultrasound and computed tomography angiography to select the most appropriate embolic protection device (EPD) and stent type. Proximal EPD and closed-cell (CC) stents were preferentially used for high-risk lesions (HR - soft/thrombus-containing/tight/ulcerated, 36.14% of all lesions) and in symptomatic patients., Results: Procedural success rate was 99.8%. In symptomatic patients, proportion of HR lesions was higher (41.1%) than in the asymptomatic group (30.8%, p = 0.001) and the usage of CC stents (76.2% vs 71.7%, p = 0.103) and proximal EPD (P-EPD, 34.8% vs 27.7% among asymptomatic patients, p = 0.010) was more frequent. CC stents were used in 82.4% of CAS procedures involving HR lesions (vs 69.1% for non-HR lesions, p < 0.01), and P-EPD were used in 83.1% of procedures involving HR lesions (vs 2.5% for non-HR lesions, p < 0.001). In-hospital complications included 6 (0.55%) deaths, 1 (0.08%) major stroke and 19 (1.61%) minor strokes. No myocardial infarctions (MI) were noted. Among 7 (0.59%) cases of hyperperfusion syndrome, 2 were fatal. Thirty-day complication rate (death/any stroke/MI) was 2.38%. Age > 75 years was a predictor of death (p = 0.015), and prior neurological symptoms were a predictor of death/stroke (p = 0.030). There were 4 cases of periprocedural embolic cerebral artery occlusion, all treated with combined intracranial mechanical and local thrombolytic therapy., Conclusions: CAS with EPD and stent type selection on the basis of thorough non-invasive diagnostic work-up (tailored- -CAS) is safe. Advanced age was associated with an increased risk of death and the presence of prior neurological symptoms was a predictor of death/stroke at 30 days. With the tailored-CAS approach, high-risk lesion features (soft/thrombus- -containing/tight/ulcerated) are eliminated as a risk factor. Hyperperfusion syndrome is a severe CAS complication which may lead to intracranial bleeding and death. Acute, iatrogenic embolic cerebral artery occlusion is rare and may be managed by combined intracranial mechanical and local thrombolytic therapy.

Purpose: To evaluate the possible role of transcranial color-coded Doppler ultrasonography (TCD) in predicting cerebral reperfusion injury (CRI) in patients undergoing carotid artery stenting (CAS) for internal carotid artery (ICA) stenosis., Methods: TCD was obtained in 210 patients (149 men; mean age 64.2+/-8.4 years, range 44-83) who underwent CAS for ICA stenosis averaging 86.7%+/-8.4%. Contralateral ICA occlusion or near occlusion (stenosis >90%) was present in 67 (31.9%) patients. TCD was performed before and 24 hours after CAS with assessment of peak systolic velocities (PSVs) in the ipsilateral middle cerebral artery (iMCA) and contralateral middle cerebral artery (cMCA). PSV ratios (PSVR) in the iMCA and cMCA were calculated from the PSVs before and after CAS., Results: CRI syndrome occurred in 3 (1.4%) patients (2 intracranial bleedings, 1 subarachnoid hemorrhage). The mean iMCA and cMCA PSVRs were 2.66+/-0.19 and 4.16+/-2.77, respectively, in CRI patients, while the PSVRs in CAS patients without neurological sequelae were 1.56+/-0.46 and 1.21+/-0.39, respectively (both p<0.001). The combination of iPSVR>2.4 and cPSVR>2.4 occurred in 4 patients with bilateral ICA disease; 3 (75%) of them developed CRI (100% sensitivity and 99% specificity for CRI prediction). The following independent CRI predictors were identified: combined iPSVR>2.4 and cPSVR>2.4 (RR 2.06, CI 1.89 to 2.24; p<0.001), high cMCA PSV after CAS (RR 1.23, CI 1.13 to 1.34; p<0.001), and contralateral ICA occlusion (RR 1.13, CI 1.03 to 1.23; p = 0.007)., Conclusion: TCD is an important tool in CRI risk evaluation. The combination of iPSVR>2.4 and cPSVR>2.4 is an independent CRI risk factor, along with contralateral ICA occlusion and high cMCA PSVs after CAS.

Purpose: To report the utility of proximal brain protection by flow reversal in endovascular management of critical internal carotid artery (ICA) stenosis coexisting with ipsilateral external carotid artery (iECA) occlusion., Case Report: Four patients with a symptomatic, critical ICA stenosis (in-stent restenosis in one) and iECA occlusion were admitted for carotid artery stenting (CAS). In all cases, the stenosis severity and high-risk lesion morphology precluded the use of filter protection. The "tailored" CAS algorithm indicated that a proximal anti-embolism system should be used to maximize the potential for effective neuroprotection. The flow reversal system, which consists of an independent guiding sheath balloon positioned in the common carotid artery (CCA) and an iECA balloon-wire, was employed, using the CCA balloon only. The system was well-tolerated, and the CAS procedures were uneventful., Conclusion: Due to a unique design with separate CCA and iECA balloons, the flow reversal system can be used for proximal neuroprotection during CAS in severe, symptomatic ICA lesions coexisting with iECA occlusion.

Purpose: To develop and prospectively evaluate the safety and efficacy of an algorithm for tailoring neuroprotection devices (NPD) and stent types to the patient/lesion in carotid artery stenting (CAS)., Methods: From November 2002 to October 2007, 499 patients (360 men; mean age 65.2+/-8.4 years, range 36-88) were prospectively enrolled in a safety and efficacy study of tailored CAS using proximal (flow blockade or reversal) or distal (filters or occlusion) NPDs and closed- or open-cell self-expanding stents. Of the 535 lesions treated in the study, 175 (32.7%) were "high risk" by morphology. Half (50.1%) the patients were symptomatic., Results: A quarter (137, 25.6%) of the procedures were performed under proximal protection and the remainder (398, 74.4%) with distal NPDs; the direct stenting rate was 66.9%. High-risk lesions were treated predominantly with a proximal NPD and closed-cell stent (77.1% and 82.9%, respectively) and less frequently by direct stenting (37.1%, p<0.0001 versus non-high-risk lesions). The in-hospital death/stroke rate was 2.0% (95% CI 0.85% to 3.23%), and the death/major stroke rate was 0.7% (95% CI 0.02% to 1.48%). There were no myocardial infarctions, but there was 1 (0.2%) further death within 30 days. With the tailored approach, symptom status and high-risk lesion morphology were not risk factors for an adverse outcome after CAS; only age >75 years (p<0.001) was a predictor of short-term death. Long-term survival (95.4% at 1 and 88.3% at 5 years) was similar for symptomatic versus asymptomatic patients, direct stenting versus predilation, and closed- vs. open-cell stent design; only coronary artery disease adversely impacted survival (p = 0.04). The rates of freedom from death/ipsilateral stroke were 94.9% at 1 year and 85.9% at 5 years., Conclusion: Tailored CAS is associated with a low complication rate and high long-term efficacy. CAS operators should have a practical knowledge of different NPDs, including at least one proximal type.