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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).

Background: Significant atherosclerotic stenosis of internal carotid artery (ICA) origin is common (5-10% at ≥ 60 years). Intravascular ultrasound (IVUS) enables high-resolution (120 µm) plaque imaging, and IVUS-elucidated features of the coronary plaque were recently shown to be associated with its symptomatic rupture/thrombosis risk. Safety of the significant carotid plaque IVUS imaging in a large unselected population is unknown., Material/methods: We prospectively evaluated the safety of embolic protection device (EPD)-assisted vs. unprotected ICA-IVUS in a series of consecutive subjects with ≥ 50% ICA stenosis referred for carotid artery stenting (CAS), including 104 asymptomatic (aS) and 187 symptomatic (S) subjects (age 47-83 y, 187 men). EPD use was optional for IVUS, but mandatory for CAS., Results: Evaluation was performed of 107 ICAs (36.8%) without EPD and 184 with EPD. Lesions imaged under EPD were overall more severe (peak-systolic velocity 2.97 ± 0.08 vs. 2.20 ± 0.08 m/s, end-diastolic velocity 1.0 ± 0.04 vs. 0.7 ± 0.03 m/s, stenosis severity of 85.7 ± 0.5% vs. 77.7 ± 0.6% by catheter angiography; mean ± SEM; p<0.01 for all comparisons) and more frequently S (50.0% vs. 34.6%, p=0.01). No ICA perforation or dissection, and no major stroke or death occurred. There was no IVUS-triggered cerebral embolization. In the procedures of (i) unprotected IVUS and no CAS, (ii) unprotected IVUS followed by CAS (filters - 39, flow reversal/blockade - 3), (iii) EPD-protected (filters - 135, flow reversal/blockade - 48) IVUS + CAS, TIA occurred in 1.5% vs. 4.8% vs. 2.7%, respectively, and minor stroke in 0% vs. 2.4% vs. 2.1%, respectively. EPD intolerance (on-filter ICA spasm or flow reversal/blockade intolerance) occurred in 9/225 (4.0%). IVUS increased the procedure duration by 7.27 ± 0.19 min., Conclusions: Carotid IVUS is safe and, for the less severe lesions in particular, it may not require mandatory EPD use. High-risk lesions can be safely evaluated with IVUS under flow reversal/blockade.

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.