Original paper
The use of a new generation self-expanding stent, Vascuflex SEC, for carotid artery stenting

Background: Technological developments in the embolic protection device (EPD) and stent designs contribute significantly to the progress in endovascular management of carotid artery stenosis.

Aim: To evaluate the safety and efficacy of carotid artery stenting (CAS) using a new generation self-expanding nitinol stent, Vascuflex SEC, with different types of embolic protection.

Material and methods: Carotid artery stenting with Vascuflex SEC was performed in 50 consecutive patients (age 66.4 ±7.8 years, men 66%, symptomatic 40%) referred for the procedure after independent neurological consultation. Embolic protection device type was selected on the basis of atherosclerotic plaque morphology by duplex ultrasound and CT angiography. In a subset of patients (n = 20), we tested the feasibility of using intravascular ultrasound with virtual histology (IVUS-VH) to guide the EPD choice and final stent post-dilation. Proximal neuroprotection by flow reversal or temporary flow cessation was applied in 23 procedures (46%). Clinical evaluation was performed at discharge and at 30 days.

Results: Procedural success was 100% and, in all cases, only one stent was implanted per patient/lesion. Direct stenting was performed in 20 patients (40%). Intraprocedural IVUS-VH was feasible and safe. Diameter stenosis was reduced from 84.1 ±7.5% to 9.1 ±7.7% (p < 0.001). There were two neurological events: one periprocedural ipsilateral minor stroke and one contralateral major stroke within 30 days. A closure device was used in 80% of patients and no access site complications occurred.

Conclusions: In an unselected population referred for carotid revascularization, CAS with Vascuflex SEC stents is safe and effective. Lesion morphology-guided selection of EPD may contribute to the low complication rate.