Flow‐Reversal Device for Cerebral Protection During Carotid Artery Stenting—Acute and Long‐Term Results

Abstract

Several types of cerebral (embolic) protection devices have been used in patients undergoing carotid stenting. This study assessed results achieved with a flow-reversal system. Carotid stenting was performed in 56 patients (mean age, 68 +/- 9 years). The mean percentage of stenosis was 77%+/- 10%. During the procedure, cerebral protection was achieved by means of balloon occlusion of the common and external carotid artery with use of a Parodi Anti-Emboli System. The patients' neurologic status was assessed during the intervention; at discharge; 1, 6, and 12 months after the procedure; and yearly thereafter. The procedure was technically successful in all cases. One patient had a minor stroke 6 hours after the intervention. No major strokes, deaths, or myocardial infarctions occurred. During long-term follow-up (to 40 months), 2 patients died of a secondary complication after intracerebral bleeding and stroke and 1 died as a result of ventricular fibrillation. Restenosis did not exceed 50% of vessel diameter in any patient. The acute results indicate that proximal occlusion and flow reversal for cerebral protection during carotid stenting is a safe and effective method. The low restenosis and complication rate during long-term follow-up is in accordance with other series of carotid angioplasty and shows that the occlusion balloons do not cause any long-term side effects.