Flow-reversal device for cerebral protection during carotid artery stenting--acute and long-term results.

Objective: 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.

Method: 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.

Results: 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.

Conclusions: 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.