Purpose: To report a prospective evaluation of the 30-day clinical neurological outcome in patients percutaneously treated for severe symptomatic and asymptomatic soft echolucent carotid plaques under cerebral protection from a proximal flow blockade system.
Methods: From December 2001 to February 2005, 84 consecutive patients (63 men; mean age 70.7 +/- 7.1 years, range 58-81) with documented soft echolucent (gray scale median < 25) extracranial carotid lesions were enrolled in a study of percutaneous stenting under cerebral protection achieved by a proximal endovascular clamping device. Primary endpoint of the study was the all stroke and death rate at 30 days. Secondary endpoints were angiographic success and any complication between discharge and 30 days. All adverse events were analyzed by an independent neurological team.
Results: Total neurological events at 30-day follow-up included 3 transient ischemic attacks and 1 minor stroke (4.8% neurological event rate). The 30-day rates of stroke and neurological death/stroke were both 1.2%; the all death/stroke rate was 2.4%. Clamping intolerance was observed in 5.9% of cases, but there was no interruption in the procedure or clinical sequelae. In 66.7% of patients, visible debris was collected during the procedure.
Conclusion: Protected CAS with proximal flow blockage can successfully be applied in selected patients for soft carotid plaques at high risk for intraprocedural embolic events.