Purpose: To evaluate the performance of the FilterWire EX for the capture and removal of debris and prevention of embolic events during endovascular carotid interventions.
Methods: In the period from October 2001 to May 2002, 100 patients (60 men; mean age 72 years, range 48-90), 69 symptomatic with >or=50% internal carotid artery (ICA) stenosis and 31 asymptomatic with >or=70% stenosis were scheduled for carotid stenting with cerebral protection provided by the FilterWire EX system. Satisfactory performance of the filter was defined as effectiveness in preventing intraprocedural embolic events shown by visible debris in the filter and unchanged neurological status assessed by an independent neurologist.
Results: The placement and retrieval of the FilterWire EX was technically successful in 93 of 100 patients. Five delivery failures were due to severe ICA angulation; one stenosis was underestimated on preprocedural imaging, and one case was aborted following a major stroke during sheath manipulation before filter introduction. In 56.9% of the protected cases, the filter contained debris. One neurological event occurred 6 hours after the procedure: a transient ischemic attack from which the patient recovered fully after 2 hours. No other procedure-related events were recorded within 30 days of the procedure. The procedural success among the 93 patients stented under FilterWire EX protection was 98% (92% by intention to treat).
Conclusion: The FilterWire EX appears to be an effective tool in the prevention of embolic events and in preserving neurological status during endovascular treatment of carotid artery stenosis.