Abstract
Objectives: To report on the early outcomes of a prospective single-center registry, which evaluated the feasibility, safety and effectiveness of carotid artery stenting using the FilterWire EZTM Embolic Protection System in high-risk patients. Methods: Between September 2005 and November 2008, 185 consecutive patients (70 +/- 9 years, 34% symptomatic, 87% at high risk) underwent 226 carotid artery stenting procedures with the FilterWire EZTM Embolic Protection System and different carotid stents.
This study included both symptomatic ( 50% carotid artery stenosis) as well as asymptomatic (70% carotid artery stenosis) patients. The primary endpoint was the rate of 30-day adverse events, defined as neurological death, stroke or postprocedural myocardial infarction.
Results: We implanted 230 stents, carotid artery stenoses before and after direct carotid artery stenting were 82 +- 10% and 10 +/- 13%, respectively. The median of fluoroscopic time was 6 min (range 2.5-31.5 min).
One patient was referred for surgical endarterectomy. There were two minor strokes, one major stroke and one myocardial infarction within 30 post-procedural days; the primary endpoint occurred in four patients (1.8%).
Two patients died from non-neurological causes unrelated to carotid stenting. Conclusion: Carotid artery stenting with the FilterWire EZTM Embolic Protection System is feasible and safe.
Short-term results with respect to neurological events are acceptable.