Feasibility, safety, and early outcomes of direct carotid artery stent implantation with use of the FilterWire EZ™ Embolic Protection System

Abstract

To report on early outcomes of prospective single-center registry, which evaluated feasibility, safety, and effectiveness of direct carotid stenting using FilterWire EZ Embolic Protection System in high-risk patients. Little is known about the use of direct carotid stenting with FilterWire EZ Embolic Protection System and different carotid stents. Between September 2005 and August 2008, 176 consecutive patients (70 +/- 9 years, 36% symptomatic, 89% at high risk) underwent 214 direct carotid artery stenting procedures with FilterWire EZ Embolic Protection System and different carotid stents. This study included both symptomatic (>or=50% carotid artery stenosis) as well as asymptomatic (>or=70% carotid artery stenosis) patients. The primary endpoint was the rate of 30-day adverse events, defined as neurological death, stroke, or myocardial infarction. We implanted 218 stents (55% with closed cell design) in 214 procedures. The technical success rate of direct stenting was 96%. Carotid artery stenosis 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). There were two (0.9%) minor strokes and one (0.5%) myocardial infarction within 30 post-procedural days; the primary endpoint occurred in three patients (1.4%). Two patients expired from nonneurological causes unrelated to carotid stenting. Direct carotid stenting with FilterWire EZ Embolic Protection System is feasible and safe. Short-term results with respect to neurological events are acceptable.