Feasibility, Safety, and Early Outcomes of Direct Carotid Artery Stent Implantation With Use of the FilterWire EZ (TM) Embolic Protection System
Abstract
Objectives: To report on early outcomes of prospective single-center registry, which evaluated feasibility, safety, and effectiveness of direct carotid stenting using FilterWire EZ (TM) Embolic Protection System in high-risk patients. Background: Little is known about the use of direct carotid stenting with FilterWire EZ (TM) Embolic Protection System and different carotid stents.
Methods: 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 (TM) 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 myocardial infarction. Results: 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. Conclusion: Direct carotid stenting with FilterWire EZ (TM) Embolic Protection System is feasible and safe.
Short-term results with respect to neurological events are acceptable.