Abstract 4422: GORE Flow Reversal European Multicenter Study Results
Background: Filters for embolic protection during carotid stenting have many disadvantages. This European trial evaluated the safety and efficacy of a new proximal embolic protection system, the Gore Flow Reversal device.
Patients and Methods: This was a prospective, controlled, multi-specialty, non-randomized, single-arm study with 10 sites participating. 122 patients with asymptomatic stenoses of the internal carotid artery ≥70% or symptomatic stenoses ≥50% had been enrolled. The primary endpoint was the appearance of any major adverse event (death, minor or major stroke) through a 30 day follow-up. The combined secondary endpoint was defined as the incidence of myocardial infarction, non Q-wave infarction and transient ischemic attacks. The mean age of patients was 69±8 years. 75% were male (n=91). 48 of 122 (39%) treated stenoses were symptomatic for neurological events within 6 months prior to the intervention: 26 transitory ischemic attacks (21%) and 22 strokes (18%).
Results: Technical success was achieved in 119 of 122 cases (98%). In 1 patient appeared a technical access failure in using the Gore flow reversal device and 2 patients did not tolerate flow reversal and the operators had to switch to distal protection. Carotid stent success was achieved in 122 lesions (100%). The average procedure time was 61±22 minutes with a flow reversal time of 8±4 minutes. 2 subjects suffered from neurological events defined as primary endpoints: 1 major stroke post procedure (0.8%) and 1 minor stroke post procedure (0.8%) that resolved within 3 days. Incidences defined as secondary endpoints occurred in 2 patients (1.6%), both subjects suffered a TIA.
Conclusion: The Gore flow reversal systems is a safe method of embolic protection with a high rate of technical success.