Study Supports Gore Flow Reversal System for Proximal Embolic Protection During Carotid Artery Stenting

January 1, 2013—In Catheterization and Cardiovascular Interventions, Horst Sievert, MD, et al published findings from a study that evaluates short- and long-term results of carotid artery stenting (CAS) with the Gore Flow Reversal System (GFRS; Gore & Associates, Flagstaff, AZ) (2013;81:133–141).

In the study, CAS was performed with the GFRS. Neurological status was assessed during the intervention and at follow-up. As summarized in Catheterization and Cardiovascular Interventions, CAS was performed in 86 patients with 87 stenoses (symptomatic in 37%). The procedure was technically successful in all cases. In 11 patients, a transient periprocedural neurologic deficit occurred related to temporary cerebral flow compromise during balloon occlusion, with complete resolution at completion of the procedure. The stroke/death rate at 1 month was 2.3%, with a combined ipsilateral stroke and death rate at 1 year of 4.6%. Because of changes in device design, results of patients treated before 2006 were also compared to those of patients treated after 2006. There was no significant difference in event rates between the newer and older device version. Overall follow-up time was 484 ± 3.4 patient years with a range of 0 to 119 months. The average yearly ipsilateral stroke rate including the first 30 days was 0.96%.

The investigators concluded that these results demonstrate that CAS using the GFRS was safe whether the original or new device versions were used. The periprocedural stroke rate is at least as low as the stroke rate reported using distal protection, and the long-term stroke rate after CAS is low.