Favorable Results Reported for the Gore Flow Reversal System in CAS
May 29, 2012—Results from a prospective, multicenter European study investigating the Gore Flow Reversal System (Gore & Associates, Flagstaff, AZ) during carotid artery stenting (CAS) were published by Dimitrios Nikas, MD, et al online ahead of print in Catheterization and Cardiovascular Interventions.
The Gore Flow Reversal System is a proximally placed embolic protection device (EPD) that reverses blood flow in the internal carotid artery during CAS, thereby directing emboli away from the brain. As summarized in the Catheterization and Cardiovascular Interventions article, this study included 122 patients (28% symptomatic) who underwent CAS using the Gore Flow Reversal System. Outcomes were assessed by intention-to-treat analysis. The primary endpoint was a major adverse event (MAE; defined as death or stroke) within 30 days of CAS, and the secondary endpoint was myocardial infarction (MI) or a nonstroke-related neurologic event within 30 days.
The investigators reported that the device could not be used in one patient because of severe vessel tortuosity and in two patients (1.6%) because of intolerance. The 30-day MAE rate and the secondary endpoint rate were each 1.6%. No patients in the series died or had an MI within 30 days. No patient who was symptomatic before CAS had an MAE. One symptomatic and one asymptomatic patient had a transient ischemic attack.
The investigators concluded that use of the Gore Flow Reversal System during CAS had a high rate of technical success and low 30-day rates of adverse neurologic and cardiac events.