Premium
Prospective, multicenter European study of the GORE flow reversal system for providing neuroprotection during carotid artery stenting
Author(s) -
Nikas Dimitrios,
Reith Wolfgang,
Schmidt Andrej,
Duda Stephan,
Mathias Klaus,
Cremonesi Alberto,
Dill Harold,
Formgren Johan,
Pieniazek Piotr,
Musialek Piotr,
Hornung Marius,
Sievert Horst,
Reimers Bernhard
Publication year - 2012
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.24402
Subject(s) - medicine , clinical endpoint , asymptomatic , stroke (engine) , cardiology , stenosis , myocardial infarction , carotid stenting , prospective cohort study , internal carotid artery , adverse effect , transcranial doppler , surgery , clinical trial , mechanical engineering , carotid endarterectomy , engineering
Background Embolic protection devices (EPDs) are used to provide protection against brain embolization during carotid artery stenting (CAS) to treat carotid artery stenosis, but the optimal type of EPD has not been determined. Distally positioned filters are commonly used but do not provide protection during crossing of the lesion. This prospective, multicenter study investigated a proximally placed device (GORE Flow Reversal System) that reverses blood flow in the internal carotid artery during CAS, thereby directing emboli away from the brain. Methods Outcomes in 122 patients (28% symptomatic), who underwent CAS using the flow reversal system were assessed (intention‐to‐treat analysis). The primary endpoint was a major adverse event (MAE; defined as death or stroke) within 30 days of CAS. The secondary endpoint was a myocardial infarction (MI) or nonstroke‐related neurologic event within 30 days. Results The flow reversal system 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 patient 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. Conclusions 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. © 2012 Wiley Periodicals, Inc.