Document Detail


Prospective, multicenter European study of the GORE flow reversal system for providing neuroprotection during carotid artery stenting.
MedLine Citation:
PMID:  22644906     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Dimitrios Nikas; Wolfgang Reith; Andrej Schmidt; Stephan Duda; Klaus Mathias; Alberto Cremonesi; Harold Dill; Johan Formgren; Piotr Pieniazek; Piotr Musialek; Marius Hornung; Horst Sievert; Bernhard Reimers
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-05-29
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  80     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-10     Completed Date:  2013-05-21     Revised Date:  2014-06-22    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1060-8     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Wiley Periodicals, Inc.
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Angioplasty, Balloon / adverse effects,  instrumentation*,  mortality
Carotid Artery, Internal / physiopathology*
Carotid Stenosis / mortality,  physiopathology,  therapy*
Cerebrovascular Circulation*
Cerebrovascular Disorders / etiology,  mortality,  physiopathology,  prevention & control*
Embolic Protection Devices*
Europe
Female
Hospitals, High-Volume
Humans
Ischemic Attack, Transient / etiology,  physiopathology,  prevention & control
Male
Middle Aged
Myocardial Infarction / etiology
Prospective Studies
Prosthesis Design
Regional Blood Flow
Stents*
Stroke / etiology,  physiopathology,  prevention & control
Time Factors
Treatment Outcome
Comments/Corrections
Comment In:
Catheter Cardiovasc Interv. 2013 Jul 1;82(1):62-3   [PMID:  23073963 ]
Catheter Cardiovasc Interv. 2013 Jul 1;82(1):60-1   [PMID:  23494846 ]
Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1069-71   [PMID:  23225647 ]
Catheter Cardiovasc Interv. 2014 Jun 1;83(7):1185-6   [PMID:  23613204 ]

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