Document Detail


Carotid artery stenting in high surgical risk patients using the FiberNet embolic protection system: the EPIC trial results.
MedLine Citation:
PMID:  20201102     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). BACKGROUND: Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. METHODS: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. RESULTS: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. CONCLUSIONS: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA).
Authors:
Subbarao Myla; J Michael Bacharach; Gary M Ansel; Eric J Dippel; Daniel J McCormick; Jeffrey J Popma
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  75     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-04-30     Completed Date:  2010-07-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  817-22     Citation Subset:  IM    
Copyright Information:
Copyright 2010 Wiley-Liss, Inc.
Affiliation:
Hoag Memorial Hospital, Newport Beach, California 92663, USA. subbaraomyla@gmail.com
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Angioplasty, Balloon / instrumentation*
Carotid Stenosis / therapy*
Cerebrovascular Circulation
Clinical Trials as Topic
Device Removal
Female
Filtration / instrumentation*
Humans
Intracranial Embolism / etiology,  prevention & control*
Male
Middle Aged
Stents*
Stroke / prevention & control

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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