Document Detail

First clinical experience with the GARDEX EPD: a novel embolic protection device for carotid artery stenting.
MedLine Citation:
PMID:  23339808     Owner:  NLM     Status:  In-Data-Review    
Aims: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy in the treatment of carotid artery disease. The use of an embolic protection device (EPD) can reduce the frequency of embolic events during CAS. Difficult vascular anatomy may complicate current generation EPD placement. This problem is addressed by a new EPD, the GARDEX System. The aim of this study was to assess the safety and performance of the GARDEX EPD during CAS. Methods and results: Thirty-eight patients underwent CAS with the GARDEX EPD in two medical centres. All patients were prospectively followed up for 30 days. Device performance and procedural details were collected and analysed prospectively. Vessel anatomy and lesion morphology were evaluated and stratified into a scoring system for anatomic difficulty. More than a third of the patients were considered to have difficult vascular anatomy for CAS. All enrolled patients were successfully treated. There was one (2.6%) minor periprocedural stroke and there were two (5.3%) periprocedural TIAs which resolved within 24 hours. No additional complications were noted during the 30-day follow-up period. Conclusions: In this first experience, CAS under cerebral protection with the GARDEX EPD was safe and feasible. Our data suggest that the use of the GARDEX EPD is simple and shows high success rates even in challenging anatomies. The role of this new device in CAS needs to be further confirmed in a larger patient population.
Martin Werner; Dierk Scheinert; Raffaello Borghesi; Alberto Cremonesi; Uri Rosenschein; Susanne Scheinert; Sven Bräunlich; Yvonne Bausback; Matthias Ulrich; Andrej Schmidt
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  8     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  France    
Other Details:
Languages:  eng     Pagination:  1026-32     Citation Subset:  IM    
Center for Vascular Medicine, Park Hospital Leipzig, Leipzig, Germany.
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