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A Novel Carotid Device for Embolic Diversion: Lessons Learned from a "First in Man" Trial in Patients with Atrial Fibrillation.
MedLine Citation:
PMID:  22009577     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
PURPOSE: This study was designed to investigate a novel device that was developed to direct emboli away from the internal carotid artery to the external carotid artery to prevent embolic stroke while avoiding the necessity for anticoagulation with warfarin. METHODS: A stent-like, self-expandable filter was developed consisting of fine cobalt alloy mesh. After promising preclinical animal testing, the device was implanted into the common carotid artery extending into the external carotid artery in three patients with atrial fibrillation, each of whom were at high-risk for cerebral emboli and were suboptimal candidates for anticoagulation. Follow-up was performed clinically and with carotid duplex ultrasound. RESULTS: The implantation was successful in all three patients. Unrestricted flow through the filter was demonstrated in each patient at 6 months by duplex sonography. However, at 7 months ultrasound demonstrated occlusion of the internal carotid artery filter in one patient, which was subsequently confirmed by angiography. Subtotal filter occlusion occurred in a second patient at 14 months. Neither patient had clinical symptoms. Both internal carotid arteries were successfully recanalized using standard angioplasty techniques without complication. The third patient had completely normal carotid blood flow at 29 months follow-up. CONCLUSIONS: Implantation of a novel device intended to divert emboli away from the internal carotid artery was feasible, but resulted in occlusive neointimal proliferation in two of three patients. These results demonstrate a discrepancy from the findings of preclinical animal studies and human investigation.
Authors:
Horst Sievert; Jennifer Franke; Ygael Grad; Boaz Nishri; Yaron Assaf; Ofer Yodfat; Albrecht Römer; Greg C Robertson; Gregg W Stone
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-10-19
Journal Detail:
Title:  Cardiovascular and interventional radiology     Volume:  -     ISSN:  1432-086X     ISO Abbreviation:  -     Publication Date:  2011 Oct 
Date Detail:
Created Date:  2011-10-19     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8003538     Medline TA:  Cardiovasc Intervent Radiol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
CardioVascular Center Frankfurt, Seckbacher Landstrasse 65, 60389, Frankfurt, Germany, info@cvcfrankfurt.de.
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