Performance Assessment Of Embolic Protection
Filters For Carotid Artery Stenting
Author(s)
E. A. Finol1, C. M. Scotti, I. Verdinelli, C. H. Amon
& M. H. Wholey
Abstract
Stroke is the third leading cause of death in the United States, accounting for 1.5
deaths reported per 1000 people. Carotid artery stenting (CAS) with cerebral
protection is slowly becoming the gold standard for treatment of carotid artery
occlusive disease in high risk patients. CAS is based on the selective cannulation
of the common carotid artery by means of an introducer sheath or guiding
catheter and the deployment of a wire mesh (stent) to treat the occluded artery
segment. The goal for CAS is the prevention of stroke and its efficacy depends
greatly on the periprocedural complications. The major concern with CAS is its
potential to produce emboli that may translate into a severe neurological
disorder. In this regard, several cerebral protection devices (CPDs) have been
developed recently as an adjunct to CAS, with the primary function of capturing
the plaque particles released from the site of vessel injury to prevent neurological
events. A category of CPD that has received recent attention due to its ability to
allow continued distal perfusion is the embolic protection filter. We tested in
vitro one FDA approved (RX Accunet Embolic Protection System, Guidant
Corporation, Indianapolis, IN) and two investigational (FilterWire EZ, Boston
Scientific, Natick, MA and Angioguard XP, Cordis Corp., Coral Gables, FL)
devices of this kind. The objective of this study was to assess the effectiveness of
emboli capture of the devices, investigate potential intangible failure modes and
complications, and set a baseline of desirable design parameters for future
generations of embolic protection filters. None of the devices tested completely
prevented embolization into the artery model. Overall, the RX Accunet device
had the best filtration performance, failing to capture 0.16% of plaque particles
when deployed in an artery model of 5.5 mm in diameter. Several complications
related to device retrieval were detected in all devices on any given set of testing
scenarios. Crossing profile, opening/closing mechanics and pore size were
among the key design variables required for improved device designs.
Keywords: cerebral protection device, embolic protection, carotid artery
stenting.
Keywords
cerebral protection device, embolic protection, carotid artery
stenting.
Related Book
Other papers in this volume
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