Integrated Embolic Protection for Reduction of Microembolization during Carotid Artery Stenting: A DW MRI Proof of Principle Study - Abstract
Background: Carotid artery stenting (CAS) has shown equivalent effectiveness and safety from major adverse events compared to carotid endarterectomy. However, the risk
of minor stroke remains higher with CAS. This may be related to the microemboli created during the CAS procedure itself, particularly during post stent dilation. To date, traditional
distal filter-based embolic protection strategies have not been able to completely mitigate the risk of minor stroke. The Paladin® balloon system with integrated embolic protection
(IEP) featuring a 40 ?m pore filter was developed to address procedural microembolization.
Methods: A total of 33 patients underwent CAS. Paladin® IEP was used for post dilation per its instructions for use in all cases. To identify new ischemic lesions, diffusion weighted
magnetic resonance imaging (DW-MRI) was performed the same day pre-procedure (baseline) and post procedurally within 48 hours.
Results: Among 33 CAS patients, the mean age was 69.7 ± 8.4 years and 84.8% were symptomatic. Mean baseline stenosis was 90.3% and mean lesion length was 16.8 mm.
CAS was performed on the internal carotid artery (63.6% right, 36.4% left) with carotid stents from 3 manufacturers. Procedure technical success was 100%. DW-MRI identified new
ischemic lesions in 7 (21.2%) patients (6 symptomatic at baseline) with a mean lesion volume of 0.044 ± 0.09 cm3.
Conclusions: Despite 84.8% of patients being symptomatic, the incidence of new cerebral lesions post-CAS detected by DW-MRI in this study was lower than has been
previously reported, suggesting that the Paladin® IEP System’s 40 ?m pore size successfully captures smaller microemboli when compared to current filters, preventing these particles
from entering the cerebral circulation.