This new “Paladin” system for post-dilation during carotid artery stenting was safe and may effectively reduce the number of particles that reach the brain, with a subsequent decreased risk for peri-procedural stroke.
This study evaluated the safety and efficacy of the Paladin System, a novel post-dilation balloon with an integrated distal protection filter designed to increase safety during one of the most critical procedural moments: post-stent dilation.
While the risk of major adverse events during stenting is equivalent to that during endarterectomy, the risk of minor stroke, much of which occurs during post-stent dilation, remains higher with carotid artery stenting.
This study enrolled a total of 106 patients in 5 centers in Germany; the primary endpoint was all-cause death, acute myocardial infarction, and stroke within 30 days from the procedure.
Among cohort patients, 30 subjects were assessed through diffusion-weighted magnetic resonance imaging before and after the procedure, in search for new lesions.
There was a retrospective analysis comparing outcomes with historical controls.
Procedural and device success rates were 100%. The combined event (death, infarction, and stroke) rates at discharge and at 30 days were 0% and 1%, respectively.
The single adverse event was a stroke at day 12 that is believed to be unrelated to the device or the procedure.
Diffusion-weighted magnetic resonance imaging found new lesions in 36.7% of patients, and 30% of such lesions were ipsilateral.
Debris was present in all filters, and 90% of these particles were <100 μm.
The Paladin System for post-stent dilation with greater protection during carotid artery stenting is effective and may reduce the number of embolic particles, with a subsequent reduction in peri-procedural stroke.
Original title: Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon with Integrated Embolic Protection.
Reference: Ralf Langhoff et al. J Am Coll Cardiol Intv 2019;12:395-403.
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