Transradial carotid artery stenting using double layer micromesh stent and novel post-dilation balloon with integrated embolic protection

Abstract

Objectives: The highest rate of embolization during carotid artery stenting occurs during post-dilation. We evaluated the ability of the Paladin system (Contego Medical, Raleigh, NC), a novel PTA balloon with an integrated 40-ɥm pore filter, to collect microemboli that may pass into the cerebral circulation when used during post-dilation.

Methods: 25 symptomatic patients underwent transradial CAS using the Paladin system in conjunction with the Roadsaver (Terumo Corporation, Tokyo, Japan) micromesh stent. No additional embolic protection was used. The Paladin filters were collected following the procedure and preserved in formalin for histological analysis. The contents were evaluated for particle count and size. Subjects were followed for 30 days and evaluated for major cardiac adverse events (death, stroke and MI). Secondary endpoints included procedure success, device success, access site complications according to EASY score classification, major vascular or ischemic complications at follow up and in-stent restenosis rate evaluated with duplex ultrasound.

Results: Mean age of patients was 68,5 years. Type 2 aortic arch was present in 77 % of patients and type 1 and type 3 in 12 % and 11 % of patients respectively. Procedural and device success was obtained in all cases without complications. The 30-day MAE rate was 0 %. Twenty-three filters underwent histological analysis. Microscopic debris was present in 100 % of filters, and 75 % of particles were less than 100ɥm in size. The mean number of particles per filter was 3352 ± 1567 (IQR 4300-2343), and the mean number of particles between 40-100ɥm per filter was 2499 ± 1240 (IQR 3227-1575).

Conclusion: CAS through radial approach can be safely and effectively performed using the IEP technology Paladin device and double-layer micromesh Roadsaver stent. This strategy can simplify the procedure and decrease peri-procedural complications and procedural time.

Keywords: Carotid stenosis; Carotid stenting; Cerebral embolic protection; Double-layer micromesh stent; Paladin device; Transradial access.