Balloon-protected carotid artery stenting -: Relationship of periprocedural neurological complications with the size of particulate debris

Background-Carotid artery stenting (CAS) has been advocated as an alternative to endarterectomy. To prevent cerebral atheroembolism during CAS, distal balloon occlusion of the target artery increasingly is employed during the procedure. A correlation of the size of captured particles with the incidence of periprocedural neurological complications (PNCs) has not been attempted. Methods and Results-In a 4-center, phase-1 trial, 54 patients (46 men; age, 69 +/-8 years) underwent 58 CAS procedures using the PercuSurge GuardWire system for distal protection. Aspirated debris was sent for histological/cytological analysis. Stent placement was successful in all cases. Mean balloon occlusion time was 10.4 +/-4.0 minutes (range, 3.0 to 22.0 minutes). Three patients (5.2%) experienced PNCs: I prolonged reversible ischemic neurological deficit that resolved in less than or equal to 48 hours, 1 stroke, and 1 transient ischemic attack. Relevant particles (those with an area greater than or equal to 10 000 mum(2)) were found in 48 aspirates (83%). The median number of particles, their maximum diameter, and their maximum area were all significantly higher in the aspirates obtained during procedures associated with PNCs than in aspirates obtained during procedures not associated with PNCs. However, pronounced overlap in the distributions (PNCs versus no PNCs) of the number and maximum diameter of particles precluded any predictive inferences. In contrast, a maximum particle area > 800 000 mum(2) (>0.8 mm(2)) was associated with a 60% chance of having a PNC. Conclusions-Despite balloon protection, PNCs occurred in 5.2% of patients who underwent CAS procedures. The maximum area of aspirated particles seems to be an indicator of increased risk for PNCs.