Background and purpose: Most neurologic events that complicate the carotid artery stent placement procedure are embolic. Strategies are being developed and evaluated for their ability to minimize the clinical embolic risk. The purpose of this study was to determine the feasibility, safety, and technical considerations of performing carotid artery stent placement with use of a distal balloon antiembolization system.
Methods: Carotid artery stent placement with use of a commercially available distal balloon antiembolization system was performed in 303 patients (325 vessels). Clinical neurologic complications were adjudicated at the time of intervention and at 1 month.
Results: Technical success was achieved in all but one case, with reduction of the mean percentage carotid artery stenosis from 79 +/- 9% to 3 +/- 8%. Intolerance to internal carotid artery occlusion occurred in 11 patients (3.6%); in one patient the procedure was aborted, and in 10 the procedures were expeditiously completed with no adverse neurologic events. The 30-day combined rate of all occurrences of stroke and death was 2%. These events included three (0.9%) retinal emboli, three (0.9%) minor strokes, and one (0.3%) fatal stroke from brain hemorrhage, all of which occurred during the procedure with no events occurring after discharge. In addition, two (0.6%) transient ischemic attacks and three (0.9%) reperfusion syndromes occurred, with the patients experiencing complete recovery.
Conclusion: Carotid artery stent placement with use of the distal balloon protection system is feasible and safe, and the short-term outcomes appear to be favorable. Optimal application of proper technique is important.