The purpose of this study was to examine the possible beneficial effect of the PercuSurge GuardWire cerebral protection device based on balloon occlusion of the distal internal carotid artery and debris aspiration for patients undergoing carotid artery stenting (CAS). A total of 268 CAS procedures were attempted under cerebral protection using the PercuSurge GuardWire system in 242 patients (194 men; mean age, 71.2 +/- 9.4 years; range, 40-91). The lesions were mainly atherosclerotic; 64% were symptomatic. Technical success was 99.3%. All lesions were stented except three postangioplasty restenoses. Prophylactic occlusion during balloon dilatation and stenting was well tolerated in 255 patients (95.9%). Microscopic analysis of the aspirated blood showed different types of particles numbering between 7 and 145 per procedure, with a mean diameter of 250 microm (mean, 56-2,652 microm). The 30-day stroke and death rate was 2.3%, with four periprocedural complications at < 48 hr (one retinal embolism and three transient ischemic attacks), one intracerebral hemorrhage at 3 days, and one death of cardiac failure at 3 weeks. This technique appears safe and efficient with a low rate of periprocedural embolic events. Protection devices seem indispensable to perform CAS and expand the applicability of the procedure. Randomized studies (surgery vs. CAS with and without cerebral protection) are awaited.
Copyright 2004 Wiley-Liss, Inc.