Purpose: To examine the possible beneficial effect of a new cerebral protection device based on balloon occlusion of the distal internal carotid artery (ICA) and debris aspiration for patients undergoing carotid artery stenting (CAS).
Methods: One hundred and eighty-four CAS procedures were attempted under cerebral protection using the PercuSurge GuardWire system in 167 patients (129 men; mean age 70.5 +/- 9.2 years, range 40-91)). The lesions were mainly atherosclerotic, and half (n = 93) were asymptomatic. Eighteen restenotic and 7 post-radiation stenoses were also treated.
Results: Technical success was 99.5%. All lesions were stented except 3 postangioplasty restenoses. Prophylactic occlusion during balloon dilation and stenting was well tolerated in 176 (95.7%) patients. 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 (56-2652 microm). The 30-day stroke and death rate was 2.7%: 3 periprocedural complications at <48 hours (1 major stroke and 2 transient ischemic attacks), 1 intracerebral hemorrhage at 3 days, and 1 death of cardiac failure at 3 weeks.
Conclusions: This study yielded a favorably low rate of periprocedural embolic events comparable with standard CAS series. Protection devices may play an important role in future carotid interventions and expand the applicability of the procedure. Randomized studies (surgery versus CAS with and without cerebral protection) are awaited.