Proximal Endovascular Occlusion for Carotid Artery Stenting. Results From a Prospective Registry of 1,300 Patients

Objectives: This single-center registry presents the results of proximal endovascular occlusion (PEO) use in an unselected patient population. Background: In published multicenter registries, the use of PEO for carotid artery stenting (CAS) has been demonstrated to be safe and efficient in patient populations selected for anatomical and/or clinical conditions. Methods: From July 2004 to May 2009, 1,300 patients underwent CAS using PEO. Patients received an independent neurological assessment before the procedure and 1 h, 24 h, and 30 days after the procedure. Results: Procedural success was achieved in 99.7% of patients. In hospital, major adverse cardiac or cerebrovascular events included 5 deaths (0.38%), 6 major strokes (0.46%), 5 minor strokes (0.38%), and no acute myocardial infarction. At 30 days of follow-up, 2 additional patients died (0.15%), and 1 patient had a minor stroke (0.07%). The 30-day stroke and death incidence was 1.38% (n = 19). Symptomatic patients presented a higher 30-day stroke and death incidence when compared with asymptomatic patients (3.04% vs. 0.82%; p < 0.05). No significant difference in 30-day stroke and death rate was observed between patients at high (1.88%; n = 12) and average surgical risk (1.07; n = 7) (p = NS). Operator experience, symptomatic status, and hypertension were found to be independent predictors of adverse events. Conclusions: The use of PEO for CAS is safe and effective in an unselected patient population. Anatomical and/or clinical conditions of high surgical risk were not associated with an increased rate of adverse events. © 2010 American College of Cardiology Foundation.