Cerebral protection during carotid stenting using flow reversal

BACKGROUND: Carotid angioplasty and stenting can be used in stroke prevention in high-risk patients. As embolic complications can occur during carotid angioplasty and stenting, a device was developed to protect from cerebral embolization. METHODS: Between September 1999 and May 2002, carotid angioplasty and stenting was performed in 100 patients (84 men; mean age, 69.2 years) with symptomatic (26%) or asymptomatic (74%) severe carotid artery stenosis. Wallstents were used in all cases with selective pre-dilatation. Cerebral protection devices (Parodi Anti-Emboli System [PAES], ArteriA, San Francisco, Calif) were used in all patients. All patients were evaluated by a neurologist, both before and after the procedure. According to the criteria set forth by the large trials, the occurrence of minor, major or fatal stroke and myocardial infarction (end points) within 30 days and follow-up were determined as end points. Data were collected prospectively. RESULTS: The overall perioperative stroke and death rate was 3% (1 noncorresponding minor stroke, 1 hemorrhagic stroke, and 1 cardiac event). Four patients developed postoperative transient neurologic events (three related to hemodynamic instability and the fourth due to postoperative embolization). The overall technical success rate for carotid angioplasty (protection device placed in position percutaneously) was 99%. CONCLUSION: The efficacy and safety of carotid angioplasty and stenting with PAES are confirmed. This innovative protection device may prevent the debris released by angioplasty from entering the cerebral circulation. Further investigation is warranted.