Initial 200 cases of carotid artery stenting using a reversal-of-flow cerebral protection device.

AIM

Because embolic complications can occur during carotid angioplasty and stenting (CAS), a new device, the Parodi Anti-Emboli System (PAES) was developed to protect the brain from embolization. We describe our initial experience with this device.

METHODS

Between September 1999 and December 2003, CAS was performed in 200 consecutive patients (146 men; mean age, 70.4 years) with symptomatic (52%) or asymptomatic (48%) severe carotid artery stenosis (>70%). De novo lesions were present in 169 patients, restenosis in 18, and radiation-induced stenosis in 13. Wallstents were inserted in all cases, with selective predilatation, and the PAES was employed during all CAS procedures. Patients were evaluated by a neurologist before and after CAS. Minor strokes, major or fatal strokes, and myocardial infarctions that occurred within 30 days of the procedure were recorded.

RESULTS

The overall technical success rate for CAS using the PAES (with the PAES placed in position percutaneously) was 99%. The overall perioperative stroke and death rate was 1.5%. There were four transient neurologic events after CAS, three of which were related to hemodynamic instability and one to postoperative embolization.

CONCLUSIONS

Our experience indicates that CAS using the PAES is safe and effective. The protection device may prevent the debris released by angioplasty from entering the cerebral circulation. Additional studies of this device are warranted.