Immediate and 30-Day Clinical Outcome of Patients Treated with the TwinOne Cerebral Protection System: Multicenter Experience in 217 Cases

There are several cerebral protection devices used for carotid artery stenting (CAS). All of them require manipulation and exchange of two separate materials (cerebral protection device + dilatation balloon), making the procedure longer and posing possible complications such as vasospasm and embolism. The new system described here is an evolution of the cerebral protection concept and allows temporary occlusion of the distal internal carotid during CAS procedures with both materials in one device. We present our experience using this new device. Between January 2007 and March 2008, consecutive patients sent for CAS (symptomatic, with stenosis ≥50%, or asymptomatic, with stenosis ≥70%) were treated using TwinOne as a cerebral protection system. All patients were treated using the “simplified” CAS technique, limiting cerebral protection to the poststenting angioplasty phase. Two hundred nine patients have been treated at our institutions; eight underwent bilateral CAS, for a total of 217 CAS procedures performed using the TwinOne for cerebral protection. There have been four periprocedural (within 3 h of procedure) cases of complications (1.8%): three disabling strokes (one in-stent thrombosis, one presumed clotting, one ipsilateral stroke with uncertain root cause) and one transient ischemic attack attributable to heart failure. There have been two in-hospital complications (0.92%): one disabling stroke of unclear origin and one contralateral transient ischemic attack. No additional adverse event has been reported at 30 days after the CAS procedure. In conclusion, this cerebral protection system is simple to use, allows a quick intervention and short occlusion time, and has a low rate of complications.