Flow‐Reversal Device for Cerebral Protection During Carotid Artery Stenting—Acute and Long‐Term Results

Abstract

The acute results indicate that proximal occlusion and flow reversal for cerebral protection during carotid stenting is a safe and effective method. The low restenosis and complication rate during long-term follow-up is in accordance with other series of carotid angioplasty and shows that the occlusion balloons do not cause any long-term side effects.

Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30‐day outcomes in the EMPiRE Clinical Study

“…Patient selection, operator skill, and device design all remain important in optimizing outcomes in high-risk populations, including the very elderly. Previous, smaller investigations of flow reversal yielded results similar to those in the EMPiRE study [25,26,28,29]. In the largest of these, Parodi et al [28] employed flow reversal and Wallstents (Boston Scientific) to treat carotid artery stenosis in 200 patients.…”

“…Three patients (1.5%) had a stroke or died within 30 days of the procedure. In the 56-patient series of Rabe et al [29], the 30-day stroke and death rate was 1.8%. Grunwald et al [26] reported a nonrandomized comparison between outcomes in 36 patients in whom flow reversal was used during CAS and 54 who underwent unprotected CAS.…”

“…Reported rates of intolerance in earlier studies of flow reversal range from 0 to 8.9% [23][24][25][26][27][28][29]; the rate in the EMPiRE study was 2.4%. Trials of a flow arrest EPD had intolerance rates of 5.8-13.8% [17][18][19][20][21].…”

“…Subsequently, several studies found this method to be safe [25][26][27][28][29]. The Embolic Protection with Reverse Flow (EMPiRE) Clinical Study, which was conducted in the United States under an investigational device exemption from the US Food and Drug Administration (FDA), began in 2006.…”

Endovascular Management of Extracranial Carotid Disease

“…Some patients will not tolerate the temporary balloon occlusion, and the device is quite bulky, which can be cumbersome in some patients with tortuous anatomy. Two European series with a total of 86 patients found no major ISs or deaths at 30 days when the flow-reversal technique was employed for CAS (Adami et al 2002;Rabe et al 2006). This device is commercially available in Europe and limited to investigational use in the United States.…”