Independent Modular Filter for Embolic Protection in Carotid Stenting

Abstract

Background-Embolic protection during carotid artery stenting reduces the rate of thromboembolic events. The Wirion Embolic Protection System is used to deploy an independent distal filter using any 0.014″ guidewire. WISE study (Wirion Study Europe) evaluated the safety and performance of Wirion Embolic Protection System in patients undergoing carotid artery stenting. Methods and Results-A prospective, multicenter, nonrandomized, open-label, single-arm study of carotid artery stenting in high surgical risk patients was performed. The primary end point, a composite of death, stroke, and myocardial infarction at 30 days, was compared with performance goal derived from historical controls. Secondary end points were components of the primary end point and the device, angiographic, procedural, and clinical success rates. Preplanned interim analysis was performed on the first 120 patients. At interim analysis, the primary end point was significantly lower for the Wirion Embolic Protection System group, compared with historical data (3.3% versus 6.3%, respectively; P value =0.0008). Analysis of primary end point components in the WISE group, compared with the historical control group, shows numerically lower mortality (0% versus 1.7%, respectively; P=0.21), stroke (2.5% versus 4.6%, respectively; P=0.18), and myocardial infarction (0.8% versus 1.5%, respectively; P=0.50). Device, angiographic, procedural, and clinical success was achieved in 99.2%, 99.1%, 98.3%, and 96.6% of cases, respectively. Conclusions-The data suggest that independent modular filter use in carotid artery stenting in high surgical risk patients is safe and effective. The outcomes suggest that use of an independent modular filter may be associated with a lower rate of embolic complications associated with carotid stent placement. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01783639.

WIRION™ Embolic Protection System for Carotid Artery Stenting and Lower Extremity Endovascular Intervention

“…Based on the available data, the Wirion distal filter was associated with high technical and clinical success in both the carotid and femoropopliteal vascular beds. These data eventually led to US FDA approval for application of the Wirion EPS at the carotid and the femoropopliteal segments [37,39].…”

“…One study was identified across literature reporting on performance of the Wirion EPS in patients undergoing CAS (NCT01783639) [37]. This was a prospective, multicenter, single-arm study enrolling 120 high surgical risk patients that underwent CAS for ≥50 and ≥80% stenosis in symptomatic and asymptomatic carotid disease, respectively [37]. The study demonstrated 98.3% procedural success and 100% periprocedural survival rate, with stroke occurring in only 2.5% of the cases [37].…”

“…This was a prospective, multicenter, single-arm study enrolling 120 high surgical risk patients that underwent CAS for ≥50 and ≥80% stenosis in symptomatic and asymptomatic carotid disease, respectively [37]. The study demonstrated 98.3% procedural success and 100% periprocedural survival rate, with stroke occurring in only 2.5% of the cases [37]. The authors also compared the performance of the Wirion EPS to a historical control groups of CAS with utilization of independent distal filter EPD [22,23,25,26] and demonstrated lower periprocedural death, stroke and myocardial infarction in the Wirion group (3.3%) versus the historical control group (6.3%; p < 0.001) [37].…”

“…The authors also compared the performance of the Wirion EPS to a historical control groups of CAS with utilization of independent distal filter EPD [22,23,25,26] and demonstrated lower periprocedural death, stroke and myocardial infarction in the Wirion group (3.3%) versus the historical control group (6.3%; p < 0.001) [37]. Thereby the authors suggested that advancements in EPDs may be related to the observed improvement of neuro-protection with the Wirion EPS [37]. In our center, three patients with severe carotid disease, deemed as high risk for surgery, underwent CAS with the utilization of the Wirion EPS.…”

Risk Factors and Complications Associated with Carotid Artery Stenting: A Retrospective Study

“…Scheinert et al 10) reported that the use of distal EPD is safe and effective in patients undergoing high-risk surgeries. Sridhara et al 11) stated that with proper technique, CAS can not only reduce stroke but also prevent stroke-associated cognitive decline, vascular injury, etc.…”