Do the Advantages of the FiberNet® Embolic Protection Device Translate into Technical Success and Comparable Event Rates in Carotid Artery Stenting?

Abstract

FiberNet® is a second generation non-conventional embolization protection device (EPD) that purports to offer several advantages: ability to capture debris as small as 40 μm, more flexibility with placement and positioning in curved segments requiring a small landing zone, ability to conform to asymmetric vessels, and improved deliverability. The design features a low profile with large surface area to capture debris. Legitimate concerns include inducement of obstruction or low flow with debris capture and requirements in the IFU to aspirate during re-capture and device removal. Our goal was to compare the results of carotid artery stenting (CAS) using FiberNet® against a multi-center experience of CAS using other filter devices to identify any differences in technical success or event rates. FiberNet® (n=25) results were compared to all CAS cases performed at the Mayo Clinic in Rochester, MN, St Mary's/Duluth Clinic in MN, and North Central Heart Institute in Sioux Falls, SD (n=250) from March 2001 to December 2008. Chi-square or means were used to compare variables, as appropriate. Bivariate logistic regression was used to identify possible correlates of adverse outcome. Statistical significance was set at < 0.05. FiberNet® patients were more likely to be older (78.1+5.4 vs 73.6+9.4, p=0.019), female (48% vs 29%, p=0.047), and have peripheral vascular disease (84.0% vs 37.2%, p=0.025), and less likely to have diabetes (8.0% vs 29.8%, p=0.012) than patients in the comparison group. FiberNet® patients had more lesion calcification (40.0% vs 18.9%, p=0.014) and increased number of type 2 and 3 arches (44.2% vs 73.9%, p=0.006). Procedural success rate was 100% in both groups. None of the FiberNet® patients showed evidence of stagnant flow. The thirty-day outcome for TIA, CVA, or death was 4% in FiberNet® versus 4.8% in the comparison group (p NS). None of the independent variables – age gender, serum creatinine, arch complexity, lesion length, lesion calcium, lesion thrombus, PVD, diabetes, contralateral carotid occlusion, or ipsilateral carotid endarterectomy – predicted adverse events. Although FiberNet® patients had more lesion calcium and more challenging arch anatomy, procedural success and adverse events were comparable between groups. The advantages of FiberNet® can be applied to CAS with good technical results and may be a promising EPD for certain high-risk situations.