Abstract
PURPOSE: To assess in vitro performance of four embolic protection filters (EPFs) with a varying mass of injected particles. Evaluation is based on capture efficiency, pressure gradient, flow rate, and vascular resistance. MATERIALS AND METHODS: A bench-top flow apparatus was used for in vitro testing of four devices (Spider RX, FilterWire EZ, RX Accunet, and Emboshield). A silicone phantom with average human carotid artery dimensions and a 70% symmetric internal carotid artery (ICA) stenosis was used to model the carotid bifurcation. A blood-mimicking solution (glycerol/deionized water) was circulated at the time-averaged mean peak velocity for the common carotid artery. Five and 10 mg of 200- or 300-mum-diameter microspheres were injected into the ICA to evaluate the capture efficiency of the devices. The normalized pressure gradient, flow rate, and vascular resistance in the ICA were calculated from measured values of pressure and flow rate. RESULTS: The Spider RX captured the most particles (99.9% for 5 mg, 98.4% for 10 mg) and was associated with the slightest increase in pressure gradient (+8%, +15%) for both masses of microspheres injected. The Spider RX and FilterWire EZ were associated with the slightest decreases in flow rate (Spider RX, -1.9% and -12.1%; FilterWire EZ, -3.5% and -8.2%) and the slightest increases in vascular resistance (Spider RX, +10.1% and +33.0%; FilterWire EZ, +20.5% and +32.7%). The device-specific porosity was calculated, and the Spider RX was found to have the greatest at 50.4%; the Emboshield had the lowest at 2.2%. CONCLUSIONS: The Spider RX and FilterWire EZ had the best overall performances. Design features such as porosity and pore density are important parameters for improving the effectiveness of EPFs. Vascular resistance in the ICA is a flow-derived variable indicative of device performance and affected by the filter design features.