Efficiency test of current carotid embolic protection devices

Area of Science:

• Biomedical Engineering
• Medical Devices
• Cardiovascular Interventions

Background:

• Carotid artery stenting (CAS) carries a risk of stroke due to embolization.
• Embolic protection devices (EPDs) are designed to mitigate this risk by capturing debris.
• Evaluating EPD performance is crucial for optimizing patient safety during CAS.

Purpose of the Study:

• To compare the in vitro capture efficiency of five different EPDs.
• To assess device performance under simulated carotid artery conditions with varying cross-sections.
• To quantify embolic material leakage for each device.

Main Methods:

• A standardized in vitro setup using silicone tubes (round and oval) to mimic vessel anatomy.
• Simulated embolic particles (150 μm polystyrene spheres) were used to represent atherosclerotic plaque.
• Five EPDs (Angioguard RX, RX Accunet, FiberNet, FilterWire EZ, EmboshieldNAV) were tested, and missed particles were quantified via laser obscuration.

Main Results:

• FilterWire EZ achieved 100% capture efficiency (0% missed particles) in round cross-sections, while RX Accunet had the lowest efficiency (34% missed).
• In oval cross-sections, FilterWire EZ leakage increased to 22%, and Angioguard RX showed the highest leakage at 89%.
• Performance varied significantly among devices and between round and oval vessel models.

Conclusions:

• EPD performance in capturing embolic debris is significantly influenced by vessel geometry.
• FilterWire EZ demonstrated superior performance in ideal conditions, but its efficacy decreased in non-ideal (oval) geometries.
• Further research is needed to optimize EPD design for diverse anatomical variations encountered in carotid stenting.