Reduction of Cerebral Emboli: In vitro Study with a Novel Cerebral Embolic Protection Device

Abstract

Aim

To assess the efficacy of the TriGUARD 3™, a novel cerebral embolic protection (CEP) device in reducing cerebral embolization by deflecting embolic debris away from the cerebral circulation using a quantitative in vitro model.

Methods and Results

This in vitro study assessed the ability of a cerebral embolic protection device to deflect embolic debris, by measuring the percent of particles and air bubbles, 200 µm and 300 µm in size, from entering the cerebral circulation compared to unprotected controls. A 3D printed silicone model of the ascending aorta, the aortic arch with its three major cerebral arteries and the descending aorta was connected to a custom-made simulator that mimics physiological pulsatile flow patterns of the left ventricle. Comparative analyses were used to assess the efficacy of the cerebral embolic protection device to deflect particles and air bubbles away from the major cerebral arteries. The percent of particles and air bubbles entering the major cerebral arteries was significantly lower with cerebral embolic protection compared to unprotected controls (p<0.0001). Cerebral protection resulted in 97.4–100% reduction in air bubble counts, and 97.4–97.8% reduction in particle counts compared to unprotected controls.

Conclusion

This in vitro study used simulated physiologic flow conditions in an aortic arch model to demonstrate >97% efficacy of the TriGUARD 3 CEP device, in reducing cerebral embolization of particulate and air bubbles of 200 µm to 300 µm in size.

Keywords:

• cerebral embolic protection device
• CEP
• deflection filter
• in vitro study
• trans-catheter aortic valve replacement
• TAVR
• in vitro simulator

Disclosure

Tamim Nazif reports personal fees, equity from Keystone Heart and Venus MedTech, personal fees from Boston Scientific, outside the submitted work. Alexandra J Lansky reports grants from Yale School of Medicine, during the conduct of the study; Institutional Research support and travel fees from Venous Medical, outside the submitted work. The authors report no other conflicts of interest in this work.