Medical Devices: Evidence and Research (Mar 2020)
Reduction of Cerebral Emboli: In vitro Study with a Novel Cerebral Embolic Protection Device
Abstract
Guy Haiman,1 Tamim Nazif,2 Jeffrey W Moses,2 Amit Ashkenazi,1 Pauliina Margolis,1 Alexandra J Lansky3,4 1Keystone Heart Ltd., Caesarea, Israel; 2Department of Cardiology, Columbia University Medical Center, New York, NY, USA; 3Division of Cardiology, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA; 4Department of Cardiology, Yale Cardiovascular Research Group, New Haven, CT, USACorrespondence: Guy Haiman; AJ Lansky Email [email protected]; [email protected]: 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
