Haiman Guy, Nazif Tamim, Moses Jeffrey W, Ashkenazi Amit, Margolis Pauliina, Lansky Alexandra J
Keystone Heart Ltd., Caesarea, Israel.
Department of Cardiology, Columbia University Medical Center, New York, NY, USA.
Med Devices (Auckl). 2020 Mar 12;13:67-73. doi: 10.2147/MDER.S234961. eCollection 2020.
To assess the efficacy of the TriGUARD , 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.
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.
This in vitro study used simulated physiologic flow conditions in an aortic arch model to demonstrate >97% efficacy of the TriGUARD CEP device, in reducing cerebral embolization of particulate and air bubbles of 200 µm to 300 µm in size.
使用定量体外模型评估新型脑栓塞保护（CEP）装置TriGUARD通过使栓塞碎片偏离脑循环来减少脑栓塞的疗效。
这项体外研究通过测量与未受保护的对照组相比，尺寸为200微米和300微米的颗粒和气泡进入脑循环的百分比，评估了一种脑栓塞保护装置使栓塞碎片偏离的能力。一个3D打印的升主动脉、带有三条主要脑动脉的主动脉弓和降主动脉的硅胶模型连接到一个定制模拟器上，该模拟器模拟左心室的生理搏动血流模式。采用比较分析来评估脑栓塞保护装置使颗粒和气泡偏离主要脑动脉的疗效。与未受保护的对照组相比，使用脑栓塞保护时进入主要脑动脉的颗粒和气泡百分比显著降低（p<0.0001）。与未受保护的对照组相比，脑保护使气泡计数减少了97.4-100%，颗粒计数减少了97.4-97.8%。
这项体外研究在主动脉弓模型中使用模拟生理流动条件，证明TriGUARD CEP装置在减少尺寸为200微米至300微米的颗粒和气泡的脑栓塞方面具有>97%的疗效。
