Reduction of Cerebral Emboli: In vitro Study with a Novel Cerebral Embolic Protection Device
Open Access
- 1 March 2020
- journal article
- research article
- Published by Taylor & Francis Ltd in Medical Devices: Evidence and Research
- Vol. ume 13, 67-73
- https://doi.org/10.2147/MDER.S234961
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
This publication has 17 references indexed in Scilit:
- Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysisEuropean Heart Journal, 2018
- Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial)The American Journal of Cardiology, 2016
- StrokeCirculation, 2012
- In‐hospital complications after transcatheter aortic valve implantation revisited according to the valve academic research consortium definitionsCatheterization and Cardiovascular Interventions, 2011
- Cerebral Embolism Following Transcatheter Aortic Valve ImplantationJournal of the American College of Cardiology, 2010
- Perioperative StrokeThe New England Journal of Medicine, 2007
- Stroke and Encephalopathy After Cardiac SurgeryStroke, 2006
- Silent and apparent cerebral embolism after retrograde catheterisation of the aortic valve in valvular stenosis: a prospective, randomised studyThe Lancet, 2003
- Stroke Complicating Percutaneous Coronary InterventionsCirculation, 2002
- Stroke as a complication of cardiac catheterization: Risk factors and clinical featuresNeurology, 2001