Carotid artery stenting is a standard method to treat calcified vessels. One risk during this operation is that plaque particles come to the brain and cause stroke. To minimize the risk of the cerebral infarction embolic protection devices (EPD) are used. They are applied during the minimal invasive operation distal to the constricted region of the vessel where the stent is set. They consist of a guiding catheter and a filter which is a barrier for the particles. The flow of blood should be reduced by the membrane of the device as few as possible to minimize the risk of complications with the blood pressure and the cerebral blood supply . So the pressure gradient should be a minimum. Figure 1 shows the Angioguard RX as an example of an EPD.
The objective of this study is to measure the pressure gradient of five different types of EPD.
2 Material and methods
To evaluate the pressure gradient of five different EPD, a test setup containing a silicone tube vessel model with an inner diameter of 5 mm was used to simulate the internal carotid artery . The setup is built after the one used in previous studies ,  and is shown in Figure 2.
The test was performed with clean water as test medium. It circulated with a flow rate of 942 ml/min (calculated after the maximal systolic velocity in the carotid artery ). A pre-filter was used to avoid contamination of the circuit and the devices were implanted through a sheath with haemostatic valve. At the beginning of the test spherical standard particles (polystyrene, COOH-covered, D = 150 μm) were brought into the model by connecting the particle reservoir to simulate plaque particles. To assure that all particles come from the reservoir to the EPD, the suspension was homogenized with a magnetic stirrer. The particles were mainly caught by the EPD and those that were missed by the protection system were collected by an inline filter. The systems were tested for 5 min each and the flow rate and the pressure were measured by a flow sensor (Leviflow LFS-008, Levitronix) and a pressure sensor (PCE-917). Table 1 shows the tested embolic systems and their pore size. The FiberNet does not consist of a porous membrane but of a collection of fibres so the pore size is defined as an equivalent by the manufacturer.
Additionally, microscopic images of the systems were taken to measure the pore size of the membranes and to get an impression of the pore arrangement. The pictures were taken with a light microscope and a lens magnification of 11.5 and the diameter of the pore sizes were measured exemplary.
The pressure gradient was calculated for each system by subtracting the differential pressure value of the test setup without system P0 of the measured pressure value during the test with the EPD Ps. Both values are mean values of 300 measurements during the test duration of 5 min. The pressure was held nearly constant during the test procedure because the particles were introduced in the circuit in a relatively short time period of a few seconds in the beginning of the test. Otherwise one would have expected an increasing pressure over time.
The results are shown in Figure 3.
The device AngioguardRX shows the highest pressure gradient of P = 180 mbar during the test in the vessel model with a flow rate of 942 ml/min. The lowest pressure gradient occurs during the test with the FiberNet. It is around zero and the pressure values with and without system are within the uncertainty of the pressure sensor equal. During the test of the device EmboshieldNAV6 the measured pressure raised over 1.8 bar. The pressure resistance of connectors of the test circuit and the inline filter is lower so that the test with this system was completed with a lower flow rate of 450 ml/min and showed a pressure gradient of 130 mbar.
Figure 4 shows the morphology of membrane pores. The FiberNet does not contain a porous membrane so it was taken an overview image of the device. In accordance with the statements of the producers the EPD EmboshieldNAV has the highest pore diameter in the microscopic images. The exemplary measured pores of the RX Accunet and FilterWireEZ are smaller than the pore size as claimed by the manufacturers.
The study shows that different EPD cause different pressure gradients in the test setup. This is in accordance with previous studies , . It is obvious that the pressure gradients are influenced by the morphology of the systems. The pore size and density might have the highest effect on the pressure gradient beside the general design of the capture device.
The soft fibres of the FiberNet have the lowest influence on the flow of the liquid, in this case water. The pressure gradient is lower than for the systems which contain porous membranes. The EmboshieldNAV causes the highest pressure gradient and has consequently the highest effect on the antegrade blood flow. The pore size is the largest but the microscopic image support the impression that the density of pores is lower than at the other three systems also containing a porous membrane. Higher number of pores in the membrane causes a lower flow resistance which has a positive influence on the pressure gradient of the entire system. The same applies for the effective surface area of the porous membranes.
Hydrodynamic differences resulting from the different design of the devices also have an influence on the pressure gradient.
The study was made under the condition of a round cross profile of the vessel model. In a real vessel one can find certain asymmetries so that the wall apposition of the device might not be optimal. That could have a decreasing effect on the pressure gradient because of gaps between vessel and device allowing a less restricted blood flow. Under these circumstances, however, a lower particle capture efficiency of the systems is expected .
The values for the pressure gradients of several systems were taken at a constant flow rate. The results and the relation of the pressure gradients to each other might differ under other conditions. The higher the flow rate the higher the resulting pressure difference will be. Assuming laminar flow conditions, flow rate and pressure are proportional (Darcy’s law) but the complex pore structures of the membranes might lead to turbulences and to a non-linear relation between pressure and flow rate .
The pressure gradients of five EPD could be measured with the vessel model of the internal carotid artery. Under the condition that the particle capture efficiency is given it is an advantage to choose a filter design that causes a low pressure gradient.
Research funding: Financial support by the Federal Ministry of Education and Research (BMBF) within RESPONSE “Partnership for Innovation in Implant Technology” is gratefully acknowledged. Conflict of interest: Authors state no conflict of interest. Material and Methods: Informed consent: Informed consent has been obtained from all individuals included in this study. Ethical approval: The research related to human use complies with all the relevant national regulations, institutional policies and was performed in accordance with the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board or equivalent committee.
Hendriks J. Carotid artery stenting and endarterectomy: a clinical evaluation. Erasmus Universiteit Rotterdam. Google Scholar
Kopp H, Ludwig M. Checkliste Doppler- und Duplexsonografie. 4th ed. Georg Thieme Verlag KG; 2012. Google Scholar
Matthies J, Kurzhals A, Schmidt W, Atamna A, Andresen R, Schmitz K-P, et al. Test setup for characterizing the efficacy of embolic protection devices. Current Directions in Biomedical Eng. 2015;1:454–7. Google Scholar
Kurzhals A, Matthies J, Andresen R, Wissgott C, Schmitz KP, Grabow N, et al. Efficiency test of current carotid embolic protection devices. In preparation. Google Scholar
Cordis. Katalog Cordis Emboli Protection Device: ANGIOGUARD® RX Emboli Capture Guidewire System Product Page; 2016. Available from: URL: http://pdf.medicalexpo.de/pdf-en/cordis/angioguard-r-rx-emboli-capture-guidewire-system-product-page/71108-153612.html [cited 2016 Feb 19].
Charalambous N, Jahnke T, Bolte H, Heller M, Schäfer PJ, Müller-Hülsbeck S. Reduction of cerebral embolization in carotid angioplasty: an in-vitro experiment comparing 2 cerebral protection devices. J Endovasc Ther. 2009;16:161–7. Google Scholar
Medtronic. FiberNet Embolic protection system: Technical specifications; 2013. Available from: http://www.peripheral.medtronicendovascular.com/international/product-type/carotid-package/fibernet/technical-specifications/index.htm [cited 2016 Feb 19].
Bostonscientific. FilterWire EZ: Embolic Protection System for carotid artery; 2016. Available from: http://www.bostonscientific.com/en-US/products/embolic-protection/filterwire-ez-embolic-protection-system.html [cited 2016 Feb 19].
Kao J. Emboshield NAV 6 Embolic Protection System 510 (k) summary FDA: Abbott Vascular; 2014. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K121015.pdf [cited 2016 Feb 18].
Atamna A. Aufbau einer in vitro Prüfeinrichtung für die experimentelle Erprobung der Wirksamkeit von Protektionssystemen für die Carotis-Stentimplantation. Rostock: Universität Rostock; 2014. Google Scholar
Siewiorek GM, Finol EA. Computational modeling of distal protection filters. J Endovasc Ther. 2010:17;777–88. Google Scholar
Siewiorek GM, Wholey MH, Finol EA. Vascular resistance in the carotid artery: an in vitro investigation of embolic protection filters. J Vasc Interv Radiol. 2008;19:1467–76. Google Scholar
Baehr HD, Stephan K. Wärme- und Stoffübertragung. 8th ed. Berlin, Heidelberg: Springer Berlin Heidelberg; 2013. Google Scholar
About the article
Published Online: 2016-09-30
Published in Print: 2016-09-01
Citation Information: Current Directions in Biomedical Engineering, Volume 2, Issue 1, Pages 359–362, ISSN (Online) 2364-5504, DOI: https://doi.org/10.1515/cdbme-2016-0080.
©2016 Anja Kurzhals et al., licensee De Gruyter.. This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License. BY-NC-ND 4.0