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      Design, Manufacturing Technology and In-Vitro Evaluation of Original, Polyurethane, Petal Valves for Application in Pulsating Ventricular Assist Devices

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          Abstract

          Minimizing of the life-threatening thrombo-emboli formation in pulsatile heart assist devices by a new biomimetic heart valve design is presently one of the most important problems in medicine. As part of this work, an original valve structure was proposed intended for pneumatic, extracorporeal ventricular assist devices. The valve design allows for direct integration with other parts of the pulsating blood pump. Strengthening in the form of the titanium or steel frame has been introduced into the polyurethane lagging, which allows for maintaining material continuity and eliminating the risk of blood clotting. The prototype of the valve was made by the injection molding method assisted by numerical simulation of this process. The prototype was introduced into a modified pulsating, extracorporeal heart assist pump ReligaHeart EXT (developed for tilting disc valves) and examined in-vitro using the “artificial patient” model in order to determine hydrodynamic properties of the valve in the environment similar to physiological conditions. Fundamental blood tests, like hemolysis and thrombogenicity have been carried out. Very low backflow through the closed valve was observed despite their slight distortion due to pressure. On the basis of immunofluorescence tests, only slight activation of platelets was found on the inlet valve and slight increased risk of clotting of the outlet valve commissures as a result of poor valve leaflets assembling in the prototype device. No blood hemolysis was observed. Few of the clots formed only in places where the valve surfaces were not smooth enough.

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          Most cited references24

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          Prosthetic heart valves: selection of the optimal prosthesis and long-term management.

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            Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children.

            Recent data suggest that the Berlin Heart EXCOR Pediatric ventricular assist device is superior to extracorporeal membrane oxygenation for bridge to heart transplantation. Published data are limited to 1 in 4 children who received the device as part of the US clinical trial. We analyzed outcomes for all US children who received the EXCOR to characterize device outcomes in an unselected cohort and to identify risk factors for mortality to facilitate patient selection. This multicenter, prospective cohort study involved all children implanted with the Berlin Heart EXCOR Pediatric ventricular assist device at 47 centers from May 2007 through December 2010. Multiphase nonproportional hazards modeling was used to identify risk factors for early (<2 months) and late mortality. Of 204 children supported with the EXCOR, the median duration of support was 40 days (range, 1-435 days). Survival at 12 months was 75%, including 64% who reached transplantation, 6% who recovered, and 5% who were alive on the device. Multivariable analysis identified lower weight, biventricular assist device support, and elevated bilirubin as risk factors for early mortality and bilirubin extremes and renal dysfunction as risk factors for late mortality. Neurological dysfunction occurred in 29% and was the leading cause of death. Use of the Berlin Heart EXCOR has risen dramatically over the past decade. The EXCOR has emerged as a new treatment standard in the United States for pediatric bridge to transplantation. Three-quarters of children survived to transplantation or recovery; an important fraction experienced neurological dysfunction. Smaller patient size, renal dysfunction, hepatic dysfunction, and biventricular assist device use were associated with mortality, whereas extracorporeal membrane oxygenation before implantation and congenital heart disease were not.
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              Polyurethane: material for the next generation of heart valve prostheses?

              The prospects for a durable, athrombogenic, synthetic, flexible leaflet heart valve are enhanced by the recent availability of novel, biostable polyurethanes. As a forerunner to evaluation of such biostable valves, a prototype trileaflet polyurethane valve (utilising conventional material of known in vitro behaviour) was compared with mechanical and bioprosthetic valves for assessment of in vivo function, durability, thromboembolic potential and calcification.
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                Author and article information

                Journal
                Polymers (Basel)
                Polymers (Basel)
                polymers
                Polymers
                MDPI
                2073-4360
                15 December 2020
                December 2020
                : 12
                : 12
                : 2986
                Affiliations
                [1 ]Institute of Metallurgy and Materials Science, Polish Academy of Sciences, Reymonta Str. 25, 30-059 Cracow, Poland
                [2 ]Department of Biosensors and Processing of Biomedical Signals, Faculty of Biomedical Engineering, Silesian University of Technology, Roosevelt Str. 40, 41-800 Zabrze, Poland
                [3 ]Artificial Heart laboratory, Foundation of Cardiac Surgery Development, Wolnosci Str. 345, 41-800 Zabrze, Poland; arti@ 123456frk.pl
                [4 ]Department of Medicine, Jagiellonian University Medical College, Skawinska Str. 8, 31-066 Cracow, Poland; nfsanak@ 123456cyf-kr.edu.pl
                [5 ]Joanneum Research Forschungsges.m.b.H., Institute of Surface Technologies and Photonics, Functional Surfaces, Leobner Str. 94, 8712 Niklasdorf, Austria; juergen.lackner@ 123456joanneum.at
                Author notes
                Author information
                https://orcid.org/0000-0002-6526-2656
                Article
                polymers-12-02986
                10.3390/polym12122986
                7765235
                33333728
                ab812a12-6d14-43bb-8472-490fe682f10b
                © 2020 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 30 October 2020
                : 09 December 2020
                Categories
                Article

                petal valve,ventricular assist device,blood–material interaction

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