Impact of aortic annulus geometry according to ISO 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses

To assess the hydrodynamic performance of transcatheter aortic valve prostheses (TAVP), in vitro test using pulse duplicators is required. Test conditions as well as minimum performance criteria are specified in ISO 5840- 3:2013 and ISO 5840-3:2019-draft. In the 2019 published draft, modifications r...

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Autores principales:	Oldenburg Jan, Kaule Sebastian, Siewert Stefan, Schmitz Klaus-Peter, Stiehm Michael, Grabow Niels
Formato:	article
Lenguaje:	EN
Publicado:	De Gruyter 2020
Materias:	iso 5840 aortic valve tavp tavi annulus aortic fixture hydrodynamic Medicine R
Acceso en línea:	https://doaj.org/article/d491a223221c40a5895e4b48c929734a
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spelling	oai:doaj.org-article:d491a223221c40a5895e4b48c929734a2021-12-05T14:10:43ZImpact of aortic annulus geometry according to ISO 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses2364-550410.1515/cdbme-2020-3117https://doaj.org/article/d491a223221c40a5895e4b48c929734a2020-09-01T00:00:00Zhttps://doi.org/10.1515/cdbme-2020-3117https://doaj.org/toc/2364-5504To assess the hydrodynamic performance of transcatheter aortic valve prostheses (TAVP), in vitro test using pulse duplicators is required. Test conditions as well as minimum performance criteria are specified in ISO 5840- 3:2013 and ISO 5840-3:2019-draft. In the 2019 published draft, modifications regarding hydrodynamic testing are proposed. Among others, the geometrical configuration of the fixation has changed, with the intention to improve the anatomical representation as well as the comparability of results from different test laboratories. We analyzed the consequences of altered annulus fixations regarding native leaflets as well as a step in the proximal area of the protheses to prevent their migration. The analyses were conducted with regard to the degree of calcification of the annulus ring on hydrodynamic parameters. By using 3D stereolithography printing technology, molds for casting of silicone elastomer of annulus models with and without native leaflets were manufactured. A modular system enabled us to use the same annulus ring to model the degree of calcification as well as different step sizes. We performed in vitro hydrodynamic testing according to ISO 5840-3:2019-draft of a selfexpandable valve prototype with porcine pericardial leaflets by using a commercially available pulse duplicator system. As expected, regurgitation increases with increasing degree of calcification, whereby the use of a step has no influence on the backflow of fluid during diastole. The effective orifice area (EOA) of the valve showed a clear tendency with respect to radial protrusion of the step. The EOA decreased as the radial protrusion increased. We also present a suggestion to prevent migration without affecting the general test results, by using a novel step design. We also found that the novel annulus model with native leaflet drastically reduced the regurgitation.Oldenburg JanKaule SebastianSiewert StefanSchmitz Klaus-PeterStiehm MichaelGrabow NielsDe Gruyterarticleiso 5840aortic valvetavptaviannulus aortic fixturehydrodynamicMedicineRENCurrent Directions in Biomedical Engineering, Vol 6, Iss 3, Pp 454-457 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	iso 5840 aortic valve tavp tavi annulus aortic fixture hydrodynamic Medicine R
spellingShingle	iso 5840 aortic valve tavp tavi annulus aortic fixture hydrodynamic Medicine R Oldenburg Jan Kaule Sebastian Siewert Stefan Schmitz Klaus-Peter Stiehm Michael Grabow Niels Impact of aortic annulus geometry according to ISO 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses
description	To assess the hydrodynamic performance of transcatheter aortic valve prostheses (TAVP), in vitro test using pulse duplicators is required. Test conditions as well as minimum performance criteria are specified in ISO 5840- 3:2013 and ISO 5840-3:2019-draft. In the 2019 published draft, modifications regarding hydrodynamic testing are proposed. Among others, the geometrical configuration of the fixation has changed, with the intention to improve the anatomical representation as well as the comparability of results from different test laboratories. We analyzed the consequences of altered annulus fixations regarding native leaflets as well as a step in the proximal area of the protheses to prevent their migration. The analyses were conducted with regard to the degree of calcification of the annulus ring on hydrodynamic parameters. By using 3D stereolithography printing technology, molds for casting of silicone elastomer of annulus models with and without native leaflets were manufactured. A modular system enabled us to use the same annulus ring to model the degree of calcification as well as different step sizes. We performed in vitro hydrodynamic testing according to ISO 5840-3:2019-draft of a selfexpandable valve prototype with porcine pericardial leaflets by using a commercially available pulse duplicator system. As expected, regurgitation increases with increasing degree of calcification, whereby the use of a step has no influence on the backflow of fluid during diastole. The effective orifice area (EOA) of the valve showed a clear tendency with respect to radial protrusion of the step. The EOA decreased as the radial protrusion increased. We also present a suggestion to prevent migration without affecting the general test results, by using a novel step design. We also found that the novel annulus model with native leaflet drastically reduced the regurgitation.
format	article
author	Oldenburg Jan Kaule Sebastian Siewert Stefan Schmitz Klaus-Peter Stiehm Michael Grabow Niels
author_facet	Oldenburg Jan Kaule Sebastian Siewert Stefan Schmitz Klaus-Peter Stiehm Michael Grabow Niels
author_sort	Oldenburg Jan
title	Impact of aortic annulus geometry according to ISO 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses
title_short	Impact of aortic annulus geometry according to ISO 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses
title_full	Impact of aortic annulus geometry according to ISO 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses
title_fullStr	Impact of aortic annulus geometry according to ISO 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses
title_full_unstemmed	Impact of aortic annulus geometry according to ISO 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses
title_sort	impact of aortic annulus geometry according to iso 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses
publisher	De Gruyter
publishDate	2020
url	https://doaj.org/article/d491a223221c40a5895e4b48c929734a
work_keys_str_mv	AT oldenburgjan impactofaorticannulusgeometryaccordingtoiso58402019draftonhydrodynamicperformanceoftranscatheteraorticvalveprostheses AT kaulesebastian impactofaorticannulusgeometryaccordingtoiso58402019draftonhydrodynamicperformanceoftranscatheteraorticvalveprostheses AT siewertstefan impactofaorticannulusgeometryaccordingtoiso58402019draftonhydrodynamicperformanceoftranscatheteraorticvalveprostheses AT schmitzklauspeter impactofaorticannulusgeometryaccordingtoiso58402019draftonhydrodynamicperformanceoftranscatheteraorticvalveprostheses AT stiehmmichael impactofaorticannulusgeometryaccordingtoiso58402019draftonhydrodynamicperformanceoftranscatheteraorticvalveprostheses AT grabowniels impactofaorticannulusgeometryaccordingtoiso58402019draftonhydrodynamicperformanceoftranscatheteraorticvalveprostheses
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Impact of aortic annulus geometry according to ISO 5840:2019 (draft) on hydrodynamic performance of transcatheter aortic valve prostheses

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