Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model
ObjectivesThe aim of the study is to evaluate the functionality, durability, and temporal biocompatibility of a novel, balloon-expandable polymeric transcatheter heart valve (ATHV) system (InFlow, CardValve Consortium, Poland). Along with expanding TAVI indications, the demand for new transcatheter...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-12-01
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| Series: | Frontiers in Cardiovascular Medicine |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.977006/full |
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| author | Mateusz Kachel Mateusz Kachel Piotr P. Buszman Piotr P. Buszman Krzysztof P. Milewski Krzysztof P. Milewski Magdalena Michalak Wojciech Domaradzki Maciej Pruski Michał Sobota Carlos Fernandez Marta Konopko Jerzy Nożyński Paweł Kaźmierczak Jakub Włodarczyk Mateusz Stojko Andrzej Bochenek Andrzej Bochenek Paweł E. Buszman Paweł E. Buszman |
| author_facet | Mateusz Kachel Mateusz Kachel Piotr P. Buszman Piotr P. Buszman Krzysztof P. Milewski Krzysztof P. Milewski Magdalena Michalak Wojciech Domaradzki Maciej Pruski Michał Sobota Carlos Fernandez Marta Konopko Jerzy Nożyński Paweł Kaźmierczak Jakub Włodarczyk Mateusz Stojko Andrzej Bochenek Andrzej Bochenek Paweł E. Buszman Paweł E. Buszman |
| author_sort | Mateusz Kachel |
| collection | DOAJ |
| description | ObjectivesThe aim of the study is to evaluate the functionality, durability, and temporal biocompatibility of a novel, balloon-expandable polymeric transcatheter heart valve (ATHV) system (InFlow, CardValve Consortium, Poland). Along with expanding TAVI indications, the demand for new transcatheter valves is increasing.MethodsA surgical ascending aortic banding model was created in 20 sheep. Two weeks later, 16 sheep were implanted with ATHV systems (15–16F). Three animals were euthanized after a 30-day follow-up, four animals after a 90-day follow-up, and six animals after a 180-day follow-up. A follow-up transthoracic echocardiography (TTE) was performed.ResultsThere was one procedure-related (6,25%) and two model-related deaths (12,5%; banding site calcification with subsequent infection originating externally from banding). TTE revealed the flow gradients (max/average) of 30,75/17,91; 32,57/19,21; and 21,34/10,63 mmHg at 30, 90, and 180 days, respectively. There were two cases of low-degree regurgitation after 180 days with no perivalvular leak observed. Histopathological analysis showed no valve degeneration at terminal follow-up with optimal healing. Small thrombi were present at the aortic wall adjacent to the base of the leaflets, and between the aortic wall and the stent in most of the valves; however, leaflets remained free from thrombi in all cases. Scanty calcifications of leaflets were reported in three animals evaluated 180 days after implantation.ConclusionThis preclinical study in the aortic banding model showed good hemodynamic performance, durability, and biocompatibility of the novel ATHV. Furthermore, regulatory studies with longer follow-ups are warranted. |
| first_indexed | 2024-04-11T05:49:46Z |
| format | Article |
| id | doaj.art-557453ff997543c489f7767176b64164 |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-11T05:49:46Z |
| publishDate | 2022-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-557453ff997543c489f7767176b641642022-12-22T04:42:06ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-12-01910.3389/fcvm.2022.977006977006Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding modelMateusz Kachel0Mateusz Kachel1Piotr P. Buszman2Piotr P. Buszman3Krzysztof P. Milewski4Krzysztof P. Milewski5Magdalena Michalak6Wojciech Domaradzki7Maciej Pruski8Michał Sobota9Carlos Fernandez10Marta Konopko11Jerzy Nożyński12Paweł Kaźmierczak13Jakub Włodarczyk14Mateusz Stojko15Andrzej Bochenek16Andrzej Bochenek17Paweł E. Buszman18Paweł E. Buszman19American Heart of Poland, Center for Cardiovascular Research and Development, Katowice, PolandDepartment of Cardiology, Andrzej Frycz Modrzewski Kraków University, Bielsko-Biała, PolandAmerican Heart of Poland, Center for Cardiovascular Research and Development, Katowice, PolandDepartment of Cardiology, Andrzej Frycz Modrzewski Kraków University, Bielsko-Biała, PolandAmerican Heart of Poland, Center for Cardiovascular Research and Development, Katowice, PolandFaculty of Medicine, University of Technology, Katowice, PolandAmerican Heart of Poland, Center for Cardiovascular Research and Development, Katowice, PolandAmerican Heart of Poland, Center for Cardiovascular Research and Development, Katowice, PolandDepartment of Epidemiology, Medical University of Silesia, Katowice, PolandCentre of Polymer and Carbon Materials, Polish Academy of Sciences, Zabrze, PolandAmerican Heart of Poland, Center for Cardiovascular Research and Development, Katowice, PolandDepartment of Cardiology, Andrzej Frycz Modrzewski Kraków University, Bielsko-Biała, PolandSilesian Center for Heart Diseases, Zabrze, PolandAmerican Heart of Poland, Center for Cardiovascular Research and Development, Katowice, PolandCentre of Polymer and Carbon Materials, Polish Academy of Sciences, Zabrze, PolandCentre of Polymer and Carbon Materials, Polish Academy of Sciences, Zabrze, PolandAmerican Heart of Poland, Center for Cardiovascular Research and Development, Katowice, PolandFaculty of Medicine, University of Technology, Katowice, PolandAmerican Heart of Poland, Center for Cardiovascular Research and Development, Katowice, PolandDepartment of Epidemiology, Medical University of Silesia, Katowice, PolandObjectivesThe aim of the study is to evaluate the functionality, durability, and temporal biocompatibility of a novel, balloon-expandable polymeric transcatheter heart valve (ATHV) system (InFlow, CardValve Consortium, Poland). Along with expanding TAVI indications, the demand for new transcatheter valves is increasing.MethodsA surgical ascending aortic banding model was created in 20 sheep. Two weeks later, 16 sheep were implanted with ATHV systems (15–16F). Three animals were euthanized after a 30-day follow-up, four animals after a 90-day follow-up, and six animals after a 180-day follow-up. A follow-up transthoracic echocardiography (TTE) was performed.ResultsThere was one procedure-related (6,25%) and two model-related deaths (12,5%; banding site calcification with subsequent infection originating externally from banding). TTE revealed the flow gradients (max/average) of 30,75/17,91; 32,57/19,21; and 21,34/10,63 mmHg at 30, 90, and 180 days, respectively. There were two cases of low-degree regurgitation after 180 days with no perivalvular leak observed. Histopathological analysis showed no valve degeneration at terminal follow-up with optimal healing. Small thrombi were present at the aortic wall adjacent to the base of the leaflets, and between the aortic wall and the stent in most of the valves; however, leaflets remained free from thrombi in all cases. Scanty calcifications of leaflets were reported in three animals evaluated 180 days after implantation.ConclusionThis preclinical study in the aortic banding model showed good hemodynamic performance, durability, and biocompatibility of the novel ATHV. Furthermore, regulatory studies with longer follow-ups are warranted.https://www.frontiersin.org/articles/10.3389/fcvm.2022.977006/fullaortic valve stenosistranscatheter aortic valve replacement (TAVR)heart valve prosthesispolymeric valvepreclinical “in vivo” study |
| spellingShingle | Mateusz Kachel Mateusz Kachel Piotr P. Buszman Piotr P. Buszman Krzysztof P. Milewski Krzysztof P. Milewski Magdalena Michalak Wojciech Domaradzki Maciej Pruski Michał Sobota Carlos Fernandez Marta Konopko Jerzy Nożyński Paweł Kaźmierczak Jakub Włodarczyk Mateusz Stojko Andrzej Bochenek Andrzej Bochenek Paweł E. Buszman Paweł E. Buszman Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model Frontiers in Cardiovascular Medicine aortic valve stenosis transcatheter aortic valve replacement (TAVR) heart valve prosthesis polymeric valve preclinical “in vivo” study |
| title | Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model |
| title_full | Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model |
| title_fullStr | Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model |
| title_full_unstemmed | Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model |
| title_short | Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model |
| title_sort | temporal biomechanical evaluation of a novel transcatheter polymeric aortic valve in ovine aortic banding model |
| topic | aortic valve stenosis transcatheter aortic valve replacement (TAVR) heart valve prosthesis polymeric valve preclinical “in vivo” study |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.977006/full |
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