6-Month Evaluation of a Transcatheter Aortic Valve (Myval) in a Novel Ovine, Supra-Aortic Banding Model

Buszman, Piotr P.; Kachel, Mateusz; Ceballos, Carlos Fernandez; Łukasik, Karolina; Domaradzki, Wojciech; Pruski, Maciej; Téllez, Armando; Rousselle, Serge; Konopko, Marta; Glanc, Michał; Kaźmierczak, Paweł; Milewski, Krzysztof

doi:10.1016/j.jacbts.2022.01.008

Cited by 5 publications

(7 citation statements)

References 11 publications

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“…The above-described mortality rate of the polymeric InFlow valve equaled 6,25% in the periprocedural period (1 out of 16) and 13,3% in the observation period (2 out of 15), respectively. The mortality is similar to our most recent study utilizing biological THV in the banding model ( 8 ). However, these numbers are significantly lower when compared to previous studies of THV technologies utilizing either the descending aorta model or implantation in the native position ( 5 , 9 , 10 ).…”

Section: Discussionsupporting

confidence: 87%

“…The study showed a proper hemodynamic performance and acceptable biocompatibility of the novel artificial polymeric InFlow ATHV, similar to biological counterparts, as evaluated in the same follow-up in the ovine banding model. Given the presence of micro-calcifications and microthrombi on several valves, a finding was also reported in other preclinical studies including biological valves ( 8 ). Further studies with longer follow-ups are warranted.…”

Section: Discussionsupporting

confidence: 70%

“…The pannus tissue showed maturation increased with time but in all cases, the pannus never formed a stenotic “collar” visible in implanted orthotopically valves. This phenomenon was reported in other studies of the biological valve utilizing surgical aortic banding and thus is considered model-related ( 8 ). Importantly, no severe cases of prosthesis insufficiency were reported, with only two cases of moderate regurgitation.…”

Section: Discussionsupporting

confidence: 58%

“…The evidence from the preclinical studies of currently available THV is very limited. The currently evaluated ATHV InFlow system shows similar healing with no degeneration at the comparable period to biological balloon-expandable THV counterparts ( 5 , 8 – 10 ).…”

Section: Discussionmentioning

confidence: 89%

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Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model

Kachel

Buszman

Milewski

et al. 2022

Front. Cardiovasc. Med.

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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.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 70%

Section: Discussionsupporting

confidence: 58%

Section: Discussionmentioning

confidence: 89%

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Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model

Kachel

Buszman

Milewski

et al. 2022

Front. Cardiovasc. Med.

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“…The banding methods have been described and previously validated [ 13 ]. Briefly, ascending aorta delicate stenosis (AS) and anchoring mechanism was created by fixing a surgical band around the aorta.…”

Section: Methodsmentioning

confidence: 99%

Long-term bio-functional performance of a novel, self-positioning balloon expandable transcatheter biological aortic valve system in the ovine aortic banding model

et al. 2024

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Background The aim of the study was to evaluate bio-functionality of a novel, proprietary balloon-expandable biological transcatheter aortic valve implantation (TAVI) system (InFlow, CardValve Consortium, Poland) in an ovine model of aortic banding. Methods Surgical ascending aorta banding was created in 21 sheep. Two weeks later, 18 biological valves were implanted within the model using 15–16 F InFlow TAVI systems and carotid cut-down approach. Follow-up transthoracic echocardiography was performed at 30, 90, and 180-day. At designated time, animals were euthanized and valves harvested for analysis. Results All sheep survived the banding procedure. There were 4 (22%) procedure related deaths within a 7-day period. During the observation an additional 2 sheep died. In one, the valve dislocated after the procedure — the animal was excluded. Two animals completed 30-day follow up, five 90-day follow-up and four terminal follow-up of 180 days. Valves examined via transesophageal echocardiography showed proper hemodynamic parameters without evidence of structural valve deterioration. The maximum and average flow gradients at 180 days were 31.4 (23.3–37.7) and 17.5 (13.1–20.2) mmHg, respectively. There was one case of moderate insufficiency and no case of perivalvular leaks. By histopathology, there were no inflammation, thrombosis, nor calcifications in any tested valves at long-term follow-up. Neointimal coverage of stent struts increased with time from basal part in “early” groups to nearly 3/4 of stent length in the 180-day group. The pannus tissue showed maturation that increased with time with no stenotic “collar” visible in orthotopically implanted valves. Conclusions The study showed good hemodynamic performance, durability and biocompatibility of the novel biological transcatheter heart valve.

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Large Animal Models for Transcatheter Heart Valve Prosthesis Development

Modine

Ali

Perrin

2022

JACC: Basic to Translational Science

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6-Month Evaluation of a Transcatheter Aortic Valve (Myval) in a Novel Ovine, Supra-Aortic Banding Model

Cited by 5 publications

References 11 publications

Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model

Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model

Long-term bio-functional performance of a novel, self-positioning balloon expandable transcatheter biological aortic valve system in the ovine aortic banding model

Large Animal Models for Transcatheter Heart Valve Prosthesis Development

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