AUTHOR=Kachel Mateusz , Buszman Piotr P. , Milewski Krzysztof P. , Michalak Magdalena , Domaradzki Wojciech , Pruski Maciej , Sobota Michał , Fernandez Carlos , Konopko Marta , Nożyński Jerzy , Kaźmierczak Paweł , Włodarczyk Jakub , Stojko Mateusz , Bochenek Andrzej , Buszman Paweł E. 

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

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 9 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.977006

DOI=10.3389/fcvm.2022.977006

ISSN=2297-055X

ABSTRACT=Objectives
To evaluate functionality, durability and temporal biocompatibility of a novel, balloon expanda-ble polymeric artificial transcatheter heart valve (ATHV) system (InFlow, CardValve Consorti-um, Poland). Along with expanding TAVI indications to low-risk group, the demand for new transcatheter valves is foreseen to increase drastically.
Methods
Surgical ascending aortic banding model was created in 20 sheep. Two weeks later, 16 were implanted with ATHV systems (15-16F). Three animals were sacrificed after 30, four - after 90 and six after 180-day follow-up. Follow-up transthoracic echocardiography (TTE) was per-formed.
Results
There was one procedure-related (6,25%) and two model-related deaths (12,5%). TTE revealed the flow gradients (max/average) of 30,75/17,91; 32,57/19,21 and 21,34/10,63 mmHg respec-tively. There were 2 cases of low-degree regurgitation after 180 days with no perivalvular leak observed. Histopathologic analysis showed no valve degeneration at terminal follow up.
Conclusions
The study showed good hemodynamic performance, durability, and biocompatibility of the novel ATHV.