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

Piotr P Buszman; Mateusz Kachel; Carlos Fernandez Ceballos; Karolina Łukasik; Wojciech Domaradzki; Maciej Pruski Jr; Armando Tellez; Serge Rousselle; Marta Konopko; Michał Glanc; Paweł Kaźmierczak; Krzysztof P Milewski; Pawel E Buszman

doi:10.1016/j.jacbts.2022.01.008

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

JACC Basic Transl Sci. 2022 May 11;7(5):486-495. doi: 10.1016/j.jacbts.2022.01.008. eCollection 2022 May.

Authors

Piotr P Buszman^{1

2}, Mateusz Kachel², Carlos Fernandez Ceballos², Karolina Łukasik², Wojciech Domaradzki², Maciej Pruski Jr^{1

2}, Armando Tellez³, Serge Rousselle⁴, Marta Konopko¹, Michał Glanc², Paweł Kaźmierczak², Krzysztof P Milewski^{2

5}, Pawel E Buszman^{2

6}

Affiliations

¹ Department of Cardiology, Andrzej-Frycz Modrzewski Kraków University, Bielsko-Biała, Poland.
² Center for Cardiovascular Research and Development, American Heart of Poland, Kostkowice, Poland.
³ Instituto Tecnológico de Estudios Superiores de Monterrey, Monterrey, Mexico.
⁴ Biostage, Mount Jackson, Virginia, USA.
⁵ University of Technology, Faculty of Medicine, Katowice, Poland.
⁶ Department of Epidemiology, Medical University of Silesia, Katowice, Poland.

Abstract

The aim of the study was to evaluate a balloon expandable transcatheter heart valve (THV) system (Myval) at 6-month follow-up in ovine banding model. Eleven THV systems were implanted via carotid approach. There were 2 procedure-related deaths and 2 premature deaths. At 6 months all valves that completed follow-up (n = 7) were functional, with no significant regurgitation, calcification, thrombi, or vegetation. Mean pressure gradient was 21.9 ± 11 mm Hg, maximum velocity = 3.3 ± 1 m/s, and ejection fraction was 53.3 ± 6%. Myval THV showed optimal hemodynamic performance and biocompatibility.

Keywords: LC, left coronary; RC, right coronary; TAVI; TAVI, transcatheter aortic valve implantation; THV, transcatheter heart valve; TTE, transthoracic echocardiography; Vmax, maximum velocity; aortic stenosis; innovation; preclinical research.