4.6 Article

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

Journal

JACC-BASIC TO TRANSLATIONAL SCIENCE
Volume 7, Issue 5, Pages 486-495

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacbts.2022.01.008

Keywords

innovation; preclinical research; TAVI; aortic stenosis

Funding

  1. Meril Life Sciences

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The study evaluated a balloon expandable transcatheter heart valve system in an ovine banding model. The results showed that the valve system had good functionality and biocompatibility.
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. (J Am Coll Cardiol Basic Trans Science 2022;7:486???495) ?? 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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