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

• Evaluation of long-term durability and biological response of new THVs has been limited in the preclinical setting. • We assessed a balloon expandable THV system (Myval) in the novel, ovine banding model. • TAVI and anchoring of valves was achieved in all cases with high procedural success. • Long-term (6-month) observation was feasible with cumulative 36.3% mortality. • The studied prosthesis showed good hemodynamic performance and optimal healing in pathology. 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.