Early Outcomes of the Myval Octacor Transcatheter Heart Valve in Transcatheter Aortic Valve Implantation: A Single-Center Study From Serbia

OBJECTIVES: Aortic stenosis (AS) is the most common valvular heart disease, with transcatheter aortic valve implantation (TAVI) now preferred for select severe cases. This study evaluated the early safety and performance of the new Myval Octacor Transcatheter Heart Valve (THV) (Meril Life Sciences), for which limited clinical data exist. METHODS: The authors retrospectively analyzed 43 consecutive patients with severe AS who underwent TAVI using the Myval Octacor THV at a tertiary cardiac center. Primary outcomes included all-cause mortality, stroke, major vascular complications, conduction abnormalities, new pacemaker implantation, paravalvular leak, and valve failure at 30 days follow-up. RESULTS: The median age was 81 years (IQR: 7), and 22 patients (51.2%) were female. Coronary artery disease was present in 24 (55.8%). Technical success rate was 100%. Mean pressure gradient decreased significantly post-procedure (55 mm Hg [IQR: 24] vs 5 mm Hg [IQR: 2]; P ≤ .001). No in-hospital deaths occurred. Two patients (4.7%) received permanent pacemakers during hospitalization, and 3 (7.0%) required pacemakers within a week because of conduction issues. Two patients (4.7%) experienced Bleeding Academic Research Consortium Type 3a bleeding. At 30 days, 42 patients remained in follow-up (98%), with 55% improved to New York Heart Association Class I. No vascular complications, stroke, acute kidney injury, valve thrombosis, or endocarditis occurred. One patient had valve failure from a significant paravalvular leak and 1 noncardiac death occurred 2 weeks post-discharge. CONCLUSIONS: Early outcomes suggest that the Myval Octacor THV is a safe and effective option for TAVI in severe AS; however, larger studies with longer follow-up are required.