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Balloon-Expandable Myval Octacor Versus Self-Expanding Evolut PRO/PRO+ and Acurate Neo2: Short-Term Outcomes From
Elisabetta Moscarella1,2, Alfonso Ielasi3, Won-Keun Kim4
1Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Background:
With transcatheter aortic valve implantation (TAVI) now extending to lower-risk and younger patients, optimizing procedural and hemodynamic outcomes is critical. The Myval Octacor, a new balloon-expandable valve (BEV), was developed to improve outcomes by reducing paravalvular regurgitation (PVL), minimizing pacemaker implantation (PPI) rates, and enhancing hemodynamic performance. However, limited data are available comparing Myval Octacor to contemporary self-expanding supra-annular valves (SEVs) Evolut PRO/PRO+ and Acurate Neo2.
Aims:
This study aimed to compare the safety, efficacy, and short-term clinical outcomes of Myval Octacor with SEVs in transfemoral TAVI patients.
Methods:
We conducted a prospective, multicenter registry including patients treated with Myval Octacor, then compared them to SEV recipients from the NEOPRO2 registry. Propensity score matching adjusted for baseline differences between groups. The primary endpoint was 30-day Valve Academic Research Consortium-3 (VARC-3) device success. Secondary endpoints included technical success, valve performance, and early safety outcomes.
Results:
Among 252 Myval Octacor patients and 2175 SEV patients, 90 matched pairs were compared. Myval Octacor patients showed higher 30-day VARC-3 device success than SEVs patients (97% vs. 88%, p = 0.024), primarily due to a numerically lower rate of moderate-to-severe PVL (1% vs. 7%, p = 0.06). The Octacor group also exhibited larger indexed effective orifice areas. Mortality, stroke, PPI, and myocardial infarction rates were similar between groups at 30 days.
Conclusions:
The Myval Octacor demonstrated comparable early safety and efficacy to supra-annular SEVs, with advantages in device success rate and hemodynamic performance. Adequately sized randomized study is required to confirm these findings.
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