Key result
The 32mm Myval valve achieves 100% device success in severe AS with extremely large annuli.
Why the study?
Extremely large aortic valve anatomy limits patient eligibility for TAVR, and initial global experience with the 32 mm Myval valve in this population was needed.
Does the 32 mm Myval transcatheter heart valve provide procedural success and safety in patients with severe aortic stenosis and extremely large aortic annuli?
Observational (n=10)
Yes
Does the 32 mm Myval transcatheter heart valve provide procedural success and safety in patients with severe aortic stenosis and extremely large aortic annuli?
The 32 mm Myval transcatheter heart valve demonstrates initial procedural safety and feasibility for patients with extremely large aortic annuli who would otherwise be excluded from TAVR.
May broaden TAVR eligibility for large annuli; hypothesis-generating and should not yet change practice.
BACKGROUND: Extremely large aortic valve anatomy is one of the remaining limitations leading to exclusion of patients for transcatheter aortic valve replacement (TAVR). AIMS: . Here we want to share the initial worldwide experience with the device. METHODS AND RESULTS: ), who underwent implantation with 32 mm Myval transcatheter heart valve at eight centers. Valve Academic Research Consortium-2 device success was achieved in all cases. Mild paravalvular leak was observed in three patients and two patients required new pacemaker implantation. One patient experienced retroperitoneal hemorrhage caused by the contralateral 6 F sheath and required surgical revision. No device-related complications, stroke, or death from any cause occurred within the 30-day follow-up period. In a studied cohort of 2219 consecutive TAVR-screened patients from a central European site, only 0.27% of patients showed larger anatomy than covered by the 32 mm Myval device by instructions for use without off-label use of overexpansion. This rate was significantly higher for the 34 mm Evolut Pro (1.8%) and 29 mm Sapien 3 (2.1%) devices. CONCLUSIONS: The Myval 32 mm prosthesis showed promising initial results in a cohort of patients who previously had to be excluded from TAVR. It is desirable that all future TAVR systems accommodate larger anatomy to allow optimal treatment of all patients.
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Holzamer et al. (2023) conducted an observational in Severe native aortic stenosis with extremely large aortic annuli (n=10). 32 mm Myval transcatheter heart valve was evaluated on Valve Academic Research Consortium-2 (VARC-2) device success. The 32 mm Myval transcatheter heart valve achieved 100% VARC-2 device success with no stroke or death at 30 days in 10 patients with severe aortic stenosis and extremely large aortic annuli.
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