Performance of the 32 Mm Myval Transcatheter Heart Valve for Treatment of Aortic Stenosis in Patients with Extremely Large Aortic Annuli in Real-World Scenario: First Global, Multicenter Experience.

BackgroundExtremely large aortic valve anatomy is one of the remaining limitations leading to exclusion of patients for transcatheter aortic valve replacement (TAVR).AimsThe newly approved Myval 32 mm device is designed for use in aortic annulus areas up to 840 mm2. Here we want to share the initial worldwide experience with the device.Methods and ResultsRetrospective data were collected from 10 patients with aortic stenosis and very large annular anatomy (mean area 765.5 mm2), 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.ConclusionsThe 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.