Performance of XL Sizes of Myval Balloon-Expandable Valve in Real-World Patients with Extremely Large Aortic Annuli

Background and Objectives: Transcatheter aortic valve replacement (TAVR) in large aortic annuli poses challenges due to limited valve-size options and increased complication risks. The aim is to evaluate the safety and performance of XL sizes (30.5 mm and 32 mm) of the Myval transcatheter heart valve (THV) for treating patients with severe aortic stenosis and large aortic annuli. Material and Methods: This retrospective observational study included consecutive patients undergoing TAVR with XL sizes of the Myval THV between December 2023 and December 2024 at a single centre. During this period, 146 TAVI procedures were performed, of which 15 patients (10.3%) with large aortic annuli (mean systolic annular area 786.5 ± 48.2 mm²) received XL valves and were included in the present analysis. Patients were followed up at discharge, 3-6 months, and 1 year. Patient evaluation included echocardiography and clinical assessments following the Valve Academic Research Consortium-3 criteria. Results: All patients were male, with a mean age of 79.1 ± 5.9 years. Technical success was achieved in 100% of cases. At discharge, none of the patients had moderate or greater paravalvular leakage (PVL); 11 patients had no PVL, while 1 had trace and 3 had mild PVL. The mean effective orifice area (EOA) improved from 0.75 ± 0.15 cm² at baseline to 2.31 ± 0.21 cm² at discharge (p < 0.0001). At the 12-month follow-up, the mean EOA was 2.4 ± 0.3 cm², and no moderate or severe PVL or major adverse clinical outcomes were observed. One patient required a permanent pacemaker implantation due to an atrioventricular block. Conclusions: The XL sizes of Myval THV showed both safety and efficacy in patients with large aortic annuli, demonstrating acceptable hemodynamic performance and low complication rates. However, large-scale studies with longer follow-ups are needed to validate these findings in diverse populations.