Key result
The Myval THV series demonstrated a significantly lower rate of moderate/severe aortic regurgitation (2.0% vs 8.0%, p=0.0057) compared to the Evolut THV series, while performing comparably to the Sapien THV series.
Why the study?
Quantitative videodensitometric aortography reliably quantifies post-TAVI aortic regurgitation, but it had not yet been evaluated in randomized trials comparing various transcatheter heart valve systems.
Does TAVI using the Myval THV series reduce post-procedural aortic regurgitation compared to Sapien and Evolut THV series in patients with severe aortic stenosis?
RCT (n=596)
Open-label
Randomized
Yes
Does TAVI using the Myval THV series reduce post-procedural aortic regurgitation compared to Sapien and Evolut THV series in patients with severe aortic stenosis?
Absolute Event Rate: 2% vs 8%
p-value: p=0.0057
Quantitative videodensitometric assessment demonstrates that the Myval THV series has a lower rate of moderate/severe aortic regurgitation compared to the Evolut THV series, and comparable performance to the Sapien THV series.
Observational data associate Myval with lower moderate/severe AR than Evolut and similar rates to Sapien; leaves open randomized confirmation before practice change.
Central illustration: Quantitative videodensitometric assessment of final aortogram post-TAVI. The quantitative videodensitometric aortography (QVDA) has reliably quantified post-TAVI aortic regurgitation (AR). However, this method has not yet been evaluated in randomized trials comparing various transcatheter heart valve (THV) systems. Here, we investigated the QVDA of AR following TAVI for severe aortic stenosis among Myval, Sapien, and Evolut THV series as part of the LANDMARK trial. The final aortograms, either without or after balloon post-dilatation (BPD) were analyzed using the advanced CAAS-A-Valve 2.1.2 software. The regurgitant fraction (RF) was computed and categorized into none/trace AR (RF < 86 %), mild AR (6 % ≤ 8RF ≤ 817 %), and moderate/severe AR (RF > 17 %). Five hundred ninety-six final analyzable aortograms and 97 aortograms following BPD were included in the analysis. The BPD resulted in a significant reduction of RF in the Myval [12.0(6.0–18.5) vs 2.0(1.0, 5.5);p = 0.0002], Sapien[18.0(1.0–19.0) vs. 2.0(1.0–3.0); p = 0.04206] and Evolut [10.5 (6.0–15.0) vs 5.0 (1.0–8.0); p = 0.0009]. The rate of final RF > 17 % was lower in the Myval(2.0 %) compared to Evolut(8.00 %), but similar to the Sapien series (4.0 %)(P Myval-Sapien = 0.2333, P Myval-Evolut = 0.0057). In the as-treated population, the Myval series demonstrated a comparable RF to the Sapien series, but a significantly lower RF compared to the Evolut [Myval: 3.0 %(1.0–7.0), Sapien:3.0 %(1.0–7.0), Evolut:5.0 %(1.0–10.0)], P Myval-Sapien = 0.8997,P Myval-Evolut = 0.0010]. The QVDA highlights the superior performance of the Myval THV series compared to the Evolut THV series, with the lowest rate of moderate/severe RF among the three THV series, and could be used with echocardiography to help in detecting cases with none/trace AR.
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Hasabo et al. (2025) conducted an RCT in Severe aortic stenosis (n=596). Myval THV vs. Sapien THV and Evolut THV was evaluated on Rate of final regurgitant fraction (RF) > 17% (moderate/severe aortic regurgitation) (p=0.0057). The Myval THV series demonstrated a significantly lower rate of moderate/severe aortic regurgitation (2.0% vs 8.0%, p=0.0057) compared to the Evolut THV series, while performing comparably to the Sapien THV series.
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