Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series

Abstract

Background: 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. Methods: 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 %). Results: 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 %)(PMyval-Sapien = 0.2333, PMyval-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)], PMyval-Sapien = 0.8997,PMyval-Evolut = 0.0010]. Conclusion: 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.