The Lotus transcatheter heart valve was associated with significantly less occurrence of paravalvular aortic regurgitation compared to the SAPIEN3 valve (OR 0.41; P=0.03).
Observational (n=162)
Does the mechanically expanding Lotus valve reduce paravalvular aortic regurgitation compared to the balloon-expanded SAPIEN3 valve in patients undergoing TAVR for aortic stenosis?
The mechanically expanding Lotus valve demonstrated comparable hemodynamic performance but significantly less paravalvular aortic regurgitation than the balloon-expanded SAPIEN3 valve.
Estimación del efecto: OR 0.41
Tasa de eventos absoluta: 13.9% vs 31.3%
valor p: p=0.02
Aims: The Lotus and SAPIEN3 are second-generation transcatheter heart valves, which are designed to minimize paravalvular aortic regurgitation (PAR) after transcatheter aortic valve replacement (TAVR). We sought to compare both devices for valve performance and with emphasis on PAR by independent core laboratory analysis. Methods and results: A total of 162 (79 Lotus and 83 SAPIEN3) consecutive patients (51% female, 80 ± 8 years, Logistic EuroSCORE 14.8 ± 9.4%) who underwent TAVR because of aortic stenosis were included. Patients with aortic valve-in-valve treatment were excluded. Pre-discharge echocardiograms were analysed by an independent core laboratory using the Valve Academic Research Consortium 2 criteria. There were no differences in baseline and procedural characteristics, except for a larger aortic annulus and sizing indices in SAPIEN3-treated patients and frequency of post-dilatation (0% in Lotus and 13.1% in SAPIEN3). Both valves have similar mean residual gradient, indexed effective orifice area and Doppler velocity index when adjusted to valve size. The frequency of mild (13.9% vs. 31.3%) and at least moderate (1.3% vs. 3.6%) PAR was less after Lotus than after SAPIEN3 implantation (P = 0.02). Multi-slice computed tomography-based annulus and left ventricular outflow tract diameters, calcification and percentage of oversizing were not different between those with or without mild or more PAR. On multivariate analysis, the use of Lotus valve was associated with less (odds ratio OR, 0.41, P = 0.03) occurrence of PAR. Conclusion: Overall, haemodynamic performance was comparable between the Lotus and SAPIEN3 valves. Lotus valve required less oversizing and was associated with less PAR than SAPIEN3.
Soliman et al. (Fri,) realizaron un estudio observacional en estenosis aórtica (n=162). Se evaluó la válvula cardiaca transcatéter Lotus vs. la válvula cardiaca transcatéter SAPIEN3 en relación con la regurgitación aórtica paravalvular leve (OR 0.41, p=0.02). La válvula cardiaca transcatéter Lotus se asoció con una disminución significativa en la ocurrencia de regurgitación aórtica paravalvular en comparación con la válvula SAPIEN3 (OR 0.41; P=0.03).
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