Clinical outcomes of the Lotus Valve in patients with bicuspid aortic valve stenosis: An analysis from the RESPOND study

Figure 1. Bicuspid valve types. The Sievers' valve classification scheme20 was used to define each bicuspid valve as type 0, type 1, or type 2 [Color figure can be viewed at wileyonlinelibrary.com]

Figure 2. Lotus valve sizing. A, The distribution of valve sizes used within the bicuspid and tricuspid patient cohorts was similar. B, Undersizing was more common in patients with bicuspid valves compared to tricuspid valves (29.0% vs. 15.1%; P = 0.04) [Color figure can be viewed at wileyonlinelibrary.com]

Figure 3. Mean aortic valve gradient and effective orifice area. Bicuspid and tricuspid patients both demonstrated a significant change in mean aortic valve gradient and effective orifice area (EOA) from baseline to discharge, which was maintained at 1 year. Baseline measurements for mean aortic gradient and mean EOA were different between the bicuspid and tricuspid cohorts at baseline, with no significant difference observed between groups at discharge or 1 year post‐TAVI. Data is core laboratory adjudicated [Color figure can be viewed at wileyonlinelibrary.com]

Figure 4. Paravalvular aortic regurgitation. There was no severe PVL observed in either the bicuspid or tricuspid cohort, as adjudicated by the core laboratory. At hospital discharge, 86.2% of the bicuspid cohort and 92.1% of the tricuspid cohort had no/trace PVL; absence from PVL was maintained in 85.0% of the bicuspid cohort and 94.9% of the tricuspid cohort at 1 year post‐TAVI

Figure 5. Principal VARC safety outcomes at 30 days and 1 year post‐TAVI. All‐cause mortality (RESPOND primary endpoint) was not significantly different between the bicuspid and tricuspid cohorts at 30 days or 1 year. There were no significant differences between groups for other principal safety outcomes through 1 year