The comparison of echocardiographic and serum parameters between Sapien 3 Ultra Resilia and Sapien 3 at one month

Abstract Background Sapien 3 Ultra Resilia (S3UR) is the latest balloon-expandable valve for transcatheter aortic valve replacement (TAVR). Compared to Sapien 3 (S3), previous model of balloon-expandable valve, the leaflets are modified to anti-calcification tissue and the outer skirt becomes 40% higher with textured polyethylene terephthalate. However, it is unknown how these structural changes affect echocardiographic and serum parameters after TAVR. Purpose To compare impacts of these design changes on relevant echocardiographic and serum parameters between S3UR and S3 in the short term. Methods Patients with severe aortic valve stenosis who underwent TAVR with S3 or S3UR were included in this study. Echocardiographic parameters and blood samples were retrospectively collected at discharge and at 1 month post-procedure. Echocardiographic outcomes included mean pressure gradient (PG), effective orifice area index (EOAi), and paravalvular leak (PVL) grade. Hemolytic anemia indicators, specifically lactate dehydrogenase (LDH) and hemoglobin (Hb), were also assessed. Findings suggestive of hemolytic anemia at 1 month were defined as "an increase in LDH level of ≧200 IU/L as well as a decrease in Hb level of ≧1.0 g/dL from pre-procedure." Results Among 443 patients (S3: April 2020-March 2023, S3UR: April 2023-December 2023), 339 patients (S3: n=270, S3UR: n=69) were available for this study. The mean PG was significantly lower in the S3UR group compared to the S3 group at discharge and at 1 month (Figure 1A). On the other hand, the EOAi was similar between the two groups at discharge and at 1 month (Figure 1B). Although the prevalence of none/trace PVL was significantly higher in the S3UR group at discharge, this difference disappeared at 1 month (Figure 1C). LDH levels were significantly increased from pre-procedure to 1 month in both groups (Figure 2A). The median of ΔLDH (1 month – pre-procedure) and %change of LDH (ΔLDH/ pre-procedure) were significantly higher in the S3UR group. The prevalence of hemolytic anemia at 1 month was also significantly higher in this group (Figure 2B). Conclusion At 1 month, S3UR demonstrated superiority in mean PG but equivalence in EOAi and PVL grade compared with S3. Although both S3UR and S3 showed significant increase in LDH from pre-procedure to 1 month, hemolytic anemia was experienced more frequently in S3UR cases. Further evaluation will be needed to assess the potential clinical impacts of these differences.