Sapien 3 Ultra RESILIA was associated with a significantly higher prevalence of ≥moderate hemolysis at one month post-TAVI compared with Evolut FX, despite a lower incidence of paravalvular leak.
Cohort (n=113)
Does the Sapien 3 Ultra RESILIA valve increase the prevalence of hemolysis compared to the Evolut FX valve in patients undergoing TAVI for severe aortic valve stenosis?
The balloon-expandable Sapien 3 Ultra RESILIA valve is associated with a significantly higher rate of laboratory hemolysis at one month post-TAVI compared to the self-expandable Evolut FX valve, warranting further investigation into its clinical impact.
Abstract Background Sapien 3 Ultra RESILIA (S3UR) is the latest balloon-expandable valve and Evolut FX is the latest self-expandable valve used for transcatheter aortic valve implantation (TAVI). Recent reports have highlighted hemolysis in S3UR, raising new concerns. However, data on hemolysis after TAVI remain limited, and no direct comparison of the prevalence of hemolysis between these two newest valves has been performed. Purpose This study aimed to compare the prevalence of hemolysis at one month after TAVI between S3UR and Evolut FX, based on several hemolytic markers. Methods We enrolled patients with severe aortic valve stenosis who underwent TAVI using S3UR or Evolut FX. Blood tests were performed pre-procedure and one month after TAVI. The severity of hemolysis was classified according to the previously reported Horstkotte criteria (no, mild, moderate, or severe) using lactate dehydrogenase (LDH) and haptoglobin levels. We defined "≥moderate hemolysis" as the presence of LDH and/or haptoglobin levels that met at least the moderate (LDH 400 IU/L, haptoglobin 10 mg/dL). We also evaluated paravalvular leak (PVL) grade at one month using echocardiography and investigated its relationship with hemolysis. Results A total of 113 patients who underwent TAVI between January 2024 and January 2025, in whom hemolytic markers were obtained, were included (S3UR: n=88; Evolut FX: n=25). LDH levels increased significantly in both groups at one month compared with pre-procedure, with a greater increase observed in the S3UR group (Panel A, upper). Haptoglobin levels at one month were significantly lower than pre-procedure in the S3UR group but showed no significant change in the Evolut FX group (Panel A, lower). According to the Horstkotte criteria, hemolysis was more marked in the S3UR group for both LDH and haptoglobin (Panel B). The prevalence of ≥moderate hemolysis was significantly higher in S3UR. Conversely, mild or greater PVL was significantly more frequent in the Evolut FX group (Panel C). Within the subgroup of patients with mild PVL, hemolysis was markedly more frequent in the S3UR group (Panel D). Conclusion Using combined LDH and haptoglobin as hemolytic markers, S3UR showed a higher prevalence of hemolysis at one month post-TAVI compared with Evolut FX. Notably, despite a higher incidence of ≥mild PVL in Evolut FX, hemolysis remained lower. However, in S3UR, even mild PVL appeared to be associated with a higher rate of hemolysis. Although hemolysis was identified only by laboratory markers and its clinical significance is yet unclear, the finding that prevalence of hemolysis may differ by valve type warrants further investigation into its underlying mechanism and potential impact on patient outcomes.
Kondo et al. (Sat,) conducted a cohort in Severe aortic valve stenosis (n=113). Sapien 3 Ultra RESILIA (S3UR) vs. Evolut FX was evaluated on Prevalence of ≥moderate hemolysis at one month. Sapien 3 Ultra RESILIA was associated with a significantly higher prevalence of ≥moderate hemolysis at one month post-TAVI compared with Evolut FX, despite a lower incidence of paravalvular leak.
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