Prevalence and Associated Factors of Subclinical Hemolysis With a Fifth-Generation Balloon-Expandable Transcatheter Heart Valve

BACKGROUND: The SAPIEN 3 Ultra RESILIA (S3UR) is the latest balloon-expandable valve used in transcatheter aortic valve implantation (TAVI). However, hemolysis is a potential concern with the S3UR. This Japanese single-center retrospective study evaluated the prevalence and associated factors of subclinical hemolysis in the S3UR compared with the SAPIEN 3 (S3). METHODS AND RESULTS: We analyzed data for 339 patients who underwent TAVI for severe aortic stenosis and completed a 1-month follow-up (S3UR, n=69; S3, n=270). Subclinical hemolysis was defined as an increase lactate dehydrogenase >2.5-fold from baseline. The prevalence of subclinical hemolysis at 1 month was significantly higher in the S3UR than S3 group (14.5% vs. 2.7%; P<0.001). Notably, subclinical hemolysis was more frequently observed in the S3UR group when mild paravalvular leak (PVL) remained at 1 month. Univariate analysis revealed that mild or greater PVL at 1 month, decreasing annular oversizing, and increasing the difference between the mean diameter of the sinus of Valsalva (SOV) and transcatheter heart valve (THV) size were associated with subclinical hemolysis in the S3UR group. CONCLUSIONS: Remaining mild or greater PVL and using an undersized THV relative to the annulus and SOV were associated with subclinical hemolysis in the S3UR. These findings highlight the importance of selecting a THV size that appropriately matches the aortic valve complex and ensuring adequate THV expansion to prevent subclinical hemolysis.