Decompensated hemolytic anemia after transcatheter aortic valve implantation (TAVI) requiring specific treatment is rarely encountered in actual clinical practice. Nevertheless, there have been several cases of clinically relevant hemolytic anemia following implantation of the recently launched SAPIEN 3 Ultra RESILIA (S3UR). This study aimed to elucidate the clinical features of hemolytic anemia following S3UR implantation. Patients who underwent TAVI using S3UR from the end of March 2023 to November 2023 were enrolled from the Japanese multicenter OCEAN (Optimized CathEter vAlvular iNtervention)-TAVI registry. Hemolytic anemia was defined as (i) a drop in hemoglobin level by >2.0 g/dL within 3 months after the index TAVI procedure and (ii) the diagnosis of mechanical hemolysis as the cause of anemia made by the attending physician and hematologist based on the presence of any 2 of the following criteria: (a) serum lactate dehydrogenase level >220 IU/L; (b) haptoglobin level <0.5 g/L; and (c) reticulocyte count ≥2%. Of the 1070 patients, 18 (1.7%) patients developed hemolytic anemia after TAVI. These patients had a significantly lower prosthesis oversizing relative to native annulus (-3.7% [-5.9%-0.1%] vs. 7.5% [0.6%-14.0%], P <0.001) and a higher prevalence of paravalvular leakage (PVL) ≥mild (mild PVL: 61.1% vs. 12.4%; moderate-to-severe PVL: 16.7% vs. 0.2%; P <0.001) than those without hemolytic anemia. PVL ≥mild was associated with a higher incidence of hemolytic anemia particularly in patients with oversizing of <-5% (33.3% vs. 1.3%, P <0.001) and in those with -5%≤ oversizing <10% (8.3% vs. 0.7%, P <0.001). In conclusion, the incidence of decompensated hemolytic anemia after S3UR implantation was not negligible, and the results of the present study support the importance of selecting a prosthesis size with a sufficient oversizing relative to native annulus to minimize residual PVL ≥mild leading to hemolytic anemia after TAVI.
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