Hemolysis After TAVR Using the Fifth-Generation Balloon-Expandable Valve: Comparison With the Third-Generation Valve.

BACKGROUND

Hemolytic anemia (HA) following transcatheter aortic valve replacement (TAVR) using the fifth-generation SAPIEN 3 Ultra RESILIA (S3UR) valves has been reported nationwide since its approval in Japan.

OBJECTIVES

The purpose of this study was to investigate the incidence and predictors of hemolysis in fifth-generation S3UR, in comparison with third-generation SAPIEN 3 (S3).

METHODS

We studied 230 consecutive patients who underwent transfemoral TAVR using S3 or S3UR between April 1, 2021, and July 31, 2024; 113 S3 and 117 S3UR. Clinically relevant HA was defined as a decline in hemoglobin of ≥2 g/dL from baseline and a nadir hemoglobin <10.0 g/dL, serum lactate dehydrogenase >500 IU/L, serum haptoglobin <10 mg/dL, reticulocyte count >2%, and no other cause of anemia, identified between postprocedure and 30-day follow-up. Incidence of HA between S3 and S3UR, and factors associated with HA in S3UR were evaluated.

RESULTS

S3UR cases, compared with S3, tended to have a lower degree of paravalvular aortic regurgitation (AR); however, the incidence of HA was significantly higher (10 of 117 [8.5%; 95% CI: 4.4%-16.0%] vs 1 of 113 [0.9%; 95% CI: 0.05%-5.5%]; P = 0.006). In S3UR, severe annular calcification, chronic hemodialysis, use of 20-mm valve, no beta-blocker use, and presence of trace or mild paravalvular AR were associated with HA. However, case-based evaluation suggested that associated factors may be multifactorial.

CONCLUSIONS

Incidence of HA after TAVR was higher in fifth-generation S3UR than in third-generation S3. Annular calcification, chronic hemodialysis, 20-mm size valve, no beta-blocker use, and presence of paravalvular AR were associated with HA in S3UR.