Does the fifth-generation balloon-expandable valve increase the incidence of hemolytic anemia compared to the third-generation valve in patients undergoing transfemoral TAVR?
The use of the fifth-generation balloon-expandable valve for TAVR is associated with a significantly higher 30-day incidence of hemolytic anemia compared to 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 500 IU/L, serum haptoglobin 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.
Kurashima et al. (Thu,) studied this question.