JACC. Asia · 2026
Hemolysis After TAVR Using the Fifth-Generation Balloon-Expandable Valve: Comparison With the Third-Generation Valve.
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Kurashima Shinichi, Okada Atsushi, Irie Yuki, Sakamoto Takahiro, Moriuchi Kenji, Amano Masashi, Amaki Makoto, Kanzaki Hideaki, Mitsui Kentaro, Takagi Kensuke, Asaumi Yasuhide, Kakuta Takashi, Kawamoto Naonori, Fukushima Satsuki, Yamamoto Kazuhiro, Kitai Takeshi, Izumi Chisato
Аннотация
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.
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.