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Multicenter Study
. 2025 Jun 15:245:71-80.
doi: 10.1016/j.amjcard.2025.02.036. Epub 2025 Mar 8.

Hemolytic Anemia Following SAPIEN 3 Ultra RESILIA Implantation (from the OCEAN-TAVI Registry)

Kenichi Ishizu  1 , Shinichi Shirai  2 , Masaomi Hayashi  2 , Toru Morofuji  2 , Akihiro Isotani  2 , Nobuhisa Ohno  3 , Shinichi Kakumoto  4 , Kenji Ando  2 , Fumiaki Yashima  5 , Hidetaka Nishina  6 , Masaki Izumo  7 , Masahiko Asami  8 , Norio Tada  9 , Masahiro Yamawaki  10 , Toru Naganuma  11 , Futoshi Yamanaka  12 , Yohei Ohno  13 , Hiroshi Ueno  14 , Masahiko Noguchi  15 , Kazuki Mizutani  16 , Kensuke Takagi  17 , Hiroto Suzuyama  18 , Kazumasa Yamasaki  19 , Kenji Nishioka  20 , Daisuke Hachinohe  21 , Yasushi Fuku  22 , Toshiaki Otsuka  23 , Yusuke Watanabe  24 , Masanori Yamamoto  25 , Kentaro Hayashida  26 ; OCEAN-TAVI Investigators
Affiliations
Multicenter Study

Hemolytic Anemia Following SAPIEN 3 Ultra RESILIA Implantation (from the OCEAN-TAVI Registry)

Kenichi Ishizu et al. Am J Cardiol. .

Abstract

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 (1) a drop in hemoglobin level by >2.0 g/dL within 3 months after the index TAVI procedure and (2) 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: (1) serum lactate dehydrogenase level >220 IU/L; (2) haptoglobin level <0.5 g/L; and (3) reticulocyte count ≥2%. Of the 1,070 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% to 0.1%] vs 7.5% [0.6% to 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.

Keywords: aortic stenosis; hemolysis; oversizing; paravalvular leakage; transcatheter aortic valve implantation.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kenichi Ishizu reports a relationship with Johnson and Johnson that includes: consulting or advisory. Kenji Nishioka reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Masaki Izumo reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Fumiaki Yashima reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Yohei Ohno reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Masahiko Asami reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Toru Naganuma reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Toru Naganuma reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Kazuki Mizutani reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Kazuki Mizutani reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Hiroshi Ueno reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Hiroshi Ueno reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Kensuke Takagi reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Kensuke Takagi reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Yasushi Fuku reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Yasushi Fuku reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Masanori Yamamoto reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Masanori Yamamoto reports a relationship with Abbott Medical that includes: consulting or advisory. Masanori Yamamoto reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Shinichi Shirai reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Shinichi Shirai reports a relationship with Abbott Medical that includes: consulting or advisory. Shinichi Shirai reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Norio Tada reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Norio Tada reports a relationship with Abbott Medical that includes: consulting or advisory. Norio Tada reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Kazumasa Yamasaki reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Kazumasa Yamasaki reports a relationship with Abbott Medical that includes: consulting or advisory. Kazumasa Yamasaki reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Daisuke Hachinohe reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Daisuke Hachinohe reports a relationship with Abbott Medical that includes: consulting or advisory. Daisuke Hachinohe reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Yusuke Watanabe reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Yusuke Watanabe reports a relationship with Abbott Medical that includes: consulting or advisory. Yusuke Watanabe reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. Kentaro Hayashida reports a relationship with Edwards Lifesciences Corporation that includes: consulting or advisory. Kentaro Hayashida reports a relationship with Abbott Medical that includes: consulting or advisory. Kentaro Hayashida reports a relationship with Medtronic Japan Co Ltd that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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