Reduced Adverse Events Without Survival Benefit With HeartMate 3 vs. HeartMate II in Japan
Abstract
BACKGROUND: HeartMate 3 (Abbott Laboratories), a fully magnetically levitated left ventricular assist device (LVAD), has shown improved hemocompatibility vs. previous devices, but nationwide real-world data in Japan remain limited. METHODS AND RESULTS: Using the Japanese nationwide registry for Mechanically Assisted Circulatory Support (J-MACS), we analyzed patients who underwent de novo implantation of HeartMate 3 or HeartMate II between 2013 and 2025. The primary outcome was a composite of all-cause death, stroke, and device dysfunction requiring exchange or explantation within 2 years. In all, 978 patients were included in the study (HeartMate 3, n=486; HeartMate II, n=492). The 2-year cumulative incidence of the primary outcome was significantly lower in the HeartMate 3 group than in the HeartMate II group (9% vs. 23%; P<0.001). HeartMate 3 was independently associated with a lower risk of the primary outcome (adjusted hazard ratio 0.35; 95% confidence interval 0.23-0.51; P<0.001), which remained consistent in competing-risk and several statistically matched analyses. The incidence of hemocompatibility-related adverse events, including major bleeding, stroke, and device dysfunction, was significantly lower in the HeartMate 3 group. In contrast, 2- and 5-year overall mortality did not differ significantly between groups (<10% for both devices). CONCLUSIONS: In this nationwide Japanese registry, HeartMate 3 reduced major LVAD-related complications without improving survival, supporting its clinical advantages in contemporary LVAD management.
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BibTeX
@article{imamura2026reduced,
title = {{Reduced Adverse Events Without Survival Benefit With HeartMate 3 vs. HeartMate II in Japan}},
author = {Teruhiko Imamura and Masahiko Ando and Koichiro Kinugawa and Takashi Nishimura and Koichi Toda and Yoshikatsu Saiki and Hiroshi Niinami and Shinichi Nunoda and Goro Matsumiya and Hirokuni Arai and Masanobu Yanase and Norihide Fukushima and Takeshi Nakatani and Akira Shiose and Ikuko Shibasaki and Yasushi Sakata and Masaru Hatano and Minoru Ono and J-MACS Investigators},
journal = {Circulation Journal},
year = {2026},
month = oct,
doi = {10.1253/circj.cj-26-0640},
url = {https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-26-0640/_article},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Reduced Adverse Events Without Survival Benefit With HeartMate 3 vs. HeartMate II in Japan
AU - Teruhiko Imamura
AU - Masahiko Ando
AU - Koichiro Kinugawa
AU - Takashi Nishimura
AU - Koichi Toda
AU - Yoshikatsu Saiki
AU - Hiroshi Niinami
AU - Shinichi Nunoda
AU - Goro Matsumiya
AU - Hirokuni Arai
AU - Masanobu Yanase
AU - Norihide Fukushima
AU - Takeshi Nakatani
AU - Akira Shiose
AU - Ikuko Shibasaki
AU - Yasushi Sakata
AU - Masaru Hatano
AU - Minoru Ono
AU - J-MACS Investigators
PY - 2026
DA - 2026/10/16
JO - Circulation Journal
DO - 10.1253/circj.cj-26-0640
UR - https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-26-0640/_article
AB - BACKGROUND: HeartMate 3 (Abbott Laboratories), a fully magnetically levitated left ventricular assist device (LVAD), has shown improved hemocompatibility vs. previous devices, but nationwide real-world data in Japan remain limited. METHODS AND RESULTS: Using the Japanese nationwide registry for Mechanically Assisted Circulatory Support (J-MACS), we analyzed patients who underwent de novo implantation of HeartMate 3 or HeartMate II between 2013 and 2025. The primary outcome was a composite of all-cause death, stroke, and device dysfunction requiring exchange or explantation within 2 years. In all, 978 patients were included in the study (HeartMate 3, n=486; HeartMate II, n=492). The 2-year cumulative incidence of the primary outcome was significantly lower in the HeartMate 3 group than in the HeartMate II group (9% vs. 23%; P<0.001). HeartMate 3 was independently associated with a lower risk of the primary outcome (adjusted hazard ratio 0.35; 95% confidence interval 0.23-0.51; P<0.001), which remained consistent in competing-risk and several statistically matched analyses. The incidence of hemocompatibility-related adverse events, including major bleeding, stroke, and device dysfunction, was significantly lower in the HeartMate 3 group. In contrast, 2- and 5-year overall mortality did not differ significantly between groups (<10% for both devices). CONCLUSIONS: In this nationwide Japanese registry, HeartMate 3 reduced major LVAD-related complications without improving survival, supporting its clinical advantages in contemporary LVAD management.
SN - 1347-4820
SN - 1346-9843
ER -