Reduced Adverse Events Without Survival Benefit With HeartMate 3 vs. HeartMate II in Japan.

Authors

Teruhiko Imamura, Masahiko Ando, Koichiro Kinugawa, Takashi Nishimura, Koichi Toda, Yoshikatsu Saiki, Hiroshi Niinami, Shinichi Nunoda, Goro Matsumiya, Hirokuni Arai, Masanobu Yanase, Norihide Fukushima, Takeshi Nakatani, Akira Shiose, Ikuko Shibasaki, Yasushi Sakata, Masaru Hatano, Minoru Ono, J-MACS Investigators

Published in

Circulation journal : official journal of the Japanese Circulation Society. Oct 16, 2026. Epub Oct 16, 2026.

Abstract

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.
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).
In this nationwide Japanese registry, HeartMate 3 reduced major LVAD-related complications without improving survival, supporting its clinical advantages in contemporary LVAD management.

PMID:
42893862
Bibliographic data and abstract were imported from PubMed on 19 Oct 2026.

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