Circulation journal : official journal of the Japanese Circulation Society · 2026
Reduced Adverse Events Without Survival Benefit With HeartMate 3 vs. HeartMate II in Japan.
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Imamura Teruhiko, Ando Masahiko, Kinugawa Koichiro, Nishimura Takashi, Toda Koichi, Saiki Yoshikatsu, Niinami Hiroshi, Nunoda Shinichi, Matsumiya Goro, Arai Hirokuni, Yanase Masanobu, Fukushima Norihide, Nakatani Takeshi, Shiose Akira, Shibasaki Ikuko, Sakata Yasushi, Hatano Masaru, Ono Minoru, J-MACS Investigators
Аннотация
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.
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.