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

Q: What are the key findings of this study?

HeartMate 3 significantly reduced the 2-year risk of the primary composite outcome of death, stroke, and device dysfunction compared to HeartMate II (HR 0.35).

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: End-stage heart failure requiring left ventricular assist device (LVAD) (n=978). Intervention: HeartMate 3 vs. HeartMate II. Primary outcome: Composite of all-cause death, stroke, and device dysfunction requiring exchange or explantation within 2 years (HR 0.35, 95% CI 0.23-0.51, p=<0.001).

Q: What does this research mean for the field?

HeartMate 3 significantly reduces the composite incidence of death, stroke, and device dysfunction compared with HeartMate II without providing a significant overall survival benefit. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To evaluate real-world clinical outcomes and adverse event rates associated with the HeartMate 3 compared with the HeartMate II in Japanese patients requiring a left ventricular assist device.

Teruhiko Imamura; Masahiko Ando; Koichiro Kinugawa; Takashi Nishimura; Köichi 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 Ōno; J-MACS Investigators

doi:10.1253/circj.cj-26-0640

Key result

HeartMate 3 linked to ~65% lower 2-year risk of major events vs. HeartMate II.

HR 0.35
95% CI 0.23-0.51
P<0.001
n=978

Why the study?

Nationwide real-world data on HeartMate 3 LVAD hemocompatibility compared to previous devices in Japan remain limited.

Does the HeartMate 3 reduce the composite outcome of all-cause death, stroke, and device dysfunction requiring exchange or explantation compared to the HeartMate II in patients undergoing left ventricular assist device implantation?

Key Points

To evaluate real-world clinical outcomes and adverse event rates associated with the HeartMate 3 compared with the HeartMate II in Japanese patients requiring a left ventricular assist device.
Analyzed 978 patients from the nationwide J-MACS registry between 2013 and 2025 who underwent primary LVAD implantation (486 HeartMate 3 vs. 492 HeartMate II recipients).
Assessed a primary composite outcome of death, stroke, device dysfunction requiring exchange, or device dysfunction requiring explantation over a 2-year observation period.
Used multivariable Cox proportional hazards modeling, Fine–Gray competing risk analysis (accounting for heart transplantation or recovery), and propensity score matching.
The 2-year cumulative incidence of the primary composite outcome was significantly lower with HeartMate 3 than HeartMate II (9% vs. 23%; adjusted HR 0.35, 95% CI 0.23–0.51; P<0.001).
Two-year cumulative mortality did not differ significantly between the HeartMate 3 and HeartMate II cohorts (5% vs. 7%, P=0.39).
In competing risk analysis, HeartMate 3 use remained independently associated with a lower incidence of the primary composite outcome (subdistribution HR 0.40, 95% CI 0.27–0.61; P<0.001).

Study Design

Type

Cohort (n=978)

Multicenter

Yes

Structured PICO

Does the HeartMate 3 reduce the composite outcome of all-cause death, stroke, and device dysfunction requiring exchange or explantation compared to the HeartMate II in patients undergoing left ventricular assist device implantation?

P

Population

978 patients with end-stage heart failure who underwent de novo implantation of HeartMate 3 or HeartMate II left ventricular assist devices in a Japanese nationwide registry.

E

Exposure

HeartMate 3 (fully magnetically levitated left ventricular assist device) implantation followed by guideline-directed medical therapy (including aspirin and warfarin with target INR 2.0-2.5)

C

Comparator

HeartMate II implantation followed by guideline-directed medical therapy (including aspirin and warfarin with target INR 2.0-2.5)

O

Outcome

Composite of all-cause death, stroke, device dysfunction requiring device exchange, and device dysfunction requiring device explantation within 2 years after implantationcomposite

Main Result

Hazard Ratio: 0.35 (95% CI 0.23–0.51)

Absolute Event Rate: 9% vs 23%

p-value: p=<0.001

Limitations

Retrospective observational design susceptible to treatment selection bias and unmeasured confounding.
Substantial differences in the implantation era between the two device groups (HeartMate II primarily 2013-2020, HeartMate 3 primarily 2019-2025).
Lack of detailed longitudinal clinical information, such as the intensity of anticoagulation management and guideline-directed medical therapy.
Follow-up duration may have been insufficient to robustly determine a long-term survival benefit.
Retrospective observational design causing potential treatment selection bias and residual confounding
Differences in implantation periods (HeartMate II 2013-2020 vs HeartMate 3 2019-2025) meaning evolving indications, management, and institutional experience may have influenced outcomes
Device selection during the 2019-2020 overlapping period was not random
Impact on other LVAD-related complications, such as infection and right heart failure, was not evaluated
Follow-up duration may have been insufficient to determine long-term survival benefit

Implication

Nationwide Japanese HeartMate 3 data now available; extends hemocompatibility evidence to real-world Asian cohorts but leaves practice implications open.

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.

Discussion

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Cite This Study

Imamura et al. (2026) conducted a cohort in End-stage heart failure requiring left ventricular assist device (LVAD) (n=978). HeartMate 3 vs. HeartMate II was evaluated on Composite of all-cause death, stroke, and device dysfunction requiring exchange or explantation within 2 years (HR 0.35, 95% CI 0.23-0.51, p=<0.001). HeartMate 3 significantly reduced the 2-year risk of the primary composite outcome of death, stroke, and device dysfunction compared to HeartMate II (HR 0.35).

synapsesocial.com/papers/6ad34de0727baf805bb60e90 https://doi.org/10.1253/circj.cj-26-0640

Topics

Heart failure

HFrEF treatment

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

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Topics

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

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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