Heart Failure2017New England Journal of Medicine

MOMENTUM 3

Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3

Sample Size

1,028

Study Design

Multicenter, randomized, controlled trial with short-term (6-month) and long-term (2-year) cohorts

Year Published

2017

Clinical Question

Is the fully magnetically levitated centrifugal-flow HeartMate 3 left ventricular assist device (LVAD) superior to the axial-flow HeartMate II in advanced heart failure patients?

Population

Patients with advanced heart failure (NYHA class IIIB or IV) who were eligible for LVAD implantation as either bridge to transplant or destination therapy at centers in the United States.

Intervention

HeartMate 3 fully magnetically levitated centrifugal-flow LVAD

Control

HeartMate II axial-flow LVAD

Primary Endpoint

Composite of survival free of disabling stroke or reoperation to replace or remove a malfunctioning device at 6 months (short-term) and 2 years (long-term)

Key Findings

At 2 years, the primary endpoint was met in 76.9% of HeartMate 3 vs 64.8% of HeartMate II patients (relative risk 0.84; p<0.001 for superiority).

Pump thrombosis requiring reoperation was 0% with HeartMate 3 vs 13.9% with HeartMate II.

Overall stroke rate was lower with HeartMate 3 (10.1% vs 19.2%; p=0.02).

Survival at 2 years was 79.5% with HeartMate 3 vs 76.6% with HeartMate II.

The fully magnetically levitated design with wider blood flow gaps virtually eliminated pump thrombosis, the Achilles heel of prior LVAD technology.

Impact on Clinical Practice

MOMENTUM 3 was a pivotal trial that established the HeartMate 3 as the dominant LVAD platform for advanced heart failure. The fully magnetically levitated design represented a major engineering breakthrough: by suspending the impeller in a magnetic field without mechanical bearings, it virtually eliminated the pump thrombosis that had plagued earlier devices. Pump thrombosis had been the most feared complication of earlier LVADs, often requiring emergency reoperation or leading to stroke and death. The 0% pump thrombosis rate with HeartMate 3 was transformative, fundamentally altering the risk-benefit calculation for mechanical circulatory support. The trial also demonstrated lower stroke rates and better overall survival free of major complications. These results, combined with the dramatically improved hemocompatibility profile, made the HeartMate 3 the standard of care for LVAD therapy and contributed to growing acceptance of durable mechanical support as a long-term treatment option for patients ineligible for heart transplant.

Guideline Impact

MOMENTUM 3 data supported the 2022 ACC/AHA/HFSA Guideline for Heart Failure Management recommendation for durable LVAD therapy in appropriately selected patients with advanced HFrEF (Class 2a for destination therapy). The HeartMate 3 is now the only commercially available durable LVAD in the United States.

Limitations

The HeartMate II comparator has been largely replaced in clinical practice; comparison with other contemporary devices would be informative.

GI bleeding rates, though numerically lower, remained substantial in both groups and continue to be a limitation of continuous-flow LVAD technology.

Right heart failure after LVAD implantation occurred in both groups and remains a challenge not fully addressed by improved pump design.

Reviewed by Callistus Ditah, MD

Surgery of the Aorta & Great Vessels

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