Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 – 5-Year Outcomes - MOMENTUM 3 – 5-Year Outcomes

Sep 13, 2022
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Abbott
Date Presented:
08/28/2022
Date Published:
09/08/2022
Date Updated:
09/13/2022
Original Posted Date:
08/30/2022
References

Contribution To Literature:

The MOMENTUM 3 – 5-Year Outcomes trial showed that a centrifugal-flow LVAD was superior at improving survival compared with an axial-flow pump.

Description:

The goal of the trial was to evaluate treatment with a magnetically levitated centrifugal-flow left ventricular assist device (LVAD) compared with an axial-flow LVAD among heart failure patients requiring advanced mechanical support. Characteristics of the centrifugal-flow pump are wide blood passages to reduce shear stress, no mechanical bearings to reduce friction, and intrinsic pulse to prevent thrombosis.

Study Design

  • Randomization
  • Parallel

The MOMENTUM 3 pivotal trial enrolled patients from 2014 to 2016 (previously published) and completed 2-year follow-up in 2018 (previously published). The 5-year post-approval extended study was an observational study following the 2-year completion study as a condition for approval as mandated by the US Food and Drug Administration (FDA). The extended study enrolled patients from 2019 to 2021.

Patients with advanced heart failure were randomized to a centrifugal-flow pump (n = 516) versus an axial-flow pump (n = 512). Patients in both groups received aspirin and warfarin (target international normalized ratio [INR] 2.0-3.0).

  • Total number of enrollees: 1,028 (1,020 comprised the per-protocol group)
  • Duration of follow-up: 5 years
  • Mean patient age: 62 years
  • Percentage female: 20%
  • Percentage with diabetes: 45%

Inclusion criteria:

  • Patients with advanced heart failure requiring LVAD
  • Patients requiring bridge (to transplantation or recovery) or destination therapy were eligible

Exclusion criteria:

  • Planned biventricular support
  • Irreversible end-organ dysfunction
  • Active infection

Principal Findings:

The primary outcome, overall survival, was 58.4% of the centrifugal-flow pump group vs. 43.7% of the axial-flow pump group (p = 0.003).

Secondary outcomes:

  • Overall survival in destination therapy patients: 54.8% of the centrifugal-flow pump group vs. 39.4% of the axial-flow pump group (p = 0.005)
  • Death due to device thrombosis, stroke, or bleeding: 3.9% of the centrifugal-flow pump group vs. 10.7% of the axial-flow pump group (p < 0.001)
  • Survival free of disabling stroke or re-operation to replace or remove a malfunctioning pump: 54.0% of the centrifugal-flow pump group vs. 29.7% of the axial-flow pump group (p < 0.001)
  • Any bleeding: 0.43 events per person-year in the centrifugal-flow pump group vs. 0.77 events per person-year in the axial-flow pump group (p < 0.001)
  • Any stroke: 0.05 events per person-year in the centrifugal-flow pump group vs. 0.14 events per person-year in the axial-flow pump group (p < 0.001)
  • Suspected or confirmed pump thrombosis: 0.01 events per person-year in the centrifugal-flow pump group vs. 0.11 events per person-year in the axial-flow pump group (p < 0.001)

Interpretation:

Among patients with advanced heart failure, use of the HeartMate 3 centrifugal-flow pump was superior to the Heartmate II axial-flow pump at improving survival over 5 years. Median survival with the HeartMate 3 device exceeds 5 years. This benefit was due to a lower incidence of death due to device thrombosis, stroke, or bleeding for the centrifugal-flow pump vs. the axial-flow pump. Serious adverse events (any bleeding, any stroke, and suspected or confirmed pump thrombosis) were lower with the centrifugal-flow pump vs. the axial-flow pump.

References:

Mehra MR, Goldstein DJ, Cleveland JC, et al. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA 2022;Sep 8:[Epub ahead of print].

Presented by Dr. Mandeep R. Mehra at the European Society of Cardiology Congress (ESC 2022), Barcelona, Spain, August 28, 2022.

Clinical Topics: Anticoagulation Management, Cardiac Surgery, Heart Failure and Cardiomyopathies, Prevention, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Mechanical Circulatory Support

Keywords: Aspirin, ESC22, ESC Congress, Heart Failure, Heart, Artificial, Heart-Assist Devices, Hemorrhage, Secondary Prevention, Stroke, Thrombosis, Warfarin


< Back to Listings