Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 – Final Report - MOMENTUM 3 – Final Report

Apr 25, 2019
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Presenter/Author:
Mandeep R. Mehra, MBBS, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Abbott
Date Presented:
03/17/2019
Date Published:
03/17/2019
Date Updated:
04/25/2019
Original Posted Date:
03/17/2019
References

Contribution To Literature:

The MOMENTUM 3 – Final Report trial showed that a centrifugal-flow LVAD demonstrated superior performance to an axial-flow LVAD.

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. The centrifugal-flow LVAD was designed to prevent disabling stroke or reoperation to replace or remove a malfunctioning device. 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

  • Randomized
  • Parallel

Patients with advanced heart failure were randomized to a centrifugal-flow pump (n = 516) versus an axial-flow pump (n = 512). This study used an adaptive trial design whereby 294 patients were randomized in a short-term cohort, followed by enrollment of additional subjects to give a long-term cohort size of 366, followed by enrollment of additional subjects to give a full cohort size of 1,028. Patients in both groups received aspirin and warfarin (target international normalized ratio [INR], 2.0-3.0) and followed for at least 2 years.

  • Total number of enrollees: 1,028
  • Duration of follow-up: 2 years
  • Mean patient age: 59 years
  • Percentage female: 20%

Inclusion criteria:

  • Patients with advanced heart failure requiring LVAD
  • Patients requiring bridge or destination therapy were eligible

Exclusion criteria:

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

Other salient baseline characteristics:

  • 61% were ineligible for transplantation
  • 86% were on intravenous inotropic therapy

Principal Findings:

The primary outcome, survival free from disabling stroke or reoperation to replace/remove a malfunctioning device at 24 months, occurred in 74.7% of the centrifugal-flow pump group vs. 60.6% of the axial-flow pump group (p < 0.001 for superiority).

Secondary outcomes (actuarial):

  • Overall survival at 24 months: 79.0% in the centrifugal-flow pump group vs. 76.7% in the axial-flow pump group (p = 0.37)
  • Any stroke at 24 months: 9.9% in the centrifugal-flow pump group vs. 19.4% in the axial-flow pump group (p < 0.001)
  • Disabling stroke at 24 months: 3.9% in the centrifugal-flow pump group vs. 5.9% in the axial-flow pump group (p = not significant)
  • Pump replacement at 24 months: 2.3% in the centrifugal-flow pump group vs. 11.3% in the axial-flow pump group (p < 0.001)
  • Any bleeding at 24 months: 43.7% in the centrifugal-flow pump group vs. 55.0% 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 free from disabling stroke or reoperation. Overall survival was similar between the groups. The centrifugal-flow pump was also associated with a reduction in any stroke, any bleeding event, and reoperation for device malfunction.

References:

Mehra MR, Uriel N, Naka Y, et al., on behalf of the MOMENTUM 3 Investigators. A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report. N Engl J Med 2019;380:1618-27.

Presented by Dr. Mandeep R. Mehra at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, March 17, 2019.

Keywords: ACC Annual Scientific Session, ACC19, Aspirin, Heart, Artificial, Heart Failure, Heart-Assist Devices, Hemorrhage, Reoperation, Secondary Prevention, Stroke, Thrombosis, Vascular Diseases, Warfarin


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