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

Nov 16, 2016
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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:
St. Jude Medical
Date Presented:
11/16/2016
Date Published:
11/16/2016
Date Updated:
11/16/2016
Original Posted Date:
11/16/2016
References

Contribution To Literature:

The MOMENTUM 3 trial showed that a centrifugal-flow LVAD was superior at preventing pump thrombosis.

Description:

The 2-year prespecified analysis from the MOMENTUM 3 trial, presented at ACC.18, can be found here.

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 pump thrombosis.

Study Design

  • Randomized
  • Parallel

Patients with advanced heart failure were randomized to a centrifugal-flow pump (n = 152) versus an axial-flow pump (n = 142).

  • Total number of enrollees: 294
  • Duration of follow-up: 6 months
  • Median patient age: 63 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

Principal Findings:

The primary outcome, freedom from disabling stroke or reoperation to replace/remove the device at 6 months, occurred in 86.2% of the centrifugal-flow pump group versus 76.8% of the axial-flow pump group (p < 0.001 for noninferiority; p = 0.04 for superiority).

Secondary outcomes:

  • Reoperation for pump malfunction: 0.7% versus 7.7% (p = 0.002); respectively, for centrifugal versus axial pump
  • Pump thrombosis: 0% versus 10.1%; respectively, for centrifugal versus axial pump

Interpretation:

Among patients with heart failure requiring advanced mechanical support, a centrifugal-flow LVAD was associated with better outcomes compared with an axial-flow LVAD. Benefit was primarily due to a reduction in pump malfunction and pump thrombosis.

References:

Mehra MR, Naka Y, Uriel N, et al., on behalf of the MOMENTUM 3 Investigators. A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med 2016;Nov 16:[Epub ahead of print].

Presented by Dr. Mandeep R. Mehra at the American Heart Association Annual Scientific Sessions (AHA 2016), New Orleans, LA, November 16, 2016.

Keywords: AHA Annual Scientific Sessions, Cardiac Surgical Procedures, Heart, Artificial, Heart Failure, Heart-Assist Devices, Reoperation, Thrombosis, Stroke


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