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

Jun 19, 2018
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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:
03/11/2018
Date Published:
05/27/2018
Date Updated:
06/19/2018
Original Posted Date:
03/15/2018
References

Contribution To Literature:

The MOMENTUM 3 – Long-Term Outcomes trial showed that a centrifugal-flow LVAD was superior at preventing reoperation to replace a malfunctioning device and disabling stroke in patients, irrespective of the intended goal of bridge to transplant or destination therapy.

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 = 190) versus an axial-flow pump (n = 176). This study used an adaptive design whereby an additional 72 patients were randomized after the initially reported 294 from the short-term cohort. Patients in both groups received aspirin and warfarin (target INR 2.0-3.0) and followed to 2 years.

  • Total number of enrollees: 366
  • Duration of follow-up: 2 years
  • Mean patient age: 61 years
  • Percentage female: 21%

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:

  • 60% were ineligible for transplantation
  • 85% 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 79.5% of the centrifugal-flow pump group versus 60.2% of the axial-flow pump group (p < 0.001 for noninferiority; p < 0.001 for superiority).

Secondary outcomes (actuarial):

  • Overall survival at 24 months: 82.8% in the centrifugal-flow pump group versus 76.2% in the axial-flow pump group (hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.44-1.15, p = 0.16)
  • Freedom from disabling stroke at 24 months: 92.5% in the centrifugal-flow pump group versus 92.8% in the axial-flow pump group (HR 1.25, 95% CI 0.54-2.93, p = 0.6)
  • Overall stroke rates at 24 months: 10.1% in the centrifugal-flow pump group versus 19.2% in the axial-flow pump group (p = 0.016)

Economic analysis:

  • Post-discharge costs: $37,685 in the centrifugal-flow pump group versus $76,599 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 preventing disabling stroke or reoperation to replace/remove a malfunctioning device. Survival was similar between the groups. The centrifugal-flow pump was associated with a reduction in overall stroke rates and a significant cost savings compared with the axial-flow pump.

References:

Mehra MR, Salerno C, Cleveland JC, et al. Health Care Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study: A Randomized Controlled Trial of a Magnetically Levitated Cardiac Pump in Advanced Heart Failure. Circulation 2018;May 27:[Epub ahead of print].

Mehra MR, Goldstein DJ, Uriel N, et al., on behalf of the MOMENTUM 3 Investigators. Two-Year Outcomes With a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med 2018;378:1386-95.

Editorial: Drazner MH. A New Left Ventricular Assist Device — Better, but Still Not Ideal. N Engl J Med 2018;378:1442-3.

Presented by Dr. Mandeep R. Mehra at the American College of Cardiology Annual Scientific Session (ACC 2018), Orlando, FL, March 11, 2018.

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

Keywords: ACC18, ACC Annual Scientific Session, Aspirin, Cardiac Surgical Procedures, Heart, Artificial, Heart-Assist Devices, Heart Failure, Reoperation, Secondary Prevention, Stroke, Thrombosis, Warfarin, Cost-Benefit Analysis


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