MOMENTUM 3
Trial question
Is magnetically levitated centrifugal continuous-flow circulatory pump superior to mechanical-bearing axial continuous-flow pump in patients with advanced HF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 366
366 patients (73 female, 293 male).
Inclusion criteria: patients with advanced HF that was refractory to guideline-mandated medical management.
Key exclusion criteria: active infection, irreversible end-organ dysfunction, or expected use of biventricular circulatory support.
Interventions
N=190 centrifugal-flow pump LVAD (HeartMate3 fully magnetically levitated centrifugal continuous-flow pump).
N=176 axial-flow pump LVAD (HeartMate II mechanical-bearing axial continuous-flow pump).
Primary outcome
Survival free of disabling stroke at 2 years
79.5%
60.2%
79.5 %
59.6 %
39.8 %
19.9 %
0.0 %
Centrifugal-flow pump
LVAD
Axial-flow pump
LVAD
Significant
increase ▲
NNT = 5
Significant increase in survival free of disabling stroke at 2 years (79.5% vs. 60.2%; HR 2.17, 95% CI 1.44 to 3.22).
Secondary outcomes
Significant decrease in reoperation for pump malfunction (1.6% vs. 17%; HR 0.08, 95% CI 0.03 to 0.27).
Significant decrease in pump thrombosis (1.1% vs. 15.7%; HR 0.06, 95% CI 0.01 to 0.26).
Significant decrease in stroke (10.1% vs. 19.2%; HR 0.47, 95% CI 0.27 to 0.84).
Safety outcomes
No significant differences in hemorrhagic stroke, right HF, surgical and nonsurgical bleeding, and infection.
Conclusion
In patients with advanced HF that was refractory to guideline-mandated medical management, centrifugal-flow pump LVAD was superior to axial-flow pump LVAD with respect to survival free of disabling stroke at 2 years.
Reference
Mehra MR, Goldstein DJ, Uriel N et al. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395.
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