"Clinical Outcomes in Advanced Heart Failure Patients with Centrifugal-Flow vs. Axial-Flow Pump". The New England Journal of Medicine. ClinicalTrials.gov number, NCT02224755.
Links to original sources: Wiki Journal Post Full Journal Article
Does a fully magnetically levitated centrifugal-flow pump improve clinical outcomes compared to a mechanical-bearing axial continuous-flow pump for patients with advanced heart failure?
In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump is superior to a mechanical-bearing axial-flow pump, with higher survival rates free of disabling stroke or reoperation due to malfunctioning device.
The MOMENTUM 3 trial compared two types of left ventricular assist systems (LVAS): the HeartMate 3 centrifugal-flow pump and the HeartMate II axial-flow pump. At 2 years, the centrifugal-flow pump showed better clinical outcomes than the axial-flow pump, especially in terms of preventing pump-related malfunctions requiring reoperation.
Left ventricular assist systems are indicated for advanced heart failure patients as a bridge to transplantation or as destination therapy.
- Multicenter, randomized noninferiority and superiority trial - 366 patients with advanced heart failure allocated to centrifugal-flow pump (n=190) or axial-flow pump (n=176) - Primary endpoint: Survival at 2 years free of disabling stroke or reoperation due to device malfunction - Noninferiority margin: -10 percentage points for the risk difference
- Adults with advanced heart failure refractory to medical management - Excluded if active infection, irreversible organ dysfunction, or needing biventricular support
Patients were randomized to the centrifugal-flow pump (HeartMate 3) or axial-flow pump (HeartMate II), with antithrombotic treatment including aspirin and warfarin.
- Primary outcome (intention-to-treat): The centrifugal-flow pump group demonstrated a higher rate of the primary endpoint (79.5%) compared to the axial-flow pump group (60.2%) (P<0.001 for noninferiority and superiority). - Secondary outcomes: Lower rates of reoperation in the centrifugal-flow pump group (1.6% vs. 17.0%, P<0.001) and overall rate of stroke (10.1% vs. 19.2%, P=0.02). - There was no significant difference in the incidence of disabling stroke or death between the two groups.
- Lack of blinding, which may have introduced bias in the study.
The study was funded by Abbott, the manufacturer of the HeartMate systems.
Full details of the MOMENTUM 3 trial, including data analysis and supplementary material, are available in The New England Journal of Medicine and linked ClinicalTrials.gov number NCT02224755.