"Clinical Outcomes in Advanced Heart Failure Patients with Centrifugal-Flow vs. Axial-Flow Pump".
The New England Journal of Medicine.
ClinicalTrials.gov number, NCT02224755.

Clinical Question

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?

Bottom Line

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.

Major Points

Guidelines

Left ventricular assist systems are indicated for advanced heart failure patients as a bridge to transplantation or as destination therapy.

Design

- 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

Population

- Adults with advanced heart failure refractory to medical management
- Excluded if active infection, irreversible organ dysfunction, or needing biventricular support

Interventions

Patients were randomized to the centrifugal-flow pump (HeartMate 3) or axial-flow pump (HeartMate II), with antithrombotic treatment including aspirin and warfarin.

Outcomes

- 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.

Criticisms

- Lack of blinding, which may have introduced bias in the study.

Funding

The study was funded by Abbott, the manufacturer of the HeartMate systems.

Further Reading