A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure
Primary result · Survival free of disabling stroke (modified Rankin score >3) or reoperation to replace or remove the deviceResult — go to the resultAbsolute difference 9.4 percentage pointsAuthors' conclusion
Among patients with advanced heart failure, implantation of a fully magnetically levitated centrifugal-flow pump was associated with better outcomes at 6 months than was implantation of an axial-flow pump, primarily because of the lower rate of reoperation for pump malfunction.
Study context
- Population
- Patients with advanced HF, bridge to transplantation or destination therapy
- Participants
- 294 patients
- Comparison
- Magnetically levitated centrifugal-flow pump vs axial-flow pump
- Centrifugal-flow pumpn = 152
- Axial-flow pumpn = 142reference
- Primary endpoint
- Survival free of disabling stroke (modified Rankin score >3) or reoperation to replace or remove the device
- Follow-up
- 6 months after implantation
Methodological detailsnon-inferiority
- Non-inferiority
Primary result
As reported in the abstract
Absolute difference
9.4 percentage points
P < 0.001 for noninferiority
Events by treatment group
Further findings
| Outcome | Centrifugal-flow pump | Axial-flow pump | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Reoperation for pump malfunction | 0.7% | 7.7% | 0.08 (0.01–0.60) | P = 0.002 | |
| 0.050.21520Hazard ratio (log scale) |
Death or disabling stroke
- No significant between-group differences
Safety
| Outcome | Centrifugal-flow pump | Axial-flow pump |
|---|---|---|
| Suspected or confirmed pump thrombosis | 0 events | 10.1% |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. Published 16 November 2016. doi:10.
Summarised from the published abstract; every number is checked against it