Heart failure & cardiomyopathiesCohort study
Trade-Off Between Bleeding and Ischemic Events From Left Ventricular Assist Devices
- Registry-based cohort study
- EUROMACS registry
Authors' conclusion
Advances in pump technology have significantly reduced HRAEs in real-world LVAD carriers and have reshaped the balance between ischemic and bleeding risks under current management.
Study context
- Population
- Patients undergoing centrifugal-flow left ventricular assist device (LVAD) implantation in EUROMACS
- Participants
- 4,320 patients
- Exposure
- HM3 vs HVAD
- HM3n = 2,232
- HVADn = 2,088reference
- Outcome
- First ischemic HRAEs (ischemic stroke, pump thrombosis, arterial non-CNS thromboembolism) and first major nonsurgical bleeding HRAEs
- Follow-up
- Between 2 weeks and 2 years from LVAD implantation
Main finding
As reported in the abstract
Bleeding HRAEs
P < 0.001
per 100 patient-years
| Outcome | HM3 | HVAD | P value |
|---|---|---|---|
| Ischemic HRAEs | 2.9% | 15.3% | P < 0.001 |
| Bleeding − ischemic events | 8.9% | 2.7% | P < 0.001 |
Observational data: associations, not effects.
Further findings
Event subtypes and subperiods (15-90, 91-365, >365 days)
- Results consistent for all subtypes of events and by subperiods
All-cause death
- Ischemic and bleeding hemocompatibility-related adverse events (HRAEs) associated with all-cause death in both cohorts
Original publication
Trade-Off Between Bleeding and Ischemic Events From Left Ventricular Assist Devices. J Am Coll Cardiol. Published 27 August 2025. doi:10.1016/j.jacc.2025.07.054
Summarised from the published abstract; every number is checked against it