Heart failure & cardiomyopathies
Clinical Outcomes With a Fully Magnetically Levitated Left Ventricular Assist Device Among Women and Men
Authors' conclusion
There were no differences in the primary composite endpoint or overall survival in women compared with men at 2 years of support.
Study context
- Population
- HeartMate3 LVAD recipients with advanced HF20.4% women
- Participants
- 2,200 recipients
- Comparison
- Women vs men with HeartMate3 (HM3) LVAD
- Womenn = 448
Methodological detailsmulticentre
- Multicentre
Primary result
As reported in the abstract
2 years
Adjusted hazard ratio
0.96
95% CI 0.75–1.24
P = 0.66
By group
Women vs Men
aHR 0.96 (95% CI 0.75–1.24); P = 0.66
Further findings
| Outcome | Women | Men | aHR (95% CI) | P value | |
|---|---|---|---|---|---|
| Overall survival · 2 years | 82.4% | 80.2% | 1.06 (0.81–1.40) | P = 0.66 | |
| 0.512Adjusted hazard ratio (log scale) |
6-minute walk distance and quality of life
- Similar gains in both groups
Safety
| Outcome | aIRR (95% CI) | P value | |
|---|---|---|---|
| Stroke, major bleeding, infection — Women vs Men · stroke | 1.52 (1.09–2.11) | P = 0.012 | |
| Stroke, major bleeding, infection — Women vs Men · major bleeding | 1.28 (1.15–1.42) | P < 0.0001 | |
| Stroke, major bleeding, infection — Women vs Men · infection | 1.14 (1.03–1.55) | P = 0.01 | |
| 0.512Adjusted incidence rate ratio (log scale) |
Stroke, major bleeding, infection
- Differences not seen among older (>65 years) patients
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Clinical Outcomes With a Fully Magnetically Levitated Left Ventricular Assist Device Among Women and Men. JACC Heart Fail. Published 11 October 2023. doi:10.
Summarised from the published abstract; every number is checked against it