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A retrospective U.S. registry study of 11,739 HeartMate 3 recipients found an 8% incidence of stroke and an 8% incidence of nonstroke neurologic adverse events over a median 1.4 years. Both event categories were associated with substantially lower survival, but researchers and outside experts cautioned that the nonstroke category combines varied conditions and the findings do not show that identified risk factors can simply be changed.
A U.S. registry study of 11,739 people with advanced heart failure who received a HeartMate 3 left ventricular assist device found that 8% experienced a stroke and another 8% had a nonstroke neurologic adverse event over a median 1.4 years. Both categories were associated with lower survival, prompting the researchers to argue that neurologic complications should be assessed beyond stroke alone.
Omar Saeed, MD, MSc, of Montefiore Medical Center and Albert Einstein College of Medicine, and colleagues analyzed records in the Society of Thoracic Surgeons INTERMACS database. The retrospective study included HeartMate 3 implants from 2017 through 2023. At two years, survival was 45% among patients who had a stroke and 56% among those with a nonstroke neurologic event; the reported difference was statistically significant (P<0.001).
Compared with recipients without a recorded neurologic event, the study found an association between stroke and a higher risk of death (hazard ratio 7.3; 95% confidence interval 6.6-8.1). Nonstroke events were also associated with increased mortality, with risk varying by category: overt central nervous system injury had a hazard ratio of 12.58, covert injury identified on imaging 9.19, and neurologic dysfunction without identified central nervous system injury 3.69. These are associations in a retrospective study, not proof that the events caused deaths.
The researchers also reported that ECMO use before LVAD placement and surgery performed at the time of implantation were associated with both types of neurologic events. Pre-implant ECMO was associated with stroke (HR 1.70) and nonstroke events (HR 1.45); concomitant surgery was associated with stroke (HR 1.23) and nonstroke events (HR 1.17). The authors identified these as potential targets for reducing neurologic dysfunction, while outside experts cautioned that the associations do not establish that either factor can be safely avoided.
Neurologic Risk Beyond Stroke
The findings suggest that focusing only on stroke may miss a substantial share of neurologic complications recorded after durable LVAD implantation. Because both event groups were associated with reduced survival, clinicians and researchers may need a broader way to recognize and report neurologic problems in this seriously ill population.
The results could also inform post-implant monitoring and future device studies. Experts quoted by MedPage Today said neurological assessment should include changes in mental status and other symptoms, not only focal signs associated with stroke. However, the study does not establish that the device caused every event or that preventing a recorded event would improve survival.
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How the Study Defined Events
LVADs support circulation in people with advanced heart failure. The study examined recipients of the magnetically levitated HeartMate 3, using registry data rather than a randomized comparison. Its “nonstroke” category covered a wide range of conditions: overt injuries such as subarachnoid hemorrhage, hypoxic-ischemic injury, subdural hemorrhage and traumatic brain injury; covert injuries detected by neuroimaging; and dysfunction without identified central nervous system injury, including encephalopathy, delirium, seizures and transient ischemic attacks.
That breadth matters when comparing the results with stroke. The categories do not represent a single, uniform condition, and the report noted that the nonstroke events were not adjudicated. Earlier attention has often centered on stroke risks such as thromboembolism, cerebrovascular disease, hypertension and anticoagulation. The new analysis brings other recorded neurologic events into focus, while leaving questions about their causes and classification open.
“Stroke and nonstroke NAEs are incurred by a similar proportion of patients, and both are associated with substantially reduced survival.”
— Omar Saeed, MD, MSc, and colleagues, the study authors
Causes and Categories Remain Unclear
The analysis cannot show whether the LVAD, a patient’s underlying illness, or another complication caused a particular neurologic event or subsequent death. Cho noted that encephalopathy may reflect infection, shock or multiorgan dysfunction. Mehra also cautioned that brain scans may be ordered when patients are already deteriorating, complicating efforts to attribute poor outcomes to covert brain injury.
The nonstroke category combined conditions with different clinical meanings and levels of severity. Cho said grouping subarachnoid hemorrhage and subdural hemorrhage alongside delirium can obscure distinctions; Mehra said many recorded events were not adjudicated and may reflect systemic illness. The study’s reported associations therefore do not establish that all nonstroke events carry the same risk or are directly attributable to the device.
ECMO before implantation may likewise be a marker of severe illness rather than a risk that can simply be removed. The supplied report ends during discussion of that caution, and does not provide further details about the researchers’ proposed prevention approach, event adjudication methods or results for individual event types.
Better Event Tracking Needed
The study authors called for more complete assessment of neurologic dysfunction and consistent terminology when evaluating durable LVAD safety. Further work would need to distinguish event types, determine whether events are attributable to the device or to other illness, and clarify how timing and severity relate to survival.
For clinicians, the outside experts’ comments point to careful neurologic checks after implantation, including attention to altered mental status as well as focal stroke symptoms. The findings do not support avoiding ECMO or concomitant surgery on their own; those decisions require clinical judgment about each patient’s condition. The report provides no specific date for a follow-up study or a change to device guidance.
Key Questions
How common were neurologic events in the study?
In the registry analysis, 8% had a stroke and 8% had a nonstroke neurologic adverse event over a median 1.4 years after HeartMate 3 implantation.
What counted as a nonstroke neurologic event?
The category included overt or imaging-detected central nervous system injury, as well as conditions such as encephalopathy, delirium, seizures and transient ischemic attacks. The researchers’ grouping was broad, and outside experts questioned whether all these events should be treated as one category.
Does the study prove that the LVAD caused these events?
No. This was a retrospective registry study reporting associations. It cannot establish whether an event was caused by the device, a patient’s underlying illness, another complication or a combination of factors.
Can ECMO or additional surgery be avoided to reduce risk?
The study found associations between pre-implant ECMO or concomitant surgery and neurologic events, but it did not prove that avoiding either would prevent them. Experts noted that ECMO may reflect the severity of a patient’s condition.
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