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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 categories were associated with substantially lower survival, though researchers and outside experts differ on how broadly the varied nonstroke events should be grouped or attributed to the device.
A U.S. registry study of 11,739 HeartMate 3 recipients found that stroke and nonstroke neurologic adverse events each affected 8% of patients over a median 1.4 years, and both categories were associated with reduced survival. The findings suggest that monitoring after left ventricular assist device (LVAD) implantation should account for neurologic problems beyond stroke, although experts caution that the nonstroke category combines conditions with different causes and severity.
Researchers led by Omar Saeed of Montefiore Medical Center and Albert Einstein College of Medicine analyzed data from the Society of Thoracic Surgeons INTERMACS registry. The retrospective study included patients who received the magnetically levitated HeartMate 3 LVAD from 2017 through 2023. Over follow-up, the registry recorded an 8% incidence of stroke and an 8% incidence of nonstroke neurologic adverse events.
At two years, survival was 45% among patients with stroke and 56% among those with nonstroke neurologic events. Compared with recipients who had no recorded neurologic event, the risk of death was higher after stroke (hazard ratio 7.3) and after nonstroke events. Within the latter group, reported mortality associations varied: hazard ratios were 12.58 for overt central nervous system injury, 9.19 for brain injury detected on imaging, and 3.69 for neurologic dysfunction without identified CNS injury. These are associations from an observational study, not proof that the events themselves caused death.
The researchers identified ECMO before LVAD implantation and surgery performed alongside implantation as factors associated with higher rates of both event categories. Pre-implant ECMO was associated with increased risk of stroke and nonstroke events; concomitant surgery was also associated with increased risk of each. The study does not establish that avoiding either factor would prevent neurologic events.
Neurologic Risk Beyond Stroke
LVAD safety discussions and clinical monitoring have often focused on stroke. The findings point to a broader set of neurologic complications that may accompany treatment and are associated with poor outcomes. If the registry pattern is borne out in further research, clinicians and researchers may need to track changes in mental status and other neurologic problems alongside focal stroke symptoms.
The results could also affect how future LVAD studies define safety outcomes. Saeed’s group argued that stroke and nonstroke events deserve comparable attention. Yet the outcomes grouped as “nonstroke” include conditions ranging from hemorrhage and imaging-detected brain injury to delirium and encephalopathy. Distinguishing these events could help identify which are related to the device, which reflect severe illness, and what care may reduce risk.
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How the Registry Grouped Events
LVADs are implanted pumps used in people with advanced heart failure. The study examined the HeartMate 3, a contemporary magnetically levitated device, using U.S. registry data rather than a randomized comparison. The analysis therefore describes event rates and associations among recipients; it cannot by itself determine whether the device, a patient’s underlying illness, or other treatment factors caused a particular event.
The study’s nonstroke category covered several different problems, including subarachnoid or subdural hemorrhage, hypoxic-ischemic injury, traumatic brain injury, abnormalities found on brain imaging, encephalopathy, delirium, seizures and transient ischemic attacks. Outside experts Sung-Min Cho of Johns Hopkins and Mandeep Mehra of Brigham and Women’s Hospital and Harvard Medical School said that this range makes the category difficult to interpret as a single outcome. They also noted that encephalopathy may reflect infection, shock or multiorgan dysfunction, rather than direct device-related brain injury.
“Stroke and nonstroke NAEs are incurred by a similar proportion of patients, and both are associated with substantially reduced survival.”
— Omar Saeed and colleagues, reporting in JACC: Heart Failure
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Limits of the Nonstroke Category
The retrospective registry analysis cannot show that LVAD implantation caused each neurologic event or that an event directly caused a later death. Some patients may have been critically ill before implantation, and the reported associations may reflect that severity. Experts also questioned whether imaging-detected brain injury is more likely to be found because scans are ordered when patients are already deteriorating.
The source material does not provide a breakdown of event counts for each nonstroke condition or establish how many events were directly attributable to the device. Mehra said many of the nonstroke events were encephalopathy, delirium, seizures or transient ischemic attacks, and argued that some may stem from sepsis or multiorgan failure. The study’s broad category and lack of adjudication limit conclusions about which specific complications carry risk and whether they share a cause.
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More Specific Safety Tracking
The reported findings support more detailed neurologic assessment after LVAD implantation, but they do not establish a prevention strategy. The researchers identified pre-implant ECMO and concomitant surgery as possible targets for further study. Mehra cautioned that ECMO is often used because a patient is in shock, so its association with neurologic events may reflect illness severity rather than a risk that can simply be avoided.
Further research would need to define and independently review neurologic outcomes, separate structural brain injuries from problems such as delirium, and clarify whether events are attributable to the device or to underlying illness and treatment. No specific follow-up study or change in clinical guidance is identified in the source material.
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Key Questions
How common were neurologic events in the study?
The registry analysis found an 8% incidence of stroke and an 8% incidence of nonstroke neurologic adverse events over a median follow-up of 1.4 years among 11,739 HeartMate 3 recipients.
What counted as a nonstroke neurologic event?
The category included overt brain injuries such as hemorrhage and hypoxic-ischemic injury, abnormalities detected by neuroimaging, and conditions including encephalopathy, delirium, seizures and transient ischemic attacks.
Does the study prove HeartMate 3 caused these events?
No. The study used retrospective registry data and found associations. It cannot establish that the device caused a particular event or that the event itself caused a patient’s death.
What factors were associated with higher neurologic risk?
Pre-implant ECMO and surgery performed alongside LVAD implantation were associated with higher rates of stroke and nonstroke events. The findings do not show that avoiding either factor would prevent complications.
Why do experts question the nonstroke findings?
Experts said the category combines conditions with different causes and clinical significance, and some may reflect severe illness rather than device-related brain injury. They called for more specific, independently assessed outcomes.
Source: rss
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