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A 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 experts cautioned that the nonstroke group combined varied conditions and the study cannot show that the device caused them.
A U.S. registry study found that stroke and nonstroke neurologic adverse events each occurred in 8% of nearly 12,000 people who received a HeartMate 3 left ventricular assist device, with both types of events associated with lower survival. The findings broaden attention beyond stroke, though researchers and outside experts said the study’s broad nonstroke category includes conditions with different causes and levels of brain injury.
Omar Saeed, MD, MSc, of Montefiore Medical Center and Albert Einstein College of Medicine, and colleagues analyzed 11,739 HeartMate 3 recipients in the Society of Thoracic Surgeons’ INTERMACS database. Patients received the magnetically levitated device from 2017 through 2023. Over a median follow-up of 1.4 years, 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 who had a stroke and 56% among those with a nonstroke event. Compared with patients without a recorded neurologic event, the analysis found a higher risk of death after stroke (hazard ratio 7.3, 95% confidence interval 6.6-8.1) and after nonstroke events. Within the latter group, the association was strongest for overt central nervous system injury, followed by brain injury identified on imaging and neurologic dysfunction without identified central nervous system injury.
The authors reported that ECMO before LVAD implantation was associated with higher rates of both event categories. Concomitant surgery was also associated with higher rates. These are statistical associations from a retrospective study; they do not establish that either factor caused neurologic events or that changing them would prevent those events.
Neurologic Risks Beyond Stroke
The findings matter because stroke has often received the most attention as a neurologic complication of LVAD treatment, while conditions such as encephalopathy, delirium and seizures may also arise during a patient’s care. The similar recorded incidence of stroke and nonstroke events suggests that focusing only on stroke could leave clinicians and researchers with an incomplete account of neurologic complications and outcomes.
The study also found that patients with recorded neurologic events had poorer survival. That association makes careful neurologic assessment relevant to the care of people with advanced heart failure receiving mechanical circulatory support. It does not, by itself, establish that the neurologic event caused a patient’s death: severe illness, infection, shock and multiorgan dysfunction may contribute to both altered mental status and mortality.
For future device safety research, the results raise a question about how neurologic outcomes should be grouped and reported. A shared, more detailed classification could help distinguish a stroke from other brain injuries and from neurologic symptoms linked to systemic illness.
LVAD neurologic event monitoring device
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How the Registry Defined Events
LVADs support blood flow in people with advanced heart failure. The HeartMate 3 is a magnetically levitated device; the study examined recipients recorded in a U.S. national registry, rather than assigning patients to a treatment or comparing the device with a control group.
The study’s nonstroke category was clinically broad. It included overt central nervous system injury, such as subarachnoid hemorrhage, hypoxic-ischemic injury, subdural hemorrhage and traumatic brain injury; abnormalities detected through neuroimaging; and dysfunction without identified central nervous system injury, including encephalopathy, delirium, seizures and transient ischemic attacks. The authors said the category should be considered alongside stroke when evaluating durable LVAD safety.
Outside experts quoted by MedPage Today questioned whether all of these conditions should be combined. Johns Hopkins neurologist Sung-Min Cho said neurological assessment after implantation should extend beyond focal stroke symptoms. Mandeep Mehra of Brigham and Women’s Hospital and Harvard Medical School emphasized that altered mental status in a very ill postoperative patient may reflect conditions such as sepsis or multiorgan failure, rather than a 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, MD, MSc, and colleagues, study authors
Cause and Event Categories Remain Unclear
The retrospective registry analysis shows associations, not causation. Patients who required ECMO before implantation may have been more severely ill, and the study does not establish that ECMO itself led to neurologic events. Outside experts cautioned against treating ECMO as a risk factor that can simply be removed, since it may be used because a patient is in shock.
The nonstroke outcome also combines conditions that may differ in severity, cause and relationship to the device. Mehra said many events in that group were encephalopathy, delirium, seizures or transient ischemic attacks and were not adjudicated. The report also noted that imaging may be ordered when a patient is already deteriorating, complicating interpretation of associations involving covert brain injury.
The supplied findings do not establish whether the recorded events were caused by the LVAD, underlying illness, surgery or other factors. They also do not show whether interventions aimed at the reported associations would reduce events or improve survival.
More Detailed Neurologic Reporting
The study authors called for a fuller account of neurologic dysfunction in LVAD care and for consistent terminology when assessing device safety. The findings support attention to neurologic status after implantation, including symptoms that do not present as a focal stroke, while clinical teams also evaluate possible systemic causes of altered mental status.
The report identifies pre-implant ECMO and concomitant surgery as factors associated with higher event rates, but it does not test preventive measures. Further work would need to separate event types, determine whether they are attributable to the device, and account for the severity of patients’ underlying illness. No specific follow-up study or change to clinical guidance was identified in the supplied report.
Key Questions
How common were neurologic events in the study?
The registry analysis recorded an 8% incidence of stroke and an 8% incidence of nonstroke neurologic adverse events over a median 1.4 years among 11,739 HeartMate 3 recipients.
What counted as a nonstroke neurologic event?
The category included several kinds of events, from overt brain injury and abnormalities detected on imaging to encephalopathy, delirium, seizures and transient ischemic attacks. Experts said these conditions should not automatically be treated as one uniform outcome.
Does the study show that HeartMate 3 caused these events?
No. The study was a retrospective registry analysis and found associations. It cannot establish whether events resulted from the device, underlying illness, surgery or other factors.
What factors were associated with higher event rates?
ECMO before implantation and concomitant surgery were associated with higher rates of stroke and nonstroke events. The findings do not prove these factors caused the events or that avoiding them would prevent them.
What do researchers say should happen next?
The study authors called for broader assessment of neurologic outcomes and consistent terminology. Outside experts said future research should distinguish event types and determine whether they are attributable to the device.
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