TL;DR
Get workout gear delivered free with Prime
- Fast, free delivery on millions of items
- Prime Video, Amazon Music and more included
- Member-only deals all year
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 groups had substantially lower survival, but outside experts caution that the nonstroke category combines varied conditions and does not establish that the device caused them.
A U.S. registry study of 11,739 people implanted with a HeartMate 3 found that stroke and nonstroke neurologic adverse events each occurred in 8% of patients over a median 1.4 years, and both groups had lower survival than patients without recorded neurologic events. The findings, reported in JACC: Heart Failure, suggest that monitoring after left ventricular assist device (LVAD) implantation should account for problems beyond stroke, while the study’s broad nonstroke category and retrospective design limit conclusions about causes.
Omar Saeed, MD, MSc, of Montefiore Medical Center and Albert Einstein College of Medicine, and colleagues analyzed Society of Thoracic Surgeons INTERMACS registry data for patients who received the magnetically levitated HeartMate 3 from 2017 through 2023. Over a median follow-up of 1.4 years, the reported incidence was 8% for stroke and 8% for nonstroke neurologic adverse events.
Two-year survival was 45% among patients who had a stroke and 56% among those with nonstroke events. Compared with patients with no neurologic event, the study associated stroke with a higher risk of death (hazard ratio 7.3, 95% confidence interval 6.6-8.1). Risk also varied within the nonstroke group: it was highest with overt central nervous system injury, followed by brain injury detected on imaging and neurologic dysfunction without identified CNS injury.
The researchers reported associations between neurologic events and two clinical circumstances: extracorporeal membrane oxygenation (ECMO) before LVAD implantation and surgery performed at the same time as implantation. Pre-implant ECMO was associated with stroke and nonstroke events; concomitant surgery was also associated with both. These are observational associations, not proof that either circumstance caused the events or that avoiding them would prevent them.
Neurologic Risks Extend Beyond Stroke
The results suggest that focusing only on stroke may leave other neurologic problems out of safety assessments and post-operative monitoring. Study authors said the similar incidence of stroke and nonstroke events, alongside reduced survival in both groups, supports giving both categories attention when evaluating durable LVADs.
That finding does not mean all nonstroke events represent the same kind of harm. The category includes structural brain injuries, imaging findings, and symptoms such as delirium or encephalopathy. As outside experts noted, some symptoms can occur amid infection, shock, or failure of multiple organs. Clinicians therefore need to evaluate both possible brain injury and the broader illness accompanying altered mental status.
LVAD neurologic event monitoring device
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
How the Registry Defined Events
LVADs support circulation in people with advanced heart failure. In recipients, stroke has received substantial attention because it can arise from several possible sources, including blood clots, existing cerebrovascular disease, high blood pressure, and anticoagulation-related factors, according to the researchers’ discussion.
The study’s nonstroke group was broader than a single diagnosis. It included overt CNS injury such as subarachnoid or subdural hemorrhage, hypoxic-ischemic injury, and traumatic brain injury; injuries found through neuroimaging; and neurologic dysfunction without identified CNS injury, including encephalopathy, delirium, seizures, and transient ischemic attacks. That mix is central to interpreting the headline finding: the category counts events that differ in type and potential cause.
“Stroke and nonstroke NAEs are incurred by a similar proportion of patients, and both are associated with substantially reduced survival.”
— Omar Saeed and colleagues, study authors
heart failure patient stroke detection monitor
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
Causes and Categories Remain Unsettled
The retrospective registry analysis shows associations, not that HeartMate 3 caused each event or that the reported risk factors are directly preventable. Patients placed on ECMO before implantation may be more critically ill, for example; experts cautioned that ECMO can mark the severity of shock rather than represent a choice clinicians can simply avoid. The supplied report ends during this discussion, so it does not provide further detail on the authors’ response to that concern.
Experts also disputed whether the nonstroke category should be treated as one endpoint comparable with stroke. Cho noted that some included hemorrhages are structural brain injuries, while other entries are symptoms or conditions with different implications. Mehra said many events were not adjudicated and could reflect sepsis or multiorgan failure. The available account does not establish how many deaths were directly attributable to neurologic injury, nor does it resolve how much imaging findings reflect the injury itself versus the circumstances that prompted a scan.
LVAD post-op neurological assessment tools
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
Better Event Classification Needed
The researchers called for more complete accounting of neurologic dysfunction to inform LVAD decisions and safety evaluation. The findings support closer neurologic assessment after implantation, particularly for patients who arrive on temporary support or undergo additional procedures, but they do not by themselves show that changing those practices will reduce events.
Further studies with clearly defined and independently adjudicated neurologic outcomes could help distinguish device-related injury from complications of critical illness and clarify the risks of individual event types. The source material does not identify a follow-up study or a specific next publication date, so when such evidence will be available remains unknown.
cerebral injury detection device for LVAD patients
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
Key Questions
How often did neurologic events occur in the study?
The registry analysis reported 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 implanted from 2017 to 2023.
What did the study mean by nonstroke neurologic events?
The category included several types of events, from brain injuries identified clinically or on imaging to encephalopathy, delirium, seizures, and transient ischemic attacks. The researchers’ broad grouping is one reason outside experts urged caution in treating it as a single outcome.
Did the study prove that LVADs caused these events?
No. This was a retrospective registry study reporting associations. It does not establish that the HeartMate 3 caused each event or that ECMO or concomitant surgery directly caused neurologic complications.
What factors were associated with higher event risk?
Pre-implant ECMO was associated with higher rates of stroke and nonstroke events, as was surgery performed at the same time as LVAD implantation. Experts cautioned that ECMO may reflect how seriously ill a patient is, so the association does not show it is a risk that can simply be removed.
Source: rss
Halloween Picks
halloween
As an affiliate, we earn on qualifying purchases.
