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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 groups had substantially lower survival, though researchers and outside experts differ on how the heterogeneous nonstroke events should be interpreted.
A U.S. registry study of 11,739 people implanted with a HeartMate 3 LVAD found that stroke and nonstroke neurologic adverse events each occurred in 8% of patients over a median 1.4 years, and both were associated with substantially lower survival. The findings, reported in JACC: Heart Failure, suggest that monitoring after implantation should account for neurologic problems beyond stroke, although outside experts caution that the study’s broad nonstroke category combines conditions with different causes and severity.
Researchers led by Omar Saeed of Montefiore Medical Center used the Society of Thoracic Surgeons’ INTERMACS database to conduct a retrospective cohort study of HeartMate 3 recipients implanted from 2017 through 2023. The contemporary device uses magnetic levitation. During 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 nonstroke neurologic events. Compared with patients without a recorded neurologic event, the risk of death was higher after stroke (hazard ratio 7.3; 95% confidence interval 6.6 to 8.1) and after nonstroke events. Within the nonstroke group, the reported mortality association was strongest for overt central nervous system injury, followed by brain injury found on imaging and neurologic dysfunction without identified CNS injury.
The nonstroke category included a wide range of conditions: subarachnoid or subdural hemorrhage, hypoxic-ischemic injury, traumatic brain injury, imaging-detected injury, and problems such as encephalopathy, delirium, seizures and transient ischemic attacks. The authors said the similar incidence of stroke and nonstroke events, and their association with reduced survival, support giving both attention when assessing durable LVAD safety.
Neurologic Risks Beyond Stroke
The findings broaden the picture of complications following durable LVAD implantation. If clinicians and device studies track stroke alone, they may miss neurologic changes that affect patient outcomes or signal a serious underlying illness. The results support attention to mental-status changes and other neurologic symptoms after surgery, alongside standard evaluation for focal stroke signs.
But the study does not establish that every event in the nonstroke category was caused by the device, or that the events themselves caused the deaths. As outside experts noted, encephalopathy and delirium can accompany infection, shock or multiorgan dysfunction. The practical implication is to recognize neurologic problems while carefully investigating their cause, rather than treating the combined category as a single device complication.
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How the Registry Grouped Events
Stroke has received particular attention in LVAD care because of potential links to thromboembolism, existing cerebrovascular disease, high blood pressure and anticoagulation. The study’s authors argue that other neurologic events have been less fully described. Their analysis used registry data rather than a randomized trial, and it focused on recipients of the HeartMate 3 implanted between 2017 and 2023.
The researchers also identified associations between pre-implantation extracorporeal membrane oxygenation (ECMO) and later neurologic events: hazard ratios were 1.70 for stroke and 1.45 for nonstroke events. Concomitant surgery was also associated with both outcomes, with hazard ratios of 1.23 for stroke and 1.17 for nonstroke events. These are observational associations; they do not show that ECMO or surgery directly caused the events. Patients receiving ECMO may be more critically ill before implantation.
“Stroke and nonstroke NAEs are incurred by a similar proportion of patients, and both are associated with substantially reduced survival.”
— Omar Saeed and colleagues, the study authors
Limits of the Nonstroke Category
The study was retrospective, so it can identify associations, not prove causation. The registry findings do not establish whether a neurologic event caused a patient’s decline or reflected an existing condition such as infection, shock or organ failure. Nor do they show that ECMO or concomitant surgery can safely be avoided to reduce risk.
Outside experts also questioned the range of conditions grouped as nonstroke events. Cho said the category combines structural injuries with conditions such as delirium, obscuring important differences. Mehra said many events were not adjudicated and argued that scans may be ordered because a patient is already deteriorating. The source report does not provide a final resolution of these concerns or establish which events were directly attributable to the LVAD.
Improving Post-Implant Monitoring
The authors call for broader and more consistent accounting of neurologic complications when clinicians evaluate LVAD safety. The findings also point to the need for careful assessment of patients arriving for implantation on ECMO or undergoing additional procedures, while recognizing that the study cannot show that changing those factors will prevent events.
Future research can help clarify the picture by defining neurologic outcomes more precisely, adjudicating events consistently and separating device-related brain injury from complications of critical illness. Until then, the registry offers evidence that neurologic events beyond stroke are common enough to warrant attention, but their causes and preventability remain unsettled.
Key Questions
What did the LVAD registry study find?
Among 11,739 HeartMate 3 recipients, the study found an 8% incidence of stroke and an 8% incidence of nonstroke neurologic adverse events over a median follow-up of 1.4 years.
What counted as a nonstroke neurologic event?
The category included brain injuries such as subarachnoid hemorrhage and hypoxic-ischemic injury, imaging-detected injury, and conditions including encephalopathy, delirium, seizures and transient ischemic attacks.
Were these events shown to be caused by the LVAD?
No. The study was retrospective and found associations with outcomes; it did not establish that the device caused each event or that the events themselves caused deaths. Experts also noted that systemic illness can contribute to neurologic dysfunction.
Does the ECMO finding mean patients should avoid ECMO?
No. Pre-implantation ECMO was associated with higher rates of neurologic events, but the study cannot show that ECMO caused them or that avoiding it would reduce risk. Patients receiving ECMO may be more severely ill.
What does the study suggest clinicians should watch for?
The authors and an outside expert support attention to neurologic changes beyond focal stroke symptoms. Clinicians also need to assess possible causes such as infection, shock or multiorgan dysfunction; the study does not prescribe a specific monitoring protocol.
Source: rss
