TL;DR
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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 does not establish that the device caused them.
The analysis used the U.S. Society of Thoracic Surgeons INTERMACS registry and included patients who received the magnetically levitated HeartMate 3 left ventricular assist device 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 study reported a significant difference between those figures (P<0.001).
Compared with recipients without a recorded neurologic event, the analysis found an elevated risk of death after stroke (hazard ratio 7.3, 95% confidence interval 6.6-8.1). Risks also varied within the nonstroke group: overt central nervous system injury had a hazard ratio of 12.58, covert injury identified on imaging 9.19, and neurologic dysfunction without identified CNS injury, including encephalopathy, 3.69. These are associations from a retrospective registry analysis, not proof that an event caused a later death.
The researchers, led by Omar Saeed of Montefiore Medical Center, reported that pre-implant extracorporeal membrane oxygenation (ECMO) and surgery performed alongside LVAD implantation were associated with higher rates of neurologic events. Pre-LVAD 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 possible targets for risk reduction, while outside experts cautioned that the associations do not show that either factor can simply be avoided.
Neurologic Risk Beyond Stroke
The findings point to a potential blind spot in how complications after durable LVAD implantation are counted. Nonstroke events occurred at the same reported rate as strokes in this cohort, and both categories were associated with worse survival. That may matter to clinicians monitoring patients after surgery and to researchers choosing which complications to track in device studies.
However, the result should not be read as showing that all nonstroke events are equivalent to stroke or are caused by the LVAD. The category includes a broad mix of brain injuries and clinical conditions. Better classification could help clinicians distinguish device-related injury from neurologic effects of severe illness and could make safety comparisons between devices and studies more informative.
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How the Registry Grouped Events
Stroke has received much of the attention around neurologic complications in LVAD recipients. The study authors noted that possible contributors include thromboembolism, pre-existing cerebrovascular disease, uncontrolled hypertension, and anticoagulation therapy. Their analysis expanded the scope to include nonstroke neurologic adverse events, which had been less fully described in this setting.
The nonstroke category covered overt CNS injuries such as subarachnoid hemorrhage, hypoxic-ischemic injury, subdural hemorrhage, and traumatic brain injury; covert injuries detected through neuroimaging; and dysfunction without identified CNS injury, including encephalopathy, delirium, seizures, and transient ischemic attacks. Outside experts said these conditions differ in cause and severity, making the combined category difficult to interpret.
“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 Event Categories
The registry analysis was retrospective and observational, so it can identify associations but cannot establish that HeartMate 3 caused the events or that ECMO or concomitant surgery caused the increased risks. Patients receiving ECMO may be critically ill before implantation, and the procedure may mark the severity of their condition rather than represent an avoidable exposure.
The study’s nonstroke endpoint also combines conditions with different causes. Cho noted that encephalopathy may reflect infection, shock, or multiorgan dysfunction; Mehra questioned whether imaging findings might be more likely to be detected in patients already doing poorly. The supplied report does not establish how much of the observed mortality association is attributable to neurologic injury, underlying illness, or other factors. The source material also does not provide a detailed breakdown of every event type or show whether the findings apply to other LVAD models.
Toward Clearer Safety Measures
The researchers called for broader and more consistent neurologic event nomenclature when evaluating durable LVAD safety. The study also points to the need for future work that separates distinct diagnoses and determines whether events are attributable to a device, a procedure, or the patient’s underlying illness.
For clinicians, the outside experts’ comments support attention to neurologic changes after implantation alongside assessment for systemic problems such as infection or shock. The findings do not establish a specific prevention strategy. Further studies with carefully adjudicated outcomes will be needed to test whether the observed risk patterns hold and whether any interventions reduce neurologic complications.
Key Questions
How often did neurologic events occur in the study?
Over a median 1.4 years, the study reported an 8% incidence of stroke and an 8% incidence of nonstroke neurologic adverse events among 11,739 HeartMate 3 recipients.
What counted as a nonstroke neurologic event?
The registry category included overt brain injuries, imaging-detected injuries, and conditions such as encephalopathy, delirium, seizures, and transient ischemic attacks. The study authors and outside experts stressed that these events are not all alike.
Did the study prove the LVAD caused the events?
No. The retrospective registry analysis found associations between recorded neurologic events and lower survival. It does not establish that the device caused an event or that an event itself caused a later death.
Were ECMO and concomitant surgery proven causes of neurologic complications?
No. Both were associated with higher event rates in the analysis, but outside experts cautioned that ECMO may indicate severe illness and that the findings do not show either factor can simply be avoided to prevent complications.
What do researchers say should happen next?
The study authors called for consistent terminology that includes nonstroke neurologic events. Outside experts said future studies should use rigorously adjudicated, device-attributable outcomes and distinguish different types and causes of neurologic dysfunction.
Source: rss
