A retrospective analysis of the U.S. INTERMACS registry found that non-stroke neurologic adverse events are nearly as common as strokes in patients receiving the contemporary magnetically levitated HeartMate 3 left ventricular assist device (LVAD). Among 11,739 people with advanced heart failure, 8% experienced a stroke and 8% experienced a non-stroke neurologic event over a median follow-up of 1.4 years. Both types of events were tied to substantially reduced survival: two-year survival was 45% for stroke patients and 56% for those with non-stroke events, compared with patients who had no neurologic complication.
The study, published in JACC: Heart Failure, grouped non-stroke events into overt central nervous system (CNS) injury such as subarachnoid or subdural hemorrhage, covert CNS injury detected by neuroimaging, and neurologic dysfunction without CNS injury such as encephalopathy, delirium, seizures, or transient ischemic attacks. Mortality risk was highest after overt CNS injury (hazard ratio 12.58), followed by covert injury (9.19), and encephalopathy-like dysfunction (3.69). The authors argue that stroke and non-stroke events should receive equal weight in evaluating LVAD safety, and they identify pre-implant ECMO and concomitant surgery as potentially modifiable risk factors.
Outside experts, however, caution against lumping these events together. Sung-Min Cho of Johns Hopkins and Mandeep Mehra of Brigham and Women's Hospital both stressed the clinical heterogeneity of the non-stroke category, noting that conditions like subarachnoid hemorrhage are structurally different from delirium, which often reflects sepsis or multiorgan failure rather than device-related brain injury. They called for rigorous, adjudicated, device-attributable neurologic endpoints in future trials, warning that unadjudicated composite outcomes could obscure rather than clarify device performance.