Summary
This randomised controlled trial evaluated two cerebral embolic protection devices against standard cannulation in 383 patients undergoing surgical aortic valve replacement at 18 North American centres. Neither the suction-based extraction device nor the intra-aortic filtration device demonstrated significant reduction in CNS infarction or 30-day composite outcomes compared with control, with freedom from CNS infarction rates of 32.0% and 25.6% respectively versus 32.4% control.
UK applicability
Findings are directly applicable to UK cardiothoracic surgical practice, as aortic valve replacement is performed across NHS centres using similar techniques. Results may inform commissioning decisions regarding adoption of embolic protection devices in the UK National Health Service.
Key measures
Primary: freedom from CNS infarction at 7 days (±3 days). Secondary: 30-day composite of mortality/clinical ischaemic stroke/acute kidney injury; delirium; mortality; serious adverse events; neurocognition.
Outcomes reported
The study measured freedom from clinical or radiographic central nervous system (CNS) infarction at 7 days post-procedure, and composite outcomes including mortality, clinical ischaemic stroke, and acute kidney injury within 30 days. Secondary measures included delirium, mortality, serious adverse events, and neurocognitive function.
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