Cerebral Embolic Protection Devices (CEPDs) During Transcatheter Aortic Valve Implantation (TAVI): A Meta-Analysis of Randomized Controlled Trials

Abstract

Aims: Transcatheter aortic valve implantation (TAVI) is associated with procedure-related stroke. Cerebral embolic protection devices (CEPDs) are designed to reduce the risk of embolic debris reaching the brain; however, the evidence supporting their efficacy remains controversial. We aim to evaluate the efficacy and safety of CEPDs in patients undergoing TAVI. Methods: Major databases were systematically searched up to April 2025. Only randomized controlled trials (RCTs) were included and critically appraised using the Cochrane Risk of Bias (ROB-2) tool. We calculated risk ratios (RRs) with the 95% confidence intervals for the outcomes, and trial sequential analysis (TSA) was conducted to reduce the risk of false-positive results due to random errors. Results: Eight RCTs (11,589 patients) were analyzed. No significant difference was observed in overall stroke incidence between CEPD and control groups (0.92 (95% CI: 0.75–1.14; p = 0.40, I2 = 0%), including disabling and non-disabling strokes. Device-specific analyses showed a non-significant reduction in disabling stroke with the Sentinel device. All-cause mortality, transient ischemic attacks, bleeding, acute kidney injury, delirium, and pacemaker implantation rates were similar between groups. CEPD use was linked to a transient improvement in cognitive function (MoCA scores) at 2–5 days post-TAVI, but this effect was not sustained at later follow-ups. TSA indicated that current evidence is insufficient to definitively refute CEPD efficacy. Conclusion: CEPDs show no significant reduction in overall, disabling, or non-disabling stroke, nor in all-cause mortality post-TAVI. Trial Registration: This meta-analysis was registered on PROSPERO. No.: CRD420251026208.