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

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.