Routine cerebral embolic protection during TAVR: A meta-analysis and trial sequential evidence from 11,000 randomized patients.

OBJECTIVES

To perform an updated meta-analysis assessing the effect of routine cerebral embolic protection (CEP) use on the incidence of stroke-disabling and non-disabling-following transcatheter aortic valve replacement (TAVR).

METHODS

Electronic databases were systematically searched through August 2025 for eligible randomized controlled trials (RCTs) comparing CEP versus no CEP in TAVR. The primary outcomes were the incidence of overall stroke, disabling stroke, and non-disabling stroke at 2-5 days and 30 days post-procedure. Random-effects model was used to estimate risk ratios (RR) with 95% confidence intervals (CI). Evaluation of the certainty of evidence was done following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Trial sequential analysis was performed to assess the conclusiveness and the reliability of the data.

RESULTS

Eight RCTs, including 11,692 patients, were analyzed. No statistically significant difference was observed in overall stroke incidence between CEP and control groups at 2-5 days (RR = 0.95; 95% CI: 0.75-1.19; p = 0.64) or at 30 days (RR = 0.93; 95% CI: 0.57-1.53; p = 0.79). Disabling stroke rates were also similar at 2-5 days (RR = 0.70; 95% CI: 0.41-1.18; p = 0.18) and at 30 days (RR = 1.18; 95% CI: 0.36-3.87; p = 0.78). Non-disabling stroke showed no significant difference at either time point. Safety outcomes, including major bleeding, vascular complications, and acute kidney injury, were also not significantly different.

CONCLUSION

This updated meta-analysis found that a routine CEP strategy during TAVR was not associated with a statistically significant reduction in overall, disabling, or non-disabling stroke. The neutral effect on safety endpoints suggests a limited role for routine CEP use, although smaller benefits, device-specific effects, or benefits in selected higher-risk patients cannot be excluded.