This meta-analysis evaluated the effectiveness and safety of cerebral embolic protection devices (CEPDs) in patients undergoing transcatheter aortic valve implantation (TAVI).

Transcatheter aortic valve implantation (TAVI) is now a widely accepted treatment for patients with severe aortic stenosis. It offers a less invasive alternative to surgical aortic valve replacement (SAVR) with faster recovery and better early quality of life. However, stroke is still a major complication that can happen during or after the procedure.

PubMed, Cochrane Central, and ScienceDirect were searched till April 2025. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled under a random-effects model using Review Manager version 5.4.1. The Cochrane risk of bias (RoB 2.0) tool was used for quality assessment. Funnel plots were assessed for publication bias.

 Eight randomized controlled trials, including 11,632 patients undergoing TAVI, were analyzed. The use of CEPDs showed a non-significant reduction in all strokes (RR 0.92, 95% CI: 0.74–1.15, p = 0.48) and disabling strokes (RR 0.80, 95% CI: 0.57–1.12, p = 0.18). There was no significant difference in all-cause mortality (RR 1.09, 95% CI: 0.71–1.67, p=0.70), disabling bleeding (RR 0.96, 95% CI: 0.28-3.31; p=0.94), and major vascular complications (RR 1.25, 95% CI: 0.56-2.78, p=0.59).

CEPD did not lead to significant changes in the rates of all strokes, disabling strokes, all-cause mortality, disabling bleeding, or major vascular complications. Current evidence does not support a statistically significant clinical benefit of CEPD use during TAVI. Although trends indicate a possible reduction in stroke, larger trials are necessary to confirm the significance of these findings.