Cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and meta-analysis of randomized controlled trials

Abstract

Background This meta-analysis aimed to assess the efficacy and safety of cerebral embolic protection devices (CEPDs) in patients undergoing transcatheter aortic valve implantation (TAVI).
Methods 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. The Cochrane risk of bias (RoB 2.0) tool was used for quality assessment. Funnel plots were assessed for publication bias.
Results Eight randomized controlled trials, including 11,632 patients undergoing TAVI, were analyzed. 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 stroke (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), acute kidney injury (AKI) (RR 0.96, 95% CI: 0.44–2.11, p = 0.93), 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).
Conclusion CEPD did not significantly reduce the incidence of ischemic lesions or neurocognitive decline. Current evidence does not support a statistically significant clinical benefit of CEPD use during TAVI. While trends suggest a potential reduction in stroke, larger trials are needed to establish the significance of these results.

Keywords: Transcatheter aortic valve replacement, transcatheter aortic valve implantation, emboli protection device, cerebral embolic protection, stroke.