The Utility of Cerebral Protection Devices in Transcatheter Aortic Valve Replacement: A Systematic Review and Bayesian Meta-analysis.

Background: Cerebral embolic protection (CEP) devices are designed to reduce procedure-related stroke during transcatheter aortic valve replacement (TAVR). In light of recent randomized controlled trials (RCTs), we performed an updated meta-analysis to evaluate their impact on stroke and mortality. Methods: We systematically searched PubMed, EMBASE, and Cochrane Central through June 2025 for RCTs comparing TAVR with or without the CEP devices. Outcomes of interest included all stroke, disabling stroke, and all-cause mortality. Data were extracted and pooled using a random-effects frequentist meta-analysis. In addition, a Bayesian meta-analysis was performed with both vague and informative priors to evaluate the probability of a clinically meaningful reduction in stroke. Results: Eight RCTs with 11,632 patients (CEP group = 5969; control group = 5663) were included. We found no difference in all strokes between the groups (risk ratio, 0.92; 95% CI, 0.74-1.15), nor in disabling stroke or all-cause mortality. In the Bayesian meta-analysis for all strokes using a vague prior, posterior probabilities that the risk ratio was <1, <0.9, and <0.67 were 71.9%, 35.6%, and 0.1%, respectively. For disabling stroke, the probabilities were 89.6%, 73.3%, and 12.1%, respectively. With an informative prior, posterior probabilities for all strokes were 95.9%, 39.0%, and 0% and the probabilities for disabling strokes were 98.3%, 73.8%, and 0%, respectively. Conclusions: CEP devices did not significantly reduce stroke or mortality during TAVR, and the probability of a clinically meaningful benefit was low. Larger studies with extended follow-up are warranted to clarify their role in contemporary practice.