Efficacy of Cerebral Embolic Protection Device in Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Abstract

Transcatheter aortic valve replacement (TAVR) is widely used to treat severe aortic stenosis; however, periprocedural stroke remains a significant concern. This systematic review and meta-analysis evaluate whether the use of cerebral embolic protection devices (CEPDs) during TAVR reduces the risk of stroke and other complications. To conduct a network meta-analysis of relevant trials to assess the efficacy of CEPDs currently used in TAVR. PubMed, Embase, and Scopus were systematically searched through April 2025 to identify studies comparing TAVR performed with and without CEPDs. Primary outcomes included stroke, all-cause mortality, major bleeding, and major vascular complications. Data were analyzed using RevMan (Version 5.4.1). A random-effects model was used for all analyses, applying the Mantel−Haenszel method for dichotomous outcomes, reported as risk ratios with 95% confidence intervals. Funnel plots were used to assess publication bias. Twenty-four studies (9 randomized controlled trials and 15 observational studies), including a total of 437,487 patients (59,274 with CEPD and 384,213 without), were included in the analysis. The mean patient age was 80 years, and 46.4% were female. Compared to patients undergoing TAVR without protection, those receiving CEPDs had significantly lower risks of stroke (RR = 0.70; 95% CI: 0.60–0.82; p < 0.0001), all-cause mortality (RR = 0.69; 95% CI: 0.50–0.93; p = 0.02), disabling stroke (RR = 0.44; 95% CI: 0.26–0.75; p = 0.003), acute kidney injury (RR = 0.84; 95% CI: 0.79–0.89; p < 0.00001), and 30-day readmission (RR = 0.75; 95% CI: 0.60–0.95; p = 0.02). A reduction in major bleeding was also observed (RR = 0.83; 95% CI: 0.59–1.17), although this did not reach statistical significance (p = 0.29). No significant differences were found between groups in terms of major vascular complications, transient ischemic attack (TIA), new pacemaker implantation, or delirium. The use of CEPDs during TAVR is associated with reduced risks of stroke, disabling stroke, acute kidney injury, and 30-day readmission. However, discrepancies between randomized and observational studies warrant cautious interpretation. Further research is needed to clarify the benefits and evaluate the cost-effectiveness of CEPD implementation in routine clinical practice.