Safety and Efficacy of Cerebral Embolic Protection Device During Transcatheter Aortic Valve Implantation: An Updated Systematic Review and Meta‐Analysis

BACKGROUND: Cerebral embolic protection (CEP) devices may mitigate the risk of embolization and stroke during transcatheter aortic-valve implantation (TAVI), yet their safety and efficacy remain debated. AIMS: To evaluate the safety and efficacy of CEP during TAVI. METHODS: We conducted a systematic search of PubMed, Embase, and the Cochrane Library from inception through April 2025 for randomized controlled trials (RCTs) and observational studies comparing TAVI performed with versus without the Sentinel CEP device. Pooled risk ratios (RRs), odds ratios (ORs), and 95% confidence intervals (CIs) were calculated using a random-effects model. RESULTS: Seventeen studies (4 RCTs and 13 observational cohorts) involving 752,164 patients were included; among them, 86,916 (11.5%) received the Sentinel device. CEP use was associated with significantly lower rates of early stroke (within 72 h; RR 0.61; 95% CI 0.40-0.94), any stroke (RR 0.78; 95% CI 0.65-0.94), 30-day stroke (RR 0.47; 95% CI 0.26-0.85), disabling stroke (RR 0.49; 95% CI 0.29-0.84), and all-cause mortality (RR 0.66; 95% CI 0.49-0.89). No significant differences were observed in transient major vascular complications, bleeding events, or acute kidney injury (AKI). In the analysis restricted to RCTs, stroke and mortality outcomes were similar between groups, with no significant differences across safety endpoints. In prespecified subgroup analyses, patients with bicuspid aortic valves derived no significant benefit from CEP (OR O.80; 95% CI 0.40-1.61), whereas those with prior stroke experienced a reduced risk of recurrent stroke (RR 0.61; 95% CI 0.45-0.82). CONCLUSION: This meta-analysis suggests that the Sentinel CEP device is associated with lower risks of stroke and mortality following TAVI, without increasing the incidence of vascular complications, bleeding, or AKI.