Sentinel Cerebral Embolic Protection in Patients with Transcatheter Aortic Valve Replacement: A Meta-analysis of Randomized Controlled Trials and Trial Sequential Analysis

Transcatheter aortic valve replacement (TAVR) is widely used to treat severe aortic stenosis, and stroke remains a serious complication. The Sentinel cerebral embolic protection (CEP) device is designed to reduce this risk. However, it is still unclear if it truly improves patient outcomes. This meta-analysis evaluates whether the Sentinel device reduces stroke, death, or neurological complications. We searched PubMed, Embase, and Cochrane Central for randomized controlled trials comparing the use of the Sentinel CEP versus no device in patients undergoing TAVR. Outcomes included stroke within 72 hours, disabling stroke, any stroke, transient ischemic attack, and mortality. Statistical analysis was performed using R version 4.4.2. Heterogeneity was assessed using the I2 statistic. Five randomized controlled trials with 11,006 patients were included; 50.0% (n = 5502) received the CEP device and 50.0% (n = 5504) did not. Lower risk of stroke within 72 hours was observed with Sentinel CEP, although the difference was nonsignificant [2.3% vs 2.5%; risk ratio (RR): 0.88, 95% confidence interval (CI): 0.69-1.12; P = 0.292; I2 = 0%]. No significant difference was observed in the incidence of transient ischemic attack between both groups (0.4% vs 0.3%; RR: 1.28, 95% CI: 0.66-2.50; P = 0.465; I2 = 0%). All-cause mortality rates were comparable between both groups (0.7% vs 0.7%; RR: 1.08, 95% CI: 0.69-1.69; P = 0.748; I2 = 0%). CEP during TAVR was not associated with a significant reduction in neurological or mortality outcomes, indicating no clear overall clinical benefit in the studied population. Further studies are needed to determine its potential role in selected high-risk patients.