Imaging and Clinical Outcomes with Sentinel Cerebral Embolic Protection During TAVR: A Meta-Analysis of Randomized Trials with Trial Sequential Analysis

Background: Stroke and subclinical cerebral ischemia remain important neurological complications of transcatheter aortic valve replacement (TAVR). The Sentinel cerebral embolic protection (CEP) device is designed to capture embolic debris during TAVR, but its impact on clinical and imaging outcomes remains incompletely characterized. Methods: PubMed, Embase, and Cochrane databases were systematically searched for randomized controlled trials (RCTs) comparing Sentinel CEP versus no protection when TAVR was performed. Outcomes of interest included all stroke, disabling stroke, infarct volume by diffusion-weighted MRI in protected and unprotected areas, all-cause mortality, acute kidney injury, and major vascular complications. Risk ratios (RRs) and median differences with 95% confidence intervals (CIs) were calculated using random-effects models and trial sequential analysis (TSA) assessed evidence robustness. Results: Four RCTs including 10,986 patients were analyzed. Sentinel CEP did not significantly reduce clinical stroke (RR 0.88, 95% CI 0.69-1.12) or disabling stroke (RR 0.68, 95% CI 0.41-1.14). Pooled DW-MRI data showed a significant reduction in new ischemic lesion volume within Sentinel CEP-protected territories (difference in medians -75.7 mm3; 95% CI -130.4 to -21.0). Subgroup analyses in elderly, female, and high-surgical-risk patients revealed no benefit with Sentinel CEP. Additionally, TSA indicated that current data are underpowered for definitive conclusions. Conclusions: The Sentinel CEP device during TAVR did not significantly reduce clinical stroke but was associated with lower MRI-detected ischemic lesion volumes compared with no protection. Further adequately powered RCTs integrating clinical and imaging endpoints are needed to define its role in neuroprotection during TAVR.