Cerebral embolic protection devices during TAVI showed no significant reduction in overall stroke incidence compared to control (RR 0.93; 95% CI 0.74-1.16; P=0.49).
Meta-Analysis (n=11,589)
Do cerebral embolic protection devices reduce stroke incidence in patients undergoing TAVI?
This meta-analysis of over 11,000 patients demonstrates that the use of cerebral embolic protection devices during TAVI does not significantly reduce the risk of stroke or mortality.
Effect estimate: RR 0.93 (95% CI 0.74-1.16)
p-value: p=0.49
Abstract Background and aims Transcatheter aortic valve implantation (TAVI) is associated with procedure-related stroke. Cerebral embolic protection devices (CEPDs) are designed to reduce the risk of embolic debris reaching the brain; however, the evidence supporting their efficacy remains controversial. In this study, we aim to evaluate the efficacy and safety of CEPDs in patients undergoing TAVI. Methods Six databases (PubMed, Scopus, Web of Science, Cochrane, Embase, and Ovid) were systematically searched up to April 4, 2025. Only randomized controlled trials (RCTs) were included and critically appraised using the Cochrane Risk of Bias 2 (ROB-2) tool. Statistical analyses were performed using R software to calculate risk ratios (RRs) with 95% confidence intervals. Results We retrieved 1609 records. Eight RCTs (11,589 patients) were analyzed. No significant difference was observed in overall stroke incidence between CEPD and control groups (RR 0.93; 95% CI: 0.74–1.16; P=0.49), including disabling and non-disabling strokes. Device-specific analyses showed a non-significant trend toward reduced disabling stroke with the Sentinel device, while the Triguard device was associated with increased major vascular complications (RR 2.18; 95% CI: 1.04–4.59). All-cause mortality, transient ischemic attacks, bleeding, acute kidney injury, delirium, and pacemaker implantation rates were similar between groups. Notably, CEPD use was linked to a transient improvement in cognitive function (MoCA scores) at 2–5 days post-TAVI, but this effect was not sustained at later follow-ups. Conclusions CEPDs show no significant reduction in overall, disabling, or non-disabling stroke, nor in all-cause mortality post-TAVI. Conflict of interest
Gbreel et al. (Fri,) conducted a meta-analysis in Patients undergoing transcatheter aortic valve implantation (TAVI) (n=11,589). Cerebral embolic protection devices (CEPDs) vs. Control was evaluated on Overall stroke incidence (RR 0.93, 95% CI 0.74-1.16, p=0.49). Cerebral embolic protection devices during TAVI showed no significant reduction in overall stroke incidence compared to control (RR 0.93; 95% CI 0.74-1.16; P=0.49).