Routine Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement: A Meta-Analysis of Randomized Controlled Trials

Abstract

The risk of periprocedural stroke with TAVR remains a significant concern. Cerebral embolic protection (CEP) devices have been developed to mitigate this risk, but their clinical benefit remains uncertain. We aimed to evaluate the effectiveness and safety of routine CEP use during TAVR through a meta-analysis of randomized controlled trials (RCTs). A systematic search of PubMed, EMBASE, and ClinicalTrials.gov was conducted from inception to May 22, 2025, to identify RCTs comparing CEP versus standard care during TAVR. The primary outcome was stroke (including disabling and nondisabling strokes). Secondary outcomes included disabling stroke, new ischemic lesions on post-TAVR brain magnetic resonance imaging, all-cause mortality, major vascular complications, life-threatening bleeding, and acute kidney injury. Risk ratios (RRs) were pooled using a random-effects model. A total of 9 RCTs encompassing 11,641 patients (5970 with CEP and 5671 without) were included. CEP use did not significantly reduce the risk of stroke (RR, 0.91; 95% CI, 0.73–1.14; P=.41), disabling stroke (RR, 0.80; 95% CI, 0.57–1.12; P=.19), or new ischemic lesions on magnetic resonance imaging (RR, 0.98; 95% CI, 0.91–1.06; P=.64). There were no significant differences in all-cause mortality or safety outcomes between the CEP and control groups. Subgroup analyses based on the type of CEP device showed no significant differences in outcomes between the 2 groups, regardless of device type. In conclusion, routine CEP use during TAVR was not associated with reductions in stroke, disabling stroke, or all-cause mortality. Future studies are warranted to identify subgroups that may benefit from selective CEP use.