Introduction:
Transcatheter aortic valve implantation (TAVI) has become a standard treatment for patients with severe aortic stenosis. However, periprocedural cerebral embolisation remains a major complication, contributing to the risk of stroke and silent cerebral infarctions. Cerebral embolic protection devices (CEPDs) have been developed to mitigate this risk, but their clinical efficacy remains uncertain.

Methods:
A systematic search of the PubMed/Medline, Embase, and Cochrane library databases was conducted for randomised controlled trials (RCTs) comparing CEPD use versus no CEPD in patients undergoing TAVI, from inception to 1 May 2025. The primary outcome was all-cause stroke. Risk ratios (RRs) and mean differences (MDs) were pooled using a random-effects model.

Results:
Eight RCTs comprising 11,611 patients (5956 with CEPD and 5655 without CEPD) were included. CEPD use was not associated with a significant reduction in all-cause stroke (RR = 0.92, 95% CI: 0.74–1.15), disabling stroke (RR = 0.80, 95% CI: 0.57–1.12), or non-disabling stroke (RR = 0.82, 95% CI: 0.58–1.16). No significant differences were observed in all-cause mortality (RR = 1.09, p = 0.70), NIHSS worsening (RR = 1.21, p = 0.41), new ischaemic lesions (RR = 0.99, p = 0.70), or lesion volume on DW-MRI (MD = –78.89 mm³, p = 0.10). Similarly, no significant differences were found in the incidence of acute kidney injury or vascular complications (p > 0.05).

Conclusions:
The use of CEPDs during TAVI was not associated with a reduction in stroke, mortality, or other adverse clinical outcomes. Further research may be needed to identify subgroups who could benefit from CEPD use.