Outcomes after using cerebral embolic protection devices during transcatheter aortic valve replacement: an updated meta-analysis.

BACKGROUND

Cerebral embolic protection (CEP) devices have been developed to reduce periprocedural embolization through transcatheter aortic valve replacement (TAVR), yet their clinical benefit remains uncertain. This study aimed to systematically evaluate the efficacy and safety of CEP devices during TAVR using evidence restricted to randomized controlled trials (RCTs).

METHODS

We conducted a systematic review and meta-analysis following PRISMA guidelines. MEDLINE, Embase, Web of Science, Scopus, and Cochrane CENTRAL were searched through July 2025 for RCTs comparing CEP devices vs. no protection in patients undergoing TAVR. The primary outcome was the all-cause stroke. Random-effects model was applied for the primary analysis.

RESULTS

Nine RCTs comprising 11,696 patients (6,000 patients in CEP, 5,696 patients in control) were analyzed. CEP use did not significantly reduce the overall risk of all-cause stroke (RR 0.92; 95% CI 0.73-1.14; p = 0.43). The results were consistent across different subgroups, either Sentinel (filter device) (RR 0.88; 95% CI 0.70-1.11; I2 = 0.00%) or TriGuard (deflection device) (RR 1.40; 95% CI 0.67-2.94; I2 = 0.00%) (Pinteraction = 0.50). Similarly, no significant differences between the two groups were observed for the risk of all-cause mortality, disabling stroke, non-disabling stroke, cardiovascular mortality, transient ischemic attack, major adverse cardiovascular and cerebrovascular events, major bleeding, major vascular complications, or acute kidney injury.

CONCLUSIONS

Among patients undergoing TAVR, CEP devices could not reduce the risk of stroke compared with the control group.

SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251114450, CRD420251114450.