This is a systematic review and meta-analysis of studies on cerebral embolic protection (CEP) devices in patients undergoing transcatheter aortic valve replacement (TAVR). The analysis synthesized data from 11,696 patients, with 6,000 in the CEP group and 5,696 in the control group receiving no protection.
The primary finding was that CEP use did not significantly reduce the overall risk of all-cause stroke, with a pooled relative risk of 0.92 (95% CI 0.73 to 1.14; p = 0.43). The authors also reported no significant differences between groups for secondary outcomes, including all-cause mortality, disabling stroke, non-disabling stroke, cardiovascular mortality, transient ischemic attack, major adverse cardiovascular and cerebrovascular events, major bleeding, major vascular complications, and acute kidney injury.
The review did not report specific limitations, safety data, or follow-up duration. The authors did not quantify heterogeneity or detail the included study designs. Given the lack of significant effect on the primary outcome and most secondary outcomes, the practice relevance for routine CEP use in TAVR appears limited based on this synthesis.
View Original Abstract ↓
BackgroundCerebral 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).MethodsWe 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.ResultsNine 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.ConclusionsAmong patients undergoing TAVR, CEP devices could not reduce the risk of stroke compared with the control group.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420251114450, CRD420251114450.