What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Patients undergoing Transcatheter Aortic Valve Implantation (TAVI) (n=11589). Intervention: Cerebral embolic protection devices (CEPDs) vs. Control. Primary outcome: Overall stroke incidence (RR 0.92, 95% CI 0.75-1.14, p=0.40).

What does this research mean for the field?

Cerebral embolic protection devices used during transcatheter aortic valve implantation do not significantly reduce the overall incidence of stroke compared to control. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This analysis evaluates the efficacy and safety of cerebral embolic protection devices during transcatheter aortic valve implantation.

April 25, 2026Open Access

Cerebral Embolic Protection Devices (CEPDs) During Transcatheter Aortic Valve Implantation (TAVI): A Meta‐Analysis of Randomized Controlled Trials

Key Result

Cerebral embolic protection devices during TAVI showed no significant reduction in overall stroke incidence compared to control (RR 0.92; 95% CI 0.75-1.14; p=0.40).

Key Points

This analysis evaluates the efficacy and safety of cerebral embolic protection devices during transcatheter aortic valve implantation.
Systematic search of major databases for randomized controlled trials up to April 2025.
Cochrane Risk of Bias tool was used for critical appraisal of included trials.
Risk ratios were calculated, and trial sequential analysis was performed to assess the robustness of findings.
No significant difference in overall stroke incidence was found between CEPD and control groups (RR 0.92, 95% CI: 0.75-1.14; p=0.40).
Device-specific analysis indicated a non-significant reduction in disabling stroke with the Sentinel device.
Transitional cognitive improvement was noted after 2-5 days of TAVI, but not at subsequent follow-ups.

Study Design

Type

Meta-Analysis (n=11,589)

Structured PICO

Does the use of cerebral embolic protection devices reduce the incidence of stroke in patients undergoing TAVI?

Population

11,589 patients undergoing transcatheter aortic valve implantation (TAVI) across 8 RCTs

Intervention

Cerebral embolic protection devices (CEPDs)

Comparator

Control group (TAVI without CEPD)

Outcome

Overall stroke incidence (including disabling and non-disabling strokes)hard clinical

The use of cerebral embolic protection devices during TAVI does not significantly reduce the risk of overall, disabling, or non-disabling stroke, nor does it affect all-cause mortality.

Main Result

Effect estimate: RR 0.92 (95% CI 0.75-1.14)

p-value: p=0.40

Limitations

Current evidence is insufficient to definitively refute CEPD efficacy based on trial sequential analysis

Abstract

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. We aim to evaluate the efficacy and safety of CEPDs in patients undergoing TAVI. METHODS: Major databases were systematically searched up to April 2025. Only randomized controlled trials (RCTs) were included and critically appraised using the Cochrane Risk of Bias (ROB-2) tool. We calculated risk ratios (RRs) with the 95% confidence intervals for the outcomes, and trial sequential analysis (TSA) was conducted to reduce the risk of false-positive results due to random errors. RESULTS: Eight RCTs (11,589 patients) were analyzed. No significant difference was observed in overall stroke incidence between CEPD and control groups (0.92 (95% CI: 0.75-1.14; p = 0.40, I2 = 0%), including disabling and non-disabling strokes. Device-specific analyses showed a non-significant reduction in disabling stroke with the Sentinel device. All-cause mortality, transient ischemic attacks, bleeding, acute kidney injury, delirium, and pacemaker implantation rates were similar between groups. 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. TSA indicated that current evidence is insufficient to definitively refute CEPD efficacy. CONCLUSION: CEPDs show no significant reduction in overall, disabling, or non-disabling stroke, nor in all-cause mortality post-TAVI. TRIAL REGISTRATION: This meta-analysis was registered on PROSPERO. No.: CRD420251026208.