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

Theodor Bilharz Research Institute

Bibliographic Information

Authors: Gbreel M.I.; Badran A.S.; Hassan M.; Balata M.

Journal: Clinical Cardiology

Publisher: John Wiley and Sons Inc

Publication Date: 23 April 2026

Volume / Issue: Volume 49 / Issue 4

Article No.: e70309

ISSN: 1609289

DOI: 10.1002/clc.70309

Scopus: View on Scopus

PubMed: 42021683

Document Type: Review

Access: All Open Access; Gold Open Access; Green Open Access

Authors and Affiliations

Gbreel M.I., Faculty of Medicine, October 6 University, Giza, Egypt; Badran A.S., Faculty of Medicine, Ain Shams University, Cairo, Egypt; Hassan M., Theodor Bilharz Research Institute, Giza, Egypt; Balata M., Department of Cardiology, University Hospital Rostock, Rostock, Germany

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. © 2026 The Author(s). Clinical Cardiology published by Wiley Periodicals LLC.

Keywords

cerebral embolic protection; meta-analysis; stroke; TAVI; transcatheter aortic valve implantation; Aortic Valve; Aortic Valve Stenosis; Embolic Protection Devices; Humans; Intracranial Embolism; Randomized Controlled Trials as Topic; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome; adverse event; brain embolism; cerebrovascular accident; embolic protection device; epidemiology; etiology; human; meta analysis; prevention and control; randomized controlled trial (topic); risk factor; surgery

Citation Information

Scopus Citations: 0

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