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 0.93, 95% CI 0.74-1.16, p=0.49).

What question did this study set out to answer?

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

May 8, 2026Open Access

Abstract Number: Esoc2026lb85 Cerebral Embolic Protection Devices (Cepds) During Transcatheter Aortic Valve Implantation (Tavi): A Meta-Analysis of 11,589 Patients From Randomized Controlled Trials.

Key Result

Cerebral embolic protection devices during TAVI showed no significant reduction in overall stroke incidence compared to control (RR 0.93; 95% CI 0.74-1.16; P=0.49).

Key Points

This study evaluates the efficacy and safety of cerebral embolic protection devices during transcatheter aortic valve implantation.
Systematic search of six databases
Inclusion of only randomized controlled trials
Statistical analysis using R software to calculate risk ratios
No significant difference in overall stroke incidence between CEPD and control groups (RR 0.93; 95% CI: 0.74–1.16; P=0.49)
Triguard device linked to increased major vascular complications (RR 2.18; 95% CI: 1.04–4.59)
Transient improvement in cognitive function post-TAVI, not sustained later.

Study Design

Type

Meta-Analysis (n=11,589)

Structured PICO

Do cerebral embolic protection devices reduce stroke incidence in patients undergoing TAVI?

Population

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

Intervention

Cerebral embolic protection devices (CEPDs) during TAVI

Comparator

Control group (TAVI without CEPD)

Outcome

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

This meta-analysis of over 11,000 patients demonstrates that the use of cerebral embolic protection devices during TAVI does not significantly reduce the risk of stroke or mortality.

Main Result

Effect estimate: RR 0.93 (95% CI 0.74-1.16)

p-value: p=0.49

Abstract

Abstract Background and 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. In this study, we aim to evaluate the efficacy and safety of CEPDs in patients undergoing TAVI. Methods Six databases (PubMed, Scopus, Web of Science, Cochrane, Embase, and Ovid) were systematically searched up to April 4, 2025. Only randomized controlled trials (RCTs) were included and critically appraised using the Cochrane Risk of Bias 2 (ROB-2) tool. Statistical analyses were performed using R software to calculate risk ratios (RRs) with 95% confidence intervals. Results We retrieved 1609 records. Eight RCTs (11,589 patients) were analyzed. No significant difference was observed in overall stroke incidence between CEPD and control groups (RR 0.93; 95% CI: 0.74–1.16; P=0.49), including disabling and non-disabling strokes. Device-specific analyses showed a non-significant trend toward reduced disabling stroke with the Sentinel device, while the Triguard device was associated with increased major vascular complications (RR 2.18; 95% CI: 1.04–4.59). All-cause mortality, transient ischemic attacks, bleeding, acute kidney injury, delirium, and pacemaker implantation rates were similar between groups. Notably, 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. Conclusions CEPDs show no significant reduction in overall, disabling, or non-disabling stroke, nor in all-cause mortality post-TAVI. Conflict of interest