Cerebral Embolic Protection Devices in Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Rowaid Ahmad1, Hassan Waseem2, Zain ul Abideen3, Muhammad Osama4, Muhammad Haseeb Khan3, Rabeya Farid5, Nohela Rehman6, Muhammad Ansari5, Muhammad Ansari1, Justin Chen7, Jamir Pitton Rissardo8, Ana Leticia Fornari Caprara8, Vishnu Byroju9, Adam Dmytriw10, Brandon Lucke-Wold11
1UTMB, 2Allama Iqbal Medical College, 3King Edward Medical University, 4Hayatabad Medical Complex, 5Jinnah Sindh Medical University, 6Dow University of Health Sciences, 7Texas A&M College of Medicine, 8Cooper University Hospital, 9Cooper University Healthcare, 10Massachusetts General Hospital, 11University of Florida
Objective:

This meta-analysis evaluated the effectiveness and safety of cerebral embolic protection devices (CEPDs) in patients undergoing transcatheter aortic valve implantation (TAVI).

Background:

Transcatheter aortic valve implantation (TAVI) is now a widely accepted treatment for patients with severe aortic stenosis. It offers a less invasive alternative to surgical aortic valve replacement (SAVR) with faster recovery and better early quality of life. However, stroke is still a major complication that can happen during or after the procedure.

Design/Methods:

PubMed, Cochrane Central, and ScienceDirect were searched till April 2025. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled under a random-effects model using Review Manager version 5.4.1. The Cochrane risk of bias (RoB 2.0) tool was used for quality assessment. Funnel plots were assessed for publication bias.

Results:

 Eight randomized controlled trials, including 11,632 patients undergoing TAVI, were analyzed. The use of CEPDs showed a non-significant reduction in all strokes (RR 0.92, 95% CI: 0.74–1.15, p = 0.48) and disabling strokes (RR 0.80, 95% CI: 0.57–1.12, p = 0.18). There was no significant difference in all-cause mortality (RR 1.09, 95% CI: 0.71–1.67, p=0.70), disabling bleeding (RR 0.96, 95% CI: 0.28-3.31; p=0.94), and major vascular complications (RR 1.25, 95% CI: 0.56-2.78, p=0.59).

Conclusions:

CEPD did not lead to significant changes in the rates of all strokes, disabling strokes, all-cause mortality, disabling bleeding, or major vascular complications. Current evidence does not support a statistically significant clinical benefit of CEPD use during TAVI. Although trends indicate a possible reduction in stroke, larger trials are necessary to confirm the significance of these findings.

10.1212/WNL.0000000000212995
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