Cerebral embolic protection devices during transcatheter aortic valve implantation: a meta-analysis of randomized controlled trials

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Title: Cerebral embolic protection devices during transcatheter aortic valve implantation: a meta-analysis of randomized controlled trials
Authors: Reddy, R
Ahmad, Y
Arnold, A
Howard, J
Item Type: Journal Article
Abstract: Background: Stroke is a feared complication of transcatheter aortic valve replacement (TAVR), which embolic protection devices (EPDs) may mitigate. This systematic review and meta-analysis synthesized randomized controlled trials (RCTs) to evaluate the effect of EPDs in TAVR. Methods: All RCTs comparing EPDs with control during TAVR were systematically identified. Prespecified primary end points were all stroke, disabling stroke, nondisabling stroke, and all-cause mortality. Safety and neuroimaging parameters were assessed. Sensitivity analyses were stratified by EPD type. Study registration was a priori (CRD42022377939). Results: Eight trials randomizing 4043 patients were included. There was no significant difference between EPDs and control for all stroke (relative risk [RR], 0.88; 95% CI, 0.65-1.18; P = .39; I2 = 0%), disabling stroke (RR, 0.67; 95% CI, 0.31-1.46; P = .32; I2 = 8.6%), nondisabling stroke (RR, 0.99; 95% CI, 0.71-1.40; P = .97; I2 = 0%), or all-cause mortality (RR, 0.87; 95% CI, 0.43-1.78; P = .71; I2 = 2.3%). There were no differences in safety end points of bleeding, vascular complications, or acute kidney injury. EPDs did not result in differences in total lesion volume or the number of new lesions. The Sentinel EPD significantly reduced the risk of disabling stroke (RR, 0.42; 95% CI, 0.20-0.88; P = .022; I2 = 0%) but did not affect all stroke, nondisabling stroke, or all-cause mortality. Conclusion: The totality of randomized data for EPDs during TAVR demonstrated no safety concerns or significant differences in clinical or neuroimaging end points. Analyses restricted to the Sentinel EPD demonstrated large, clinically meaningful reductions in disabling stroke. Ongoing RCTs may help validate these results.
Issue Date: Sep-2023
Date of Acceptance: 24-Apr-2023
DOI: 10.1016/j.jscai.2023.101031
ISSN: 2772-9303
Publisher: Elsevier
Journal / Book Title: Journal of the Society for Cardiovascular Angiography & Interventions
Volume: 2
Issue: 5
Copyright Statement: © 2023 The Author(s). Published by Elsevier Inc. on behalf of the Society for Cardiovascular Angiography and Interventions Foundation. This is an open access article under the CC BY license (
Publication Status: Published
Article Number: 101031
Online Publication Date: 2023-08-25
Appears in Collections:Department of Metabolism, Digestion and Reproduction
National Heart and Lung Institute
Faculty of Medicine

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