The Utility of Cerebral Protection Devices in Transcatheter Aortic Valve Replacement: A Systematic Review and Bayesian Meta-analysis

Tomonari M. Shimoda, Yosuke Sakurai, Minami Watanabe, Shinichi Fukuhara, Yujiro Yokoyama, Hiroki A. Ueyama, Roger J. Laham, Michel Pompeu Sá, Kaveh Hosseini, Tsuyoshi Kaneko, Toshiki Kuno*

*Corresponding author af dette arbejde

Abstract

Background Cerebral embolic protection (CEP) devices are designed to reduce procedure-related stroke during transcatheter aortic valve replacement (TAVR). In light of recent randomized controlled trials (RCTs), we performed an updated meta-analysis to evaluate their impact on stroke and mortality. Methods We systematically searched PubMed, EMBASE, and Cochrane Central through June 2025 for RCTs comparing TAVR with or without the CEP devices. Outcomes of interest included all stroke, disabling stroke, and all-cause mortality. Data were extracted and pooled using a random-effects frequentist meta-analysis. In addition, a Bayesian meta-analysis was performed with both vague and informative priors to evaluate the probability of a clinically meaningful reduction in stroke. Results Eight RCTs with 11,632 patients (CEP group = 5969; control group = 5663) were included. We found no difference in all strokes between the groups (risk ratio, 0.92; 95% CI, 0.74-1.15), nor in disabling stroke or all-cause mortality. In the Bayesian meta-analysis for all strokes using a vague prior, posterior probabilities that the risk ratio was <1, <0.9, and <0.67 were 71.9%, 35.6%, and 0.1%, respectively. For disabling stroke, the probabilities were 89.6%, 73.3%, and 12.1%, respectively. With an informative prior, posterior probabilities for all strokes were 95.9%, 39.0%, and 0% and the probabilities for disabling strokes were 98.3%, 73.8%, and 0%, respectively. Conclusions CEP devices did not significantly reduce stroke or mortality during TAVR, and the probability of a clinically meaningful benefit was low. Larger studies with extended follow-up are warranted to clarify their role in contemporary practice.

OriginalsprogEngelsk
Artikelnummer104047
TidsskriftJournal of the Society for Cardiovascular Angiography and Interventions
Vol/bind5
Udgave nummer1
Antal sider8
ISSN2772-9303
DOI
StatusUdgivet - jan. 2026

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