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The Utility of Cerebral Protection Devices in Transcatheter Aortic Valve Replacement: A Systematic Review and
Tomonari M Shimoda1,2, Yosuke Sakurai3, Minami Watanabe4
1United States Naval Hospital Yokosuka, Yokosuka, Japan.
Insights
Cerebral embolic protection (CEP) devices do not significantly reduce stroke or mortality during transcatheter aortic valve replacement (TAVR). Further research is needed to determine their clinical benefit in modern TAVR procedures.
Area of Science:
- Cardiovascular Interventions
- Neurology
- Medical Device Technology
Background:
- Cerebral embolic protection (CEP) devices aim to mitigate stroke risk associated with transcatheter aortic valve replacement (TAVR).
- Recent randomized controlled trials (RCTs) prompt an updated evaluation of their efficacy.
Purpose of the Study:
- To conduct an updated meta-analysis evaluating the impact of CEP devices on stroke and mortality in TAVR patients.
- To assess the probability of a clinically meaningful stroke reduction using Bayesian meta-analysis.
Main Methods:
- Systematic literature search of RCTs comparing TAVR with and without CEP devices.
- Inclusion of 8 RCTs involving 11,632 patients.
- Frequentist and Bayesian meta-analysis to evaluate stroke and mortality outcomes.
Main Results:
- No significant difference in all strokes (RR 0.92; 95% CI 0.74-1.15), disabling stroke, or all-cause mortality.
- Bayesian analysis indicated a low probability of clinically meaningful stroke reduction with CEP devices.
Conclusions:
- CEP devices did not demonstrate a significant reduction in stroke or mortality during TAVR.
- Further large-scale studies with extended follow-up are necessary to clarify the role of CEP devices in current TAVR practice.
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.
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