The Utility of Cerebral Protection Devices in Transcatheter Aortic Valve Replacement: A Systematic Review and...

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.