Abstract

Introduction: Cerebral embolic protection devices (CEP) have been introduced to capture embolic debris and reduce the risk of stroke during Transcatheter Aortic Valve Replacement (TAVR). Available evidence regarding the safety and efficacy of CEP is inconclusive. Therefore, we aimed to determine the safety and efficacy of CEP use during TAVR. Methods: Major electronic databases were searched for the relevant articles with appropriate search terms. All relevant data from 17 studies were extracted into a standardized form. Statistical analyses were performed using Revman 5.4. Odds Ratio (OR) or mean differences (MD) were used to estimate the desired outcome with a 95% confidence interval (CI). Results: A total of 17 studies involving 204,875 patients (15,880 in the CEP arm and 188,995 in the non-CEP arm) were included. No significant difference in 30-day stroke was observed with the use of CEP between the two groups (OR 0.75, 95% CI 0.55 to 1.03). The use of CEP was associated with a lower odds of 30-day mortality by 39% (OR 0.61, 95% CI 0.53 to 0.70). Based on diffusion weighted-magnetic resonance imaging (DW-MRI), there were no differences in the occurrence of new lesions, the total volume of lesions, and the number of new lesions. In addition, the use of CEP in patients undergoing TAVR was associated with a reduction in major or life-threatening bleeding events (OR 0.89, 95% CI 0.81 to 0.98). No differences were observed in the outcomes of acute kidney injury and major vascular complications between both arms. Conclusion: No significant difference in 30-day stroke was observed with the use of CEP in TAVR patients. The use of CEP was associated with significantly lower odds of 30-day mortality and lower rates of major or life-threatening bleeding compared with no CEP in patients undergoing TAVR. Further studies are needed to confirm current findings

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