Cerebral embolic protection in transcatheter aortic valve implantation (TAVI): a pooled analysis of 4091 patients.

Background: Transcatheter aortic valve implantation (TAVI) is increasingly used for severe aortic stenosis, but debris embolization during the procedure can lead to strokes, impacting survival and quality of life. The role of cerebral embolic protection devices (CEPDs) in mitigating stroke risk remains debated. We aim to evaluate the impact of CEPDs on the risk of stroke and neurocognitive outcomes after TAVI.

Methods: Six databases (PubMed, Scopus, Web of Science, Cochrane, Embase, and Ovid) were searched until 20 January 2023. Original randomized controlled trials (RCTs) were only included and critically appraised using the Cochrane risk of bias (ROB) tool.

Results: Seven RCTs (4091 patients) were analyzed. CEPDs significantly reduced the risk of disabling stroke within 2-5 days post-TAVI (relative risk = 0.455, 95% CI: [0.214, 0.967]; p = 0.041). However, there was no significant difference in disabling stroke risk between the two groups at the 30-day follow-up (relative risk = 1.295, 95% CI: [0.373, 4.493]; p = 0.684). No significant differences were observed in non-disabling or overall stroke rates at 2-5 days, 30 days, or 90 days. Additionally, CEPDs did not significantly affect risks of life-threatening bleeding, major vascular complications, mortality, or acute kidney injury.

Conclusion: CEPDs are effective in reducing disabling stroke risk in the immediate post-TAVI period (2-5 days) but did not significantly affect the rates of non-disabling stroke, overall stroke, or disabling stroke after 30 days when compared to non-CEPD use. These findings suggest that CEPDs may offer short-term neuroprotection.