Abstract

One of the most feared complications of transcatheter aortic valve implantation (TAVI) is stroke, with increased mortality and disability observed in patients suffering a stroke after TAVI. There has been no significant decline in stroke rates seen over the last 5 years; attention has therefore been given to strategies for cerebral embolic protection. With the emergence of new randomized trial data, we sought to perform an updated systematic review and meta-analysis to examine the effect of cerebral embolic protection during TAVI both on clinical outcomes and on neuroimaging parameters. We performed a random-effects meta-analysis of randomized clinical trials of cerebral embolic protection during TAVI. The primary end point was the risk of stroke. The risk of stroke was not significantly different with the use of cerebral embolic protection: relative risk (RR) 0.88, 95% confidence interval (CI) 0.57 to 1.36, p = 0.566. Nor was there a significant reduction in the risk of disabling stroke, non-disabling stroke or death. There was no significant difference in total lesion volume on MRI with cerebral embolic protection: mean difference -74.94, 95% CI -174.31 to 24.4, p = 0.139. There was also not a significant difference in the number of new ischemic lesions on MRI: mean difference -2.15, 95% -5.25 to 0.96, p = 0.176, although there was significant heterogeneity for the neuroimaging outcomes. In conclusion, cerebral embolic protection during TAVI is safe but there is no evidence of a statistically significant benefit on clinical outcomes or neuroimaging parameters.

Highlights

  • The authors are grateful for infrastructural support from the National Institute for Health Research (NIHR) Biomedical Research Centre based at Imperial College Healthcare NHS Trust and Imperial College London

  • We performed a systematic search of the MEDLINE, Cochrane Central Register of Controlled Trials, and Embase databases from December 2010 through October 2020 for all randomized trials comparing cerebral embolic protection to control during transcatheter aortic valve implantation (TAVI)

  • The risk of stroke was not significantly different with the use of cerebral embolic protection: relative risk (RR) 0.88, 95% confidence interval (CI) 0.57 to 1.36, p = 0.566

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Summary

Introduction

We extracted event counts to calculate relative risks (RR) and performed random-effects meta-analyses using the restricted maximum likelihood estimator, with fixed effect as a sensitivity analysis. The risk of stroke was not significantly different with the use of cerebral embolic protection: RR 0.88, 95% CI 0.57 to 1.36, p = 0.566 (see Figure 1). The risk of death was not significantly different with the use of cerebral embolic protection: RR 0.56, 95% CI 0.21 to 1.51, p = 0.255.

Results
Conclusion
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