Safety and efficacy of cerebral embolic protection devices during TAVI: a meta-analysis and sequence analysis of trials.
Aldo José Silva de Castro Costa, Marcus Vinícius Costa Fernandes, Thaynar Cavalcante Batista et al.
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In 30 seconds
This systematic review and meta-analysis of randomized trials assessed cerebral embolic protection (CEP) devices during transcatheter aortic valve implantation (TAVI). Eight trials included 11,589 patients, randomized to CEP or no device. CEP use was not significantly associated with fewer all-cause strokes (OR = 0.92, 95% CI: 0.73-1.15, p = 0.46) or disabling strokes (OR = 0.80, 95% CI: 0.57-1.13, p = 0.20). Trial sequential analysis found the evidence insufficient for cerebrovascular outcomes, while supporting futility for a mortality reduction.
Key findings
- All-cause stroke odds did not differ significantly with CEP use (OR = 0.92, 95% CI: 0.73-1.15, p = 0.46).
- Disabling stroke odds were not significantly reduced with CEP (OR = 0.80, 95% CI: 0.57-1.13, p = 0.20).
- Mortality was not significantly different (OR = 1.09, 95% CI: 0.71-1.69, p = 0.69); sequential analysis supported futility for mortality reduction.
Why it matters
Stroke prevention is an important consideration around TAVI, but these pooled randomized-trial results do not establish that CEP reduces stroke or disabling stroke. The sequential analysis also indicates that the cerebrovascular evidence remains insufficient, so the absence of a significant effect should not be interpreted as definitive proof of no benefit.
What to keep in mind
Trial sequential analysis found that the accumulated evidence was insufficient for cerebrovascular outcomes.