Routine cerebral embolic protection during TAVR: A meta-analysis and trial sequential evidence from 11,000 randomized patients.
Zeyad Kholeif, Ahmed Elmorsy Mohamed, Mohamed Elnady et al.
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In 30 seconds
This updated meta-analysis pooled eight randomized controlled trials involving 11,692 patients undergoing transcatheter aortic valve replacement (TAVR) to assess routine cerebral embolic protection (CEP). CEP was not associated with a statistically significant reduction in overall stroke at 2–5 days (RR = 0.95; 95% CI: 0.75-1.19; p = 0.64) or 30 days (RR = 0.93; 95% CI: 0.57-1.53; p = 0.79). Disabling and non-disabling stroke rates were also not significantly different, nor were the reported safety outcomes. The findings do not establish a benefit from routine CEP use.
Key findings
- Overall stroke did not differ significantly with CEP at 2–5 days (RR = 0.95; 95% CI: 0.75-1.19; p = 0.64) or 30 days (RR = 0.93; 95% CI: 0.57-1.53; p = 0.79).
- Disabling stroke rates were similar at 2–5 days (RR = 0.70; 95% CI: 0.41-1.18; p = 0.18) and 30 days (RR = 1.18; 95% CI: 0.36-3.87; p = 0.78).
- Non-disabling stroke and safety outcomes, including major bleeding, vascular complications, and acute kidney injury, showed no significant differences.
Why it matters
Stroke prevention is an important consideration during TAVR, but this synthesis of randomized evidence found no statistically significant reduction in stroke with routine CEP. The results help frame the uncertainty around using protection devices for all patients, while the authors note that smaller benefits, device-specific effects, or benefits in selected higher-risk patients remain possible.
What to keep in mind
The analysis does not exclude smaller benefits, device-specific effects, or benefit in selected higher-risk patients; the reported stroke follow-up was limited to 2–5 days and 30 days.