Valvular & structural heart diseaseMeta-analysis
Cerebral embolic protection devices for transcatheter aortic valve replacement: A meta-analysis and trial sequential analysis
- meta-analysis and trial sequential analysis
- randomized controlled trials
- random-effects models
- meta-regression
Authors' conclusion
Current-generation CEPD devices during TAVR did not significantly reduce the risk of any stroke, disabling stroke, or all-cause mortality. Trial sequential analysis indicates that, at least with available data, cumulative evidence appears sufficient to question the predefined benefit thresholds for existing systems. These findings suggest the lack of routine use of current-generation CEPD in TAVR.
Study context
- Population
- Patients undergoing transcatheter aortic valve replacement (TAVR) in randomized controlled trials (RCTs) of current-generation cerebral embolic protection devices8 RCTs (5 filter-based and 3 shield-based)
- Participants
- 11,596 patients
- Comparison
- routine CEPD use vs no CEPD use
Pooled result
Any stroke
Relative risk
0.92
95% CI 0.75–1.14
As reported in the abstract
Further pooled results
| Outcome | RR (95% CI) | |
|---|---|---|
| Disabling stroke | 0.80 (0.55–1.15) | |
| New magnetic resonance imaging-detected lesions | 1.00 (0.93–1.07) | |
| All-cause mortality | 1.04 (0.71–1.51) | |
| 0.512Relative risk (log scale) |
Trial sequential analysis
- Trial sequential analysis provided conclusive meta-analytic evidence and affirmed the absence of CEPD benefit
Meta-regression of stroke risk on patient-level covariates (age, sex, diabetes, prior stroke, atrial fibrillation)
- No significant association
- all P > .05
Original publication
Summarised from the published abstract; every number is checked against it