We read with great interest the study by Park et al., which demonstrated that a cerebral embolic protection (CEP) device significantly reduced both the number and volume of new MRI-detected cerebral lesions in a high-risk cohort undergoing transcatheter aortic valve replacement (TAVR). These findings contrast sharply with the neutral results from 2 large all-comer randomized controlled trials—PROTECTED TAVR2 and BHF PROTECT-TAVI —neither of which showed significant reduction in clinical stroke with routine CEP use ( Table ).
Table
Comparison of key cerebral embolic protection trials.
| Characteristic | Park et al. Sentinel Registry | PROTECTED TAVR | BHF PROTECT-TAVI |
|---|---|---|---|
| Study design | Prospective registry with historical control | Randomized controlled trial | Randomized controlled trial |
| Sample size (CEP/control) | 49/170 | 1501/1499 | 3795/3799 |
| Patient population | Enriched for high-risk embolic features | All-comers, representative TAVR population | All-comers, representative UK TAVR population |
| Primary endpoint | Number/volume of new MRI lesions | Any stroke within 72 h or discharge | Stroke within 72 h or discharge |
| Primary endpoint pesult | Significant reduction with CEP ( P <.001) | No significant difference (2.3% vs 2.9%; P =.30) | No significant difference (2.1% vs 2.2%; P =.94) |
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