Table 2.
Cerebral protection devices and current evidence base.
| Embrella | Claret | TriGuard | |
|---|---|---|---|
| Manufacturer | Edwards Lifesciences; Irvine, California, United States | Claret Medical, Inc.; Santa Rosa, California, United States | Keystone Heart Ltd., Herzliya, Israel |
| Structure | Oval shaped nitinol frame (length 59 mm, width 25.5 mm) Covered with a porus polyurethane membrane Pore size: 100 μm | Two oval coned mesh positioned within brachiocephalic (sized 9–15 mm diameter) and left common arteries (sized 6.5–10 mm in diameter) Pore size: 140 μm | Single-wire nitinol frame and mesh filter, maintained by stabilizers in the brachiocephalic artery and the inner curvature of the aortic arch. Pore size: 130 μm |
| Delivery approach | Radial/brachial artery | Radial/brachial artery | Femoral |
| Sheath Size | 6 French | 6 French | 9 French |
| Primary Mechanism | Deflection | Filter and capture | Deflection |
| Coverage | Brachiocephalic and the left common carotid arteries | Brachiocephalic and the left common carotid arteries | Brachiocephalic, left common carotid, and left subclavian arteries |
| Most relevant study | PROTAVI-C (41) | SENTINEL (43) | DEFLECT III (44) |
| Methods | Prospective, non-randomized study. Device n = 54 Control n = 12 | RCT Safety arm n = 123 Device arm n = 121 Imaging control arm n = 119 | RCT Device n = 46 Control n = 39 |
| Patient and procedural characteristics | 52% male, median age 83 years. Only balloon expandable TAVR (Edwards Sapien XT) Only Transfemoral TAVR Successful device positioning in 100% | 48% male, medial 83 years Balloon expandable TAVR in 70% Transfemoral TAVR in 95% Successful device positioning in 94% | 46% male, mean age 82 years Balloon expandable TAVR in 64% Transfemoral TAVR in 97% Successful device positioning in 89% |
| Outcomes |
DW-MRI: - Non-significant increase in lesion numbers (8 vs. 4, P = 0.41) in device group. - Significantly lower lesion volumes (40% smaller, P = 0.003) in device group. TCD: - Higher procedural HITS rates in device group. |
DW-MRI: Protected territories: - 42% reduction in device arm of total lesion volume (P = 0.33) - 33% reduction in number (P = 0.90). All territories: - 5% reduction of total lesion volume (P = 0.81), 40% in number (P = 0.77). Neurocognitive: - no difference in overall composite scores at baseline, 30 days, or 90 days. - Change in neurocognitive scores from baseline to 30-day follow-up correlated with median new lesion volume in protected territories |
DW-MRI: - Device related greater freedom from new cerebral DWI lesions (21.2 vs. 11.5%), - 44% reduction of median lesion size Neurocognitive: - Reduction worsening in National Institutes of Health Stroke Scale score from baseline (2.6 vs. 12.1%) in device arm |
| Ongoing studies | No registered on-going study | Ongoing study powered for efficacy (PROTECT-TAVI Trial; ClinicalTrials.gov Identifier: NCT02895737) | Ongoing study powered for efficacy (REFLECT Trial; ClinicalTrials.gov Identifier: NCT02536196) |