Table 5. WOS classification and retreatment status at each evaluation time point.
| Procedure | Post-procedure day 180 | Post-procedure year 1 | |
|---|---|---|---|
| Ruptured aneurysms | |||
| Number of lesions with successful device deployment (number of patients),* n (n) | 25 (25) | 22 (22) | 19 (19) |
| Number of lesions assessed for WOS (number of patients), n (n) | 25 (25) | 12 (12) | 17 (17) |
| WOS classification of lesions, n (%) | |||
| WOS grade A: Complete occlusion | 0 (0.0%) | 3 (25.0%) | 11 (64.7%) |
| WOS grade B: Complete occlusion | 0 (0.0%) | 2 (16.7%) | 3 (17.6%) |
| WOS grade C: Residual neck | 2 (8.0%) | 0 (0.0%) | 2 (11.8%) |
| WOS grade D: Residual aneurysm | 20 (80.0%) | 7 (58.3%) | 1 (5.9%) |
| Unassessable | 3 (12.0%) | 0 (0.0%) | 0 (0.0%) |
| WOS A+B complete occlusion | 0 (0.0%) | 5 (41.7%) | 14 (82.4%) |
| WOS A+B+C adequate occlusion | 2 (8.0%) | 5 (41.7%) | 16 (94.1%) |
| Retreatment—Yes, n (%) | — | 2 (9.1%) | 0 (0.0%) |
| Unruptured aneurysms | |||
| Number of lesions with successful device deployment (number of patients),* n (n) | 101 (100) | 100 (99) | 93 (92) |
| Number of lesions assessed for WOS (number of patients), n (n) | 101 (100) | 75 (74) | 78 (77) |
| WOS classification of lesions, n (%) | |||
| WOS grade A: Complete occlusion | 19 (18.8%) | 25 (33.3%) | 26 (33.3%) |
| WOS grade B: Complete occlusion | 15 (14.9%) | 13 (17.3%) | 18 (23.1%) |
| WOS grade C: Residual neck | 3 (3.0%) | 22 (29.3%) | 19 (24.4%) |
| WOS grade D: Residual aneurysm | 58 (57.4%) | 14 (18.7%) | 15 (19.2%) |
| Unassessable | 6 (5.9%) | 1 (1.3%) | 0 (0.0%) |
| WOS A+B complete occlusion | 34 (33.7%) | 38 (50.7%) | 44 (56.4%) |
| WOS A+B+C adequate occlusion | 37 (36.6%) | 60 (80.0%) | 63 (80.8%) |
| Retreatment—Yes, n (%) | — | 1 (1.0%) | 2 (2.2%) |
| Total | |||
| Number of lesions with successful device deployment (number of patients),* n (n) | 126 (125) | 122 (121) | 112 (111) |
| Number of lesions assessed for WOS (number of patients), n (n) | 126 (125) | 87 (86) | 95 (94) |
| WOS Classification of lesions, n (%) | |||
| WOS grade A: Complete occlusion | 19 (15.1%) | 28 (32.2%) | 37 (38.9%) |
| WOS grade B: Complete occlusion | 15 (11.9%) | 15 (17.2%) | 21 (22.1%) |
| WOS grade C: Residual neck | 5 (4.0%) | 22 (25.3%) | 21 (22.1%) |
| WOS grade D: Residual aneurysm | 78 (61.9%) | 21 (24.1%) | 16 (16.8%) |
| Unassessable | 9 (7.1%) | 1 (1.1%) | 0 (0.0%) |
| WOS A+B complete occlusion | 34 (27.0%) | 43 (49.4%) | 58 (61.1%) |
| WOS A+B+C adequate occlusion | 39 (31.0%) | 65 (74.7%) | 79 (83.2%) |
| Retreatment—Yes, n (%) | — | 3 (2.5%) | 2 (1.8%) |
Denominator for WOS assessment: The denominator is the number of lesions assessed for WOS at each evaluation time point. Denominator for retreatment: The denominator is the number of lesions with successful device deployment at each evaluation time point.
*In this table, the “Number of lesions with successful device deployment (number of patients)” includes only successfully treated lesions (patients) in which survival was confirmed beyond predefined time thresholds (i.e., ≥38 days for Post-procedure day 180 and ≥223 days for Post-procedure year 1).
W-EB, Woven EndoBridge, MicroVention, Aliso Viejo, CA, USA, distributed by Terumo, Tokyo, Japan; WOS, W-EB Occlusion Scale