Table 4.
Adverse events & reinterventions
| Adverse events | 12 months (n = 90) | 36 months (n = 70) |
|---|---|---|
| Allergic Skin Reaction (Redness/itch) | 0 (0.0) | 0 (0.0) |
| Pulling Sensation | 8 (8.9) | 2 (2.9) |
| Newly Developed | ||
| Heaviness | 3 (3.3) | 2 (2.9) |
| Swelling | 1 (1.1) | 1 (1.4) |
| Hyperpigmentation | 1 (1.1) | 1 (1.4) |
| Recurrence of symptoms | ||
| Varicosities | 0 (0.0) | 3 (4.3) |
| Heaviness | 0 (0.0) | 3 (4.3) |
| Swelling | 3 (3.3) | 7 (10.0) |
| Ulcers | 0 (0.0) | 0 (0.0) |
| Further Interventions for CVI | 5 (5.6) | 7 (10.0) |
| Deep Vein Interrogation | 4 (80.0) | 4 (57.1)a |
| Mean time to Deep Vein Interrogation procedure, months (± SD) | 7.6 ± 3.2 | 11.4 ± 7.6 |
| Superficial Vein Ablation | 1 (20.0) | 3 (42.9)b |
| Mean Time to SVA procedure, months (± SD) | 7.1 (NA) | 17.6 ± 1.0 |
aOne new IVUS/stenting procedure between 1–3 years timepoints
bTwo new below the knee GSV ablation for new symptomatic reflux