Clinical outcomes at (12 ± 6 months) follow-up of patients with arteriovenous fistula treated with the Penumbra SMART COIL System. Data are reported as percentage (n/N)
| Arteriovenous fistula(N = 41) | ||
|---|---|---|
| Primary safety | ||
| Procedural device-related SAEs * | 0.0% (0/41) | |
| Primary effectiveness | ||
| Retreatment through follow-up | 3.4% (1/29) | |
| Secondary effectiveness | ||
| Re-access with a guidewire required due to catheter kickout | ||
| 0 | 85.4% (35/41) | |
| 1 | 7.3% (3/41) | |
| 2+ | 7.3% (3/41) | |
| Complete or adequate occlusion immediately after the procedure | 87.8% (36/41) | |
| Unassisted coiling | 96.0% (24/25) | |
| Coiling plus liquid embolic | 80.0% (8/10) | |
| Stent-assisted coiling or balloon-assisted coiling | 66.7% (4/6) | |
| Additional periprocedural† outcomes | ||
| SAEs | 2.4% (1/41)‡ | |
| Mortality | 0.0% (0/41) | |
| Additional one-year outcomes | ||
| Better or stable lesion occlusion | 93.3% (28/30) | |
| Unassisted coiling | 95.0% (19/20) | |
| Coiling plus liquid embolic | 85.7% (6/7) | |
| Stent-assisted coiling or balloon-assisted coiling | 100% (3/3) | |
| SAEs, after 24 hours through 1 year (±6 months ) after procedure § | 26.8% (11/41) | |
| All-cause mortality | 2.4% (1/41) | |
| Modified Rankin Scale score of 0-2 | 90.9% (20/22) | |
Abbreviation: SAE, serious adverse event. *Occurring within 24 hours of arterial puncture.† Intraprocedural or within 24 hours of the procedure. ‡ Retroperitoneal hematoma.