Table 6. Late adverse events at least 6 months after atrial septal defect device closure (n=256).
| Adverse event | Group 1 (n=207) | Group 1 (n=49) | p value | |
|---|---|---|---|---|
| Related death | 0 (0.0) | 0 (0.0) | NS | |
| Not related death | 1* (0.5) | 0 (0.0) | 0.620 | |
| Device erosion | 0 (0.0) | 0 (0.0) | NS | |
| Device fracture | 0 (0.0) | 0 (0.0) | NS | |
| Neurologic events | 9 (4.3) | 2 (4.1) | 0.668 | |
| Infarction | 1† | 0 | ||
| Migraine | 8 | 2 | ||
| Arrhythmias | 3 (1.4) | 2 (4.1) | 0.562 | |
| Sinus node dysfunction | 0 | 0 | ||
| Newly developed AF | 2 | 2 | ||
| Non-sustained AT | 1 | 0 | ||
| Follow-up duration (months) | 46±32.1 (6.0–135.5) | 52.5±33.1 (7.4–119.0) | 0.215 | |
AF = atrial fibrillation; AT = atrial tachycardia; NS = not significant.
*One patient died of cholangiocarcinoma 3 years after device closure; †One patient had a persistent atrial fibrillation before atrial septal defect device closure, and had taken a warfarin.