Table 3.
Serious adverse events at 1 year of follow-up in all treated patients (n = 64)
| Event | 0–6 months of follow-up | 6 months to 1 year of follow-up |
|---|---|---|
| Death (3%) | 1 | 1 |
| COPD exacerbation (14%) | 7 | 2 |
| Pneumonia (8%) | 3 | 2 |
| Pneumonia treated lobe | 1 | 2 |
| Pneumonia nontreated | 2 | 0 |
| Pneumothorax (22%) | 14 | 0 |
| Valve replacement (17%) | 8 | 3 |
| Valve expectoration | 3 | 0 |
| Valve migration/dislocation | 3 | 3 |
| Increased complaints without benefit | 1 | 0 |
| Valve replacement with finally permanent valve removal (5%) | 2 | 1 |
| Permanent valve removal (17%) | 9 | 2 |
| Recurrent pneumothorax | 4 | 0 |
| Torsion of the bronchus | 2 | 0 |
| Pneumonia distal to valve | 1 | 0 |
| Granulation tissue and/or lack of efficacy | 2 | 2 |
| Stroke (3%) | 2 | 0 |
| Paroxysmal atrial fibrillation (2%) | 1 | 0 |
Serious adverse events were all adverse events which were fatal, required or prolonged hospitalization, caused substantial risk of dying at the time of the event, resulted in permanent impairment of a body function, or required medical or surgical intervention to prevent permanent impairment of a body function. COPD, chronic obstructive pulmonary disease.