Table 5.
Adverse events
| N (%) | |
|---|---|
| Major complications | 29 (1.6%) |
| Oesophageal fistula | 0 |
| Oesophageal dysmotility | 0 |
| Pulmonary vein stenosis | 0 |
| Pericardial tamponade | 17 (0.97) |
| Percutaneous treatment | 13 (0.74) |
| Surgical treatment | 4 (0.23) |
| Stroke | 7 (0.39)a |
| Phrenic nerve injury (persistent) | 0 |
| Vascular complications requiring surgery | 4 (0.23) |
| Coronary artery spasm | 1 (0.06) |
| Death | 1 (0.06)a |
| Minor complications | 68 (3.86%) |
| TIA | 2 (0.11) |
| Phrenic nerve injury (transient) | |
| Transient effect | 8 (0.46) |
| Sustained effectb | 0 |
| Vascular | |
| Hematoma | 43 (2.44) |
| Pseudoaneurysm | 4 (0.22) |
| AV fistula | 3 (0.17) |
| Other | 6 (0.34) |
| Other complications | 2 (0.11) |
a
One patient who sustained a stroke subsequently died.
b
Defined as persisting beyond hospital discharge.