Table 4. Safety events.
| Adverse events | Korea cohort (n = 299) | |
|---|---|---|
| Serious* device- or procedure-related adverse events | 2 (2, 0.7) | |
| Incision site hematoma | 1 (1, 0.3) | |
| Vascular pseudoaneurysm | 1 (1, 0.3) | |
| Non-serious procedure-related adverse events | 5 (5, 1.7) | |
| Phrenic nerve injury | 3 (3, 1.0) | |
| Urinary retention | 1 (1, 0.3) | |
| Haemoptysis | 1 (1, 0.3) | |
| Non-procedure-related serious* adverse events | 55 (45, 15.1) | |
| Arrhythmia supraventricular | 6 (6, 2.0) | |
| Atrial fibrillation | 32 (29, 9.7) | |
| Atrial flutter | 5 (5, 1.7) | |
| Cholecystitis acute | 1 (1, 0.3) | |
| Coronary artery disease | 1 (1, 0.3) | |
| Gastritis | 1 (1, 0.3) | |
| Hashimoto’s encephalopathy | 1 (1, 0.3) | |
| Hypertrophic cardiomyopathy | 1 (1, 0.3) | |
| Inguinal hernia | 1 (1, 0.3) | |
| Pneumonia | 2 (2, 0.7) | |
| Sinus node dysfunction | 3 (3, 1.0) | |
| Thermal burn | 1 (1, 0.3) | |
Numbers are presented as events (subjects with events, % subjects).
*Serious adverse events were defined according to international standards (ISO 14 155:2001) and included all events that led to death, or to a serious deterioration in health that resulted in either (a) a life-threatening illness or injury, (b) a permanent impairment in body structure or function, (c) in-patient or prolonged hospitalization, or (d) medical intervention to prevent life-threatening illness or injury.