Table 2.
SAEs related to catheter, procedure, or AAD (safety population)
| AE, n (%) | RF ablation (n = 102) | AAD only (n = 108) | Crossover (n = 15) |
|---|---|---|---|
| Procedure-related SAEs | 12 (11.8) | — | 0 |
| Pericardial effusion | 1 | — | 0 |
| Tamponade | 1 | — | 0 |
| Pericarditis | 2 | — | 0 |
| Intracardiac thrombus | 1 | — | 0 |
| Atrial fibrillation | 1 | — | 0 |
| Atrial flutter | 3 | — | 0 |
| Congestive heart failure | 1 | — | 0 |
| Vascular access complication | 2 | — | 0 |
| Serious ADRsa | 5 (4.9) | 6 (5.6) | 2 (13.3) |
| Haemorrhage | 1 | 2 | 0 |
| CVA/stroke | 0 | 1 | 0 |
| Atrial fibrillation | 0 | 0 | 1 |
| Tachycardia | 0 | 1 | 0 |
| Bradycardia | 2 | 1 | 0 |
| Epistaxis | 1 | 0 | 0 |
| Lung disorder | 1 | 0 | 0 |
| Back pain | 0 | 1 | 0 |
| Cardiac ablation | — | — | 1 |
| Primary AEsb | 8 (7.8) | — | 0 |
| Vascular pseudoaneurysm | 2 | — | 0 |
| Haematoma | 2 | — | 0 |
| Atrial flutter | 1 | — | 0 |
| Bradycardia | 1 | — | 0 |
| Cardiac tamponade | 1 | — | 0 |
| Pericardial effusion | 1 | — | 0 |
AAD, antiarrhythmic drug; ADR, adverse drug reaction; AE, adverse event; CVA, cerebrovascular accident; RF, radiofrequency; SAE, serious adverse event.
a
Patients in the RF ablation group also received AAD therapy.
b
Occurring within 7 days of the procedure.