Table 4.
Periprocedural complications
| All | T1 (1–25) | T2 (>25) | P | |
|---|---|---|---|---|
| Patients | 317 | 150 | 167 | |
| Serious adverse events | 19 (6.0) | 14 (9.3) | 5 (3.0) | 0.018 |
| Minor complications | 12 (3.8) | 8 (6.5) | 4 (2.4) | 0.171 |
| Death from any cause, n (%) | 0 | 0 | 0 | 1.000 |
| Pericardial tamponade with intervention, n (%) | 1 (0.3) | 1 (0.7) | 0 | 0.473 |
| Pericardial effusion without intervention, n (%) | 3 (0.9) | 2 (1.3) | 1 (0.6) | 0.500 |
| Pericardial effusion without intervention and prolonged hospitalization, n (%) | 1 (0.3) | 1 (0.7) | 0 | 0.473 |
| Atrioesophageal fistula, n (%) | 0 | 0 | 0 | 1.000 |
| Phrenic nerve injury, n (%) | 13 (4.1) | 10 (6.7) | 3 (1.8) | 0.029 |
| Phrenic nerve recovered until end of procedure, n (%) | 3 (0.9) | 2 (1.3) | 1 (0.6) | 0.500 |
| Phrenic nerve injury at RSPV, (%) | 9 (69.2) | 5 (3.3) | 4 (2.4) | 0.616 |
| Phrenic nerve injury at RIPV, (%) | 4 (30.8) | 2 (1.3) | 2 (1.2) | 0.914 |
| Phrenic nerve injury persistent until discharge, n (%) | 10 (3.2) | 8 (6.5) | 2 (1.2) | 0.035 |
| Phrenic nerve injury persistent at 6 months follow-up, n (%) | 7 (2.2) | 6 (4) | 1 (0.6) | 0.040 |
| Time to phrenic nerve injury (s) | 121 (81, 144) | |||
| Temperature at phrenic nerve injury (°C) | −55 (−59, −53) | |||
| PV isolated at time of phrenic nerve injury, n (%) | 12 (92.3) | |||
| Immediate stop at phrenic nerve injury, (%) | 10 (77) | |||
| Double stop at phrenic nerve injury, n (%) | 8 (62) | |||
| DMS warning at phrenic nerve injury, (%) | 6 (46) | |||
| Minimal DMS at phrenic nerve injury, (%) | 27 (21, 34) | |||
| Stroke, n (%) | 2 (1.7) | 1 (0.7) | 1 (0.6) | 0.939 |
| Transient ischaemic attack, n (%) | 1 (0.3) | 1 (0.7) | 0 | 0.473 |
| Severe bleeding of the puncture site, n (%) | 0 | 0 | 0 | 1.000 |
| Minor bleeding of the puncture site, n (%) | 2 (1.7) | 1 (0.7) | 1 (0.6) | 0.939 |
| Groin aneurysm with conservative treatment, n (%) | 1 (0.3) | 0 | 1 (0.6) | 0.999 |
| Arterial-venous fistula with conservative treatment, n (%) | 2 (1.7) | 2 (1.3) | 0 | 0.223 |
| Transient air embolism, n (%) | 5 (1.6) | 3 (2) | 2 (1.2) | 0.567 |
| ST-elevation during air embolism, n (%) | 5 (1.6) | 3 (2) | 2 (1.2) | 0.567 |
Values expressed as n (%), mean ± standard deviation or median (range) as appropriate. PV(s) = Pulmonary vein(s), PVI = pulmonary vein isolation, RSPV = right superior pulmonary vein, RIPV = right inferior pulmonary vein, DMS = diaphragm movement sensor. Only events adjudicated as possible, probable, or definitely related to the ablation procedure were mentioned. Bold numbers are denoted as serious adverse events. An adverse event was considered serious if it resulted in permanent injury or death, required an intervention for treatment, or required hospitalization for more than 24 h.