Table 2.
Procedural complications until discharge
| CBA | RFA | P-valuea | Univariable CBA vs. RFA |
Multivariable CBA vs. RFA |
|||
|---|---|---|---|---|---|---|---|
| OR (95% CI) | P-value | OR (95% CI) | P-value | ||||
| MACCE (death, MI, stroke) | 0.3% | 0.4% | 0.42 | n.a. | n.a. | n.a. | n.a. |
| Death | 0.1% = 2 pt | 0.1% = 2 pt | 1.00 | ||||
| 1 tamponade plus stroke, 1 tamponade | 1 tamponade 1 groin bleeding | ||||||
| Myocardial infarction | – | – | |||||
| Stroke | 0.2% | 0.3% | 0.55 | ||||
| Other major complications | 2.0% | 2.0% | 0.96 | 1.01 (0.65–1.57) | 0.96 | 1.33 (0.67–2.66) | 0.41 |
| PNP not resolved until discharge | 1.1% | 0.1% | <0.0001 | ||||
| Pericardial effusion treated by drainage or surgery | 0.3% | 0.5% | 0.35 | ||||
| Severe bleeding | 0.1% | 0.6% | 0.013 | ||||
| TIA | 0.0% | 0.3% | 0.09 | ||||
| Pulmonary embolism | 0.0% | 0.1% | 0.44 | ||||
| Haemato-/pneumothorax | 0.0% | 0.0% | 1.00 | ||||
| Groin complications treated interventionally or by surgery | 0.5% | 0.8% | 0.31 | ||||
| Retroperitoneal haematoma | 0.0% | 0.1% | 0.44 | ||||
| Gastric motility dysfunction | 0.0% | 0.1% | 0.44 | ||||
| Successful resuscitation w/o sequelae | 0.1% | 0.1% | 1.00 | ||||
| Minor complications | 6.3% | 9.8% | <0.0001 | 0.63 (0.50–0.79) | <0.0001 | 0.80 (0.45–1.45) | 0.48 |
| PNP resolved until discharge | 1.6% | 0.1% | <0.0001 | ||||
| Pericardial effusion treated conservatively | 0.6% | 2.6% | <0.0001 | ||||
| Groin complications treated conservatively | 2.5% | 4.3% | 0.002 | ||||
| Moderate bleeding | 0.4% | 0.4% | 1.00 | ||||
| Oesophageal lesion symptomatic or asymptomatic | 0.1% | 0.6% | 0.004 | ||||
| Cardiac complication (e.g. decompensation) | 0.1% | 0.2% | 0.42 | ||||
| Bronchial complication (e.g. haemoptysis, bronchitis) | 0.3% | 0.1% | 0.049 | ||||
| Pericarditis | 0.2% | 0.2% | 0.74 | ||||
| Haematuria | 0.0% | 0.1% | 0.59 | ||||
| Allergic reaction | 0.0% | 0.3% | 0.094 | ||||
| Systemic infection | 0.1% | 0.3% | 0.25 | ||||
| Others | 0.5% | 1.0% | 0.06 | ||||
| Total number of complicationsb | 8.2 | 11.3 | <0.0001 | 0.69 (0.56–0.85) | <0.001 | 0.95 (0.55–1.66) | 0.87 |
The table depicts the event rates of procedural complications, the odds ratios (OR) with 95% confidence intervals (CI), determined by univariable and multivariable analysis. The level of statistical significance was set at P < 0.05. See Supplementary material online, Table S4 for details of the adjustments performed.
n (%), mean ± SD, or median (IQR).
Fisher exact test.
Total number of complications is the sum of MACCEs, major complications, and minor complications.
CBA, cryoballoon ablation; CI, confidence interval; MACCE, major adverse cardiovascular and cerebrovascular event; MI, myocardial infarction; n.a., not applicable; OR, odds ratio; PNP, phrenic nerve palsy; RFA, radiofrequency ablation; TIA, transitory ischaemic attack.