Table 3.
Rates of adverse events after discharge
| CBA | RFA | P-value | Univariable CBA vs. RFA |
Multivariable CBA vs. RFA |
|||
|---|---|---|---|---|---|---|---|
| HR (95% CI) | P-value | HR (95% CI) | P-value | ||||
| Post-hospital MACCE | 0.6% | 2.2% | <0.001 | n.a. | n.a. | n.a. | n.a. |
| Death | 0.2% | 0.9% | 0.003 | ||||
| Stroke | 0.3% | 0.8% | 0.08 | ||||
| Myocardial infarction | 0.1% | 0.3% | 0.10 | ||||
| Other major adverse events after discharge | 1.3% | 3.2% | <0.001 | 0.44 (0.26–0.72) | <0.001 | 0.47 (0.27–0.84) | 0.010a |
| TIA | 0.1% | 0.1% | 0.42 | ||||
| Atrial-oesophageal fistula | 0.0% | 0.0% | n.a. | ||||
| PNP at follow-up | 0.4% | 0.2% | 0.38 | ||||
| PV stenosisb | 0.5% | 1.5% | 0.004 | ||||
| Severe bleeding | 0.3% | 0.7% | 0.072 | ||||
| Pericardial effusion treated by drainage or surgery | 0.1% | 0.5% | 0.012 | ||||
| Pulmonary and systemic embolism | 0.1% | 0.2% | 0.46 | ||||
| Minor adverse events after discharge | 4.0% | 6.1% | 0.006 | 0.64 (0.47–0.89) | 0.006 | 0.66 (0.46–0.95) | 0.025a |
| Phlebothrombosis | 0.1% | 0.1% | 0.80 | ||||
| Pericardial effusion treated conservatively or treatment indefinite | 0.3% | 0.5% | 0.46 | ||||
| Syncope | 0.6% | 1.3% | 0.028 | ||||
| Moderate bleeding | 0.8% | 1.1% | 0.37 | ||||
| Inguinal problems | 2.3% | 3.3% | 0.079 | ||||
| Total adverse events after discharge | 5.3% | 9.3% | <0.001 | 0.60 (0.47–0.80) | <0.001 | 0.64 (0.48–0.88) | 0.005a |
This table shows the unadjusted rates of those adverse events observed after discharge during follow-up. The HRs were calculated in univariable and multivariable models for adjustments. Binary regression with a complementary log-log-link function was calculated including 21 covariates, follow-up type, and log follow-up time. Given the cumulative reports of events at follow-up, it was not possible to divide the adverse events into those related to the initial ablation procedure or to additional repeat ablation procedures during follow-up. As an example, the higher incidence of PV stenosis observed in the RFA group might be attributed to the initial technique, to the higher rate of repeat procedures in this group, and/or to the fact that the PV stenosis was identified in the second procedure. Level of statistical significance was set at P < 0.05.
Random centre effect not applicable.
In total, 32 cases of PV stenosis (10 CBA vs. 22 RFA) were documented. Of those, 14 (44%) occurred without repeat ablation during FU (rates for CBA 0.48% vs. RFA 0.35%) and 18 (56%) occurred with repeat ablation during FU (rates for CBA 0.05% vs. RFA 1.18%).
CBA, cryoballoon ablation; FU, follow-up; MACCE, major adverse cardiovascular and cerebrovascular event; PNP, phrenic nerve palsy; PV, pulmonary vein; RFA, radiofrequency ablation; TIA, transitory ischaemic attack.