Procedural outcomes
The overall rate of complication was 9.3%. No procedure-related deaths
were reported. A low incidence of thromboembolism (0.7%) was observed,
with only one patient on interrupted VKA (with heparin bridging)
suffering from an ischemic stroke immediately after the ablation with
minor neurological sequalae. No thromboembolic events were reported in
the NOAC group.
There was a numerically higher rate of major bleeding with VKA versus
NOAC (6.8% vs. 1.4%, respectively; p=0.09); after excluding patients
on interrupted VKA with heparin bridging the numerical difference was
confirmed (5.8% vs. 1.4%, p=0.16). The overall rate of pericardial
effusion requiring pericardiocentesis was 4.0%, and was numerically
higher in the VKA versus NOAC group (4.5% vs 1.4%, respectively;
p=0.11). Puncture complications fulfilling major bleeding criteria were
observed in 3 patients (1.3%) on VKA. The incidence of minor bleeding
was low (0.9%) and comparable between the two groups. These results are
shown in Table 3 and S-Table 4.