Nineteen percent of the patients in the RFA group had SAEs. This is
markedly higher than that reported (4.5–6.3%) in recent AF ablation
surveys[14,15]. However, it has to be taken into account that we calculated all adverse events that occurred during the study period whereas the
surveys focused on events that were clearly related to the ablation therapy. In the current study more than half of the SAEs in the RFA group were
evidently not directly related to the procedure (e.g., cancer and knee
arthroscopy). In addition, unmonitored retrospective surveys tend to
underestimate the prevalence of complications. Hence, the incidence of
procedure-related SAEs (about 6–9%) in our study was in the same
range as in the surveys and prior studies. In the RAAFT-2 trial, 9% of the
patients in the ablation group experienced procedure-related SAEs[12].
There were no deaths or strokes in the RAATF-2 trial but in our study
one patient died from perioperative stroke. In a systematic multicentre
survey the incidence of death due to AF ablation was 1 in 1000 patients
[16]. On the other hand, despite the wide use of intracardiac echocardiography the frequency of pericardialtamponade was higher in the RAAFT-2
than in our study (6% vs. 0.9%)[12].
The occurrence of SAEs tended to be lower among patients who
received only antiarrhythmic medication compared to those treated
with RFA or with a combination of RFA and AAD therapy, but the difference was not statistically significant. According to the meta-analysis by
Calkins et al. antiarrhythmic medication caused adverse events more
often compared to catheter ablation, but the events caused by ablation
were more serious[17].Thesefindings not only underscore the risk of
severe complications associated with AF ablation, but also indicate
that antiarrhythmic medication is not risk free. In clinical practice AAD
therapy warrants meticulous long-term monitoring for adverse events
whereas complications related to ablation usually occur within few
weeks after the procedure