Adverse events
Major adverse events were defined as those causing termination of the
procedure, prolonged hospital stay, long-term disability, requiring
surgical intervention, CIED lead repositioning or bleeding requiring
transfusion. In general, we focused on adverse events that could be
directly attributed to TSP. Pericardial effusions occurring after
completion of ablation procedures were not attributed to TSP.
Periprocedural adverse events were monitored within 30-days of the
ablation procedure. Cardiac perforation was suspected when the symptoms
such as substernal discomfort, shoulder discomfort, abdominal
discomfort, nausea, or clinical signs of hemodynamic instability were
detected and pericardial effusion was confirmed with ICE or
transthoracic echocardiogram. Pericardial effusion that necessitated
intervention was defined as cardiac tamponade.