Thromboembolic and bleeding events
The following safety and efficacy endpoints were assessed [8]:
  1. All-cause peri-procedural death.
  2. Thromboembolism, which was defined as a composite of stroke, transient ischaemic attack (TIA), systemic or pulmonary embolism. A stroke was defined as a sudden focal neurological deficit of presumed cerebrovascular aetiology lasting for 24 hours, not due to another identifiable cause and confirmed by computed tomography or magnetic resonance imaging of the brain. If symptoms were short lasting (<24 h) and no evidence of necrosis was found on brain imaging, the event was considered to be a TIA. A systemic embolic event was defined as an abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of another likely mechanism (e.g. atherosclerosis, instrumentation, or trauma). A pulmonary embolism was diagnosed when dyspnoea or other suggestive clinical presentation was accompanied by a confirmation of a new pulmonary perfusion or intra-luminal defect.
  3. Major bleeding, which was defined as composite of cardiac tamponade, bleeding requiring intervention (e.g., either thrombin injection or surgery) or transfusion, massive haemoptysis, haemothorax, retroperitoneal bleeding, fatal bleed, or any other bleeding leading to prolongation of hospitalisation.
  4. Minor bleeding, which was defined as a composite of puncture site bleeding, thigh ecchymosis or haematoma, pericardial effusion with no haemodynamic compromise, minor gastrointestinal bleeding, epistaxis, or any bleeding treated conservatively with no need for transfusion, surgery, or prolonged hospitalization.
The criteria for definition of major or minor bleeding are strongly based on the recommendation from the International Society on Thrombosis and Haemostasis [9], but adapted for catheter ablation of AF [8].