Thromboembolic and bleeding events
The following safety and efficacy endpoints were assessed [8]:
- All-cause peri-procedural death.
- 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.
- 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.
- 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].