Clinically non-relevant |
|
Clinically relevant |
Treated with therapeutic pericardiocentesis
Treated with surgical intervention
Requiring blood transfusion
Resulting in shock and/or death
|
LAAO therapy associated with epicardial approach |
Clinically non-relevant (minor): Requiring no intervention, treated pharmacologically or <500 mL of bloody fluid was aspirated and not requiring blood transfusion or surgical intervention
Clinically relevant (major): Aspiration of >500 mL of bloody fluid or an effusion that required blood transfusion or surgical intervention
The presence or placement of pericardial catheter/drain at the end of the procedure should not be considered as clinically relevant effusion |
Time of occurrence |
Intraprocedural—occurred during the index procedure |
Acute—up to 48 h from the index procedure |
Late—more than 48 h from the index procedure |