Table 1: Definitions for adverse event severity.
|
Severity Level |
Definition |
Examples |
|
1. None |
No harm, no change in condition, may have required monitoring to assess for potential change in condition with no intervention indicated. |
Balloon rupture |
|
2. Minor |
Transient change in condition, not life-threatening, condition returns to baseline, required monitoring, required minor intervention such as holding a medication, or obtaining laboratory test. |
Groin hematoma |
|
3. Moderate |
Transient change in condition may be life-threatening if not treated, condition returns to baseline, required monitoring, required intervention such as reversal agent, additional medication, transfer to the intensive care unit for monitoring, or moderate transcatheter intervention to correct condition. |
Unstable arrhythmia with preserved blood pressure requiring intervention |
|
4. Major |
Change in condition, life-threatening if not treated, change in condition may be permanent, may have required an intensive care unit admission or emergent readmit to hospital, may have required invasive monitoring, required interventions such as electrical cardioversion or unanticipated intubation or required major invasive procedures or transcatheter interventions to correct condition. |
Event requiring cardiopulmonary resuscitation |
|
5. Catastrophic |
Any death, and emergent surgery or heart lung bypass support (ECMO) to prevent death with failure to wean from bypass support. |
Event resulting in death |