Table 3.
Adverse event rate (cumulative incidence) at 5 days | Increment to incidence by:* |
||||
---|---|---|---|---|---|
Event Type | 10 days | 20 days | 30 days | 60 days | |
ANY ADVERSE EVENT CARDIAC/VASCULAR | 64.1 | 8.7 | 8.7 | 4.1 | 3.6 |
Arrhythmia, any | 24.6 | 5.1 | 4.1 | 1.1 | 1.5 |
Tamponade | 15.9 | 6.2 | 5.1 | 1.0 | 0.0 |
RV failure | 9.7 | 0.0 | 1.1 | 0.0 | 0.0 |
Thromboembolism (non-CNS) | 5.1 | 1.1 | 0.5 | 0.5 | 1.5 |
Hemolysis | 1.5 | 0.6 | 0.0 | 0.5 | 0.5 |
OTHER ORGAN SYSTEMS | |||||
Respiratory | 8.7 | 7.1 | 7.2 | 1.0 | 0.0 |
Neurologic | 4.1 | 4.6 | 3.6 | 3.6 | 8.8 |
Renal | 8.2 | 2.6 | 2.0 | 0.5 | 1.1 |
Hepatic | 6.1 | 1.1 | 1.5 | 0.0 | 0.0 |
Gastrointestinal | 0.0 | 0.0 | 0.0 | 0.5 | 0.0 |
OTHER | |||||
Bleeding | 34.3 | 5.2 | 6.7 | 0.5 | 1.0 |
Infection | 11.3 | 7.7 | 10.7 | 7.7 | 4.7 |
Reoperation | 12.0 | 5.1 | 9.7 | 3.3 | 1.2 |
Device Malfunction | 2.6 | 0.0 | 1.5 | 0.5 | 4.6 |
Each incremental value indicates the increased risk accrued since the previous period. For example, the increase in risk of any AE by 10 days was 8.7 beyond the risk of 64.1 (i.e., cumulative incidence) at 5 days. The increase by 20 days was 8.7 over the total risk (cumulative incidence) at 10 days; the increase by 30 days was 4.1 over the total risk at 20 days; the increase by 60 days was 3.7 over the total risk at 30 days.