Table 2.
Patient risk of clinically significant adverse events (AEs): Cumulative incidence by 60 days after VAD implant.
| Total Sample (N = 195) |
LVAD patients (n = 124)b |
BiVAD patients (n = 71)b |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Event Type | No. of patients with AE |
AE rate: Cumulative incidencea |
95% Confidence Interval |
No. of patients with AE |
AE rate: Cumulative Incidencea |
95% Confidence Interval |
No. of patients with AE |
AE rate: Cumulative incidencea |
95% Confidence Interval |
| ANY ADVERSE EVENT | 174 | 89.2 | 84.0, 92.8 | 112 | 90.3 | 83.6, 94.4 | 62 | 87.3 | 77.1, 93.2 |
| CARDIAC/VASCULAR | |||||||||
| Arrhythmia, any | 71 | 36.4 | 29.7, 43.1 | 56 | 45.2 | 36.2, 53.6 | 15 | 21.1 | 12.5, 31.2 |
| Ventricular | 36 | 18.5 | 13.4, 24.2 | ||||||
| Atrial | 42 | 21.5 | 16.1, 27.5 | ||||||
| Tamponade | 55 | 28.2 | 22.1, 34.6 | 37 | 29.8 | 22.1, 38.0 | 18 | 25.3 | 16.0, 35.8 |
| RV failure | 21 | 10.8 | 6.9, 15.6 | 21 | 16.9 | 11.0, 24.0 | -- | -- | -- |
| Thromboembolism (non-CNS) | 17 | 8.7 | 5.3, 13.2 | 13 | 10.5 | 5.9, 16.6 | 4 | 5.6 | 1.8, 12.7 |
| Hemolysis | 6 | 3.1 | 1.3, 6.2 | 2 | 1.6 | 0.3, 5.2 | 4 | 5.6 | 1.8, 12.7 |
| OTHER ORGAN SYSTEMS | |||||||||
| Respiratory, any | 47 | 24.1 | 18.3, 30.3 | 24 | 19.4 | 12.9, 26.7 | 23 | 32.3 | 21.9, 43.3 |
| Tracheostomy | 24 | 12.3 | 8.2, 17.3 | ||||||
| Reintubation | 26 | 13.3 | 9.0, 18.5 | ||||||
| Neurologic | 48 | 24.7 | 18.9, 30.9 | 33 | 26.8 | 19.3, 34.8 | 15 | 21.1 | 12.5, 31.2 |
| Infarct or Hemorrhagic CVA | 30 | 15.4 | 10.7, 20.8 | ||||||
| Transient Ischemic Attack | 23 | 11.8 | 7.8, 16.8 | ||||||
| Renal | 28 | 14.4 | 9.9, 19.7 | 13 | 10.5 | 5.9, 16.6 | 15 | 21.1 | 12.5, 31.2 |
| Hepatic | 17 | 8.7 | 5.3, 13.2 | 7 | 5.6 | 2.5, 10.7 | 10 | 14.1 | 7.2, 23.2 |
| Gastrointestinal | 1 | 0.5 | 0.0, 2.6 | 1 | 0.8 | 0.1, 4.0 | 0 | -- | -- |
| OTHER | |||||||||
| Bleeding, any | 93 | 47.7 | 40.5, 54.5 | 49 | 39.5 | 30.9, 48.0 | 44 | 62.0 | 49.6, 72.1 |
| Coagulopathy | 33 | 16.9 | 12.0, 22.5 | ||||||
| Mediastinum or Pocket | 51 | 26.2 | 20.2, 32.5 | ||||||
| Thorax | 20 | 10.2 | 6.5, 15.0 | ||||||
| Gastrointestinal | 10 | 5.1 | 2.6, 8.9 | ||||||
| Infection, any | 82 | 42.1 | 35.1, 48.9 | 48 | 38.7 | 30.2, 47.2 | 34 | 47.8 | 35.9, 58.9 |
| Driveline | 34 | 17.4 | 12.5, 23.1 | ||||||
| Blood Stream | 35 | 17.9 | 12.9, 23.6 | ||||||
| Pulmonary | 35 | 17.9 | 12.9, 23.6 | ||||||
| Mediastinum or Pocket | 12 | 6.1 | 3.3, 10.1 | ||||||
| Reoperation, any | 61 | 31.3 | 24.9, 37.9 | 42 | 33.9 | 25.7, 42.2 | 19 | 26.8 | 17.2, 37.4 |
| Bleeding | 45 | 23.1 | 17.4, 29.2 | ||||||
| Infection | 12 | 6.1 | 3.3, 10.1 | ||||||
| Wound dehiscence | 3 | 1.5 | 0.4, 4.1 | ||||||
| Wound debridement | 13 | 6.7 | 3.7, 10.7 | ||||||
| Device Malfunction | 18 | 9.2 | 5.7, 13.8 | 10 | 8.1 | 4.1, 13.7 | 8 | 11.3 | 5.3, 19.8 |
a
adjusted for the competing hazards of death, transplantation, or recovery/wean.
b
see Table 4 for tests of differences in rates between LVAD vs. BiVAD patients.