TABLE 3.
Adverse Events Under Total Artificial Heart Support
| Adverse Event | Patients With ≥1 Event (n [%]) | Total Number Events | Events per 100 Patient-Months |
|---|---|---|---|
| Neurologic | |||
| Transient ischemic attack | 4 (4) | 5 | 0.82 |
| Ischemic stroke | 17 (17) | 28 | 4.60 |
| Intracranial hemorrhage | 8 (8) | 9 | 1.48 |
| Seizures | 4 (4) | 4 | 0.66 |
| Anoxic brain injury | 1 (1) | 1 | 0.16 |
| Encephalopathy | 1 (1) | 1 | 0.16 |
| Infectious | |||
| Any major infection | 45 (45) | 96 | 15.77 |
| Respiratory | 30 (30) | 36 | 5.91 |
| Urinary tract | 13 (13) | 16 | 2.62 |
| Gastrointestinal | 11 (11) | 11 | 1.81 |
| Sternal wound | 1 (1) | 1 | 0.16 |
| Mediastinitis | 3 (3) | 3 | 0.49 |
| Bloodstream | 5 (5) | 6 | 0.99 |
| Driveline | 4 (4) | 7 | 1.15 |
| Bleeding | |||
| Mediastinala | 16 (16) | 21 | 3.45 |
| Gastrointestinalb | 18 (18) | 26 | 4.27 |
a
Requiring reoperation;
b
Requiring endoscopic intervention.