Table 1. Adverse events following the implantation of total artificial heart.
Adverse events | No. (%) | |
---|---|---|
Infection | 306 (20.2) | |
Pulmonary infection | 101 | |
Bacteremia | 36 | |
Gastrointestinal infection | 31 | |
Device-related infection | 25 | |
Mediastinal infection | 17 | |
Fungemia | 12 | |
Non-specified infection | 84 | |
Device malfunction | 304 (20.1) | |
Freedom driver-related | 44 | |
Line-related | 27 | |
Non-specified/Device thrombosis | 233 | |
Bleeding events | 249 (16.5) | |
Respiratory failure | 152 (10.1) | |
Neurological dysfunction | 132 (8.7) | |
Cerebrovascular accident | 110 | |
Non-specified neurological dysfunction | 22 | |
Renal dysfunction | 114 (7.5) | |
Hepatic dysfunction | 34 (2.2) | |
Other thromboembolic events | 27 (1.8) | |
Venous thromboembolism | 12 | |
Arterial thromboembolism (non-CVA) | 8 | |
Non-specified thromboembolism | 7 | |
Pericardial effusion | 27 (1.8) | |
Hemolysis | 15 (1.0) | |
Others | 152 (10.1) | |
Wound dehiscence | 9 | |
Hypertensive events | 4 | |
Pulmonary edema | 2 | |
Anastomotic leak | 1 | |
Arrhythmia | 1 | |
Abdominal migraine | 1 | |
Non-specified | 134 | |
Total | 1,512 (100.0) |
CVA = cerebrovascular accident.