Table 3.
Incidences of complications or adverse events during Impella 5.0 support
| Type of complication | Values |
|---|---|
| Major device malfunction, n (%) | 4 (10) |
| Minor device malfunction, n (%) | 3 (8) |
| Device displacement (intra-aortic or intraventricular moving), n (%) | 8 (20) |
| Including successful bedside repositioning, n | 6 |
| Bleeding requiring transfusion during surgical implantation, n (%) | 7 (18) |
| Bleeding requiring surgery after implantation, n (%) | 0 (0) |
| RBC transfusion on MCS, units [IQR] | 4 [1.5–8] |
| RBC transfusion by day on MCS, units [IQR] | 0.4 [0.1–1.2] |
| Upper or lower limb ischemia on implantation site, n (%) | 1 (3) |
| Thromboembolic events, n (%) | 1 (3) |
| Major hemolysis, n (%) | 1 (3 %) |
| Suspected or minor hemolysis, n (%) | 3 (8 %) |
| Ventricular arrhythmia, n (%) | 3 (8) |
| Device-related infection, n (%) | 7 (18) |
| Surgical site infection, n (%) | 4 (10) |
| Infected thrombus on the head of the pump, n (%) | 3 (8) |
| Bloodstream infection during MCS, n (%) | 5 (13) |
Major hemolysis: anemia without bleeding associated with an increase of free bilirubin and lactate dehydrogenase (LDH). Suspected or minor hemolysis: low increase of free bilirubin and LDH without unexplained anemia
RBC red blood cells, MCS mechanical circulatory support, IQR interquartile range