Table 2. Outcomes at 2 years post implantation for axial flow LVADs placed 2010–2015 compared with published clinical trials.
| Outcomes | HM II Recipients (MOMENTUM)* | INTERMACS | HM II Recipients (ENDURANCE) | P | INTERMACS with no exclusion criteria | INTERMACS with 1+ exclusion criteria | P |
|---|---|---|---|---|---|---|---|
| Axial Flow LVADs | |||||||
| N = 505 | |||||||
| N = 10,937 | N = 149 | ||||||
| N = 6,133 | N = 4,804 | ||||||
| Primary endpoints | |||||||
| Death | 13.1† | 26.1 | 32.2 | <0.001 | 23.7 | 29.3 | <0.001 |
| Stroke‡ | 19.4 | 15.7 | 12.1 | 0.04 | 15.8 | 15.5 | 0.70 |
| Pump reoperation | 14.3† | 14.0 | 16.2† | 0.73 | 14.1 | 14.0 | 0.91 |
| Adverse events | |||||||
| LVAD Infection | 19.4 | 17.0 | 15.4 | 0.32 | 16.9 | 17.0 | 0.89 |
| Bleeding | 55.0 | 45.6 | 60.4 | <0.001 | 44.6 | 46.9 | 0.02 |
| Right Heart Failure | 28.3 | 24.8 | 26.8 | 0.18 | 24.1 | 25.6 | 0.07 |
| LVAD Thrombosis | 13.9 | 12.1 | 10.7 | 0.43 | 12.8 | 11.2 | 0.01 |
| Arrhythmias | 41.0 | 29.1 | 40.9 | <0.001 | 28.3 | 30.1 | 0.04 |
| Hepatic Dysfunction | 5.3 | 5.8 | 8.1 | 0.46 | 4.8 | 7.2 | <0.001 |
| Respiratory Failure | 19.4 | 20.4 | 25.5 | 0.26 | 17.7 | 23.9 | <0.001 |
| Renal Dysfunction | 11.1 | 14.4 | 12.1 | 0.09 | 12.0 | 17.4 | <0.001 |
*2.3% (4 patients) who did not receive the assigned implant and 1.7% (3 patients) who withdrew from the trial after implant were counted toward the primary outcome in the MOMENTUM trial.
†Primary endpoint of death and pump reoperation was reported with N = 512 in MOMENTUM and pump reoperation was reported with N = 148 in ENDURANCE.
‡Data on Rankin score were not available for enough stroke events to quantify severity of stroke. Here, stroke includes all strokes recorded as an adverse event. Sources and definitions in S1 Table.