Table 1. Baseline characteristics of patients in the INTERMACS registry and in landmark clinical trials who received durable axial flow LVADs.
| Patient Characteristics | HM II LVAD | INTERMACS | HM II LVAD Recipients | P |
|---|---|---|---|---|
| Recipients (MOMENTUM) | Axial Flow LVADs | |||
| (ENDURANCE) | ||||
| Time Frame | 2014–2019 | 2010–2015 | 2010–2014 | |
| Number | 512 | 10,937 | 148 | |
| Age, Years | 60 (12) | 58.0 (12.9) | 66.2 (10.2) | <0.001 |
| Male, % | 81.8 | 79.5 | 82.4 | 0.31 |
| White, % | 71.7 | 68.8 | 77.7 | 0.03 |
| BSA | 2.1 (0.3) | 2.1 (0.3) | 2.0 (0.3) | <0.001 |
| Coronary Artery Bypass, % | 22.3 | 23.3 | N/A | 0.63 |
| Valve Replacement/Repair, % | 6.1 | 2.8 | N/A | <0.001 |
| Ischemic Cardiomyopathy, % | 46.9 | 42.5 | 60.1 | <0.001 |
| Stroke*, % | 10.9 | 3.9 | 16.2 | <0.001 |
| Inotropes, % | 82.6 | 80.7 | 73.0 | 0.03 |
| Diuretics, % | 90.8 | 90.4 | 81.8 | 0.002 |
| ACE Inhibitor or ARB, % | 33.8 | 36.9 | 27.7† | 0.03 |
| Beta-Blockers, % | 53.3 | 55.2 | 57.4 | 0.60 |
| Sodium | 135.5 (4.2) | 135.0 (4.7) | 134.8 (4.8) | 0.05 |
| Creatinine | 1.4 (0.4) | 1.4 (0.7) | 1.4 (0.5) | 1.00 |
| ICD, % | 74.6 | 81.5 | 91.2 | <0.001 |
| Critical Cardiogenic Shock (IM1), % | 3.5 | 13.5 | 3.4 | <0.001 |
| Progressive Decline (IM2), % | 28.5 | 36.0 | 31.1 | 0.001 |
| Stable but inotrope dependent (IM3), % | 49.0 | 31.8 | 40.5 | <0.001 |
| Resting Symptoms (IM4). % | 16.0 | 14.5 | 18.2 | 0.29 |
| Exertion intolerant, limited, or Advanced NYHA Class III (IM 5–7), % | 2.9‡ | 4.2 | 6.8 | 0.11 |
*In INTERMACS, this is limited to provider indication of history of major stroke in the patient as a barrier to transplantation. In the ENDURANCE trial, it included stroke and TIA. In INTERMACS, N = 6981 for 2010–2015 and there was insufficient data to report for 2008–2009.
†In the ENDURANCE trial only number of patients on ACEi was reported.
‡INTERMACS profile 5–7 or not provided: INTERMACS profile for 5 patients in the MOMENTUM trial axial-flow pump recipient group were not assessed.