Table 2.
TRIAL | TREATMENT | CONDITION | PRIMARY | RESULT | SECONDARY |
---|---|---|---|---|---|
Tandem heart | IABP vs Tandem heart | Cardiogenic shock | Hemodynamic | Improved cardiac power index PCW, lactate | 30 day mortality NS 45% IABP 43% VAD |
Shock II trial | IABP vs Medical Rx | Cardiogenic shock | 30 day survival | 39.7% IABP 41.3% medical P = 0.69 |
1 yr survival 48% IABP 49% medical |
ISAR shock | Impella 2.5 vs IABP | Cardiogenic shock | Hemodynamic 2 yr follow-up organ function | Improved CO, BP, PCW, lactate NS–46% mortality both groups 30 days |
NS difference in LVEF, organ dysfunction, neurologic status 38% mortality both groups |
Protect II trial | Impella 2.5 vs IABP | High risk PCI | 30 day major adverse events | 35.1% Impella 40.1% IABP P = 0.227 |
90 day MAE 40.6% Impella 49.3% IABP P = 0.066 |
Recover right trial | Impella RP | Right ventricular failure within 48 hrs; post LVAD [group 1], post cardiotomy or MI shock [group 2] | 30 day survival, hospital discharge, or bridge to therapy | 73% 30 day survival 83.3% in the first group 58.3% in the latter group | |
Centrifugal flow-right ventricular support device registry | Tandem heart | Multiple causes of right heart failure | Improved hemodynamics | 57% in-hospital mortality | |
TRIS trial | Tandem heart to reduce infarct size | STEMI with PCI | Myocardial salvage index | On-going | long term mortality, repeat hospitalization, ICD use |