Table 2.

Selected clinical trials.

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