CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass

Inclusion Criteria

• •At least 18 years of age
• •Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass
• •Subjects who are on IABP, CPB, ECMO or CPS support prior to evaluation should have the device turned off, if possible, for the purpose of measuring inclusion hemodynamics. However, these devices should not be turned off in patients who would be harmed by interruption of support.
• •All subjects must meet the following criteria at the time of enrollment:
• •Hemodynamics:
• •1. cardiac index ≤ 2.2 L/min/m2
• •2. For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or PADP ≥ 18 mmHg or LAP ≥ 18 mmHg
• •3. For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat
• •4. Enrollment without hemodynamic measurements due to frequent or unpredictable dysrhythmias, unacceptable cardiac function, or hemodynamic instability is allowed.
• •Placement of an intra-aortic balloon pump has been attempted unless contraindicated
• •All possible measures have been attempted to correct low arterial pH, arterial blood gas abnormalities, electrolytes, hypovolemia, hypervolemia, inadequate cardiac rate, dysrhythmias and residual hypothermia
• •Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted
• •Written, signed, and dated informed consent