User's Manual

Indications, Contraindications, and Potential Adverse Events 2
Indications
RECOVER BP IABP/VAD System – Operator’s Manual 2.3
Appropriate patient groups include those that are likely to recover
cardiac function after the myocardium is permitted to rest on
ventricular support. Examples include, but are not limited to:
• Patients who fail to wean from cardiopulmonary bypass (CPB)
following heart surgery.
• Failed transplant patients who require ventricular assist following
heart transplantation.
• Patients who require right ventricular assist device (RVAD)
support while on implantable left ventricular assist device
(LVAD) support.
• Patients suffering from acute cardiac disorders such as viral
myocarditis.
A patient is a candidate for mechanical assistance with the
RECOVER BP System if she/he meets all of the following criteria:
• Patient has a body surface area > 1.3 m² and is ≤ 75 years of age.
• Patient is in relatively good health other than the cardiovascular
problem for which surgery was undertaken.
• All appropriate 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 employing pharmacologic agents has been
attempted. While the use of an Intra-Aortic Balloon Pump (IABP)
is recommended prior to RECOVER BP System assistance, its use
may not always be appropriate (e.g., fibrillating heart, peripheral
atherosclerosis).
• Patient is unable to be weaned from CPB or is unable to maintain
acceptable hemodynamics in the immediate postoperative period
(< 6 hours after the first attempt to wean from CPB), or patient is
unable to maintain acceptable hemodynamics following a
significant cardiac event despite the measures cited above.