a. New York Heart Association (NYHA) Class IV Heart Failure
b. Not eligible for heart transplantation
c. Have failed to respond to optimal medical management (including beta-blockers, and ACE inhibitors if tolerated) for at least 45 of the last 60 days, or have been balloon pump dependent for 7 days, or IV inotrope dependent for 14 days; and,
d. Have a left ventricular ejection fraction (LVEF) < 25%; and,
e. Have demonstrated functional limitation with a peak oxygen consumption of ≤ 14 ml/kg/min unless balloon pump or inotrope dependent or physically unable to perform the test.
Table 2: Centers for Medicare & Medicaid Services (CMS) Guidelines for Destination Therapy LVAD Implantation