Implantable ventricular assist devices (VADs) with U.S. Food and Drug Administration (FDA) approval or clearance may be considered medically necessary as destination therapy for adult individuals with end-stage heart failure who meet the following criteria:
New York Heart Association (NYHA) Class III heart failure with dyspnea upon mild physical activity or NYHA Class IV;
Left ventricular ejection fraction ≤25%;
Inotrope-dependent; OR cardiac index <2.2 liters/min/m2, while not on inotropes and also meeting one of the following: On optimal medical management, based on current heart failure practice guidelines for at least 45 of the last 60 days and are failing to respond, OR Advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for ≥7 days. Bridge to Transplantation Implantable VADs with FDA approval or clearance may be considered medically necessary as a bridge to heart transplantation for individuals who are: Currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, OR Are undergoing evaluation to determine candidacy for heart transplantation. Implantable VADs with FDA approval or clearance, including humanitarian device exemptions, may be considered medically necessary as a bridge to heart transplantation in children 16 years old or younger who are: Currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, OR Are undergoing evaluation to determine candidacy for heart transplantation. Total artificial hearts (TAHs) with FDA approved devices may be considered medically necessaryas a bridge to heart transplantation for individuals with biventricular failure who: Have no other reasonable medical or surgical treatment options, are ineligible for other univentricular or biventricular support devices, and are currently listed as heart transplantation candidates, OR Have no other reasonable medical or surgical treatment options, are ineligible for other univentricular or biventricular support devices, are undergoing evaluation to determine candidacy for heart transplantation, and not expected to survive until a donor heart can be obtained. Postcardiotomy Setting/Bridge to Recovery Implantable VADs with FDA approval or clearance may be considered medically necessary in the postcardiotomy setting in individuals who are unable to be weaned off cardiopulmonary bypass. Other Indications Other applications of implantable ventricular assist devices (VADs) or total artificial hearts (TAHs) are considered investigational, including, but not limited to, the use of TAHs as destination therapy. The use of non-FDA-approved or cleared implantable VADs or TAHs is considered investigational. Percutaneous VADs are considered investigational for all indications.
