This document addresses mechanical circulatory support and artificial heart systems. Devices addressed include the following:

• Ventricular assist devices (VADs), a mechanical pump used to help hearts that can no longer pump blood effectively due to heart failure. VADs may be used as a bridge to transplantation or as a permanent alternative to heart transplantation.
• Percutaneous ventricular assist devices (pVADs), also known as circulatory assist devices are small mechanical pumps typically inserted through a femoral artery with the proposed use as a short-term bridge to recovery.
• Total artificial heart, a pulsating bi-ventricular device that is implanted into the chest to replace the individual's left and right ventricles. The total artificial heart provides a bridge to transplantation for individuals who have no other reasonable medical or surgical treatment options.

Note: This document does not address the percutaneous intra-aortic balloon assist pump (IABP).

Note: Please see the following related document for additional information:

• TRANS.00033 Heart Transplantation

Position Statement

I. Ventricular Assist Devices (VADs) including Left, Right and Biventricular Assist Devices (Adult)   

Medically Necessary:

1. U.S. Food and Drug Administration (FDA) approved ventricular assist devices (VADs)*, used in accordance with FDA approval, are considered medically necessary as a bridge to heart transplant for individuals when all of the following criteria have been met:
   1. Have severe end stage heart failure; and
   2. Are not expected to survive until a donor heart can be obtained; and
   3. When one of the following criteria has been met:
      1. Currently listed as a heart transplant candidate; or
      2. Undergoing evaluation to determine candidacy for heart transplant.
2. FDA approved VADs*, used in accordance with FDA approval, are considered medically necessary in the post-cardiotomy setting as a means of myocardial recovery support for individuals who are unable to be weaned off cardiopulmonary bypass.
3. FDA approved VADs*, used in accordance with FDA approval, are considered medically necessary when used as a permanent alternative (destination therapy) to heart transplantation for an individual when all of the following criteria have been met:
   1. Was evaluated and determined not to be eligible for a heart transplant; and
   2. Has documented Class III or IV New York Heart Association (NYHA) end stage left ventricular heart failure; and
   3. Has received optimal medical management, for at least 45 of the last 60 days or the individual’s survival is in jeopardy; and
   4. Has a life expectancy of less than 2 years due to heart disease.

*Note: Please refer to the background section of the document for a list of FDA approved VADs.

Not Medically Necessary:

VADs are considered not medically necessary when the medically necessary criteria above are not met and for all other indications.

II. Ventricular Assist Devices (Pediatric)

Medically Necessary

1. FDA approved VADs appropriate for pediatrics, including humanitarian device approvals, used in accordance with FDA approval, are considered medically necessary for use in children when all of the following criteria have been met:
   1. Child has documented end-stage left ventricular or biventricular failure; and
   2. Pediatric appropriate VAD* (based on FDA approved use) will be used; and meets either criteria (a) or (b) below:
      1. Until a donor heart can be obtained; or
      2. When used as a permanent alternative (destination therapy) in children who have been evaluated and determined not to be eligible for a heart transplant.

*Current FDA approved ventricular assist devices appropriate for pediatrics:

1. Child under age 5: the Berlin Heart EXCOR^® Pediatric Ventricular Assist Device (severe isolated left ventricular or biventricular dysfunction); or
2. Child between ages 5 and 16: either the HeartAssist^®5 Pediatric Ventricular Assist Device or the Berlin Heart EXCOR Pediatric Ventricular Assist Device (severe isolated left ventricular or biventricular dysfunction); or
3. Child with body surface area (BSA) greater than or equal to 1.0 meter squared (m²): The HeartMate™ 3 Left Ventricular Assist System (FDA approved as bridge to transplant or destination therapy without a specific age requirement and this may be used in pediatric populations).

Not Medically Necessary:

Pediatric VADs are considered not medically necessary in children when the medically necessary criteria above are not met and for all other indications.

III. Percutaneous Ventricular Assist Devices (pVADs)

Medically Necessary:

FDA approved pVADs*, used in accordance with FDA approval are considered medically necessary for the treatment of individuals with cardiogenic shock when the following criteria are met:

1. Treatment is intended as an alternative to extracorporeal membrane oxygenation (ECMO); or
2. Optimal medical management and conventional treatment measures (that is, volume loading and use of pressors and inotropes) has failed to provide sufficient improvement; and
3. Individual is suspected to have a reversible cardiac injury and does not have irreversible end-organ injury including renal, hepatic or neurologic systems (care is not felt to be futile).

*Note: Please refer to the background section of the document for a list of FDA approved pVADs.

Not Medically Necessary:

The use of pVADs is considered not medically necessary when the medically necessary criteria above are not met, and for all other indications.

IV. Artificial Heart Systems

Medically Necessary:

The SynCardia temporary Total Artificial Heart (TAH-t), used in accordance with FDA approval, is considered medically necessary as a bridge to heart transplantation for individuals who have no other reasonable medical or surgical treatment options, who are ineligible for other univentricular or biventricular support devices, and who meet all of the following criteria:

1. Eligible for heart transplantation; and
2. Listed for heart transplantation and in imminent danger of dying within 48 hours or becoming ineligible for transplant; and
3. NYHA Functional Class IV; and
4. Presence of biventricular failure and rapid decompensation; and
5. Unavailability of heart donor and likelihood that condition will deteriorate before donor can be identified; and
6. Body surface area 1.7-2.5 m²*, or have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) greater than or equal to 10 cm (See asterisk below for factors that may allow an exception to this criteria.); and
7. Absence of active systemic infection; and
8. Absence of irreversible organ dysfunction; and
9. Serum Creatinine less than 5 mg/dl; and
10. Total Bilirubin less than 5 mg/dl; and
11. Cytotoxic antibody level less than 10%; and
12. Pulmonary Vascular Resistance less than 8 Wood units; and
13. Unresponsive to optimal medical therapy; and
14. Presence of hemodynamic insufficiency demonstrated by either of the following:
    1. Cardiac index less than or equal to 2 L/min/M² and one of the following:
       1. Systolic arterial pressure less than or equal to 90 mm Hg;
       2. Central venous pressure greater than or equal to 18 mm Hg.
          or
    2. Two of the following:
       1. Dopamine greater than or equal to 10 μg/kg/min; or
       2. Dobutamine greater than or equal to 10 μg/kg/min; or
       3. Epinephrine greater than or equal to 2 μg/kg/min; or
       4. Isoproterenol greater than or equal to 2 μg/kg/min; or
       5. Amrinone greater than or equal to 10 μg/kg/min; or
       6. Other cardioactive drugs at maximal doses; or
       7. IABP; or
       8. Failure to wean from cardiopulmonary bypass (CPB).

Not Medically Necessary:

The SynCardia temporary Total Artificial Heart (TAH-t) is considered not medically necessary when the medically necessary criteria above are not met, and for all other indications.

All other artificial heart systems, including the AbioCor^® Implantable Replacement Heart System, are considered not medically necessary for all indications.

*Note: The proper functioning of the implanted SynCardia TAH-t can be impaired in smaller individuals, that is, those with a body surface area of less than 1.7 m² and a heart size less than or equal to 1500 cc, or whose anteroposterior diameter from the sternum inner table to the anterior vertebral body is less than 10 cm. In these cases, the implanted device may compress the inferior vena cava or the pulmonary veins. If an individual has a body size area less than 1.7 m², implantation of a TAH may still be possible if the presence of cardiomegaly allows for sufficient space for device placement.
Note: In general age greater than or equal to 18 years and less than or equal to 59 years is a relative indication.