A heart transplant and re-transplant consists of replacing a diseased heart with a healthy donor heart. Transplantation is used for individuals with refractory end-stage cardiac disease.

Human heart transplantation may be considered medically necessary for select adults and children with end-stage heart failure when the following individual selection criteria are met:

• Adult Individuals 18 years or older
  • Accepted indications for cardiac transplantation
    • Hemodynamic compromise due to heart failure demonstrated by ANY of the following:
      • Circulatory support, mechanical; or
      • Maximal oxygen consumption (Vo₂) less than 10 mL/kg/min with achievement of anaerobic metabolism; or
      • Refractory cardiogenic shock; or
      • Documented dependence on intravenous inotropic support to maintain adequate organ perfusion; or
    • Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty; or
    • Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities.
  • Probable indications for cardiac transplantation
    • Maximal Vo₂ less than 14 mL/kg/min and major limitation of the individual's activities; or
    • Recurrent unstable ischemia not amenable to bypass surgery or angioplasty; or
    • Instability of fluid balance/renal function not due to individual noncompliance with a regimen of weight monitoring, flexible use of diuretic drugs, and salt restriction.
  • Inadequate indications for cardiac transplantation unless other factors as listed above are present:
    • Ejection fraction less than 20 percent; or
    • History of functional class III or IV symptoms of heart failure; or
    • Previous ventricular arrhythmias; or
    • Maximal Vo₂ greater than 15 mL/kg/min.
• Pediatric Individuals 17 years or younger
  • Individuals with heart failure with persistent symptoms at rest who require ONE or MORE of the following:
    • Circulatory support, mechanical; or
    • Infusion of intravenous inotropic agents, continuous; or
    • Ventilator support, mechanical; or
  • Individuals with heart disease with symptoms of heart failure who do not meet the above criteria but who have at least ONE of the following:
    • Anatomic and physiologic conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
    • Anatomic and physiologic conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction; or
    • Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease; or
    • Restrictive cardiomyopathy with reactive pulmonary hypertension; or
    • Severe limitation of exercise and activity (if measurable, such individuals would have a maximum Vo₂ less than percent predicted for age and sex); or
    • Near sudden death and/or life-threatening arrhythmias, untreatable with medications or an implantable defibrillator; or
    • Reactive pulmonary hypertension and risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future.

Heart re-transplantation after a failed primary heart transplant may be considered medically necessary in individuals who meet criteria for heart transplantation. 

Heart transplantation or re-transplantation not meeting the criteria as indicated in this policy is considered not medically necessary.

In addition to the above criteria and subject to the discretion of the transplant center, a Hepatitis C Virus (HCV) positive donor organ may be considered an acceptable organ option for an HCV negative adult recipient 18 years of age or older.

General Criteria

Potential contraindications for solid organ transplant subject to the judgment of the transplant center include the following:

• Known current malignancy, including metastatic cancer; or
• Recent malignancy with a high risk of recurrence; or
• Untreated systemic infection making immunosuppression unsafe, including chronic infection; or
• Other irreversible end-stage diseases not attributed to heart or lung disease; or
• History of cancer with a moderate risk of recurrence; or
• Systemic disease that could be exacerbated by immunosuppression; or
• Psychosocial conditions or chemical dependency affecting the ability to adhere to therapy.

Policy-specific potential contraindications include:

• Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance greater than six (6) Wood units, or transpulmonary gradient greater than or equal to 16 mm/Hg despite treatment; or
• Severe pulmonary disease, despite optimal medical therapy, not expected to improve with heart transplantation

Pediatric individuals must meet the United Network for Organ Sharing (UNOS) guidelines for status one A or one B (1A, 1B), or status two (2). Adult individuals must meet the United Network for Organ Sharing (UNOS) guidelines for status. One (1), two (2), three (3) or four (4).

Cardiac-Specific Criteria

Specific criteria for prioritizing donor thoracic organs for transplant are provided by the Organ Procurement and Transplantation Network (OPTN) and implemented through a contract with UNOS. Donor thoracic organs are prioritized by UNOS on the basis of recipient medical urgency, distance from donor hospital, and pediatric status. Individuals who are most severely ill (Adults status 1 or Pediatrics status 1A) are given the highest priority. The following factors are considered in assessing the severity of illness: reliance on continuous mechanical ventilation, infusion of intravenous inotropes, and/or dependency on mechanical circulatory support (i.e., total artificial heart, intra-aortic balloon pump, extracorporeal membrane oxygenator, ventricular assist device).

Additional criteria, which are considered in pediatric individuals, include diagnosis of an OPTN-approved congenital heart disease diagnosis, presence of ductal dependent pulmonary or systemic circulation, and diagnosis of hypertrophic or restrictive cardiomyopathy while less than one (1-) year-old. Of note, pediatric heart transplant candidates who remain on the waiting list at the time of their 18^th birthday without receiving a transplant continue to qualify for medical urgency status based on the pediatric criteria.