This document addresses cardiac transplantation, a therapeutic modality for individuals with end-stage heart disease, characterized by heart failure (also known as cardiac failure or HF) that does not respond to standard, optimal medical or surgical treatments.

Note: Please see TRANS.00026 Heart/Lung Transplantation for additional information.

Position Statement

Medically Necessary:

Heart transplantation is considered medically necessary in carefully selected individuals when the following clinical indications and the General Individual Selection criteria below are met.

Adult Clinical Indications* - Adults with end-stage, irreversible, refractory, symptomatic heart failure requiring maximal continuous medical or mechanical support must have:

1. A low functional status; and
2. A poor probability of survival; and
3. ONE of the following underlying conditions:
   1. Supported by a mechanical circulatory support device; or
   2. Supported by an intra-aortic balloon pump (IABP); or
   3. Refractory cardiogenic shock; or
   4. Dependency on intravenous (IV) inotropic support to maintain adequate organ perfusion; or
   5. Maximal VO₂ less than or equal to 10 ml/kg/min with achievement of anaerobic metabolism; or
   6. Maximal VO₂ greater than 10 and less than 15 ml/kg/min (or 55% of predicted) and major limitation of the individual’s activities; or
   7. Severe ischemia consistently limiting routine activity not amenable to bypass surgery or percutaneous coronary intervention (PCI); or
   8. Recurrent unstable ischemia not amenable to bypass surgery or percutaneous coronary intervention (PCI); or
   9. Recurrent symptomatic ventricular arrhythmias refractory to ALL therapeutic modalities; or
   10. Ischemic cardiomyopathy not amenable to medical therapy or revascularization procedures.

Pediatric Clinical Indications* - Heart transplant is an accepted treatment option for selected children with end-stage heart disease characterized by intractable symptoms and heart failure that cannot be treated with conventional medical or surgical methods. Children must have:

1. Low cardiac output; and
2. ONE of the following conditions:
   1. Intractable heart failure not amenable to medical or surgical interventions; or
   2. Complex congenital heart disease not amenable to surgical repair or palliation or for which the surgical procedure carries a higher risk of mortality than transplantation; or
   3. Heart disease with reactive pulmonary hypertension and a potential of developing fixed, irreversible increased pulmonary vascular resistance (PVR) that would preclude a future orthotopic heart transplantation; or
   4. Heart disease associated with near sudden death; or
   5. Life-threatening arrhythmias untreatable with medications or an implantable defibrillator.

*Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with a concurrent medical condition which would be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the other organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member’s candidacy for transplantation.

Heart Retransplantation

Retransplantation in individuals with graft failure of an initial heart transplant, due to either technical reasons or hyperacute rejection is considered medically necessary.

Retransplantation in individuals with chronic rejection, moderate graft vasculopathy or recurrent disease is considered medically necessary when the individual meets general individual selection criteria as defined below.

Investigational and Not Medically Necessary:

A heart transplantation is considered investigational and not medically necessary when the above criteria are not met.

General Individual Selection Criteria

In addition to having end-stage heart disease, the member must not have a contraindication to transplantation, as defined by the American Society of Transplantation (Steinman, 2001) and the International Society for Heart and Lung Transplantation (Mehra, 2016) as listed below.

Relative Contraindications for Transplant Recipients include, but are not limited to, the following:

1. Pulmonary hypertension that is fixed as evidenced by either:
   1. Pulmonary vascular resistance (PVR) greater than 5 Wood units; or
   2. Trans-pulmonary gradient (TPG) greater than or equal to 16 mm/Hg.

Absolute Contraindications for Transplant Recipients include, but are not limited to, the following:

1. Metastatic cancer;
2. Ongoing or recurring infections that are not effectively treated;
3. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery;
4. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured;
5. Active, systemic lupus erythematosus or sarcoid with multisystem involvement;
6. Any systemic condition with a high probability of recurrence in the transplanted heart;
7. Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations;
8. Potential complications from immunosuppressive medications are unacceptable to the patient;
9. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention [CDC] definition of CD4 count, 200 cells/mm³) unless the following are noted:
   1. CD4 count greater than 200 cells/mm³ for greater than 6 months;
   2. HIV-1 RNA undetectable;
   3. On stable anti-retroviral therapy greater than 3 months;
   4. No other complications from AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm);
   5. Meeting all other criteria for heart transplantation.