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
Accepted Indications for Cardiac Transplantation
Hemodynamic compromise due to heart failure demonstrated by any of the following 3 bulleted items,
Maximal oxygen consumption (Vo2) <10 mL/kg/min with achievement of anaerobic metabolism; Refractory cardiogenic shock; 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 <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. The following conditions are inadequate indications for cardiac transplantation unless other factors as listed above are present. Ejection fraction <20%; History of functional class III or IV symptoms of heart failure; Previous ventricular arrhythmias; Maximal Vo2 >15 mL/kg/min.
Pediatric Individuals
Individuals with heart failure and persistent symptoms at rest who require 1 or more of the following:
Continuous infusion of intravenous inotropic agents; or
Mechanical ventilatory support; or
Mechanical circulatory support.
Individuals with heart disease and symptoms of heart failure who do not meet the above criteria but who have:
Severe limitation of exercise and activity (if measurable, such individuals would have a maximum Vo2 <50% predicted for age and sex); or Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease; or Near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator; or Restrictive cardiomyopathy with reactive pulmonary hypertension; or Reactive pulmonary hypertension and risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or 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. Heart retransplantation after a failed primary heart transplant may be considered medically necessary in individuals who meet the criteria for heart transplantation. Heart transplantation is considered investigational in all other situations.
