Coverage Policy Manual
Policy #: 1998107
Category: Surgery
Initiated: February 1998
Last Review: February 2024
  Transplant, Heart

Description:
A heart transplant and a retransplant consist of replacing a diseased heart with a healthy donor heart. Transplantation is used for patients with refractory end-stage cardiac disease.
 
Solid organ transplantation offers a treatment option for patients with different types of end-stage organ failure that can be lifesaving or provide significant improvements to a patient’s quality of life (Black, 2018). Many advances have been made in the last several decades to reduce perioperative complications. Available data support improvement in long-term survival as well as improved quality of life, particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Patients are prioritized for transplant by mortality risk and severity of illness criteria developed by the Organ Procurement and Transplantation Network and United Network for Organ Sharing (UNOS).
 
Heart Transplant
In 2022, 42,880 transplants were performed in the United States procured from more than 14,900 deceased donors and 6,400 living donors (UNOS, 2021). Heart transplants were the third most common procedure with 4,109 transplants performed from both deceased and living donors in 2022. As of June 2023, there were 3,355 patients on the waiting list for a heart transplant (OPTN, 2023).
 
Most heart transplant recipients now are hospitalized as status 1 patients at the time of transplant. This shift has occurred due to the increasing demand for the scarce resource of donor organs resulting in an increased waiting time for recipients. Patients initially listed as status 2 candidates may deteriorate to a status 1 candidate before a donor organ becomes available. Alternatively, as medical and device therapy for advanced heart failure improves, some patients on the transplant list will recover enough function to be delisted. Lietz and Miller reported on survival for patients on the heart transplant waiting list, comparing the era between 1990 and 1994 with the era of 2000 to 2005 (Lietz, 2007). One-year survival for a UNOS status 1 candidate improved from 49.5% to 69.0%. Status 2 candidates fared even better, with 89.4% surviving 1 year compared with 81.8% in the earlier time period.
 
Johnson et al reported on waiting list trends in the U.S. between 1999 and 2008 (Johnson, 2010). The proportion of patients listed as status 1 increased, even as the waiting list and posttransplant mortality for this group have decreased. Meanwhile, status 2 patients have decreased as a proportion of all candidates. Completed transplants have trended toward the extremes of age, with more infants and patients older than age 65 years having transplants in recent years. Bakhtiyar et al evaluated survival among patients (N=95,323) wait-listed for heart transplantation between January 1, 1987 and December 29, 2017 using UNOS data (Bakhtiyar, 2020). Results revealed 1-year survival on the wait list increased from 34.1% in 1987 to 1990 to 67.8% in 2011 to 2017 (difference in proportions, 0.34%; 95% confidence interval [CI], 0.32% to 0.36%; p<.001). One-year wait list survival also significantly increased for candidates with ventricular assist devices from 10.2% in 1996 to 2000 to 70% in 2011 to 2017 (difference in proportions, 0.60%; 95% CI, 0.58% to 0.62%; p<.001).
 
Alshawabkeh et al reported on the 1-year probability of the combined outcome of death or delisting due to clinical worsening for patients on the heart transplant waiting list, comparing the periods of April 1, 1986 to January 19, 1999 (early era) and January 20, 1999 to June 2, 2014 (current era) (Alshawabkeh, 2018). For adults without congenital heart disease (CHD), the probability of the combined outcome was lower in the current era compared with the early era, regardless of whether the patient was listed in status I (14.5% vs. 22.7%; p<.0001) or 2 (9.0% vs. 12.8%, p<.0001). When comparing the current and early eras in adults with CHD, a reduction in the probability of the combined outcome was demonstrated in those listed in status I (17.6% vs. 43.3%, respectively; p<.0001), whereas the outcome remained unchanged for those listed in status 2 (10.6% vs. 10.4%, respectively; p=.94).
 
In adults with CHD, factors associated with waitlist death or delisting due to clinical worsening within 1 year were also examined by Alshawabkeh et al (Alshawabkeh, 2016). A multivariate analysis identified that an estimated glomerular filtration rate less than 60 ml/min/1.73 m2 (hazard ratio [HR], 1.4; 95% CI, 1.0 to 1.9; p=.043), albumin less than 3.2 g/dl (HR, 2.0; 95% CI, 1.3 to 2.9; p<.001), and hospitalization at the time of listing in the intensive care unit (HR, 2.3; 95% CI, 1.6 to 3.5; p<.001) or a non-intensive care hospital unit (HR, 1.9; 95% CI, 1.2 to 3.0; p=.006) were associated with waitlist death or delisting due to clinical worsening within 1 year.
 
Magnetta et al reported outcomes for children on the heart transplant waiting list, comparing the periods of December 16, 2011 to March 21, 2016 (era 1) and March 22, 2016 to June 30, 2018 (era 2) (Magnetta, 2019). There was a significant decrease from era 1 to era 2 in the proportion of patients listed as status 1 (70% vs. 56%; p<.001), while the proportion of patients with CHD significantly increased across eras (49% to 54%; p=.018). The median time on the waitlist increased from 68 days to 78 days (p=.005). There were no significant differences across eras in the cumulative incidence of death on the waitlist among all candidates (subdistribution HR, 0.96; 95% CI, 0.80 to 1.14; p=.63) and among those listed status 1A (subdistribution HR, 1.16; 95% CI, 0.95 to 1.41; p=.14). Graft survival at 90 days was also similar across eras in the overall population and in those with CHD (p>.53 for both).
 
As a consequence, aggressive treatment of heart failure has been emphasized in recent guidelines. Prognostic criteria have been investigated to identify patients who have truly exhausted medical therapy and thus are likely to derive the maximum benefit for heart transplantation. Maximal oxygen consumption (Vo2max), which is measured during maximal exercise, is a measure suggested as a critical objective criterion of the functional reserve of the heart. The American College of Cardiology and American Heart Association have adopted Vo2max as a criterion for patient selection (Hunt, 2005). Studies have suggested that transplantation can be safely deferred in those patients with a Vo2max greater than 14 mL/kg/min. The importance of Vo2max has also been emphasized by the American Heart Association when addressing heart transplant candidacy (Costanzo, 1995). In past years, a left ventricular ejection fraction of less than 20% or a New York Heart Association class III or IV status might have been used to determine transplant candidacy. However, as indicated by the American College of Cardiology criteria, these measurements are no longer considered adequate to identify transplant candidates. These measurements may be used to identify patients for further cardiovascular workup but should not be the sole criteria for transplant.
 
Methods other than Vo2max have been proposed as predictive models in adults (Aaronson, 1997; Alla, 2000; Hansen, 2001; Lee, 2003). The Heart Failure Survival Scale and the Seattle Heart Failure Model (SHFM) are examples. In particular, the SHFM provides an estimate of 1-, 2-, and 3-year survival with the use of routinely obtained clinical and laboratory data. Information on pharmacologic and device usage is incorporated into the model, permitting some estimation on the effects of current, more aggressive heart failure treatment strategies. Levy et al introduced the model using a multivariate analysis of data from the Prospective Randomized Amlodipine Survival Evaluation-1 heart failure trial (N=1125) (Levy, 2006). Applied to the data of 5 other heart failure trials, SHFM correlated well with actual survival (r=0.98). SHFM has been validated in both ambulatory and hospitalized heart failure populations but with a noted underestimation of mortality risk, particularly in Black adults and device recipients (Gorodeski, 2010; Ketchum, 2010; Nutter, 2010; Kalogeropoulos, 2009; May 2007). None of these models has been universally adopted by transplant centers.
 
Regulatory Status
Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration (FDA).
 
The FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.
 
 
Reimbursement for solid organ transplant (that has been pre-authorized if that is required) is made as a global fee limited to the lesser of billed charges or the average allowable charge authorized by the Blue Distinction Centers for Transplant in the geographic region where the transplant is performed. This global payment includes all related transplant services including institutional, professional, ancillary, and organ procurement. The global period begins one day prior to the date of the transplant and continues for 37 days after the transplant for a total of 38 days. This covers the inpatient/outpatient stay and provides a per diem outlier payment if necessary. This global fee also includes the cost of complications arising from the original procedure when services are rendered within the global postoperative period for the particular transplant.

Policy/
Coverage:
Heart Transplant. Cardiac transplantation requires that the individual being considered for transplant is an acceptable candidate based on established criteria in United States of America and that the candidate can be listed for cardiac transplant with  United Network for Organ Sharing (UNOS). UNOS oversees credentialling of transplant centers, listing of transplant candidates and allocation of organs. UNOS was established by the OPTN Organ Procurement Transplant Network. OPTN was established by Congress in NOTA Nation Organ Transplant Act 1984. OPTN contracts with UNOS to manage certification of transplant centers, listing of transplant candidates and allocation of organs for transplant.
 
To meet ABCBS primary Coverage Criteria for Cardiac Transplant, member must receive transplant in a UNOS certified cardiac transplant center. The member must be listed for transplant through UNOS and must meet the United Network for Organ Sharing (UNOS) guidelines for Status 1A, 1B or 2 (and not currently be listed as Status 7 which is inactive). Cardiac allografts must be allocated through UNOS using the established hierarchy.
 
Effective March 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Adults
Human heart transplant for adults with end-stage heart failure meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following situations:
 
    1. Hemodynamic compromise due to heart failure demonstrated by any of the following items:
 
        1. Maximal oxygen consumption (VO2) less than 10 mUkg/min with achievement of anaerobic metabolism; (Note: The peak oxygen consumption requirement will be waived if the patient is unable to perform the test required to obtain this measurement. The reason the test cannot be performed must be clearly documented in the patient’s medical record.)  
        2. Refractory cardiogenic shock;
        3. Documented dependence on intravenous inotropic support to maintain adequate organ perfusion;
OR
 
2. Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty;
OR
 
3. Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities;
OR
 
4. Individuals with heart failure not meeting the above criteria but who have one or more of the following:
 
        1. Maximal Vo2 less than 14 mL/kg/min and major limitation of the patient’s activities; or
        2. Recurrent unstable ischemia not amenable to bypass surgery or angioplasty; or
        3. Instability of fluid balance/renal function not due to patient noncompliance with a regimen of weight monitoring, flexible use of diuretic drugs and salt restriction.
OR
 
5. An individual with a LVAD as a bridge to transplant meets primary coverage criteria that there be scientific evidence for effectiveness when individual being considered for transplant is an acceptable candidate based on established criteria in the United States and can be listed for cardiac transplant with UNOS.
 
Heart re-transplantation after a failed primary heart transplant meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in individuals who meet the criteria for heart transplantation.
 
Pediatrics
 
Human heart transplant for pediatric individuals, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following situations:
 
    1. Individuals with heart failure with persistent symptoms at rest who require one or more of the following:
 
        1. Continuous infusion of intravenous inotropic agents, or
        2. Mechanical ventilatory support, or
        3. Mechanical circulatory support.
 OR
 
2. Individuals with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have one or more of the following:
 
        1. Severe limitation of exercise and activity (if measurable, such individuals would have a peak maximum oxygen consumption <50% predicted for age and sex); or
        2. Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease; or
        3. Near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator; or
        4. Restrictive cardiomyopathy with reactive pulmonary hypertension; or
        5. Reactive pulmonary hypertension and potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or
        6. Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
        7. Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction.
 OR
 
3. An individual with a LVAD as a bridge to transplant meets primary coverage criteria that there be scientific evidence for effectiveness when individual being considered for transplant is an acceptable candidate based on established criteria in the United States and can be listed for cardiac transplant with UNOS.
 
Heart re-transplantation after a failed primary heart transplant meets primary coverage criteria for effectiveness in improving health outcomes in individuals who meet the criteria for heart transplantation.
 
Combined heart-liver transplant meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for adults who have both heart failure and liver failure simultaneously and meet ALL the following criteria:
 
    1. Member qualifies for both Heart Transplant and Liver Transplant independently based on ABCBS criteria of policies 1998107 (Heart Transplant) and 1998104 (Liver Transplant) and  
    2. It is in the member’s best interest and medically necessary to transplant both organs in the same transplant procedure and
    3. The Transplant Program must be:
 
        1. UNOS approved for Heart and Liver transplant and
        2. Be in good standing with UNOS and
        3. Have experience doing simultaneous Heart Liver Transplants.
 
NOTE: A positive Hepatitis C status of organs for transplant is NOT a contraindication for transplant.
NOTE: A donor whose heart is considered high-risk because of advanced age can be used for heart transplantation.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Heart transplantation in individuals with any of the following, including but not limited to, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
 
    1. Ejection fraction less than 20%, if other factors listed above are not present;
    2. History of functional class III or IV symptoms of heart failure, if other factors listed above are not present;
    3. Previous ventricular arrhythmias if other factors listed above are not present;
    4. Maximal VO2 greater than 15 mL/kg/min, if other factors listed above are not present;
    5. Known current malignancy, including metastatic cancer (with the exception of basal cell or squamous cell carcinoma of the skin);
    6. Recent malignancy with a high risk of recurrence;
    7. Untreated systemic infection (active infectious process)  making immunosuppression unsafe, including chronic infection;
    8. Other irreversible end-stage diseases not attributed to heart or lung disease (e.g., amyloidosis, HIV disease);
    9. History of cancer with a moderate risk of recurrence;
    10. Systemic disease that could be exacerbated by immunosuppression;
    11. Psychosocial conditions or chemical dependency (e.g. active substance or alcohol abuse) affecting the ability to adhere to therapy;
    12. Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance greater than 5 Wood units, or transpulmonary gradient greater than or equal to 16 mm/Hg despite treatment. (Some individuals may be candidates for combined heart and lung transplantation);
 
For contracts without primary coverage criteria, heart transplantation in individuals with any of the above conditions, including but not limited to those conditions, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Human heart transplant for pediatric individuals that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, human heart transplant for pediatric individuals that does not meet the criteria indicated above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Combined heart-liver transplant that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, combined heart-liver transplant that does not meet the criteria indicated above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective February 1, 2023 through February 28, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
*Note: A positive Hepatitis C status of organs for transplant is NOT a contraindication for transplant.
 
Human heart transplant for adults with end-stage heart failure meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following situations when the criteria are met.
 
Adults
 
  1. Accepted Indications for Cardiac Transplant
a, Hemodynamic compromise due to heart failure demonstrated by any of the following items:
      1. Maximal oxygen consumption (VO2) less than 10 mUkg/min with achievement of anaerobic metabolism;
      2. Refractory cardiogenic shock;
      3. Documented dependence on intravenous inotropic support to maintain adequate organ perfusion;
OR
b. Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty;
OR
c. Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities.
 
2. Probable Indications for Cardiac Transplantation
a. Maximal Vo2 less than 14 mL/kg/min and major limitation of the patient’s activities; or
b. Recurrent unstable ischemia not amenable to bypass surgery or angioplasty; or
c. Instability of fluid balance/renal function not due to patient noncompliance with a regimen of weight monitoring, flexible use of diuretic drugs and salt restriction.
 
Heart re-transplantation after a failed primary heart transplant meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in individuals who meet the criteria for heart transplantation.
 
(Note: The peak oxygen consumption requirement will be waived if the patient is unable to perform the test required to obtain this measurement. The reason the test cannot be performed must be clearly documented in the patient’s medical record.)  
 
A donor whose heart is considered high-risk because of advanced age can be used for heart transplantation.
 
Pediatric Patients
 
Human heart transplant for pediatric patients, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following situations:
 
1. Pediatric patients with heart failure with persistent symptoms at rest who require one or more of the following:
a. Continuous infusion of intravenous inotropic agents, or
b. Mechanical ventilatory support, or
c. Mechanical circulatory support.
 
2. Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have one or more of the following:
 
a. Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <50% predicted for age and sex); or
b. Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease; or
c. Near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator; or
d. Restrictive cardiomyopathy with reactive pulmonary hypertension; or
e. Reactive pulmonary hypertension and potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or
f. Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
g. Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction.
 
Heart re-transplantation after a failed primary heart transplant meets primary coverage criteria for effectiveness in improving health outcomes in individuals who meet the criteria for heart transplantation.
 
Combined heart-liver transplant meets primary coverage criteria that there be scientific evidence of effectivenessin improving health outcomes and is covered for adults who have both heart failure and liver failure simultaneously and meet ALL the following criteria:
 
1. Member qualifies for both Heart Transplant and Liver Transplant independently based on ABCBS criteria of policies 1998107 (Heart Transplant) and 1998104 (Liver Transplant) and  
2. It is in the member’s best interest and medically necessary to transplant both organs in the same transplant procedure and
3. The Transplant Program must be:
a. UNOS approved for Heart and Liver transplant and
b. Be in good standing with UNOS and
c. Have experience doing simultaneous Heart Liver Transplants.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Heart transplantation in patients with any of the following, including but not limited to, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
 
    1. Ejection fraction less than 20%, if other factors listed above are not present;
    2. History of functional class III or IV symptoms of heart failure, if other factors listed above are not present;
    3. Previous ventricular arrhythmias if other factors listed above are not present;
    4. Maximal VO2 greater than 15 mL/kg/min, if other factors listed above are not present;
    5. Known current malignancy, including metastatic cancer (with the exception of basal cell or squamous cell carcinoma of the skin);
    6. Recent malignancy with a high risk of recurrence;
    7. Untreated systemic infection (active infectious process)  making immunosuppression unsafe, including chronic infection;
    8. Other irreversible end-stage diseases not attributed to heart or lung disease (e.g., amyloidosis, HIV disease);
    9. History of cancer with a moderate risk of recurrence;
    10. Systemic disease that could be exacerbated by immunosuppression;
    11. Psychosocial conditions or chemical dependency (e.g. active substance or alcohol abuse) affecting the ability to adhere to therapy;
    12. Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance greater than 5 Wood units, or transpulmonary gradient greater than or equal to 16 mm/Hg despite treatment. (Some individuals may be candidates for combined heart and lung transplantation);
 
For contracts without primary coverage criteria, heart transplantation in patients with any of the above conditions, including but not limited to those conditions, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Human heart transplant for pediatric patients that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, human heart transplant for pediatric patients that does not meet the criteria indicated above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Combined heart-liver transplant that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, combined heart-liver transplant that does not meet the criteria indicated above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective November 2022 through January 31, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
*Note: A positive Hepatitis C status of organs for transplant is NOT a contraindication for transplant.
 
Human heart transplant for adults with end-stage heart failure meets primary coverage criteria for effectiveness in the following situations the criteria are met.
 
Adults
 
  1. Accepted Indications for Cardiac Transplant
 
    1. Hemodynamic compromise due to heart failure demonstrated by any of the following items:
        1. Maximal oxygen consumption (VOz) <10 mUkg/min with achievement of anaerobic metabolism;
        2. Refractory cardiogenic shock;
        3. Documented dependence on intravenous inotropic support to maintain adequate organ perfusion;
OR
 
2. Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty;
 
OR
 
3. Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities
 
B. Probable Indications for Cardiac Transplantation
 
    1. Maximal Vo2 less than 14 mL/kg/min and major limitation of the patient’s activities; or
    2. Recurrent unstable ischemia not amenable to bypass surgery or angioplasty; or
    3. Instability of fluid balance/renal function not due to patient noncompliance with a regimen of weight monitoring, flexible use of diuretic drugs and salt restriction.
 
Heart re-transplantation after a failed primary heart transplant meets primary coverage criteria for effectiveness in individuals who meet the criteria for heart transplantation.
(Note: The peak oxygen consumption requirement will be waived if the patient is unable to perform the test required to obtain this measurement. The reason the test cannot be performed must be clearly documented in the patient’s medical record.)  
 
A donor whose heart is considered high-risk because of advanced age can be used for heart transplantation.
 
Pediatric Patients
 
Human heart transplant for pediatric patients, meets primary coverage criteria for effectiveness that there be scientific evidence of effectiveness in improving health outcomes in the following situations:
 
1. Pediatric patients with heart failure with persistent symptoms at rest who require one or more of the following:
 
        1. Continuous infusion of intravenous inotropic agents, or
        2. Mechanical ventilatory support, or
        3. Mechanical circulatory support.
 
2. Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have one or more of the following:
 
        1. Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <50% predicted for age and sex); or
        2. Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease; or
        3. Near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator; or
        4. Restrictive cardiomyopathy with reactive pulmonary hypertension; or
        5. Reactive pulmonary hypertension and potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or
        6. Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
        7. Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction.
 
Heart re-transplantation after a failed primary heart transplant meets primary coverage criteria for effectiveness in individuals who meet the criteria for heart transplantation.
 
Combined heart-liver transplant meets primary coverage criteria for effectiveness and is covered for adults who have both heart failure and liver failure simultaneously and meet ALL of the following criteria:
 
  1. Member qualifies for both Heart Transplant and Liver Transplant independently based on ABCBS criteria of policies 1998107 (Heart Transplant) and 1998104 (Liver Transplant) and  
  2. It is in the member’s best interest and medically necessary to transplant both organs in the same transplant procedure and
  3. The Transplant Program must be:
 
    1. UNOS approved for Heart and Liver transplant and
    2. Be in good standing with UNOS and
    3. Have experience doing simultaneous Heart Liver Transplants.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Heart transplantation in patients with any of the following, including but not limited to, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
 
    1. Ejection fraction less than 20%, if other factors listed above are not present;
    2. History of functional class III or IV symptoms of heart failure, if other factors listed above are not present;
    3. Previous ventricular arrhythmias, if other factors listed above are not present;
    4. Maximal Vo2 greater than 15 mL/kg/min, if other factors listed above are not present;
    5. Known current malignancy, including metastatic cancer (with the exception of basal cell or squamous cell carcinoma of the skin);
    6. Recent malignancy with a high risk of recurrence;
    7. Untreated systemic infection (active infectious process)  making immunosuppression unsafe, including chronic infection
    8. Other irreversible end-stage diseases not attributed to heart or lung disease (e.g. amyloidosis, HIV disease);
    9. History of cancer with a moderate risk of recurrence;
    10. Systemic disease that could be exacerbated by immunosuppression
    11. Psychosocial conditions or chemical dependency (e.g. active substance or alcohol abuse) affecting the ability to adhere to therapy.
    12. Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance greater than 5 Wood units, or transpulmonary gradient greater than 16 mm/Hg despite treatment. (Some individuals may be candidates for combined heart and lung transplantation).
 
 
For contracts without primary coverage criteria, heart transplantation in patients with any of the above conditions, including but not limited to, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For contracts without primary coverage criteria, heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Human heart transplant for pediatric patients that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, human heart transplant for pediatric patients that does not meet the criteria indicated above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Combined heart-liver transplant that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, combined heart-liver transplant that does not meet the criteria indicated above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective February 2021 through October 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
*Note: A positive Hepatitis C status of organs for transplant is NOT a contraindication for transplant.
 
Human cadaver heart transplant meets primary coverage criteria for effectiveness and is covered for patients that meet all of the following criteria:
 
    • End-stage heart disease that limits prognosis for survival over 2 years or severely limits daily quality of life despite optimal medical and other surgical therapy;
    • Recipient must have a suitable psychological profile and social support system;
    • Peak oxygen consumption (Vo2):
 
        • Vo2 less than 14 ml/kg/min in patients who intolerant of a  ß-blocker OR
        • Vo2 less than 12 ml/kg/min in presence of  ß-blocker
 
(Note: The peak oxygen consumption requirement will be waived if the patient is unable to perform the test required to obtain this measurement. The reason the test cannot be performed must be clearly documented in the patient’s medical record.)  
 
A donor whose heart is considered high-risk because of advanced age can be used for heart transplantation.
 
Combined cadaver heart-liver transplant meets primary coverage criteria for effectiveness and is covered for adults who have both heart failure and liver failure simultaneously and meet ALL of the following criteria:
 
    • Member qualifies for both Heart Transplant and Liver Transplant independently based on ABCBS criteria of policies 1998107 (Heart Transplant) and 1998104 (Liver Transplant) and  
    • It is in the member’s best interest and medically necessary to transplant both organs in the same transplant procedure and
    • The Transplant Program must be:
 
        • UNOS approved for Heart and Liver transplant and
        • Be in good standing with UNOS and
        • Have experience doing simultaneous Heart Liver Transplants.
 
Pediatric Patients
 
Human cadaver heart transplant for pediatric patients, meets primary coverage criteria for effectiveness that there be scientific evidence of effectiveness in improving health outcomes in the following situations:
 
1. Pediatric patients with heart failure with persistent symptoms at rest who require one or more of the following:
 
    • Continuous infusion of intravenous inotropic agents, or
    • Mechanical ventilatory support, or
    • Mechanical circulatory support.
 
2. Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have one or more of the following:
 
    • Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <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 potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or
    • Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
    • Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Cadaver heart transplantation in patients with any of the following, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
 
    • Peak oxygen consumption (Vo2):
 
        • Vo2 greater than or equal to 14 ml/kg/min in patients who intolerant of a  ß-blocker;
        • Vo2 greater than or equal to 12 ml/kg/min in presence of  ß-blocker  
 
    • An active infectious process;
    • Active malignancy within the past two years with the exception of basal cell and squamous cell carcinoma of the skin.  (Additionally, recent data on recurrence of tumors post transplant indicate that a waiting period of at least 5 years is prudent for extracapsular renal cell tumors, breast cancer that is stage 2 or higher, colon cancer staged higher than Dukes A, and melanoma, level III or higher;)
    • Any systemic process with a high probability of recurring in the transplanted heart (e.g., amyloidosis, HIV disease);
    • Severe pulmonary hypertension (Pulmonary vascular resistance greater than five Wood units; transpulmonary gradient greater than 15 mm/Hg);
    • Active substance or alcohol abuse;
    • Peripheral or cerebrovascular disease not amenable to surgical correction;
    • Diabetes mellitus with end-organ damage (e.g., neuropathy, nephropathy, or proliferative retinopathy);
    • Severe pulmonary disease.
 
For contracts without primary coverage criteria, cadaver heart transplantation in patients with any of the above conditions, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Human cadaver heart transplant for pediatric patients that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, human cadaver heart transplant for pediatric patients that does not meet the criteria indicated above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Combined cadaver heart-liver transplant that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, combined cadaver heart-liver transplant that does not meet the criteria indicated above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to February 2021
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
*Note: A positive Hepatitis C status of organs for transplant is NOT a contraindication for transplant.
 
Human cadaver heart transplant meets primary coverage criteria for effectiveness and is covered for patients that meet all of the following criteria:
 
    • End-stage heart disease that limits prognosis for survival over 2 years or severely limits daily quality of life despite optimal medical and other surgical therapy;
    • Recipient must have a suitable psychological profile and social support system;
    • Peak oxygen consumption (Vo2):
        • Vo2 less than 14 ml/kg/min in patients who intolerant of a  ß-blocker OR
        • Vo2 less than 12 ml/kg/min in presence of  ß-blocker
 
(Note: The peak oxygen consumption requirement will be waived if the patient is unable to perform the test required to obtain this measurement. The reason the test cannot be performed must be clearly documented in the patient’s medical record.)  
 
A donor whose heart is considered high-risk because of advanced age can be used for heart transplantation.
 
Combined cadaver heart-liver transplant meets primary coverage criteria for effectiveness and is covered for adults who have both heart failure and liver failure simultaneously and meet ALL of the following criteria:
 
    • Member qualifies for both Heart Transplant and Liver Transplant independently based on ABCBS criteria of policies 1998107 (Heart Transplant) and 1998104 (Liver Transplant) and  
    • It is in the member’s best interest and medically necessary to transplant both organs in the same transplant procedure and
    • The Transplant Program must be:
        • UNOS approved for Heart and Liver transplant and
        • Be in good standing with UNOS and
        • Have experience doing simultaneous Heart Liver Transplants.
 
Pediatric Patients
 
Human cadaver heart transplant for pediatric patients, meets primary coverage criteria for effectiveness that there be scientific evidence of effectiveness in improving health outcomes in the following situations:
 
1. Pediatric patients with heart failure with persistent symptoms at rest who require one or more of the following:
 
    • Continuous infusion of intravenous inotropic agents, or
    • Mechanical ventilatory support, or
    • Mechanical circulatory support.
 
2. Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have one or more of the following:
 
    • Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <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 potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or
    • Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
    • Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Cadaver heart transplantation in patients with any of the following, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
 
    • Peak oxygen consumption (Vo2):   
        • Vo2 greater than or equal to 14 ml/kg/min in patients who intolerant of a  ß-blocker;
        • Vo2 greater than or equal to 12 ml/kg/min in presence of  ß-blocker  
    • An active infectious process;
    • Active malignancy within the past two years with the exception of basal cell and squamous cell carcinoma of the skin.  (Additionally, recent data on recurrence of tumors post transplant indicate that a waiting period of at least 5 years is prudent for extracapsular renal cell tumors, breast cancer that is stage 2 or higher, colon cancer staged higher than Dukes A, and melanoma, level III or higher;)
    • Any systemic process with a high probability of recurring in the transplanted heart (e.g., amyloidosis, HIV disease);
    • Severe pulmonary hypertension (Pulmonary vascular resistance greater than five Wood units; transpulmonary gradient greater than 15 mm/Hg);
    • Active substance or alcohol abuse;
    • Peripheral or cerebrovascular disease not amenable to surgical correction;
    • Diabetes mellitus with end-organ damage (e.g., neuropathy, nephropathy, or proliferative retinopathy); or
    • Severe pulmonary disease.
 
For contracts without primary coverage criteria, cadaver heart transplantation in patients with any of the above conditions, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Human cadaver heart transplant for pediatric patients that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, human cadaver heart transplant for pediatric patients that does not meet the criteria indicated above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Combined cadaver heart-liver transplant that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, combined cadaver heart-liver transplant that does not meet the criteria indicated above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to July 2020
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
*Note: A positive Hepatitis C status of organs for transplant is NOT a contraindication for transplant.
 
Human cadaver heart transplant meets primary coverage criteria for effectiveness and is covered for patients that meet all of the following criteria:
 
    • End-stage heart disease that limits prognosis for survival over 2 years or severely limits daily quality of life despite optimal medical and other surgical therapy;
    • Recipient must have a suitable psychological profile and social support system;
    • Peak oxygen consumption (Vo2):
        • Vo2 less than 14 ml/kg/min in patients who intolerant of a  ß-blocker OR
        • Vo2 less than 12 ml/kg/min in presence of  ß-blocker
 
(Note: The peak oxygen consumption requirement will be waived if the patient is unable to perform the test required to obtain this measurement. The reason the test cannot be performed must be clearly documented in the patient’s medical record.)  
 
A donor whose heart is considered high-risk because of advanced age can be used for heart transplantation.
 
Pediatric Patients
 
Human cadaver heart transplant for pediatric patients, meets primary coverage criteria for effectiveness that there be scientific evidence of effectiveness in improving health outcomes in the following situations:
 
1. Pediatric patients with heart failure with persistent symptoms at rest who require one or more of the following:
 
    • Continuous infusion of intravenous inotropic agents, or
    • Mechanical ventilatory support, or
    • Mechanical circulatory support.
 
2. Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have one or more of the following:
 
    • Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <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 potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or
    • Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
    • Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Cadaver heart transplantation in patients with any of the following, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
 
    • Peak oxygen consumption (Vo2):   
        • Vo2 greater than or equal to 14 ml/kg/min in patients who intolerant of a  ß-blocker;
        • Vo2 greater than or equal to 12 ml/kg/min in presence of  ß-blocker  
    • An active infectious process;
    • Active malignancy within the past two years with the exception of basal cell and squamous cell carcinoma of the skin.  (Additionally, recent data on recurrence of tumors post transplant indicate that a waiting period of at least 5 years is prudent for extracapsular renal cell tumors, breast cancer that is stage 2 or higher, colon cancer staged higher than Dukes A, and melanoma, level III or higher;)
    • Any systemic process with a high probability of recurring in the transplanted heart (e.g., amyloidosis, HIV disease);
    • Severe pulmonary hypertension (Pulmonary vascular resistance greater than five Wood units; transpulmonary gradient greater than 15 mm/Hg);
    • Active substance or alcohol abuse;
    • Peripheral or cerebrovascular disease not amenable to surgical correction;
    • Diabetes mellitus with end-organ damage (e.g., neuropathy, nephropathy, or proliferative retinopathy); or
    • Severe pulmonary disease.
 
For contracts without primary coverage criteria, cadaver heart transplantation in patients with any of the above conditions, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Human cadaver heart transplant for pediatric patients that does not meet the criteria indicated above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, human cadaver heart transplant for pediatric patients that does not meet the criteria indicated above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to May 2019
 
Human cadaver heart transplant meets primary coverage criteria for effectiveness and is covered for patients with end-stage heart disease that limits prognosis for survival over 2 years or severely limits daily quality of life despite optimal medical and other surgical therapy.  The recipient must have a suitable psychological profile and social support system.
 
Exclusions from coverage of cadaver heart transplantation include patients with:
    • Peak oxygen consumption (Vo2):   
        • Vo2 greater than or equal to 14 ml/kg/min in patients who intolerant of a  ß-blocker;
        • Vo2 greater than or equal to 12 ml/kg/min in presence of  ß-blocker
 
(Note: The peak oxygen consumption requirement will be waived if the patient is unable to perform the test required to obtain this measurement. The reason the test cannot be performed must be clearly documented in the patient’s medical record.)
 
    • An active infectious process;
    • Active malignancy within the past two years with the exception of basal cell and squamous cell carcinoma of the skin.  In addition, recent data on recurrence of tumors post transplant indicate that a waiting period of at least 5 years is prudent for extracapsular renal cell tumors, breast cancer that is stage 2 or higher, colon cancer staged higher than Dukes A, and melanoma, level III or higher;
    • Any systemic process with a high probability of recurring in the transplanted heart (e.g., amyloidosis, HIV disease);
    • Severe pulmonary hypertension (Pulmonary vascular resistance greater than five Wood units; transpulmonary gradient greater than 15 mm/Hg);
    • Active substance or alcohol abuse;
    • Peripheral or cerebrovascular disease not amenable to surgical correction;
    • Diabetes mellitus with end-organ damage (e.g., neuropathy, nephropathy, or proliferative retinopathy); or
    • Severe pulmonary disease.
 
A donor whose heart is considered high-risk because of advanced age can be used for heart transplantation.
 
Heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Pediatric Patients
 
Human cadaver heart transplant for pediatric patients meets primary coverage criteria for effectiveness that there be scientific evidence of effectiveness in improving health outcomes in the following situations:
 
1. Pediatric patients with heart failure with persistent symptoms at rest who require one or more of the following:
    • Continuous infusion of intravenous inotropic agents, or
    • Mechanical ventilatory support, or
    • Mechanical circulatory support.
 
2. Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have one or more of the following:
    • Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <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 potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or
    • Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
    • Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction.
 
Effective prior to January 2014
 
Human cadaver heart transplant meets primary coverage criteria for effectiveness and is covered for patients with end-stage heart disease that limits prognosis for survival over 2 years or severely limits daily quality of life despite optimal medical and other surgical therapy.  The recipient must have a suitable psychological profile and social support system.
 
Exclusions from coverage of cadaver heart transplantation include patients with:
    • Peak oxygen consumption (Vo2):  
      • Vo2 greater than or equal to 14 ml/kg/min in patients who intolerant of a  β-blocker;
      • Vo2 greater than or equal to 12 ml/kg/min in presence of  β-blocker
(Note: The peak oxygen consumption requirement will be waived if the patient is unable to perform the test required to obtain this measurement. The reason the test cannot be performed must be clearly documented in the patient’s medical record.) (Effective 5/2010)
    • An active infectious process;
    • Active malignancy within the past two years with the exception of basal cell and squamous cell carcinoma of the skin.  In addition, recent data on recurrence of tumors post transplant indicate that a waiting period of at least 5 years is prudent for extracapsular renal cell tumors, breast cancer that is stage 2 or higher, colon cancer staged higher than Dukes A, and melanoma, level III or higher;
    • Any systemic process with a high probability of recurring in the transplanted heart (e.g., amyloidosis, HIV disease);
    • Severe pulmonary hypertension (Pulmonary vascular resistance greater than five Wood units; transpulmonary gradient greater than 15 mm/Hg);
    • BMI > 30 kg/m2 or percent ideal body weight (PIBW) > 140%
    • Active substance or alcohol abuse;
    • Peripheral or cerebrovascular disease not amenable to surgical correction;
    • Diabetes mellitus with end-organ damage (e.g., neuropathy, nephropathy, or proliferative retinopathy); or
    • Severe pulmonary disease.
 
A donor whose heart is considered high-risk because of advanced age can be used for heart transplantation.
 
Heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, heart transplant with a non-human or mechanical heart and heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Pediatric Patients
 
Human cadaver heart transplant for pediatric patients meets primary coverage criteria for effectiveness that there be scientific evidence of effectiveness in improving health outcomes in the following situations:
 
1. Pediatric patients with heart failure with persistent symptoms at rest who require one or more of the following:
· Continuous infusion of intravenous inotropic agents, or
· Mechanical ventilatory support, or
· Mechanical circulatory support.
 
2. Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have one or more of the following:
· Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <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 potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or
· Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
· Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction.
 
 

Rationale:
In contrast to the 1980s when the majority of heart transplant recipients were sick but stable patients waiting at home, the majority of heart transplant recipients are now hospitalized Status 1 patients at the time of transplant. This shift has occurred due to the increasing demand on the scarce resource of donor organs resulting in an increased waiting time for donor organs. Patients initially listed as a Status 2 candidate may deteriorate to a Status 1 candidate before a donor organ becomes available. At the same time, medical therapy of heart failure has improved (particularly with the advent of ACE inhibitors), making it imperative that heart transplantation be limited to those patients who have truly exhausted medical therapy and thus are likely to derive the maximum benefit for heart transplantation. Consequently, there has been a search to identify prognostic criteria that could identify such patients. As noted in the ACC criteria above, the VO-2 max serves as a critical objective criterion. The VO-2 max, measured during maximal exercise, reflects the functional reserve of the heart. Studies have suggested that transplantation can be safely deferred in those patients with a VO-2 max of greater than 14 ml/kg/min. The importance of the VO-2 max has also been emphasized by an American Heart Association Scientific Statement addressing heart transplant candidacy.  In past years, a left ventricular ejection fraction of less than 20% or a NYHA class III or IV status may have been used to determine transplant candidacy. However, as indicated by the ACC criteria above, these measurements are no longer considered adequate to identify transplant candidates. These measurements may be used to identify patients for further cardiovascular work-up, but should not be the sole criteria for transplant.
 
2007 Update - from ISHLT guidelines, 2006:
Guidelines addressing the management of heart failure are now available from the European Society of Cardiology (ESC) as well as the American College of Cardiology (ACC), American Heart Association (AHA) and Heart Failure Society of America (HFSA) in the USA; however, these statements are not comprehensive regarding the criteria for listing patients for heart transplantation.
 
CPX testing is routinely used in the determination of candidacy for cardiac transplantation.  Mancini et al first demonstrated the prognostic utility of CPX testing.  Patients were divided into 3 groups: peak Vo2 <14 ml/kg/min and eligible for transplantation; peak Vo2 <14 ml/kg/min and ineligible for transplantation; and peak Vo2 >14 ml/kg/min. Patients with a peak Vo2 <14 ml/kg/min had a significant survival benefit with cardiac transplantation compared with the group ineligible for transplantation and who continued on their current medical regimen. However, the cutoff peak Vo2 of 14 ml/kg/min was arbitrary. Within the entire group, patients with peak Vo2 <10 ml/kg/min had a lower survival rate than those with a peak Vo2 of between 10 and 14 ml/kg/min.  Based on this observation, the currently accepted indication for transplantation is patients with a peak Vo2 <10 ml/kg/min who achieved anaerobic threshold.  Patients with a peak Vo2 between 10 and 14 ml/kg/min who also have a major limitation to their activities of daily living (ADL) are categorized as having a probable indication for transplantation.
 
Since this initial study, advances in medical therapy and in the interpretation of CPX tests have occurred. β-blockers and implantable cardioverter defibrillators (ICDs) are now routinely prescribed for potential transplant patients.  Many patients also have biventricular pacemakers implanted. These therapies improve survival for heart failure patients.  However, with the exception of biventricular pacemakers, they do not appreciably change exercise capacity.  Consideration should be given to revising the existing listing criteria because currently used therapies can improve survival but have a negligible effect on exercise performance. Zugck et al evaluated a group of 408 patients with an average peak Vo2 of 14.4 ml/kg/min and found that the group taking a β-blocker had a significant reduction (34% vs 16%) in the combined end-point of hospital admission for worsening congestive heart failure (CHF) or death within 1 year.  This study was followed by 3 other studies, all of which showed improved survival in patients on β-blockers with an equivalent Vo2.  Peterson et al demonstrated that, for patients on β-blockers, only those with a peak Vo2 of <12 ml/kg/min had a survival advantage with cardiac transplantation at 1 year and 3 years.
 
Obese patients have a greater risk of morbidity and mortality after open-heart surgery.  This is manifested in poor wound healing, increased risk of infection, lower-extremity thrombosis and pulmonary complications. Several methods may be used to measure obesity, including BMI, percent ideal body weight (PIBW) and direct measure of adiposity. BMI is measured as weight in kilograms divided by height in meters squared, and PIBW is weight expressed as a percentage of the mean ideal weight for a given height and gender. Both have been found to be associated with outcomes.
 
In cardiac transplantation, one study reported that 55 obese (BMI >30 kg/m2) patients demonstrated nearly twice the 5-year mortality of 351 normal-weight or overweight recipients (53% vs 27%, respectively, p = 0.001).  In addition, these obese recipients had a shorter time to high-grade acute rejection (p = 0.004) as well as an increased annual high-grade rejection frequency when compared with normal-weight recipients (p = 0.001). By multivariate analysis, the incidence of transplant-related coronary artery disease (TCAD) was not increased in these obese patients.  Previous reports have demonstrated that obesity is a risk factor for the development of TCAD.  In a multicenter (Cardiac Transplant Research Database [CTRD]) study of 4,515 cardiac transplant patients, pre-operative obesity (>140% of PIBW) was associated with increased 4-year mortality in males (p < 0.001) and a trend toward increased mortality in females (p = 0.07). These obese patients also had increased infections after cardiac transplantation. The increased infection rate was observed in both males and females <55 years of age, and in patients with ischemic heart disease. In this study, pre–heart transplant BMI and PIBW were not associated with acute rejection or cardiac allograft arteriopathy after transplant.
 
A study that investigated factors predicting 10-year survival after heart transplantation found a lower incidence of pre–heart transplantation diabetes (in addition to donor age, incidence of infection, and rejection within 2 years of heart transplantation) in those with better survival.  The ISHLT registry demonstrated an approximately 20% to 40% increase in 1- and 5-year mortality, even in carefully selected diabetes patients.  A specific area of grave concern is the presence of autonomic dysfunction due to diabetes and in those individuals with hypoglycemia unawareness. Anecdotal evidence suggests that these sub-groups represent an area of concern in heart transplant candidates and caution must be exercised in such individuals.  Although background retinopathy alone is not considered a contraindication, proliferative retinopathy is.
 
2012 Update
This update focuses on the concerns regarding a potential recipient’s history of cancer which were based on the observation of significantly increased incidence of cancer in kidney transplant patients (Kasiske, 2004).  In fact, carcinogenesis is 2 to 4 times more common in heart transplant patients, likely due to the higher doses of immunosuppression necessary for the prevention of allograft rejection, the majority of which are skin cancers (Taylor, 2005).  The incidence of de novo cancer in heart transplant patients approaches 26% at 8 years post-transplant. For renal transplant patients who had a malignancy treated prior to transplant, the incidence of recurrence ranged from zero to more than 25% depending on the tumor type (Trofe, 2004; Otley, 2005).  However, it should be noted that the availability of alternate treatment strategies informs recommendations for a waiting period following high-risk malignancies: in renal transplant, a delay in transplantation is possible due to dialysis; end-stage heart failure patients may not have another option. A small study (n=33) of survivors of lymphoproliferative cancers who subsequently received cardiac transplant had 1-, 5-, and 10-year survival rates of 77%, 64%, and 50%, respectively (Taylor, 2000).  By comparison, overall 1-, 5-, and 10-year survival rates are expected to be 88%, 74%, and 55%, respectively, for the general transplant candidate. The evaluation of a candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. UNOS has not addressed malignancy in current policies. Therefore, the coverage statement has been changed to remove the criteria that excludes a transplant for recent history of malignancy. No studies were identified that would prompt additional changes to the coverage statement.
 
2013 Update
A literature search was conducted using the MEDLINE database through the period of July 2013. There was no new literature identified that would prompt a change in the coverage statement.
 
2014 Update
This policy was reviewed and a literature search was conducted through December 2013. The policy statement is changed to remove the exclusion for cadaver heart transplant based on BMI or PIBW. No literature was identified that would prompt any other changes in the coverage statement.
   
 
2015 Update
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Pediatric Considerations
According to OPTN data, in 2013, 193 heart transplants were performed in children younger than 18 Years (OPN, 2014). Five-year survival rates by age group were: <1 year: 71.7% (95% CI: 66.3% to 77.1%); 1-5 years: 74.6% (95% CI: 68.6% to 80.6%); 6-10 years: 77.3% (95% CI: 70.2% to 84.5%); and 11-17 years: 72.1% (95% CI: 67.1% to 77.1%). A retrospective analysis of OPTN data focusing on the adolescent population was published by Savla et al in 2014 (Savla, 2014). From 1987 to 2011, heart transplants were performed in 99 adolescents (age 13-18) with myocarditis and 456 adolescents with CHD. Among adolescent transplant recipients with myocarditis, median graft survival was 6.9 years (95% CI: 5.6 to 9.6 years, which was significantly less than other age groups (ie, 11.8 years and 12.0 years in younger and older adults, respectively). However, adolescents with CHD had a graft survival rate of 7.4 years (95% CI: 6.8 to 8.6 years), similar to that of other age groups.
 
Heart Retransplantation
An analysis of OPTN data from 1995 to 2012 reported that 987 retransplants were performed out of 28,464 heart transplants (3.5% of all transplants) (Belli, 2014). Median survival among retransplant recipients was 8 years. The estimated survival at 1, 5, 10 and 15 years following retransplant was 80%, 64%, 47% and 30%, respectively. Compared with primary transplant recipients, retransplant patients had a somewhat higher risk of death (RR: 1.27, 95% CI: 1.13 to 1.42).
 
Pediatric Considerations
As with initial heart transplants, children awaiting heart retransplantation have high waitlist mortality. A 2014 study by Bock et al evaluated data on 632 pediatric patients who were listed for a heart retransplant at least 1 year (median of 7.3 years) after the primary transplant (Bock, 2014). Patients’ median age was 4 years at the time of the primary transplant and 14 years when they were relisted. Median waiting time was 75.3 days and mortality was 25.2% (159 of 632). However, wait list mortality decreased significantly after 2006 (31% before 2006 and 17% after 2006, p<0.01).
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The demand for heart transplants far exceeds the availability of donor organs, and the length of time patients are on the waiting list for transplants has increased. According to data from the Organ Procurement and Transplantation Network (OPTN), in 2014, a total of 2655 heart transplants were performed in the United States.  As of October 30, 2015, there were 4207 patients on the waiting list for a heart transplant. Also in recent years, advances in medical and device therapy for patients with advanced heart failure has improved the survival of patients awaiting heart transplantation The chronic shortage of donor hearts has led to the prioritization of patients awaiting transplantation to ensure greater access for patients most likely to derive benefit. Prioritization criteria are issued by the Organ Procurement and Transplantation Network (OPTN) and fulfilled through a contract with the United Network for Organ Sharing (OPTN, 2015).
 
Initial Heart Transplant
Survival
According to the Organ Procurement and Transplantation Network (OPTN), based on available U.S. data as of October 30, 2015, the 1-year survival after heart transplant was 88.0% and 86.2% for men and women, respectively (OPTN, 2015). Three-year survival rates were 79.3% and 77.2% for men and women, respectively, and 5-year survival rates were 73.1% and 69.1% for men and women, respectively.
 
Rana and colleagues conducted a retrospective analysis of solid organ transplant recipients registered in the UNOS database from 1987 to 2012, including 54,746 patients who underwent a heart transplant (Rana, 2015). Transplant recipients were compared with patients listed for transplant but who did not receive a transplant after propensity score matching based on a variety of clinical characteristics. After matching, the median survival was 9.5 years in transplant recipients compared with 2.1 years in waiting list patients.
 
Pediatric Considerations
According to OPTN data, in 2014, 404 heart transplants were performed in children younger than 18 years (OPTN, 2015). Five-year survival rates by age group were: less than 1 year: 68.1% (95% confidence interval [CI] 62.6% to 73.7%); 1 to 5 years: 70.8% (95% CI 64.7% to 76.9%); 6 to 10 years: 75.0% (95% CI 67.6% to 82.3%); and 11 to 17 years: 68% (95% CI 62.9% to 82.3%). Data from the Pediatric Heart Transplant Study, which includes data on all pediatric transplants at 35 participating institutions, suggest that 5-year survival for pediatric heart transplants has improved over time (76% for patients transplanted from 2000- 2004 vs 83% for patients transplanted from 2005-2009) (Dipchand, 2013).
 
Heart Retransplantation
A 2014 study using data from the United Network for Organ Sharing (UNOS) reported that there were no survival differences between 3rd and 2nd transplants (76% for 3rd transplant vs 80% for 2nd transplant at1 year; 62% for 3rd transplant vs 58% for 2nd transplant at 5 years; 53% for 3rd transplant vs 34% for 2nd transplant at 10years, P=0.73) (Friedland, 2014). However, generalizing from this study’s results may be limited given the small number (n=25) of 3rd heart transplants.
 
Concerns regarding a potential recipient’s history of cancer were based on the observation of significantly increased incidence of cancer in kidney transplant patients. In fact, carcinogenesis, primarily skin cancers, is 2 to 4 times more common in heart transplant patients, likely due to the higher doses of immunosuppression necessary for the prevention of allograft rejection. The incidence of de novo cancer in heart transplant patients approaches 26% at 8 years posttransplant. For renal transplant patients who had a malignancy treated before transplant, the incidence of recurrence ranged from 0% to more than 25% depending on the tumor type with a mean incidence of cancer recurrence after heart transplant for all tumors reported at 11.5% (Yoosabai, 2015).  However, it should be noted that the availability of alternate treatment strategies informs recommendations for a waiting period following high-risk malignancies: in renal transplant, a delay in transplantation is possible due to dialysis; end-stage heart failure patients may not have another option. A small study (n=33) of survivors of lymphoproliferative cancers who subsequently received cardiac transplant had 1-, 5-, and 10-year survival rates of 77%, 64%, and 50%, respectively.37 By comparison, overall 1-, 5-, and 10-year survival rates are expected to be 88%, 74%, and 55%, respectively, for the general transplant candidate. The evaluation of a candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. UNOS has not addressed malignancy in current policies.
 
HIV
Solid organ transplant for patients who are HIV-positive was historically controversial, due to the long-term prognosis for HIV positivity and the impact of immunosuppression on HIV disease. The availability of highly active antiretroviral therapy (HAART), has markedly changed the natural history of the disease. A 2009 retrospective case series reported favorable outcomes for 7 patients with HIV who received a heart transplant (Uriel, 2009). There is little data directly comparing outcomes for patients with and without HIV.
 
The evidence for the use of heart transplant in individuals with end stage heart failure includes case series and registry data. Relevant outcomes include overall survival, symptoms, morbid events, and treatment-related morbidity and mortality. Despite an improvement in prognosis for many patients with advanced heart disease, heart transplant remains a viable treatment for those who have exhausted other medical or surgical remedies, yet are still in end-stage disease. Given the exceedingly poor survival without transplantation of patients who have exhausted other treatments, evidence of post-transplant survival is sufficient to demonstrate that heart transplantation provides a survival benefit in appropriately selected patients. Heart transplantation is contraindicated in patients in whom the procedure is expected to be futile due to comorbid disease or in whom post transplantation care is expected to significantly worsen comorbid conditions. Similarly, evidence suggests that heart retransplantation after a failed primary heart transplant provides a survival benefit in patients who still meet criteria for heart transplantation and do not have contraindications.
 
American College of Cardiology and American Heart Association
Guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) on the diagnosis and management of chronic heart failure, updated in 2005 and then in 2009, provide statements about the accepted indications, probable indications, and contraindications for heart transplantation (Hunt, 2005):
 
Adult Patients
  1. Accepted Indications for Transplantation
    1. Hemodynamic compromise due to heart failure demonstrated by any of the following 3 bulleted items,
        • Maximal VO2 (oxygen consumption) <10 mL/kg/min with achievement of anaerobic metabolism
        • Refractory cardiogenic shock
        • Documented dependence on intravenous inotropic support to maintain adequate organ perfusion,
Or
2.  Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty, or
3. Recurrent symptomatic ventricular arrhythmias refractory to ALL accepted therapeutic modalities.
II. Probable Indications for Cardiac Transplantation
    1. Maximal VO2 <14 mL/kg/min and major limitation of the patient’s activities, or
    2. Recurrent unstable ischemia not amenable to bypass surgery or angioplasty, or
    3. Instability of fluid balance/renal function not due to patient noncompliance with regimen of weight monitoring, flexible use of diuretic drugs, and salt restriction
III. The following conditions are inadequate indications for transplantation unless other factors as listed above are present.
    1. Ejection fraction <20%
    2. History of functional class III or IV symptoms of heart failure
    3. Previous ventricular arrhythmias
    4.  Maximal VO2 >15 mL/kg/min
 
Pediatric Patients
  1. Patients with heart failure with persistent symptoms at rest who require one or more of the following:
      • Continuous infusion of intravenous inotropic agents, or
      • Mechanical ventilatory support, or
      • Mechanical circulatory support.
  1. Patients with pediatric heart disease with symptoms of heart failure who do not meet the above criteria but who have:
      • Severe limitation of exercise and activity (if measurable, such patients would have a peak maximum oxygen consumption <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 potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or
      • Anatomical and physiological conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or
      • Anatomical and physiological conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction.
 
International Society for Heart and Lung Transplantation (ISHLT)
In 2014, the ISHLT issued updated guidelines on the management of pediatric heart failure (ISHLT, 2014). These guidelines do not provide updated guidance about transplantation listing because the IHSLT was in the process of updating its overall guidance about heart transplantation listing criteria.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2018. No new literature was identified that would prompt a change in the coverage statement.
 
According to data from the Organ Procurement and Transplantation Network, in 2016, a total of 3191 heart transplants were performed in the United States (OPTN, 2017). As of July 16, 2017, there were 3996 patients on the waiting list for a heart transplant. In recent years, innovations in medical and device therapy for patients with advanced heart failure has also improved the survival of patients awaiting heart transplantation.
 
Pediatric Considerations
According to OPTN, patients between the ages of 11 and 17 years old held the highest 1- and 3- year survival rates among pediatric patients who underwent a heart transplant in the U.S. between 2008 and 2015. Patients younger than 1 year of age had the lowest 1-, 3-, and 5-year survival rates among pediatric patients.
 
Rossano et al (2016) examined survival among pediatric heart transplant recipients using the ISHLT Registry (Rossanl, 2016). Among 12,091 pediatric patients undergoing heart transplantation between 1982 and 2014, the overall median survival was 20.7 years for infants (n=2994), 18.2 years for children between the ages of 1-to-5 years old (n=2720), 14.0 years for those ages 6-to-10 years old (n=1743), and 12.7 years for those ages 11-to-17 years old (n=4684). Because the first year posttransplant represents the greatest risk for mortality, survival conditional on survival to 1 year was longer.
 
Authors conducted a multivariable analysis of pediatric patients undergoing heart transplant between 2003 and 2013 to identify the factors associated with 1-year mortality. Infection requiring intravenous drug therapy within 2 weeks of transplant (HR=1.36; 95% CI, 1.10 to 1.68; n=681), ventilator use (HR=1.41; 95% CI, 1.13 to 1.76; n=826), donor cause of death (cerebrovascular accident vs head trauma; HR=1.59; 95% CI, 1.20 to 2.09; n=396), diagnosis (congenital heart disease [CHD] vs cardiomyopathy; HR=1.91; 95% CI, 1.46 to 2.52; n=1979; retransplant vs cardiomyopathy; HR=2.23; 95% CI, 1.53 to 3.25; n=304), recipient dialysis (HR=2.36; 95% CI, 1.57 to 3.57; n=146), extracorporeal membrane oxygenation (ECMO) with a diagnosis of CHD vs no ECMO (HR=2.42; 95% CI, 1.74 to 3.35; n=145), ischemic time (p<0.001), donor weight (p<0.001), estimated glomerular filtration rate (eGFR; p=0.002), and pediatric center volume (p<0.001) were risk factors for 1-year mortality. Earlier era (1999-2000 vs 2007-2009), CHD (vs dilated cardiomyopathy), use of ECMO (vs no device), and pediatric center volume were risk factors for 5-, 10-, and 15-year mortality. A panel-reactive antibody greater than 10% was associated with worse 5- and 10-year survival and eGFR was associated with 5- and 10-year mortality.
 
Data from the Pediatric Heart Transplant Study (2013), which includes data on all pediatric transplants at 35 participating institutions, suggest that 5-year survival for pediatric heart transplants has improved over time (76% for patients transplanted from 2000 to 2004 vs 83% for patients transplanted from 2005 to 2009) (Dipchand, 2013).
 
 
Malignancy
Pretransplant malignancy is considered a relative contraindication for heart transplantation because malignancy has the potential to reduce life expectancy and could prohibit immune suppression after transplantation. However, with improved cancer survival over the years and use of cardiotoxic chemotherapy and radiotherapy, the need for heart transplantation has increased in this population, Mistiaen et al (2015) conducted a systematic review to study posttransplant outcomes of patients with pretransplant malignancy (Mistiaen, 2015). Most selected studies were small case series (median sample size, 17 patients; range, 7-1117 patients; mean age range, 6-52 years). Hematologic malignancy and breast cancer were the most common types of pretransplant malignancies. Dilated, congestive, or idiopathic cardiomyopathy were the most common reasons for transplantation in 4 case series, chemotherapy-related cardiomyopathy was the most important reason for transplantation in the other series. Hospital mortality rates varied between 0% and 33%, with small sample size potentially explaining the observed variation. One large series (2012) reported similar short- and long-term posttransplant survival rates for patients who received chemotherapy-related (n=232) and for those with other nonischemic-related cardiomyopathy (n=8890) (Oliveira, 2012). The 1-, 3-, and 5-year survival rates of were 86%, 79%, and 71% for patients with chemotherapy-related cardiomyopathy compared with 87%, 81%, and 74% for other transplant patients, respectively. Similar findings were observed for 1-year survival in smaller series. Two-, 5-, and 10-year survival rates among patients with pretransplant malignancy were also comparable with other transplant patients. In addition to the non-malignancy-related factors such as cardiac, pulmonary, and renal dysfunction, 2 malignancy-related factors were identified as independent predictors of 5-year survival. Malignancy-free interval (the interval between treatment of cancer and heart transplantation) of less than 1 year was associated with lower 5-year survival (<60%) than with a longer interval (>75%). Patients with prior hematologic malignancies had increased posttransplant mortality rates in 3 small series. Recurrence of malignancy was more frequent among patients with a shorter disease-free interval (63%, 26%, and 6% among patients with <1 year, 1-5 years, and >5 years of disease-free interval, respectively) (Sigurdardottir, 2012).
 
Yoosabai et al (2015) retrospectively reviewed data on 23,171 heart transplant recipients in the OPTN/UNOS database to identify whether pretransplant malignancy increases the risk of posttransplant malignancy (Yoosabai, 2015). Posttransplant malignancy was diagnosed in 2673 (11.5%) recipients during the study period. A history of any pretransplant malignancy was associated with increased risk of overall posttransplant malignancy (subhazard ratio [SHR], 1.51; p<0.01), skin malignancies (SHR=1.55, p<0.01), and solid organ malignancies (SHR=1.54, p<0.01) on multivariate analysis.
 
The evaluation of a candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients for whom cancer is thought to be cured should not be excluded from consideration for transplant. ISHLT guidelines have recommended stratifying each patient with pretransplant malignancy as to his or her risk of tumor recurrence and that cardiac transplantation should be considered when tumor recurrence is low based on tumor type, response to therapy, and negative metastatic work-up. The guidelines also recommended that the specific amount of time to wait to transplant after neoplasm remission will depend on these factors and no arbitrary time period for observation should be used.
 
HIV Infection
Solid organ transplant for patients who are HIV-positive was historically controversial, due to the long-term prognosis for HIV positivity and the impact of immunosuppression on HIV disease. The availability of highly active antiretroviral therapy (HAART) has markedly changed the natural history of the disease. Aguero et al (2016) reported of a review on heart transplants among HIV-infected patients (Aguero, 2016). Since 2001, 12 heart transplantations in HIV-infected patients have been reported and 3 patients acquired HIV after heart transplantation. Fourteen (93%) of these 15 patients were younger than 50 years of age, with cluster of differentiation 4 (CD4) counts greater than 200 cells/mm3, and all recipients were taking antiretroviral therapy. Thirteen were alive with normal graft function at the end of follow-up. One patient had suboptimal adherence to antiretroviral therapy and died of multiorgan failure. The cause of death in the other patient was not reported (Uriel, 2009). There are few data directly comparing outcomes for patients with and without HIV.
 
Age
The maximum acceptable age for heart transplantation is an issue for debate. While the maximum recipient age for heart transplantation was set at 55 years during the early years of heart transplantation, with increasing evidence of comparable survival rates among older population following heart transplantation, transplant centers have been accepting older recipients. However, the upper age limit for heart transplant candidates is still controversial and is generally defined by the transplant centers.
 
Cooper et al (2016) analyzed UNOS data to assess the long-term outcomes of older recipients of orthotopic heart transplantation (OHT) in the United States between 1987 and 2014 (Cooper, 2016). During this period, 50,432 patients underwent OHT; 71.8% (n=36,190) were 18 to 59 years old, 26.8% (n=13,527) were 60 to 69 years old, and 1.4% (n=715) were 70 years old of age or older. The 5-year mortality rate was 26.9% for recipients 18 to 59 years old, 29.3% for recipients 60 to 69 years old, and 30.8% for recipients 70 years of age and older. Survival between the oldest group and the 60- to 69-year-old group did not differ significantly (p=0.48).
 
Awad et al (2016) reported on a single-center retrospective review of 704 adults who underwent heart transplantation from 1988 to 2012 to investigate the mortality and morbidity rates of heart transplantations among recipients 70 years of age and older (n=45) compared with recipients younger than 70 years (n=659) (Awad, 2016). The older and younger groups had similar 1-year (93.0 vs 92.1; p=0.79), 5-year (84.2 vs 73.4; p=0.18), and 10-year (51.2 vs 50.2; p=0.43) survival rates, respectively.
 
In 2012, Kilic et al analyzed UNOS data on 5330 patients age 60 and older (mean age, 63.7 years) who underwent heart transplantation between 1995 and 2004 (Kilic, 2012). A total of 3492 (65.5%) patients survived to 5 years. In multivariate analysis, statistically significant predictors of 5-year survival included younger age (OR=0.97; 95% CI, 0.95 to 1.00), younger donor age (OR=0.99; 95% CI, 0.99 to 1.00), white race (OR=1.23; 95% CI, 1.02 to 1.49), shorter ischemic time (OR=0.93; 95% CI, 0.87 to 0.99), and lower serum creatinine (OR=0.92; 95% CI, 0.87 to 0.98). In addition, hypertension, diabetes, and mechanical ventilation each significantly decreased the odds of surviving to 5 years. Patients with 2 or more of these factors had a 12% lower rate of 5-year survival than those with none of them.
Children With Intellectual Disability
Considering the shortage of available donor organs, heart transplantation in children with intellectual disability has been debated. In 2016, ISHLT removed explicit mention of “mental retardation” as a relative contraindication to heart transplantation from its official guidelines. Multiple studies in recent years have examined whether intellectual disability in children is associated with significantly lower survival following heart transplantation compared with children without intellectual disability.
 
Goel et al (2017) conducted a retrospective cohort study using UNOS data from 2008 to 2015 to evaluate the prevalence and outcomes of heart transplantation in this population (Goel, 2017). Intellectual disability was assessed by using the cognitive development, academic progress, and academic level (5-point Likert scale scores for each of those) reported by transplant centers to UNOS. There were 565 pediatric (<19 years) patients with definite (n=131) or probable (n=434) intellectual disability who received their first heart transplant, accounting for 22.4% of all first pediatric heart transplants (N=2524). Intellectual disability was associated with prolonged waitlist time (p<0.001). Patient survival rates at 1 and 3 years, respectively, were 88.9% and 86.0% for the definite intellectual disability group, 91.6% and 82.4% for probable intellectual disability group, and 91.8% and 86.2% for no intellectual disability group. Patient survival did not differ between groups at any time posttransplant (p=0.578). Intellectual disability status at listing was not associated with graft mortality hazards in univariate and multivariate analyses.
 
Wightman et al (2017) performed a retrospective cohort analysis of 1204 children receiving a first isolated heart transplant for whom cognitive and educational data were available in the UNOS dataset between 2008 and 2013 (Wightman, 2017). Children categorized as “definitely cognitive delay/impairment” by their transplant center using the Likert scales for cognitive development. All other recipients were classified as “no intellectual disability.” Kaplan-Meier curves and log-rank tests did not suggest a significant difference in graft survival during the first 4 years after transplantation (p=0.07), however, they did suggest poorer patient survival among the intellectual disability group during the first 4 years following transplantation (p=0.05). In unadjusted Cox regression, intellectual disability was associated with poorer graft (HR=1.66; 95% CI, 1.01 to 2.72; p=0.05) and patient survival (HR=1.71; 95% CI, 0.99 to 2.94; p=0.05). However, after adjusting for covariates, there was no association between intellectual disability and graft survival (HR=0.95; 95% CI, 0.49 to 1.88; p=0.89) or patient survival (HR=0.80; 95% CI, 0.36 to 1.75; p=0.58).
 
Prendergast et al (2017) assessed the impact of cognitive delay on pediatric heart transplantation outcomes using academic progress as a surrogate for cognitive performance among pediatric heart transplant recipients (2004-2014) with data reporting academic progress in the OPTN database (n=2245) (Prendergast, 2017). Of the patients with complete academic progress data, 1707 (76%) were within 1 grade level of peers (WGL), 269 (12%) had delayed grade level, and 269 (12%) required special education. There was no significant difference in posttransplant survival between patients WGL and those who required special education. However, patients with delayed grade level demonstrated worse posttransplant survival than patients WGL and those who required special education (p<0.001). Delayed grade level remained as an independent predictor of posttransplant graft loss (adjusted HR=1.4; 95% CI, 1.02 to 1.79; p=0.03) in multivariate analysis. Authors conducted a secondary analysis substituting cognitive delay for academic progress; patients were divided into 2 groups based on whether any concerns for cognitive delay (questionable, probable, or definite) were ever reported at the time of heart transplantation or during follow-up (1176 with cognitive delay, 1783 with no documented cognitive delay). There was no significant difference in posttransplant graft survival based on the presence of cognitive delay (p=0.57). Cognitive delay remained a statistically nonsignificant predictor in multivariate analysis (adjusted HR=1.01; 95% CI, 0.83 to 1.22; p=0.953).
Because all these studies assessed the patients who received transplants and did not evaluate children who were refused listing by a transplant center or never referred to transplant center, the prevalence of intellectual disability among potential candidates of heart transplantation might have been underestimated. With low-risk intellectual disability patients receiving heart transplant and individuals with intellectual disability and other high-risk conditions being excluded, results might also have a positive selection bias.
 
 
PRACTICE GUIDELINES AND POSITION STATEMENTS
 
American College of Cardiology Foundation and American Heart Association
Guidelines from the American College of Cardiology Foundation and American Heart Association on management of heart failure, updated in 2013, recommended evaluation for cardiac transplantation for patients with stage D heart failure despite guideline-directed medical therapy, device, and surgical management (Yancy, 2013).
 
International Society for Heart and Lung Transplantation
In a 2004 statement, the International Society for Heart and Lung Transplantation (ISHLT) recommended that children with the following conditions be evaluated for heart transplantation (Rosenthal, 2004):
    • Diastolic dysfunction that is refractory to optimal medical/surgical management because they are at high risk of developing pulmonary hypertension and of sudden death
    • Advanced systemic right ventricular failure (Heart Failure Stage C described as patients with underlying structural or functional heart disease and past or current symptoms of heart failure that is refactory to medical therapy
 
In 2016, ISHLT published a 10-year update to its listing criteria for heart transplantation (Mehra, 2016). The guidelines recommended updates or changes to the 2006 guideline:
    • Recommended use of heart failure prognosis scores (eg, Seattle Heart Failure Model, Heart Failure Survival Score) along with cardiopulmonary exercise test to determine prognosis and guide listing for transplantation for ambulatory patients.
    • Periodic right heart catheterization for routine surveillance is not recommended in children
    • Carefully selected patients >70 years of age may be considered for cardiac transplantation.
    • Pre-existing neoplasm, BMI of 35 kg/m2, diabetes with “end-organ damage (other than non-proliferative retinopathy) or poor glycemic control … despite optimal effort,” irreversible renal dysfunction, clinically severe symptomatic cerebrovascular disease, peripheral vascular disease, and frailty are considered relative contraindications to heart transplantation.
    • Considering active smoking during previous 6 months as a risk factor for poor outcomes after transplantation, active tobacco smoking is considered a relative contraindication for heart transplantation. Similarly, patients who remain active substance abusers (including alcohol) are nor recommended to receive heart transplantation.
 
The 2010 guidelines from ISHLT include the following recommendations on cardiac retransplantation (Costanzo, 2010):
    • “Retransplantation is indicated in children with at least moderate systolic heart allograft dysfunction and/or severe diastolic dysfunction and at least moderate CAV (cardiac allograft vasculopathy).”
    • “It is reasonable to consider listing for retransplantation those adult HT [heart transplant] recipients who develop severe CAV not amenable to medical or surgical therapy and symptoms of heart failure or ischemia.”
    • “It is reasonable to consider listing for retransplantation those HT recipients with heart allograft dysfunction and symptomatic heart failure occurring in the absence of acute rejection.”
    • “It is reasonable to consider retransplantation in children with normal heart allograft function and severe CAV.”
 
American Heart Association
The American Heart Association indicated in 2007 that, based on level B (nonrandomized studies) or level C (consensus opinion of experts) evidence, heart transplantation is indicated for pediatric patients as therapy for the following indications (Canter, 2007):
    • Stage D heart failure (interpreted as abnormal cardiac structure and/or function, continuous infusion of intravenous inotropes, or prostaglandin E1 to maintain patency of a ductus arteriosus, mechanical ventilatory and/or mechanical circulatory support) associated with systemic ventricular dysfunction in patients with cardiomyopathies or previous repaired or palliated congenital heart disease,
    • Stage C heart failure (interpreted as abnormal cardiac structure and/or function and past or present symptoms of heart failure) associated with pediatric heart disease and severe limitation of exercise and activity, in patients with cardiomyopathies or previously repaired or palliated congenital heart disease and heart failure associated with significant growth failure attributed to heart disease, pediatric heart disease with associated near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator, or in pediatric restrictive cardiomyopathy disease associated with reactive pulmonary hypertension;
    • The guidelines state that heart transplantation is feasible in the presence of other indications for heart transplantation, “in patients with pediatric heart disease and an elevated pulmonary vascular resistance index >6 Woods units/m2 and/or a transpulmonary pressure gradient >15 mm Hg if administration of inotropic support or pulmonary vasodilators can decrease pulmonary vascular resistance to <6 Woods units/m2 or the transpulmonary gradient to <15 mm Hg.”
 
European Society of Cardiology
The 2016 European Society of Cardiology guidelines on the diagnosis and treatment of acute and chronic heart failure recommended considering heart transplantation for patients with end-stage heart failure with severe symptoms, poor prognosis, and no alternative treatment options (Ponikowski, 2016). Active infection, severe peripheral arterial or cerebrovascular ischemia, pharmacologically irreversible pulmonary hypertension, cancer, renal insufficiency, systemic disease with multiorgan involvement, pretransplant body mass index greater than 35 kg/m2, current alcohol or drug abuse, and insufficient social support to achieve compliant care in outpatient setting were considered relative contraindications for heart transplantation.
 
ONGOING AND UNPUBLISHED CLINICAL TRIALS
A search of ClinicalTrials.gov in July 2017 did not identify any ongoing or unpublished trials that would likely influence this review.
 
2019 Update
A literature search was conducted through December 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
2020 Update
A literature search was conducted through December 2019.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2019, 39,719 transplants were performed in the United States procured from almost 11,900 deceased donors and 7,400 living donors (UNOS, 2020). Heart transplants were the third most common procedure with 3,552 transplants performed from both deceased and living donors in 2019.
 
Alshawabkeh et al reported on the 1-year probability of the combined outcome of death or delisting due to clinical worsening for patients on the heart transplant waiting list, comparing the periods of April 1, 1986 to January 19, 1999, (early era) and January 20, 1999 to June 2, 2014 (current era) (Alshawabkeh, 2018). For adults without congenital heart disease (CHD), the probability of the combined outcome was lower in the current era compared with the early era, regardless of whether the patient was listed in status I (14.5% vs 22.7%; p<0.0001) or 2 (9.0% vs 12.8%, p<0.0001). When comparing the current and early eras in adults with CHD, a reduction in the probability of the combined outcome was demonstrated in those listed in status I (17.6% vs 43.3%, respectively; p<0.0001), whereas the outcome remained unchanged for those listed in status 2 (10.6% vs 10.4%, respectively; p=0.94).
 
In adults with CHD, factors associated with waitlist death or delisting due to clinical worsening within 1 year were also examined by Alshawabkeh et al (Alshawabkeh, 2016). A multivariate analysis identified that an estimated glomerular filtration rate less than 60 ml/min/1.73 m2 (hazard ratio [HR], 1.4; 95% confidence interval [CI], 1.0 to 1.9; p=0.043), albumin less than 3.2 g/dl (HR, 2.0; 95% CI, 1.3 to 2.9; p<0.001), and hospitalization at the time of listing in the intensive care unit (HR, 2.3; 95% CI, 1.6 to 3.5; p<0.001) or a non-intensive care hospital unit (HR, 1.9; 95% CI, 1.2 to 3.0; p=0.006) were associated with waitlist death or delisting due to clinical worsening within 1 year.
 
Magnetta et al reported outcomes for children on the heart transplant waiting list, comparing the periods of December 16, 2011 to March 21, 2016 (era 1), and March 22, 2016 to June 30, 2018 (era 2) (Magnetta, 2019). There was a significant decrease from era 1 to era 2 in the proportion of patients listed as status 1 (70% vs 56%; p<0.001), while the proportion of patients with CHD significantly increased across eras (49% to 54%; p=0.018). The median time on the waitlist increased from 68 days to 78 days (p=0.005). There were no significant differences across eras in the cumulative incidence of death on the waitlist among all candidates (subdistribution hazard ratio, 0.96; 95% CI, 0.80 to 1.14; p=0.63) and among those listed status 1A (subdistribution hazard ratio, 1.16; 95% CI, 0.95 to 1.41; p= 0.14). Graft survival at 90 days was also similar across eras in the overall population and in those with CHD (p>0.53 for both).
 
In a study analyzing UNOS data from January 1996 and November 2017, Miller et al reported that 349 (0.6%) early/acute retransplants (occurring 1 year after the previous transplant) and 2,202 (3.5%) late retransplants (occurring >1 year after the previous transplant) were performed from a sample of 62,112 heart transplants (Miller, 2019). Compared with a matched group of patients undergoing initial transplantation, patients undergoing late retransplantation were not at an increased risk of death (HR, 1.08; p=0.084) or the combined outcome of death or retransplantation (HR, 1.07; p=0.114). Additionally, patients undergoing late retransplant had comparable rates of 1-year all-cause mortality when compared to patients undergoing initial transplant (13.8% vs 14.5%, respectively; p=0.517). Conversely, patients undergoing early/acute transplant had higher rates of 1-year all-cause mortality when compared to patients undergoing initial transplant (35% vs 21.6%; p<0.001). Furthermore, early/acute retransplantation was associated with an increased risk of all-cause mortality (HR, 1.79; p<0.001) and the combined outcome of death or retransplantation (HR, 1.72; p<0.001).
 
A retrospective report by Arshad et al compared renal outcomes and survival in patients who received an LVAD (n=45) or heart transplant (n=58) (Arshad, 2019). The eGFR was similar between LVAD and transplant groups on day 30 after procedure (75.1 mL/min/1.73 m2 and 65.8 mL/min/1.73 m2, respectively; p=0.057), and significantly higher with LVAD versus transplant at 6 months (68.3 mL/min/1.73 m2 and 59.4 mL/min/1.73 m2; p=0.046) and 1 year (68.3 mL/min/1.73 m2 and 56.8 mL/min/1.73 m2; p=0.15). Survival rates were similar between LVAD and transplant groups at 1 year (84.4% and 81.0%, respectively; p=0.540) and 2 years (78.3% and 78.8%, respectively; p=0.687) after the procedure.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In the U.S., approximately 6 million people 20 years of age and older have heart failure and 1 in 8 deaths have heart failure mentioned on the death certificate (Virani, 2021).
 
There are few data directly comparing outcomes for patients with and without HIV. In 2021, Doberne et al compared survival outcomes of cardiac transplantation in HIV-positive recipients with HIV-negative recipients (Doberne, 2021). Utilizing UNOS data on first-time heart transplant recipients and their donors between January 2005 and June 2019, a total of 75 HIV-positive transplant recipients and 29,848 HIV-negative recipients were included in an analysis. Results revealed no difference in 30-day, 1-year, and 5-year survival of HIV-positive versus HIV-negative heart transplant recipients. However, HIV-positive recipients had significantly longer median lengths of hospital stays (18 vs. 15 days; p=.006), rate of acute rejection during initial hospitalization (38.7% vs. 17.7%; p<.001), and rate of anti-rejection treatment administration (26.7% vs. 10.4%; p<.001).
 
Wightman et al also investigated the prevalence and long-term outcomes of initial kidney, liver, and heart transplants from 2008 to 2017 using UNOS data in children with an intellectual disability (Wightman, 2021). During this study period, children with definite intellectual disability accounted for 324 (9%) of 3722 initial heart transplant recipients. In these patients, intellectual disability was not significantly associated with patient or graft survival.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Zhu et al evaluated outcomes after heart retransplantation for 123 patients (112 adult and 11 pediatric patients) as compared to those who received a primary heart transplant at a single-center over a 50-year period (January 6, 1968 to June 2019) (Zhu, 2022). The indications for retransplantation included cardiac allograft vasculopathy (80%), primary graft dysfunction (15%), and refractory acute rejection (5%). The mean time interval between the primary and re-transplant was 6.4 years. Patients who underwent a retransplantation were significantly more likely to have hypertension (73.3% vs. 53.3%; p=.0022), hyperlipidemia (66.7% vs. 30.7%; p<.0001), and require dialysis (11.7% vs. 2.9%; p=.0025) as compared to those undergoing a primary heart transplant. After matching, postoperative outcomes and complications including hospital stay (mean 22.9 vs. 25.8 days; p=.49), intensive care unit stay (mean 12.2 vs. 9.9 days; p=.48), respiratory failure (41.7% vs. 20.6%; p=.083), dialysis (21.2% vs. 24.2%; p=.82), pneumonia (12.9% vs. 9.6%; p=.48), septicemia (1.6% vs. 9.4%; p=.10), and rejection within the first year after transplantation requiring hospitalization (21.5% vs. 26.2%; p=.82) were similar between the retransplant and primary transplant groups, respectively. Matched median survival after retransplantation was 4.6 years versus 6.5 years after primary heart transplantation (p=.36).
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Heart failure guidelines from the American College of Cardiology Foundation, the American Heart Association, and the Heart Failure Society of America were updated in 2022 (Heidenreich, 2022).
 
Recommendations for cardiac transplantation by the joint committee were as follows:
 
    • "For selected patients with advanced HF [heart failure] despite GDMT [guideline-directed medical therapy], cardiac transplantation is indicated to improve survival and QOL [quality of life] (class of recommendation, 1; level of evidence, C-LD)
    • In patients with stage D (advanced) HF despite GDMT, cardiac transplantation provides intermediate economic value (value statement: intermediate value)"

CPT/HCPCS:
33940Donor cardiectomy (including cold preservation)
33945Heart transplant, with or without recipient cardiectomy

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