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Heart Transplant and Combined Heart-Kidney Transplantation

Policy Number: MP-390

Latest Review Date: September 2022

Category: Surgery                                                                  

POLICY:

Effective for dates of service on or after November 15, 2022:

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

Adult Patients:

I. Accepted Indications for Transplantation

  1. Hemodynamic compromise due to heart failure demonstrated by any of the following 3 bulleted items; OR
  • Maximal V02 (oxygen consumption) <10 ml/kg/min with achievement of anaerobic metabolism; or
  • Refractory cardiogenic shock; or
  • Documented dependence on IV inotropic support to maintain adequate organ perfusion

      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.

      2.     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.

Heart retransplantation after a failed primary heart transplant may be considered medically necessary in patients who meet criteria the for heart transplantation.

Combined heart-kidney transplantation may be considered medically necessary in patients who qualify for heart transplantation and have advanced irreversible kidney disease.

Heart transplantation is considered investigational in all other situations.

Patients must meet the United Network for Organ Sharing (UNOS) guidelines for Status 1A, 1B or 2 (and not currently be Status 7).

Note: For Heart/Lung transplantation refer to medical policy #373-Heart/Lung Transplant.

POLICY GUIDELINES:

General Criteria

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

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

Policy-specific potential contraindications include:

  • Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance (PVR) greater than 5 Woods units, or trans-pulmonary gradient (TPG) greater than or equal to 16mm/Hg despite treatment*;
  • Severe pulmonary disease despite optimal medical therapy, not expected to improve with heart transplantation*.

Cardiac Specific Guidelines:

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

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

Specific criteria for prioritizing donor thoracic organs for retransplant include severe coronary allograft vasculopathy, mild or moderate coronary allograft vasculopathy with a left ventricular ejection fraction less than 45%, coronary allograft vasculopathy with restrictive physiology, or symptomatic graft dysfunction without evidence of active rejection.

Effective for dates of service on or after September 1, 2020 through November 14, 2022:

Human heart transplantation may be considered medically necessary for coverage for selected adult and pediatric patients with end-stage heart disease.

EACH candidate (Adult or Pediatric) must meet ALL of the following criteria:

  • Absence of irreversible end stage disease not attributed to heart or kidney disease.
  • Absence of significant infection that could be exacerbated by immunosuppressive therapy (e.g., chronic active viral hepatitis B, hepatitis C, and human immunodeficiency virus).
  • Absence of significant systemic disease or multisystemic disease (other than cardiorenal failure) that could be exacerbated by immunosuppression.
  • No history of malignancy within 5 years of transplantation, excluding non-melanomatous skin cancers, AND
  • Documentation of patient compliance with medical management.

I. Adult Patients:

   1. Accepted Indications for Transplantation

   2. Hemodynamic compromise due to heart failure demonstrated by any of the following 3 bulleted items; OR

  • Maximal V02 (oxygen consumption) <10 ml/kg/min with achievement of anaerobic metabolism; or
  • Refractory cardiogenic shock; or
  • Documented dependence on IV inotropic support to maintain adequate organ perfusion

   3.   Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty; OR

   4.   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.

    2.     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.

Heart retransplantation after a failed primary heart transplant may be considered medically necessary in patients who meet criteria the for heart transplantation.

Combined heart-kidney transplantation may be considered medically necessary in patients who qualify for heart transplantation and have advanced irreversible kidney disease.

Heart transplantation is considered investigational in all other situations.

Heart transplantation for patients who are HIV-positive may be considered medically necessary when:

  • Adherent with treatment, particularly antiretroviral therapy; and
  • CD4 count greater than 100 cells/mL (ideally >200 cells/mL) for at least 3 months; and
  • Undetectable HIV viremia (<50 HIV-1 RNA copies/mL) for at least 6 months; and
  • No opportunistic infections for at least 6 months; and
  • No history of progressive multifocal leukoencephalopathy, chronic intestinal cryptosporidiosis, or lymphoma.

POLICY GUIDELINES:

Heart transplantation in patients with the following absolute contraindications, as defined by the American Society of Transplantation in Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation, is considered not medically necessary:

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

Policy-specific potential contraindications include:

  • Pulmonary hypertension that is fixed as evidenced by pulmonary vascular resistance (PVR) greater than 5 Woods units, or trans-pulmonary gradient (TPG) greater than or equal to 16mm/Hg despite treatment*;
  • Severe pulmonary disease despite optimal medical therapy, not expected to improve with heart transplantation*.

Patients must meet the United Network for Organ Sharing (UNOS) guidelines for Status 1A, 1B or 2 (and not currently be Status 7).

Note:  For Heart/Lung transplantation refer to policy #373-Heart/Lung Transplant.

Cardiac Specific Guidelines:

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

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

Specific criteria for prioritizing donor thoracic organs for retransplant include severe coronary allograft vasculopathy, mild or moderate coronary allograft vasculopathy with a left ventricular ejection fraction less than 45%, coronary allograft vasculopathy with restrictive physiology, or symptomatic graft dysfunction without evidence of active rejection.

DESCRIPTION OF PROCEDURE OR SERVICE:

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

Solid Organ Transplantation

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. Many advances have been made in the last several decades to reduce perioperative complications. Available data supports 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 Organ Procurement and Transplantation Network and United Network for Organ Sharing.

Heart Transplant

In 2021, 41,354 transplants were performed in the United States procured from 13,863 deceased donors and 6,540 living donors. Heart transplants were the third most common procedure with 3,817 transplants performed from both deceased and living donors in 2021. As of June 2022, there were 3,443 patients on the waiting list for a heart transplant.

At the time of transplant, most heart transplant recipients now are hospitalized as status 1 patients. This shift has occurred due to the increasing demand for the limited 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 (2007) 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. 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.

In 2010, Johnson et al reported on waiting list trends in the U.S. between 1999 and 2008. 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 (2020) evaluated survival among patients (N=95,323) wait-listed for heart transplantation between January 1, 1987 and December 29, 2017 using UNOS data. 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).

In 2018, 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). 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 (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.

In 2019, 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). 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).

Consequently, 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. 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. 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. 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 (2006) introduced the model using a multivariate analysis of data from the Prospective Randomized Amlodipine Survival Evaluation-1 heart failure trial (N=1125). 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. None of these models has been universally adopted by transplant centers.

KEY POINTS:

The most recent literature update was performed through June 10, 2022.

Due to the nature of the population discussed herein, there are no RCTs comparing heart transplantation with alternatives, including ventricular assist devices (LVADs). Systematic reviews are based on case series and registry data. RCTs have been published on related

topics (e.g., comparing surgical technique, infection prophylaxis regimens, or immunosuppressive therapy) but are not germane to this evidence review.

Summary of Evidence

For individuals who have end-stage heart failure who receive a heart transplant, the evidence includes retrospective studies and registry data. Relevant outcomes are overall survival, symptoms, and morbid events. Heart transplant remains a viable treatment for those with severe heart dysfunction despite appropriate medical management with medication, surgery, or medical devices. Given the exceedingly poor survival rates without transplantation for these patients, evidence of posttransplant survival is sufficient to demonstrate that heart transplantation provides a survival benefit. Heart transplantation is contraindicated in patients for whom the procedure is expected to be futile due to comorbid disease or in whom posttransplantation care is expected to worsen comorbid conditions significantly. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have had a prior heart transplant complicated by graft failure or severe dysfunction of the heart who receive a heart retransplant, the evidence includes systematic reviews, retrospective studies, and registry data. Relevant outcomes are overall survival, symptoms, and morbid events. Despite improvements in the prognosis for many patients with graft failure, cardiac allograft vasculopathy, and severe dysfunction of the transplanted heart, heart retransplant remains a viable treatment for those whose severe symptoms persist despite treatment with other medical or surgical remedies. Given the exceedingly poor survival rates without retransplantation for patients who have exhausted other treatments, evidence of posttransplant survival is sufficient to demonstrate that heart retransplantation provides a survival benefit in appropriately selected patients. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

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 were updated in 2017. Evaluation for heart transplantation was recommended for patients in whom heart failure is assessed as refractory based on New York Heart Association functional class III or IV (stage D) for heart failure after previous guideline-directed medical therapy, use of devices such as an implantable cardioverter defibrillator or a cardiac resynchronization therapy device, or surgical management.

International Society for Heart and Lung Transplantation

The International Society for Heart and Lung Transplantation (ISHLT) recommended in a 2004 statement that children with the following conditions should be evaluated for heart transplantation (see Table 1).

Table 1. Recommendations for Pediatric Heart Transplant

Recommendation

LOE

Diastolic dysfunction that is refractory to optimal medical/surgical management because they are at high risk of developing pulmonary hypertension and of sudden death

B

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 refractory to medical therapy

C

LOE B is based on a single randomized trial or multiple nonrandomized trials; LOE C is based primarily on expert consensus opinion.

LOE: level of evidence.

In 2016, the ISHLT published a 10-year update to its listing criteria for heart transplantation. The guidelines recommended the following updates or changes to the prior guideline:

  • Recommended use of heart failure prognosis scores (e.g., Seattle Heart Failure Model, Heart Failure Survival Score) along with a cardiopulmonary exercise test to determine prognosis and guide listing for transplantation for ambulatory patients.
  • Periodic right heart catheterization for routine surveillance was not recommended in children.
  • Carefully selected patients >70 years of age may be considered for cardiac transplantation.
  • Pre-existing neoplasm, body mass index 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 the 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 not recommended to receive heart transplantation.

In 2016, this same ISHLT guideline update states the following regarding retransplantation indications:

“Retransplantation is indicated for those patients who develop significant CAV [(cardiac allograft vasculopathy)] with refractory cardiac allograph dysfunction, without evidence of ongoing acute rejection (Class IIa, Level of Evidence: C).”

The guideline cites the published consensus by Johnson et al (2007) on indications for retransplantation. It states that based on available data, appropriate indications for retransplantation include “the development of chronic severe CAV with symptoms of ischemia or heart failure, CAV without symptoms but with moderate to severe LV [(left ventricle)] dysfunction, or symptomatic graft dysfunction without evidence of active rejection.” Retransplantation within the first 6 months after previous transplantation, especially with immunologic complications as a primary cause, was considered high-risk.

For pediatric heart transplantation, the 2016 guideline update states, “although nearly half of all HTs [(heart transplants)] in children are done for CHD [(congenital heart disease)],… it should be noted that general considerations vary for more traditional indications, such as idiopathic dilated cardiomyopathy, for transplantation in the pediatric population….Thus, as these guidelines are translated to the younger patient, such prudence will need to be exercised.”

In 2010, the guidelines from ISHLT on the care of heart transplant recipients include the following recommendations on cardiac retransplantation:

  • "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

In 2007, the American Heart Association indicated 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:

  • 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 guideline states 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."

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force has not addressed heart transplantation.

KEY WORDS:

Cardiac Transplant, Heart Transplant, Heart Retransplantation, Cardiac Retransplantation, Isolated Cardiac Transplantation, ICT, Orthotopic Heart Transplant, OHT, Combined Heart and Kidney Transplantation, CHKT, Kidney Transplant, HKT, Heart-Kidney Transplant

APPROVED BY GOVERNING BODIES:

Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration 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.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

33940          

Donor cardiectomy (including cold preservation)

33944

Backbench standard preparation of cadaver donor heart allograft prior to transplantation, including dissection of allograft from surrounding tissues to prepare aorta, superior vena cava, inferior vena cava, pulmonary artery, and left atrium for implantation

33945          

Heart transplant, with or without recipient cardiectomy

50300

Donor nephrectomy (including cold preservation); open from cadaver, unilateral or bilateral

50323

Backbench standard preparation of cadaver donor renal allograft prior to transplantation, including dissection and removal of perinephric fat, diaphragmatic and retroperitoneal attachments, excision of adrenal gland, and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches as necessary

50327

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; venous anastomosis, each

50328

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; arterial anastomosis, each

50329

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; ureteral anastomosis, each

50340          

Recipient nephrectomy

50360

Renal allotransplantation, implantation of graft; without recipient nephrectomy

50365

Renal allotransplantation, implantation of graft; with recipient nephrectomy

REFERENCES:

  1. Aaronson KD, Schwartz JS, Chen TM et al. Development and prospective validation of a clinical index to predict survival in ambulatory patients referred for cardiac transplant evaluation. Circulation 1997; 95(12):2660-2667.
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  6. Alshawabkeh LI, Hu N, Carter KD, et al. Wait-List Outcomes for Adults With Congenital Heart Disease Listed for Heart Transplantation in the U.S. J Am Coll Cardiol. Aug 30 2016; 68(9): 908-17.
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  14. Bock MJ, Nguyen K, Malerba S, et al. Pediatric cardiac retransplantation: Waitlist mortality stratified by age and era. J Heart Lung Transplant. Apr 2015; 34(4):530-537.
  15. Canter CE, Shaddy RE, Bernstein D, et al. Indications for heart transplantation in pediatric heart disease: A scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young; the Councils on Clinical Cardiology, Cardiovascular Nursing, and Cardiovascular Surgery and Anesthesia; and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation 2007; 115(5):658-676.
  16. Conway J, Manlhiot C, Kirk R, et al. Mortality and morbidity after retransplantation after primary heart transplant in childhood: an analysis from the registry of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. Mar 2014; 33(3):241-251.
  17. Cooper LB, Lu D, Mentz RJ, et al. Cardiac transplantation for older patients: Characteristics and outcomes in the septuagenarian population. J Heart Lung Transplant. Mar 2016; 35(3):362-369.
  18. Costanzo MR, Augustine S, Bourge R, et al. Selection and treatment of candidate for heart transplantation. A statement for health professionals from the Committee on Heart Failure and Cardiac Transplantation of the Council on Clinical Cardiology, American Heart Association. Circulation 1995; 92(12):3593-3612.
  19. Costanzo MR, Dipchand A, Starling R et al. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant 2010; 29(8):914-956.
  20. De Santo LS, Romano G, Maiello C et al. Pulmonary artery hypertension in heart transplant recipients: how much is too much? Eur J Cardiothorac Surg 2012; 42(5):864-869; discussion 869-870.
  21. Dipchand AI, Kirk R, Mahle WT, et al. Ten yr. of pediatric heart transplantation: a report from the Pediatric Heart Transplant Study. Pediatr Transplant. Mar 2013; 17(2):99-111.
  22. Doberne JW, Jawitz OK, Raman V, et al. Heart Transplantation Survival Outcomes of HIV Positive and Negative Recipients. Ann Thorac Surg. May 2021; 111(5): 1465-1471.
  23. Egan TM. Ethical issues in thoracic organ distribution for transplant. Am J Transplant 2003; 3(4):366-372.
  24. Fischer S, Glas KE. A review of cardiac transplantation. Anesthesiol Clin 2013; 31(2):383-403.
  25. Friedland-Little JM, Gajarski RJ, Yu S, et al. Outcomes of third heart transplants in pediatric and young adult patients: analysis of the United Network for Organ Sharing database. J Heart Lung Transplant. Sep 2014; 33(9):917-923.
  26. Goel AN, Iyengar A, Schowengerdt K, et al. Heart transplantation in children with intellectual disability: An analysis of the UNOS database. Pediatr Transplant. Mar 2017; 21(2).
  27. Goldraich LA, Stehlik J, Kucheryavaya AY, et al. Retransplant and medical therapy for cardiac allograft vasculopathy: international society for heart and lung transplantation registry analysis. Am J Transplant. Jan 2016; 16(1):301-309.
  28. Gorodeski E, Chu E, Chow C et al. Application of the Seattle heart failure model in ambulatory patients presented to an advanced heart failure therapeutics committee. Circ Heart Fail 2010; 3(6):706-714.
  29. Hansen A, Haass M, Zugck C et al. Prognostic value of Doppler echocardiographic mitral inflow patterns: implications for risk stratification in patients with chronic congestive heart failure. J Am Coll Cardiol 2001; 37(4):1049-1055.
  30. Hong KN, Merlo A, Chauhan D, et al. Evidence supports severe renal insufficiency as a relative contraindication to heart transplantation. J Heart Lung Transplant. Jul 2016; 35(7):893-900.
  31. Hunt SA, Abraham WT, Chin MH et al. ACC/AHA 2005 Guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (writing committee to update the 2001 guidelines for the evaluation and management of heart failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation 2005; 112(12):e154-235.
  32. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  33. Jamil A, Qin H, Felius J, et al. Comparison of Clinical Characteristics, Complications, and Outcomes in Recipients Having Heart Transplants <65 Years of Age Versus ≥65 Years of Age. Am J Cardiol. Sep 15 2017 120(12):2207-2212.
  34. Jaramillo N, Segovia J, Gomez-Bueno M et al. Characteristics of patients with survival longer than 20 years following heart transplantation. Rev Esp Cardiol 2013; 66(10):797-802.
  35. Johnson MR, Meyer KH, Haft J et al. Heart transplantation in the United States, 1999-2008.  Am J Transplant 2010; 10(4 Pt 2):1035-1046.
  36. Kalogeropoulos AP, Georgiopoulou VV, Giamouzis G et al. Utility of the Seattle Heart Failure Model in patients with advanced heart failure. J Am Coll Cardiol 2009; 53(4):334-342.
  37. Ketchum ES, Moorman AJ, Fishbein DP et al. Predictive value of the Seattle Heart Failure Model in patients undergoing left ventricular assist device placement. J Heart Lung Transplant 2010; 29(9):1021-1025.
  38. Kilic A, Weiss ES, George TJ et al. What predicts long-term survival after heart transplantation? An analysis of 9,400 ten-year survivors. Ann Thorac Surg 2012; 93(3):699-704.
  39. Kilic A, Weiss ES, Yuh DD et al. Factors associated with 5-year survival in older heart transplant recipients. J Thorac Cardiovasc Surg 2012; 143(2):468-474.
  40. Kirk R, Dipchand AI, Rosenthal DN, et al. The International Society of Heart and Lung Transplantation Guidelines for the management of pediatric heart failure: Executive summary. J Heart Lung Transplant. Sep 2014; 33(9):888-909.
  41. Kolsrud O, Karason K, Holmberg E, et al. Renal function and outcome after heart transplantation. J Thorac Cardiovasc Surg. Dec 14 2018 155(4):1593-1604.e1591.
  42. Lee DS, Austin PC, Rouleau JL et al. Predicting mortality among patients hospitalized for heart failure: derivation and validation of a clinical model. Jama 2003; 290(19):2581-2587.
  43. Levy WC, Mozaffarian D, Linker DT et al. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation 2006; 113(11):1424-1433.
  44. Lietz K, Miller LW. Improved survival of patients with end-stage heart failure listed for heart transplantation: analysis of organ procurement and transplantation network/U.S.  United Network of Organ Sharing data, 1990 to 2005. J Am Coll Cardiol 2007; 50(13):1282-1290.
  45. Lund LH, Edwards LB, Dipchand AI, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirty-third Adult Heart Transplantation Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. J Heart Lung Transplant. Oct 2016; 35(10):1158-1169.
  46. Magnetta DA, Godown J, West S, et al. Impact of the 2016 revision of US Pediatric Heart Allocation Policy on waitlist characteristics and outcomes. Am J Transplant. Dec 2019; 19(12): 3276-3283.
  47. May HT, Horne BD, Levy WC et al. Validation of the Seattle Heart Failure Model in a community-based heart failure population and enhancement by adding B-type natriuretic peptide. Am J Cardiol 2007; 100(4):697-700.
  48. Mehra MR, Canter CE, Hannan MM, et al. The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: A 10-year update. J Heart Lung Transplant. Jan 2016; 35(1):1-23.
  49. Miller RJH, Clarke BA, Howlett JG, et al. Outcomes in patients undergoing cardiac retransplantation: A propensity matched cohort analysis of the UNOS Registry. J Heart Lung Transplant. Oct 2019; 38(10): 1067-1074.
  50. Mistiaen WP. Heart transplantation in patients with previous malignancy. An overview. Acta Cardiol. Apr 2015; 70(2):123-130.
  51. Nguyen VP, Mahr C, Mokadam NA, et al. The benefit of donor-recipient matching for patients undergoing heart transplantation. J Am Coll Cardiol. Apr 04 2017; 69(13):1707-1714.
  52. Nutter AL, Tanawuttiwat T, Silver MA. Evaluation of 6 prognostic models used to calculate mortality rates in elderly heart failure patients with a fatal heart failure admission. Congest Heart Fail 2010; 16(5):196-201.
  53. Oliveira GH, Hardaway BW, Kucheryavaya AY, et al. Characteristics and survival of patients with chemotherapy-induced cardiomyopathy undergoing heart transplantation. J Heart Lung Transplant. Aug 2012; 31(8):805-810.
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  56. Perez-Villa F, Farrero M, Cardona M et al. Bosentan in heart transplantation candidates with severe pulmonary hypertension: efficacy, safety and outcome after transplantation. Clin Transplant 2013; 27(1):25-31.
  57. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. Jul 14 2016; 37(27):2129-2200.
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  59. Prendergast C, McKane M, Dodd DA, et al. The impact of cognitive delay on pediatric heart transplant outcomes. Pediatr Transplant. Mar 2017; 21(2).
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POLICY HISTORY:

Medical Policy Group, September 2009 (3)

Medical Policy Administration Committee, September 2009

Available for comment September 18-November 2, 2009

Medical Policy Group, December 2011(3): 2011 Updated to Key Points & References

Medical Policy Group, December 2012 (3): 2012 Update to Description, Key Points, & References.

Medical Policy Panel, November 2013

Medical Policy Group, November 2013 (3):  Updates to Description, Key Points and References; policy statement updated to include coverage for heart retransplantation after a failed primary heart transplant

Available for comment December 5, 2013 through January 18, 2014

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (3): Updates to Description, Key Points, and References. Updated policy statement to include “Heart transplantation does not meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage in all other situations and is considered investigational”- No change in coverage intent.

Medical Policy Panel, November 2015

Medical Policy Group, December 2015 (2): 2015 Updates to Description, Key Points, and References; policy guidelines updated in policy statement section; no change in policy statement or intent.

Medical Policy Panel, September 2017

Medical Policy Group, October 2017 (7): 2017 Updates to Description, Key Points, and References; Policy statement- updated guidelines; added HIV criteria; removed policy information from 2013. No change in intent.

Medical Policy Administration Committee, October 2017

Available for comment October 10 through November 23, 2017

Medical Policy Panel, August 2018

Medical Policy Group, August 2018 (3): Updates to Description, Key Points, Approved By Governing Bodies, References, and Key Words. No changes to policy statement or intent.

Key Words: added heart retransplantation, cardiac retransplantation, Isolated Cardiac Transplant, ICT, Orthotopic Heart Transplant, and OHT.

Medical Policy Panel, August 2019

Medical Policy Group, September 2019 (3): 2019 Updates to Key Points and Practice Guidelines and Postion Statements. No change to policy statement or intent.

Medical Policy Panel, August 2020

Medical Policy Group, September 2020 (3): 2020 Updated to Description, Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, References and Key Words: added: Combined Heart and Kidney Transplantation, CHKT, Kidney Transplant, HKT, Heart-Kidney Transplant. Added policy statement: Combined heart-kidney transplantation may be considered medically necessary in patients who qualify for heart transplantation and have advanced irreversible kidney disease. Removed language: Adequate pulmonary, liver, and renal status under candidate criteria and replaced statement with: Absence of irreversible end stage disease not attributed to heart or kidney disease. Added multisystemic disease (other than cardiorenal failure) to candidate criteria to make it more specific to the heart transplant policy. Title changed from Heart Transplant to Heart Transplant and Combined Heart-Kidney Transplantation. Coding updated to include kidney transplantation: 50300, 50323, 50327, 50328, 50329, 50340, 50360, and 50365. No other changes to policy statement or intent.

Available for comment from September 18, 2020 through November 2, 2020.

Medical Policy Administration Committee, October 2020

Medical Policy Panel, August 2021

Medical Policy Group, September 2021 (3): 2021 Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to remove "not medically necessary", where appropriate. 

Medical Policy Panel, August 2022

Medical Policy Group, September 2022 (3): 2022 Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Removed Adult or Pediatric criteria for coverage in the policy section. Removed HIV positive patient criteria from policy section to reflect standard of care guidelines from the American Society of Transplantation. Removed absolute contraindications in policy guidelines and changed verbiage to “Potential contraindications for solid organ transplant subject to the judgment of the transplant center.” No other changes to policy statement or intent.

Available for comment from October 1, 2022 through November 15, 2022.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.