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This record addresses cardiac transplantation, a therapeutic modality for individuals with end-stage heart disease, characterized by cardiac failure the does not respond come standard, optimal clinical or operation treatments.

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Position Statement

Medically Necessary:

Heart transplantation is thought about medically necessary in closely selected individuals when the complying with clinical indications and the basic Individual selection criteria listed below are met.

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

A low sensible status; andA poor probability that survival; andONE the the following underlying conditions:Supported by a mechanically circulatory support device; orSupported by an intra-aortic balloon pump (IABP); orRefractory cardiogenic shock; orDependency on intravenous (IV) inotropic assistance to preserve adequate organ perfusion; orMaximal VO2 less than or equal to 10 ml/kg/min with success of anaerobic metabolism; orMaximal VO2 greater than 10 and also less than 15 ml/kg/min (or 55% the predicted) and major limitation the the individual’s activities; orSevere ischemia repetitively limiting routine activity not amenable come bypass surgical procedure or percutaneous coronary intervention (PCI); orRecurrent unstable ischemia not amenable come bypass surgical treatment or percutaneous coronary treatment (PCI); orRecurrent symptomatic ventricular arrhythmias refractory to every therapeutic modalities; orIschemic cardiomyopathy no amenable to medical therapy or revascularization procedures.

Pediatric Clinical Indications* - heart transplant is an welcomed treatment choice for selected children with end-stage heart an illness characterized by intractable symptoms and also heart failure the cannot be treated through conventional medical or surgical methods. Youngsters must have:

Low cardiac output; andONE that the following conditions:Intractable heart failure no amenable to clinical or surgical interventions; orComplex congenital heart an illness not amenable to surgical fix or palliation or because that which the operation procedure dead a higher risk the mortality than transplantation; orHeart condition with reactive pulmonary hypertension and a potential of arising fixed, irreversible raised pulmonary vascular resistance (PVR) that would certainly preclude a future orthotopic heart transplantation; orHeart condition associated with close to sudden death; orLife-threatening arrhythmias untreatable with medications or one implantable defibrillator.

*Note: because that multi-organ transplant requests, criteria have to be met because that each organ requested. In those situations, an separation, personal, instance may existing with a concurrent medical condition which would certainly be considered an exclusion or a comorbidity that would preclude a successful outcome, however would it is in treated with the other body organ transplant. Such cases will be reviewed top top an separation, personal, instance basis for coverage determination to assess the member’s candidacy for transplantation.

Heart Retransplantation

Retransplantation in individuals with graft failure of one initial love transplant, due to either technical factors or hyperacute rejection is taken into consideration medically necessary.

Retransplantation in individuals with chronic rejection, middle graft vasculopathy or recurrent an illness is taken into consideration medically necessary when the separation, personal, instance meets basic individual an option criteria as characterized below.

Investigational and also Not medically Necessary:

A love transplantation is taken into consideration investigational and also not median necessary once the above criteria are not met.

General Individual choice Criteria

In enhancement to having end-stage heart disease, the member have to not have actually a contraindication to transplantation, as characterized by the American society of Transplantation (Steinman, 2001) and also the International culture for Heart and Lung Transplantation (Mehra, 2016) as detailed below.

Relative Contraindications because that Transplant Recipients include, yet are not minimal to, the following:

Pulmonary hypertension that is solved as evidenced by either:Pulmonary vascular resistance (PVR) better than 5 timber units; orTrans-pulmonary gradient (TPG) greater than or equal to 16 mm/Hg.

Absolute Contraindications because that Transplant Recipients include, but are not restricted to, the following:

Metastatic cancer;Ongoing or recurring infections that are not successfully treated;Serious cardiac or other continuous insufficiencies that produce an inability to pardon transplant surgery;Serious problems that space unlikely to be enhanced by transplantation together life expectations can it is in finitely measured;Active, systemic lupus erythematosus or sarcoid through multisystem involvement;Any systemic problem with a high probability of recurrence in the transplanted heart;Demonstrated patience noncompliance, which locations the body organ at danger by not adhering to clinical recommendations;Potential complications from immunosuppressive medications are unacceptable to the patient;Acquired immune deficiency syndrome (AIDS) (diagnosis based upon Centers for an illness Control and also Prevention meaning of CD4 count, 200 cells/mm3) uneven the following are noted:CD4 count better than 200 cells/mm3 for better than 6 months;HIV-1 RNA undetectable;On secure anti-retroviral therapy higher than 3 months;No other complications native AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or various other neoplasm);Meeting all various other criteria for heart transplantation.
Rationale

Heart transplantation is a typical treatment for individuals with end-stage heart an illness that is no amenable to medical or operation therapies. In the 2013 American college of Cardiology foundation (ACCF)/American heart Association (AHA) reminder for the monitoring of heart failure authors reported:

Cardiac transplantation is considered the gold traditional for the treatment of refractory end-stage HF. Because the very first successful cardiac transplantation in 1967, breakthroughs in immunosuppressive therapy have vastly boosted the long-term survival the transplant recipients v a 1, 3, and also 5 year post-transplant survival price of 87.8%, 78.5%, and also 71.7% in adults, respectively. Similarly, cardiac transplantation has actually been presented to boost functional status and heart fail with reduced ejection fraction (HRQOL) (Yancy, 2013).

The ahead guidelines because that heart transplantation from the International society for Heart and Lung Transplantation (ISHLT) were arisen before the organization of β-blocker and device therapies because that the treatment of so late or end-stage heart condition (Mehra, 2006). Mehra and colleagues (2006) reported early studies showing a far-ranging survival advantage with heart transplantation in adults through a peak VO2 much less than 14 ml/kg/min when contrasted to individuals who to be not thought about eligible because that transplantation and were kept on a clinical regimen. A subset of people with a peak VO2 less than 10 ml/kg/min who accomplished anaerobic threshold had actually a reduced survival rate when compared to people with a VO2 in between 10-14 ml/kg/min. Clinical therapies made use of in adults for therapy of heart condition have additionally been incorporated into the pediatric population. In addition, there have actually been far-ranging improvements in all at once survival because that staged palliative surgeries because that left hypoplastic heart disease (Canter, 2007). Therefore, the love transplant listing criteria for adults and pediatrics were re-evaluated.

Over time complex congenital heart disease may be worsened with details anatomic and also physiological conditions. These people are eligible because that heart transplantation and the conditions described by Canter and also colleagues (2007) include, yet are not minimal to:

Severe stenosis or atresia in proximal coronary arteries;Moderate to severe stenosis or insufficiency of the atrioventricular or systemic semilunar valve(s);Severe ventricular dysfunction;Pulmonary hypertension and also a potential threat of occurring fixed, irreversible elevated PVR that may preclude future orthotopic heart transplant;Severe aortic or systemic AV valve insufficiency no amenable to operation correction;Severe arterial oxygen desaturation;Persistent protein-losing enteropathy intractable to optimal medical-surgical therapies.

Cardiopulmonary practice test results are on regular basis utilized to recognize transplant candidacy. Experimentation is restricted to individuals older than 7-8 year of age (Canter, 2007). Maximal VO2 describes the maximum quantity of oxygen used while exerting maximal physical task per kilogram of body load per minute. The testing is commonly performed on a treadmill or ~ above a cycloergometer. Over there are various calculators to estimate VO2 max. Individuals that space physically to the right have greater VO2 max values and also can perform much more intense exercises. VO2 max is properly established by the Fick Equation: VO2max = Q (CaO2−CvO2) where Q is cardiac output, CaO2 is arterial oxygen content, and CvO2 is venous oxygen content. The mean young untrained male will have actually a VO2 max of roughly 45 ml/min/kg. The mean young untrained female will certainly score a VO2 max of 38 ml/min/kg. These scores have the right to improve with training and generally decrease v age.

Post-transplant morbidity and mortality are frequently caused by best heart failure. References by the International culture for Heart and Lung Transplantation (ISHLT) encompass a pre-transplant vasodilator challenge to it is in administered if one of two people pulmonary vascular resistance (PVR) is greater than 3 lumber units or the transpulmonary gradient (TPG) is greater than or equal to 15. Regardless of the lack of pure cutoff worths that would contraindicate transplantation, analyses of the ISHLT registry demonstrated incremental threats as PVR increased. Survive comparison that those v 1-3 timber units had better outcomes when contrasted to people with a PVR of higher than 5 timber units. Relative contraindications to love transplant incorporate PVR better than 5 lumber units or TPG better than 16-20 mm Hg or PVR table of contents is higher than 6 (Canter, 2007; Mehra, 2016).

Coronary artery vasculopathy (CAV) is a diffuse an illness process that results in steady coronary artery atherosclerosis and is a threat to irreversible survival. CAV is the most common reason of complications and death ~ the very first year post-heart transplant. Angiographically confirmed graft vasculopathy results in a negative prognosis. Graft ns or fatality within 2 year of diagnosis was detailed in 24% of individuals with any kind of degree of vasculopathy and also 50% of individuals with moderate to serious graft vasculopathy. Canter and colleagues (2007) report a 2-3% annual risk of fatality or graft loss, through 70% of the events because of cardiac fail resulting native graft vasculopathy, rejection or a combination of both. A pediatric study resulted in similar 3-year survivals the 82% compared with 77% in re-transplantations versus main transplantations (Canter, 2007). There have actually been various hypotheses and also studies to determine the etiology, diagnosis, prevention and treatment of CAV. Regardless of therapeutic interventions, CAV may an outcome in end-stage heart fail requiring a retransplantation. Due to the fact that of limited donors and also the mortality prices with CAV, ongoing clinical researches are concentrated on preventative therapies to reduce the incidence and also severity that CAV (Boucek, 2007; Kobashigawa, 2000; Ross, 2007).

Groetzner and also colleagues (2005) reported on 50 pediatric love transplantations performed in between 1988 and 2002. Actuarial survival rates at 1, 5 and also 10 years were 86%, 80% and also 80% for individuals transplanted thru 1995. Through the addition of newer drugs such as the calcineurin inhibitor tacrolimus, immunosuppressant mycophenolate mofetil (MMF), and also improved prophylactic therapies, the actuarial survival rates improved to 92% for both 1 and also 5 years for individuals transplanted after ~ 1995. A 6% perioperative mortality price was a an outcome of major graft failure. Acute rejections resulted in fatality for 12% of individuals. Rejection and also infections proceed to be serious complications for pediatric heart transplantation. Added studies need to be ongoing to identify the long-term effects of immunosuppressants, graft courage disease, neoplastic disorders, renal complications and also quality that life. The shortage the donor organs borders pediatric heart transplantation to people that have medically and also surgically untreatable heart fail without therapeutic choices (Groetzner, 2005).

Background/Overview

Heart transplants show off the removal of either all or part of a cadaver heart and also its implantation right into a recipient. There are two species of cardiac transplant: orthotopic and heterotopic. Orthotopic transplant is the more common that the 2 methods and also involves replacing the recipient heart through the donor heart implanting the ventricles the the donor love onto the ideal atria and also main arteries that the recipient’s heart. Heterotopic transplants involve place the entire donor heart into the chest cavity and surgically it is registered it come the recipient’s entire heart.

In comparison to the 1980s once the bulk of love transplant recipients were sick yet stable individuals waiting at home, the majority of love transplant recipients are now hospitalized standing 1A or 1B individuals at the time of transplant. This change has occurred due come the increasing demand on the scarce resource of donor organs causing an raised waiting time for donor organs. Individuals initially provided as a condition 2 candidate may deteriorate to a standing 1A or 1B candidate before a donor organ becomes available. At the very same time, medical therapy of heart failure has improved (particularly with the arrival of ACE inhibitors), making the imperative the heart transplantation be limited to those people who have actually truly worn down medical therapy and also thus are likely to have the maximum advantage from love transplantation. Consequently, there has been a search to determine prognostic criteria that can identify together individuals. As provided in the American college of Cardiology (ACC) criteria (Hunt, 2009), the VO2 max serves together a an important objective criterion. The VO2 max, measured throughout maximal exercise, mirrors the practical reserve that the heart. Studies have said that transplantation deserve to be safely deferred in those people with a VO2 max of better than 14 ml/kg/min. The prestige of the VO2 max has likewise been emphasized by one American heart Association clinical Statement addressing love transplant candidacy (Costanzo, 1995; Mudge, 1995). In previous years, a left ventricular ejection portion of less than 20% or one NYHA course III or IV standing may have actually been provided to recognize transplant candidacy. However, as suggested by the ACC criteria, these dimensions are no longer taken into consideration adequate to determine transplant candidates. These measurements may be supplied to identify individuals for additional cardiovascular workup, yet should not be the sole criteria because that transplant.

The limiting element for love transplantation is the brief supply the donor organs. The procurement and also distribution of heart organs for transplantation in the U.S. Is under the direction of united Network for organ Sharing (UNOS). A national database the transplant candidates, donors, recipients, and donor-recipient matching and histocompatibility is kept by UNOS. A policy for allocation of heart and heart-lung offal prioritizes donor love organs follow to the principles of clinical urgency (UNOS, 2020). The careful an option of candidates using specific an option criteria has steadily boosted the survival prices for those that have undergone love transplantation. The best accessible evidence, built up from retrospective registry data on love transplantation in the unified States, is based upon UNOS data collected from 2008-2015 i beg your pardon reports 1-year, 3-year and also 5-year survival data (90.9%, 85.5%, 78.6%). The number of heart transplant candidates and also heart transplants carry out in the unified States continues to climb annually, with 3440 love transplants perform in 2018 (Colvin, 2018). Right now to date in 2020 there space 3502 candidates ~ above the waitlist because that heart transplant in the joined States, with 3552 love transplants perform in 2019 and also 2427 performed to date in 2020.

Definitions

End-stage heart failure: In human being with love failure, the body does not obtain an enough supply the oxygen. As a result, they have the right to feel weak, fatigued or short of breath result in limited functional capacity. Everyday activities such together walking, climbing stairs, carrying groceries and yard work can end up being quite difficult. In end-stage love failure, the heart is so dilute the individual will certainly die without a love transplant.

Heart transplant: removal of an individual's heart and also replacing it v a donor heart.

Mechanical circulatory support an equipment (MCSD): an implanted ventricular assist an equipment or percutaneous ventricular assist device.

New York love Association (NYHA) definitions:

The NYHA group of heart failure is a tiered mechanism that categorizes subjects based upon subjective impression of the degree of practical compromise; the class III and IV NYHA functional classes room as follows:

Class III. Patients with cardiac condition resulting in significant limitation of physical activity. They room comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea (difficulty breathing) or anginal (chest) pain.Class IV. Patients with cardiac condition resulting in the i can not qualify to bring on any physical activity without discomfort. Symptom of heart failure or the anginal (chest) syndrome might be current even at rest. If any type of physical task is undertaken, uncomfortable is increased.
Coding

The following codes because that treatments and procedures applicable come this record are included listed below for informational purposes. Consists or exclusion of a procedure, diagnosis or maker code(s) does not constitute or indicate member coverage or centregalilee.com reimbursement policy. Please describe the member's contract services in effect at the time of service to determine coverage or non-coverage that these solutions as it uses to an individual member.

When services might be Medically crucial when criteria space met:

CPT

00580

Anesthesia for heart transplant or heart/lung transplant

33940

Donor cardiectomy (including cold preservation)

33944

Backbench standard preparation that cadaver donor love allograft before transplantation, including dissection of allograft from bordering soft tissues to prepare aorta, remarkable vena cava, inferior vena cava, pulmonary artery, and also left atrium for implantation

33945

Heart transplant, v or without recipient cardiectomy

ICD-10 Procedure

02YA0Z0

Transplantation the heart, allogeneic, open approach

02YA0Z1

Transplantation the heart, syngeneic, open approach

ICD-10 Diagnosis

All diagnoses

When solutions are Investigational and also Not median Necessary:For the codes listed above as soon as criteria room not met, or when the code describes a procedure suggested in the place Statement section as investigational and not median necessary.

References

Peer the review Publications:

Bauer J, Thul J, Kramer U, et al. Love transplantation in children and also infants: temporary outcome and also long-term follow-up. Pediatr Transplant. 2001; 5(6):457-462.Boucek MM, Waltz DA, Edwards LB, et al. International society for Heart and Lung Transplantation. Registry of the International culture for Heart and Lung Transplantation: 9th official pediatric heart transplantation report--2006. J love Lung Transplant. 2006; 25(8):893-903.Canter CE, Shaddy RE, Bernstein D, et al. Indications because that heart transplantation in pediatric love disease: a clinical statement from the American love Association the supervisory board on Cardiovascular condition in the Young; the Councils ~ above Clinical Cardiology, Cardiovascular Nursing, and also Cardiovascular Surgery and Anesthesia; and also the high quality of Care and Outcomes study Interdisciplinary functioning Group. Circulation. 2007; 115(5):658-676.Costanzo MR, Augustine S, Bourge R, et al. An option and therapy of candidates for heart transplantation. A statement because that health specialists from the Committee on love Failure and Cardiac Transplantation that the board of directors on Clinical Cardiology, American love Association. Circulation. 1995; 92(12):3593-3612.Dearani GA, Razzouk AJ, Gundry SR, et al. Pediatric cardiac retransplantation: intermediate-term results. Ann Thorac Surg. 2001; 71(1):66-70.Dellgren G, Koirala B, Sakopoulus A, et al. Pediatric love transplantation: boosting results in high-risk patients. J Thorac Cardiovasc Surg. 2001; 121(4):782-791.Gandhi SK, Canter CE, Kulikowska A, huddressone CB. Infant heart transplantation ten years later – where room they now? Ann Thorac Surg. 2007; 83(1):169-171.Groetzner J, Reichart B, Roemer U, et al. Cardiac transplantation in pediatric patients: fifteen-year suffer of a single center. Ann Thorac Surg. 2005; 79(1):53-61.Gronda E, Bourge RC, Costanzo MR, et al. Heart rhythm considerations in love transplant candidates and considerations for ventricular help devices: International culture for Heart and also Lung Transplantation guidelines for the treatment of cardiac transplant candidates – 2006. J heart Lung Transplant. 2006; 25(9):1043-1056.Hosenpud JD, Pamidi SR, Fiol BS, et al. Outcomes in patients who room hepatitis B surface ar antigen-positive prior to transplantation: an analysis and research using the joint ISHLT/UNOS thoracic registry. J love Lung Transplant. 2000; 19(8):781-785.Jessup M, Banner N, Brozena S, et al. Optimal pharmacologic and non-pharmacologic management of cardiac transplant candidates: ideologies to be considered prior come transplant evaluation: International society for Heart and Lung Transplantation Guidelines because that the treatment of cardiac transplant candidates – 2006. J love Lung Transplant. 2006; 25(9):1003-1023.Kobashigawa, J. What is the optimal prophylaxis therapy of cardiac allograft vasculopathy? Curr control Trials Cardiovasc Med. 2000; 1(3):166-171.Mudge GH, Goldstein S, Addonizio LJ, et al. 24th Bethesda Conference: Cardiac transplantation. Task pressure 3: recipient guidelines/prioritization. J am Coll Cardiol. 1993; 22(1):21-31.Rosenthal D, Chrisant MR, Edens E, et al. International society for Heart and also Lung Transplantation: practice guidelines for administration of heart failure in children. J love Lung Transplant. 2004; 23(12):1313-1333.Ross M, Kouretas P, Gamberg P, et al. Ten- and 20-year survivors the pediatric orthotopic love transplantation. J heart Lung Transplant. 2006; 25(3):261-270.Srivastava R, Keck BM, Bennett LE, Hosenpud JD. The outcomes of cardiac retransplantation: an analysis of the joint International society for Heart and also Lung Transplantation/United Network for body organ Sharing Thoracic Registry. Transplantation. 2000; 70(4):606-612.Steinman TI, Becker BN, Frost AE, et al. Guidelines for the referral and also management of patient eligible for solid organ transplantation. Transplantation. 2001; 71(9):1189-1204.

Government Agency, medical Society, and also Other classic Publications:

Colvin M, smith JM Skeans MA, et al. OPTN/SRTR 2018 annual data report: to be J Transplant. 2020; (20)1:291-362.Medicare/HCFA. Love Transplants. Medicare clinical Policy Guidelines. 1999; 2.Steinman TL, Becker BN, Frost AE, et al. Clinical practice Committee, American society of Transplantation. Guidelines for the referral and also management of patients eligible for solid body organ transplantation. Transplantation. 2001; 71(9):1189-1204.
Websites for added Information
Index

Heart TransplantationHuman heart TransplantationTransplantation, human Heart

Document History

Status

Date

Action

Reviewed

Medical policy & an innovation Assessment Committee (MPTAC) review. Updated Rationale, References and also Websites sections.

Revised

MPTAC review. Clarified MN clinical indication because that heart transplantation in adult requiring mechanical support, readjusted “presence of” an implanted VAD or IABP come “supported by” a mechanically circulatory support machine or IABP. Update Background, Definitions, References and Websites sections.

Reviewed

MPTAC review. Updated Background, References and Websites sections.

Reviewed

MPTAC review. Updated formatting in MN position statement. Update Background, References and Websites sections.

Reviewed

MPTAC review. The paper header wording updated native “Current efficient Date” come “Publish Date.” updated Rationale, Background, References and Websites sections.

Reviewed

MPTAC review. To update formatting in place Statement section. Update Rationale, Background, References and Websites sections.

Revised

MPTAC review. Defined abbreviation in investigational and not medically vital statement. Update Background, References and Websites sections. Eliminated ICD-9 codes from Coding section.

Reviewed

MPTAC review. Updated Description. Rationale, Background, References and also Websites sections.

Reviewed

MPTAC review. Update Rationale, Background, References and Websites.

Reviewed

MPTAC review. Update Definitions, References and also Websites.

Revised

MPTAC review. Amendment adult heart transplant medically necessary statement to include presence of intra-aortic balloon pump (IABP) together an basic condition. To update Background, References and also Websites.

Reviewed

MPTAC review. Removed “and/or” phrase from medically essential statement. Reason updated. Update References and also Websites.

Revised

MPTAC review. Clarified medically crucial statement and adult medically vital criteria because that heart transplant. Referrals updated.

Reviewed

MPTAC review. Referrals updated.

Reviewed

MPTAC review. No readjust in position statement. Update references. The phrase “investigational/not medically necessary” to be clarified to read “investigational and also not median necessary” in ~ the November 29, 2007 MPTAC meeting.

Revised

MPTAC review. Medical necessity criteria updated to align with ACC, AHA and also ISHLT criteria. Added retransplantation criteria. Updated references, background, websites and coding.

Reviewed

MPTAC review. No alters to criteria. Referrals were updated to encompass the 2005 updated ACC/AHA reminder for the Diagnosis and also Management that Chronic Heart failure in the Adult.

Added reference for Centers because that Medicare and Medicaid services (CMS) – nationwide Coverage determination (NCD).

Revised

MPTAC review. Revision based on: Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last review Date

Document Number

Title

Anthem, Inc.

TRANS.00005H

Heart Transplant

Archived

WellPoint wellness Networks, Inc.

7.04.02

Heart Transplantation-Adult

7.04.03

Heart Transplantation-Pediatric

Federal and State law, and also contract language, including meanings and details contract provisions/exclusions, take it precedence over clinical Policy and also must be considered first in determining eligibility for coverage. The member’s contract benefits in impact on the date that solutions are rendered need to be used. Clinical Policy, which addresses clinical efficacy, must be considered prior to utilizing medical opinion in adjudication. Medical an innovation is continually evolving, and also we to make reservation the right to review and also update clinical Policy periodically.

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