Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Artificial Heart, Total

Description:

According to a 2022 report from the American Heart Association and based on data collected from 2015 to 2018, roughly 6 million Americans ages 20 years or older had heart failure during that time frame (Tsao, 2022). Prevalence of heart failure is projected to affect more than 8 million people 18 years of age and older by the year 2030. Between 2015 and 2018, the prevalence of heart failure was highest in non-Hispanic Black males. Based on data from the Multi-Ethnic Study of Atherosclerosis (MESA), in those without baseline cardiovascular disease, Black individuals had the highest risk of developing heart failure (4.6 per 1000 person-years), followed by Hispanic (3.5 per 1000 person-years), White (2.4 per 1000 person-years), and Chinese individuals (1.0 per 1000 person-years) (Lewsey, 2021). Similar findings were demonstrated in the Atherosclerosis Risk in Communities (ARIC) Community Surveillance data, in which Black men and women had the highest burden of new-onset heart failure cases and the highest-age adjusted 30-day case fatality rate in comparison to White men and women. Higher risk reflected differential prevalence of hypertension, diabetes, and low socio-economic status.

Heart failure may be the consequence of a number of etiologies, including ischemic heart disease, cardiomyopathy, congenital heart defects, or rejection of a heart transplant. The reduction of cardiac output is considered to be severe when systemic circulation cannot meet the body's needs under minimal exertion. Heart transplantation improves quality of life and has survival rates at 1, 3, and 5 years of about 91%, 85%, and 78%, respectively (OPTN, 2018). The number of candidates for transplants exceeds the supply of donor organs; thus the interest in the development of mechanical devices.

The total artificial heart (TAH) is a biventricular device that completely replaces the function of the diseased heart. An internal battery requires frequent recharging from an external power source. Many systems use a percutaneous power line, but a transcutaneous power-transfer coil allows for a system without lines traversing the skin, possibly reducing the risk of infection. Because the native heart must be removed, failure of the device is synonymous with cardiac death.

Currently the Syncardia Temporary Total Artificial Heart (Syncardia Systems) is the only Total Artificial Heart available in the US. The SynCardia Temporary Total Artificial Heart (Formerly CardioWest Total Artificial Heart and Jarvik Total Artificial Heart), manufactured by SynCardia Systems, was approved by the FDA in 2004 as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

The AbioCor Total Artificial Heart was FDA approved under the Humanitarian Device Exemption program in 2006, but it is no longer being marketed or in development.

Policy/
Coverage:

Effective June 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

The use of total artificial hearts with FDA-approved devices meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a bridge to heart transplantation in patients:

With biventricular failure who have no other reasonable medical or surgical treatment options; AND
Who are ineligible for other univentricular or biventricular support devices; AND
Who are currently listed as heart transplantation candidates or are undergoing evaluation to determine candidacy for heart transplantation; AND
Who are not expected to survive until a donor heart can be obtained.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of total artificial hearts for any other indication or under any other circumstances does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, the use of total artificial hearts for any other indication or under any other circumstances is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective Prior to June 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

With biventricular failure who have no other reasonable medical or surgical treatment options; and
Who are ineligible for other univentricular or biventricular support devices; and
Who are currently listed as heart transplantation candidates; and
Who are not expected to survive until a donor heart can be obtained.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Effective prior to 1/1/2014

The use of total artificial hearts with FDA-approved devices meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a bridge to heart transplantation in patients:

With biventricular failure who have no other reasonable medical or surgical treatment options; and
Who are ineligible for other univentricular or biventricular support devices; and
Who are currently listed as heart transplantation candidates; and
Who are not expected to survive until a donor heart can be obtained.

The use of total artificial hearts for any other indication or under any other circumstances including out-of-hospital management of the total artificial heart does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. Out-of-hospital management of total artificial heart recipients is currently being studied in a clinical trial and the supplementary device(s) which allow for home use are not FDA approved and still under investigation.

For contracts without primary coverage criteria, the use of total artificial hearts for any other indication or under any other circumstances including out-of-hospital management of the total artificial heart is considered investigational. Investigational services are considered contract exclusions in most member benefit certificates of coverage. Out-of-hospital management of total artificial heart recipients is currently being studied in a clinical trial and the supplementary device(s) which allow for home use are not FDA approved and still under investigation.

Effective, July 2006 - June 2011

The use of a total artificial heart does not meet Primary Coverage Criteria for effectiveness in improving health outcomes.

For contracts without Primary Coverage Criteria the use of a total artificial heart is considered investigational and is not covered. Investigational services are an exclusion in the member benefit contract.

Rationale:

This policy was initially developed in 2006, because of success with ventricular assist devices and development of total artificial hearts.

Total artificial hearts represent a natural extension of VADs as destination therapy. In 2004, the CardioWest Total Artificial Heart received FDA approval for use as a bridge to transplant. The approval was based on the results of a nonrandomized, prospective study of 81 patients (Copeland, 2004) Patients had failed inotropic therapy and had biventricular failure and thus were not considered appropriate candidates for an LVAD. The rate of survival to transplant was 79%, which was considered comparable to the experience with LVAD in patients with left ventricular failure. The mean time from entry into the study until transplantation or death was 79.1 days.

In 2006, the FDA approved the first totally implanted artificial heart for patients with advanced heart failure involving both ventricles under the Humanitarian Use Device (HUD) provisions of the Food, Drug and Cosmetic Act. The AbioCor Implantable Replacement Heart, made by Abiomed, Inc. (Danvers, MA), is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention. The AbioCor system consists of a 2-pound mechanical heart that takes over the pumping function of the diseased heart, which is removed during the implantation procedure; a power transfer coil that powers the system across the skin and recharges the internal battery from the outside; and a controller and an internal battery, which are implanted in the patient's abdomen. The controller monitors and controls the functioning of the device, including the pumping rate of the heart. The internal battery allows the recipient to be free from all external connections for up to 1 hour. The system also includes 2 external batteries that allow free movement for up to 2 hours. During sleep and while batteries are being recharged, the system can be plugged into an electrical outlet. To receive the artificial heart, in addition to meeting other criteria, patients must undergo a screening process to determine if their chest volume is large enough to hold the device. The current, approved device is too large for about 90% of women and for many men. The FDA is requiring the company to provide a comprehensive patient information package to patients and families that clearly describes the risks as well as the probable benefits of the device and explains what patients should expect before, during, and after surgery. To further refine and improve the use of this artificial heart technology, Abiomed will conduct a post-marketing study of 25 additional patients. The post-market study was recommended by the Circulatory Systems Devices Panel, a part of the FDA's Medical Devices Advisory Committee.

Further data concerning this device as destination therapy is available from information concerning the FDA approval (Abiocor) and from a published article describing results for the first 7 patients (Dowling, 2004) The FDA indicated that their decision was based on the company's laboratory and animal testing and on a small clinical study of 14 patients conducted by Abiomed. The patients had a 1-month survival prognosis of not more than 30%, were not eligible for cardiac transplants, and were felt to not benefit from VAD therapy. The study was reported to show that the device is safe and has likely benefit for people with severe heart failure whose death is imminent and for whom no alternative treatments are available. Of the 14 patients in the study, 12 survived surgery. Mean duration of support for the patients was 5.3 months. In some cases the device extended survival by several months; survival was 17 months in 1 patient. Six patients were ambulatory; 1 patient was discharged home. Complications included postoperative bleeding and neurological events. Device-related infection was "non-existent." This device shows technological progress, and these initial results are encouraging; however, a number of questions remain. One issue is to further analyze relevant patient outcomes (complications, quality of life, survival, etc). Therefore, based on current information, the artificial heart for destination therapy is considered investigational.

2011 Update

There were no new prospective trials identified on the safety and efficacy of the CardioWest temporary total artificial heart (TAH-t). In 2008, over 700 CardioWest TAH-ts were implanted worldwide (Copeland, 2008). More than 68 TAH-t recipients have been discharged from the hospital and managed at home in Germany, France and Italy (Copeland, 2010). A new operating system, the SynCardia Freedom Driver System is being studied in a clinical trial (NCT0073347). This system weighs only about 14 lbs and is designed to allow out-of hospital management of clinically stable TAH-t recipients. At this time, there is a lack of scientific evidence regarding the safety and efficacy of out-of hospital management of TAH-t recipients.

2012 Update

A search of the MEDLINE database through September 2012 did not reveal any published data from randomized controlled trials on the use of the total artificial heart. The policy statement is unchanged.

2013 Update

A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement.

2016 Update

A literature review conducted through December 2015 did not identify any new literature that would prompt a change in the coverage statement.

Torregrossa et al reported on 47 patients who received a TAH at 10 worldwide centers and had the device implanted for more than 1 year (Torregrossa, 2014). Patients were implanted for dilated cardiomyopathy (n=23), ischemic cardiomyopathy (n=15), and “other” reasons (n=9). Over a median support time of 554 days (range, 365-1373 days), 34 patients (72%) were successfully transplanted, 12 patients (24%) died while on device support, and 1 patient (2%) was still supported. Device failure occurred in 5 patients (10%). Major complications were common, including systemic infection in 25 patients (53%), driveline infections in 13 patients (27%), thromboembolic events in 9 patients (19%), and hemorrhagic events in 7 patients (14%). Two of the deaths occurred secondary to device failure.

2016 Update

A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

A fully bioprosthetic TAH, which is fully implanted in the pericardial sac and is electrohydrolically actuated, has been developed and tested in 2 patients, but is currently experimental (Carpentier, 2015).

2018 Update

A literature search was conducted through November 2018. 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 November 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through November 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

The International Society for Heart and Lung Transplantation and the Heart Failure Society of America released a guideline on acute Mechanical Circulatory Support (MCS) in 2023 (Bernhardt, 2023). The guideline focuses on timing, patient, and device selection of acute MCS, and periprocedural and postprocedural care for cardiogenic and pulmonary shock. They provide specific recommendations depending on which MCS device is chosen. Below is a summary of relevant recommendations for timing of acute MCS made in the guidelines. Additional recommendations related to specific devices is related to procedural considerations.

"Acute MCS should be initiated as soon as possible in patients with cardiogenic shock who fail to stabilize or continue to deteriorate despite initial interventions." Class or Recommendation I; Level of Evidence B

"The use of acute MCS should be considered in patients with multiorgan failure to allow successful optimization of clinical status and neurologic assessment before placement of durable MCS or organ transplantation." Class or Recommendation II; Level of Evidence C

CPT/HCPCS:

References:

Carpentier A, Latremouille C, Cholley B, et al.(2015) First clinical use of a bioprosthetic total artificial heart: report of two cases. Lancet. Oct 17 2015;386(10003):1556-1563. PMID 26231456

Copeland J.(2010) Out-of-Hospital total artificial heart patients. Texas Heart Institute Journal. 2010;35(6):654-55.

Copeland JG, Smith RG, Arabia FA et al.(2004) Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med 2004; 351(9):859-67.

Copeland JG, Smith RG, Bose RK, et al.(2008) Risk factor analysis for Bridge to Transplantation with the CardioWest Total Artificial Heart. Ann Thorac Surg 2008;85:1639-45.

Copeland JG, Smith RG, et al.(2004) Cardiac replacement with a total artificial heart as a bridge to transplantation. NEJM 2004; 351:859-67.

Dowling RD, Gray LA Jr, Etoch SW et al.(2004) Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg 2004; 127(1):131-41.

FDA Approval letter. http://www.accessdata.fda.gov/cdrh_docs/pdf4/h040006a.pdf

Koerfer R.(2008) Risk factor analysis for Bridge to Transplantation with the CardioWest Total Artificial Heart. Invited Commentary. Ann Thorac Surg 2008;85:1645.

Rihal CS, Naidu SS, Givertz MM, et al.(2015) 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care: Endorsed by the American Heart Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention. J Am Coll Cardiol. May 19 2015;65(19):e7-e26. PMID 25861963

Stevenson LW, Kormos RL, et al.(2001) Mechanical cardiac support 2000: current applications and future trial designs. J Am Coll Cardiol 2001; 37:340-70.

SynCardia Freedom Driver System Study. NCT00733447. ClinicalTrials.gov. Last accessed. June 2011

Torregrossa G, Morshuis M, Varghese R, et al.(2014) Results with SynCardia total artificial heart beyond 1 year. ASAIO J. Nov-Dec 2014;60(6):626-634. PMID 25158888

Total artificial heart, temporary or permanent biventricular support device. Hayes Technology Assessment 2005.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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