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Total Artificial Hearts and Implantable Ventricular Assist Devices

Policy Number: MP-033

Latest Review Date: September 2022

Category: Surgery                                                                  

POLICY:

Effective for dates of service on or after 10/04/2021:

Long-Term Devices

Destination Therapy

VAD- Adult

Implantable VADs with FDA approval or clearance may be considered medically necessary as destination therapy with end-stage heart failure adult patients who meet the following criteria:

  • New York Heart Association (NYHA) Class III heart failure with mild dyspnea upon physical activity or NYHA Class IV;
  • Left ventricular ejection fraction ≤ 25%;
  • Inotrope-dependent; OR cardiac index <2.2 liters/min/m2, while not on inotropes and also meeting one of the following:
    • On optimal medical management, based on current heart failure practice guidelines for at least 45 of the last 60 days and are failing to respond OR
    • Advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for ≥7 days.

Short-Term Devices

Bridge to Transplantation

Implantable ventricular assist devices (VADs) with U.S. Food and Drug Administration (FDA) approval or clearance may be considered medically necessary as a bridge to heart transplantation for patients who meet one of the following criteria:

  • Currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, OR
  • The patient is undergoing evaluation to determine candidacy for heart transplantation.

Postcardiotomy Setting/Bridge to Recovery

Implantable VADs with FDA approval or clearance may be considered medically necessary in the postcardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass.

Bridge to Transplantation

TAH

Total artificial hearts with FDA-approved devices meet medical criteria for coverage when performed in a Medicare-approved heart transplant facility as a bridge to heart transplantation when ALL of the following criteria are met:

  • Biventricular failure AND,
  • No other reasonable medical or surgical treatment options; and
  • Are ineligible for other univentricular or biventricular support devices; and
  • Are currently listed as heart transplantation candidates

OR

  • Are undergoing evaluation to determine candidacy for heart transplantation; and
  • Are not expected to survive until a donor heart can be obtained.

*Pediatric- VAD

Pediatric ventricular assist devices with FDA-approval may be considered medically necessary when both of the following criteria are met:

  • Child has documented NYHA Class IV end-stage (i.e., left ventricular) heart failure refractory to medical therapy; AND
  • An age and size-appropriate VAD will be used until a donor heart can be obtained*

*Note: See Approved By Governing Bodies section of policy for listing of FDA approved devices.

Right Ventricular Assist Devices

FDA-approved right ventricular assist devices (RVADs; e.g., The Thoratec® CentriMag® Blood Pump) is considered medically necessary for temporary circulatory support in accordance with the FDA’s Humanitarian Device Exemption (HDE) requirements when the following criteria are met:

  • Device is used for up to 30 days for an individual in cardiogenic shock due to acute right ventricular failure and the individual is willing and able to be treated with heparin or an appropriate alternative anticoagulation; OR
  • For use for up to 6 hours to provide hemodynamic stabilization for an individual in need of cardiopulmonary support.

Percutaneous Ventricular Assist Devices

Percutaneous ventricular assist devices (pVAD) with FDA approval or clearance meet medical criteria for coverage for use in patients undergoing high-risk percutaneous coronary intervention (PCI) when ALL of the following are met:

  • Patient has LVEF of less than 35% AND;
  • Will undergo PCI on an unprotected left main coronary artery or last patent coronary conduit.

Other Indications

Total artificial hearts including, but not limited to, the use of total artificial hearts as destination therapy is considered investigational for all other indications.

Ventricular assist devices and percutaneous ventricular assist devices are considered investigational for all other indications.

Use of a non-FDA approved ventricular assist device is considered investigational.

Implantable Aortic Counterpulsation Ventricular Assist Devices (e.g., the NuPulseCV iVAS and the Symphony Heart Assist System) A permanently implantable aortic counterpulsation VAD for any indication is investigational.

POLICY GUIDELINES:

The intent of treatment may evolve over the course of treatment; for example, there is not necessarily a strict delineation between bridge to transplant and destination therapy.

Only 2 ventricular assist devices (VADs) have approval from the U.S. Food and Drug Administration (FDA) for the pediatric population. The DeBakey VAD Child device and the Berlin Heart EXCOR Pediatric VAD have FDA approval through the humanitarian device exemption process. The DeBakey VAD is indicated for use in children ages 5 to 16 years who are awaiting a heart transplant (i.e., a bridge to transplant) while the Berlin Heart EXCOR VAD is indicated for children with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support.

In general, candidates for bridge to transplant implantable VADs are those who are considered appropriate heart transplant candidates but who are unlikely to survive the waiting period until a human heart donor is available. Some studies have included the following hemodynamic selection criteria: either a left atrial pressure of 20 mm Hg or a cardiac index of less than 2.0 L/min/m while receiving maximal medical support. Patients with VADs are classified by the United Network for Organ Sharing as status I (i.e., persons who are most ill and are considered the highest priority for transplant).

The median duration for time on the device is between 20 and 120 days.

Contraindications for bridge to transplant VADs and total artificial hearts include conditions that would generally exclude patients for heart transplant. Such conditions are chronic irreversible hepatic, renal, or respiratory failure; systemic infection; coagulation disorders, and inadequate psychosocial support. Due to potential problems with adequate function of the VAD or total artificial heart, implantation is also contraindicated in patients with uncorrected valvular disease.

The Centers for Medicare and Medicaid Services requires that “Beneficiaries receiving a VAD must be managed by an explicitly identified, cohesive, multidisciplinary team of medical professionals with appropriate qualifications, training, and experience. The team embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in informed decision making. The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD.

The team must include, at a minimum:

  • At least 1 physician with cardiothoracic surgery privileges and individual experience implanting at least 10 durable, intracorporeal, left ventricular assist devices over the course of the previous 36 months with activity in the last year.
  • At least 1 cardiologist trained in advanced heart failure with clinical competence in medical- and device-based management including VADs, and clinical competence in the management of patients before and after placement of a VAD.
  • A VAD program coordinator.
  • A social worker.
  • A palliative care specialist.”

See Medical Policy #390- Heart Transplant and Combined Heart-Kidney Transplantation for further discussion of heart transplant candidacy.

Effective for dates of service on or after May 29, 2021 through October 3, 2021:

Bridge to Recovery

Ventricular assist devices with FDA approval or clearance may be considered medically necessary in patients in the post-cardiotomy setting who are unable to be weaned off cardiopulmonary bypass.

*Pediatric- VAD

Pediatric ventricular assist devices with FDA-approval may be considered medically necessary when both of the following criteria are met:

  • Child has documented NYHA Class IV end-stage (i.e., left ventricular) heart failure refractory to medical therapy; AND
  • An age and size-appropriate VAD will be used until a donor heart can be obtained*

*Note: See Approved By Governing Bodies section of policy for listing of FDA approved devices.

VAD- Adult

Ventricular assist devices with FDA approval or clearance meet medical criteria for coverage for short-term (e.g., bridge-to-recovery and bridge-to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support for heart failure patients who meet the following criteria:

  • New York Heart Association (NYHA) Class IV heart failure not responding to optimal medical management for at least 60 days,

OR

  • NYHA Class III/IV for at least 28 days and received ≥ 7  days support with an intra-aortic balloon pump,

or

  • NYHA Class III/IV for at least 28 days and dependent on intravenous (IV) inotropic agents, with two failed weaning attempts; AND
  • Proven functional limitation with a peak oxygen consumption of less than or equal to 14 ml/kg/min.  (Note: This measure may be waived in persons who are balloon pump or intravenous inotrope dependent or are otherwise unable to tolerate exercise stress testing); and
  • Left ventricular ejection fraction (LVEF) < 25%; and

Patients must not be candidates for human heart transplant for one or more of the following reasons:

  • Age > 65 years; OR
  • Insulin-dependent diabetes mellitus with end-organ damage; or
  • Chronic renal failure with serum creatinine > 2.5 mg/dl for ≥ 90 days; or
  • Other clinically significant condition.

FDA-approved right ventricular assist devices (RVADs; e.g., The Thoratec® CentriMag® Blood Pump) is considered medically necessary for temporary circulatory support in accordance with the FDA’s Humanitarian Device Exemption (HDE) requirements when the following criteria are met:

  • Device is used for up to 30 days for an individual in cardiogenic shock due to acute right ventricular failure and the individual is willing and able to be treated with heparin or an appropriate alternative anticoagulation; OR
  • For use for up to 6 hours to provide hemodynamic stabilization for an individual in need of cardiopulmonary support.

Percutaneous ventricular assist devices (pVAD) with FDA approval or clearance meet medical criteria for coverage for use in patients undergoing high-risk percutaneous coronary intervention (PCI) when ALL of the following are met:

  • Patient has LVEF of less than 35% AND;
  • Will undergo PCI on an unprotected left main coronary artery or last patent coronary conduit.

Bridge to Transplantation

TAH

Total artificial hearts with FDA-approved devices meet medical criteria for coverage when performed in a Medicare-approved heart transplant facility as a bridge to heart transplantation when ALL of the following criteria are met:

  • Biventricular failure AND,
  • No other reasonable medical or surgical treatment options; and
  • Are ineligible for other univentricular or biventricular support devices; and
  • Are currently listed as heart transplantation candidates

OR

  • Are undergoing evaluation to determine candidacy for heart transplantation; and
  • Are not expected to survive until a donor heart can be obtained.

Other Indications

Total artificial hearts including, but not limited to, the use of total artificial hearts as destination therapy is considered investigational for all other indications.

Ventricular assist devices and percutaneous ventricular assist devices are considered investigational for all other indications.

Use of a non-FDA approved ventricular assist device is considered investigational.

Implantable Aortic Counterpulsation Ventricular Assist Devices (e.g., the NuPulseCV iVAS and the Symphony Heart Assist System) A permanently implantable aortic counterpulsation VAD for any indication is investigational.

POLICY GUIDELINES:

Only two ventricular assist devices (VADs) have approval from the U.S. Food and Drug Administration (FDA) for the pediatric population. The DeBakey VAD Child device and the Berlin Heart EXCOR Pediatric VAD have FDA approval through the humanitarian device exemption process. The DeBakey VAD is indicated for use in children ages 5 to 16 years who are awaiting a heart transplant (i.e., a bridge to transplant) while the Berlin Heart EXCOR VAD is indicated for children with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support.

In general, candidates for bridge to transplant implantable VADs are those who are considered appropriate heart transplant candidates but who are unlikely to survive the waiting period until a human heart donor is available. Some studies have included the following hemodynamic selection criteria: either a left atrial pressure of 20 mm Hg or a cardiac index of less than 2.0 L/min/m2 while receiving maximal medical support. The United Network classifies patients with VADs for Organ Sharing as status I (i.e., persons who are most ill and are considered the highest priority for transplant).

The median duration for time on the device is between 20 days and 120 days.

Contraindications for bridge to transplant VADs and total artificial hearts include conditions that would generally exclude patients for heart transplant. Such conditions are chronic irreversible hepatic, renal, or respiratory failure; systemic infection; coagulation disorders, and inadequate psychosocial support. Due to potential problems with adequate function of the VAD or total artificial heart, implantation is also contraindicated in patients with uncorrected valvular disease.

See Medical Policy #390- Heart Transplant and Combined Heart-Kidney Transplantation for further discussion of heart transplant candidacy.

In addition, patients must have sufficient space in the thorax and/or abdominal cavity for the device. In the case of the CardioWest Temporary Total Artificial Heart, this excludes patients with body surface areas less than 1.7 m2 or who have a distance between the sternum and 10th anterior rib of less than 10 cm, as measured by computed tomography scan.

Effective for dates of service on or after October 5, 2013 and prior to May 29, 2021:

POLICY:

Ventricular assist device (VAD) implantation may be considered medically necessary only when performed in a Medicare-approved heart transplant facility OR Medicare-approved VAD destination therapy facility AND follows individual criteria for specific indications listed below.  A list of these facilities is maintained on the CMS web site and available at: www.cms.gov/CertificationandComplianc/Downloads/ApprovedTransplantPrograms.pdf and www.cms.gov/Medicare/Medicare-General-Information/MedicareApprovedFacilities/VAD-Destination-Therapy-Facilities-Aug2007.html.

Bridge to Recovery

Ventricular assist devices with FDA approval or clearance may be considered medically necessary in patients in the post-cardiotomy setting who are unable to be weaned off cardiopulmonary bypass.

Percutaneous ventricular assist devices (pVAD) with FDA approval or clearance meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage for use in patients undergoing high-risk percutaneous coronary intervention (PCI) when ALL of the following are met:

  • Patient has LVEF of less than 35% AND;
  • Will undergo PCI on an unprotected left main coronary artery or last patent coronary conduit.

Bridge to Transplantation

TAH

Total artificial hearts with FDA-approved devices meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage when performed in a Medicare-approved heart transplant facility as a bridge to heart transplantation when ALL of the following criteria are met:

  • Biventricular failure AND,
  • No other reasonable medical or surgical treatment options; and
  • Are ineligible for other univentricular or biventricular support devices; and
  • Are currently listed as heart transplantation candidates

OR

Are undergoing evaluation to determine candidacy for heart transplantation; AND

  • Are not expected to survive until a donor heart can be obtained.

VAD- Adult

Ventricular assist devices with FDA approval or clearance meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage as a bridge to transplantation when ALL of the following criteria are met:

  • Patient is diagnosed with severe congestive heart failure (CHF); AND
  • Is an approved heart transplant candidate by an approved heart transplant center;

OR

Is undergoing evaluation to determine candidacy for heart transplantation; AND

  • Is at risk of dying before a donor heart is available**; and
  • On optimal inotropic (influencing the contractility of muscular tissue) support; and
  • If possible, on an intra-aortic balloon pump.

**The criteria listed below may be used as hemodynamic selection criteria:

  1. Either a left atrial pressure of 20m Hg or a cardiac index of less than 2.0L/min/m while on maximum medical support;
  2. Patients who are usually being treated as inpatients and according to the American Heart Association or comparable, as Class IV CHF;
  3. Classified as status I by the United Network for Organ Sharing (considered the highest priority for transplantation).

Pediatric- VAD

Ventricular assist devices with FDA approval or clearance, including humanitarian device exemptions meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage in children 16 years old and younger as a bridge to heart transplantation who:

  • Are currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained; OR
  • Are undergoing evaluation to determine candidacy for heart transplant.

Destination Therapy

Ventricular assist devices with FDA approval or clearance meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage when used as a permanent alternative (destination therapy) for patients with end-stage heart failure and who are not candidates for heart transplantation when ALL of the following criteria are met:

  • New York Heart Association (NYHA) Class IV heart failure not responding to optimal medical management for at least 60 days,

OR

NYHA Class III/IV for at least 28 days and received ≥ 14 days support with an intra-aortic balloon pump

or

NYHA Class III/IV for at least 28 days and dependent on intravenous (IV) inotropic agents, with two failed weaning attempts; AND

  • Left ventricular ejection fraction (LVEF) < 25%; and
  • Patients must not be candidates for human heart transplant for one or more of the following reasons:
  • Age > 65 years; OR
  • Insulin-dependent diabetes mellitus with end-organ damage; or
  • Chronic renal failure with serum creatinine > 2.5 mg/dl for ≥ 90 days; or
  • Other clinically significant condition.

Other Indications

Total artificial hearts including, but not limited to, the use of total artificial hearts as destination therapy is considered investigational for all other indications.

Ventricular assist devices and percutaneous ventricular assist devices are considered investigational for all other indications.

Use of a non-FDA approved ventricular assist device is considered investigational.

Implantable Aortic Counterpulsation Ventricular Assist Devices (e.g., the NuPulseCV iVAS and the Symphony Heart Assist System) A permanently implantable aortic counterpulsation VAD for any indication is investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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. 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). 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.

Mechanical devices to assist or replace a failing heart have been developed over many decades of research. A ventricular assist device (VAD) is a mechanical support, attached to the native heart and vessels to augment cardiac output. The total artificial heart (TAH) replaces the native ventricles and is attached to the pulmonary artery and aorta; the native heart is typically removed. Both the VAD and TAH may be used as a bridge to heart transplantation or as destination therapy in those who are not candidates for transplantation. The VAD has also been used as a bridge to recovery in patients with reversible conditions affecting cardiac output.

Heart Failure

Heart failure may be the consequence of a number of differing 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 91%, 85%, and 78%, respectively. The number of candidates for transplants exceeds the supply of donor organs; thus the interest in the development of mechanical devices.

Treatment

Ventricular Assist Devices (VAD)

Implantable ventricular assist devices are attached to the native heart, which may have enough residual activity to withstand a device failure in the short term. In reversible conditions of heart failure, the native heart may regain some function, and weaning and explanting of the mechanical support system after months of use has been described. Ventricular assist devices can be classified as internal or external, electrically or pneumatically powered, and pulsatile or continuous flow. Initial devices were pulsatile, mimicking the action of a beating heart. Devices that are more recent may utilize a pump, which provides continuous flow. Continuous devices may move blood in rotary or axial flow.

At least one VAD system has been developed that is miniaturized and generates an artificial pulse, the HeartMate III™ LVAD (St. Jude Medical, Pleasanton, California).  The HeartMate® III™ was FDA approved August 23, 2017.

Surgically implanted ventricular assist devices represent a method of providing mechanical circulatory support for patients not expected to survive until a donor heart becomes available for transplant or for whom transplantation is otherwise contraindicated or unavailable. They are most commonly used to support the left ventricle, but right ventricular and biventricular devices may be used. The device is larger than most native hearts, and therefore the size of the patient is an important consideration: the pump may be implanted in the thorax or abdomen or remain external to the body. Inflow to the device is attached to the apex of the failed ventricle, while outflow is attached to the corresponding great artery (aorta for left ventricle, pulmonary artery for right ventricle). A small portion of ventricular wall is removed for insertion of the outflow tube; extensive cardiotomy affecting the ventricular wall may preclude VAD use.

Total Artificial Heart (TAH)

Initial research into mechanical assistance for the heart focused on the total artificial heart, a biventricular device that completely replaces the function of the diseased heart. An internal battery required frequent recharging from an external power source. Many systems utilize 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.

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.

Percutaneous Ventricular Assist Devices (pVADs)

Devices in which the majority of the system’s components are external to the body are for short-term use (six hours to 14 days) only, due to the increased risk of infection and need for careful, in-hospital monitoring. Some circulatory assist devices are placed percutaneously, (i.e., are not implanted). These may be referred to as percutaneous VADs (pVADs). The pVADs are placed through the femoral artery.  Two different pVADs have been developed, the TandemHeart™, and the Impella® device. In the TandemHeart™ system, a catheter is introduced through the femoral vein and passed into the left atrium via transseptal puncture. Oxygenated blood is then pumped from the left atrium into the arterial system via the femoral artery. The Impella® device is introduced through a femoral artery catheter. In this device, a small pump is contained within the catheter that is placed into the left ventricle. Blood is pumped from the left ventricle, through the device, and into the ascending aorta. Adverse events associated with pVAD include access site complications such as bleeding, aneurysms, or leg ischemia. Cardiovascular complications can also occur, such as perforation, myocardial infarction (MI), stroke, and arrhythmias.

Implantable Aortic Counter-Pulsation Ventricular Assist Systems 

Implantable Aortic Counter-Pulsation Ventricular Assist Systems are inserted through the left or right subclavian artery and implanted into the aorta. The device inflates during diastole to reduce diastolic ventricular pressures without re-routing the blood flow. Cardiac rhythm is monitored using three subcutaneous electrodes that transmit cardiac electrical information to an implanted skin interface device. Implantable aortic counterpulsation ventricular assist systems decrease left ventricular afterload and improve left ventricular performance and contractility.  Its function is comparable to that of the intra-aortic balloon pump (IABP). However, this device uses a permanently implanted balloon intended for long-term use, while the IABP is a short-term solution to stabilize the patient and is usually removed within 48 hours. Currently, this device is in clinical trials to evaluate its use as a bridge to transplant and recovery for acute and chronic heart failure patients.

KEY POINTS:

The most recent literature search was performed for the period through June 22, 2022.

Summary of Evidence

Ventricular Assist Device

For individuals who have end-stage heart failure who receive a VAD as a bridge to transplant, the evidence includes a RCT, single-arm trials, and observational studies. Relevant outcomes are OS , symptoms, functional outcomes, QOL, and treatment-related mortality and morbidity. There is a substantial body of evidence from clinical trials and observational studies supporting implantable VADs as a bridge to transplant in patients with end-stage heart failure, possibly reducing mortality as well as improving QOL. These studies have reported that substantial numbers of patients have survived to transplant in situations in which survival would not be otherwise expected. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have end-stage heart failure who receive a VAD as destination therapy, the evidence includes RCTs and multiple single-arm studies. Relevant outcomes are OS, symptoms, functional outcomes, QOL, and treatment-related mortality and morbidity. A well-designed trial with 2 years of follow-up data has demonstrated an advantage of implantable VADs as destination therapy for patients ineligible for a heart transplant. Despite an increase in adverse events, both mortality and QOL appear to be improved for these patients. A more recent trial comparing VADs has broader inclusion criteria and supports that criteria move away from use of transplant ineligibility, as treatment may evolve over the course of treatment. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Total Artificial Heart

For individuals who have end-stage heart failure who receive a TAH as a bridge to transplant, the evidence includes case series. Relevant outcomes are OS, symptoms, functional outcomes, QOL, and treatment-related mortality and morbidity. Compared with VADs, the evidence for TAHs in these settings is less robust. However, given the lack of medical or surgical options for these patients and the evidence case series provide, TAH is likely to improve outcomes for a carefully selected population with end-stage biventricular heart failure awaiting transplant who are not appropriate candidates for a left VAD. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have end-stage heart failure who receive a TAH as destination therapy, the evidence includes 2 case series. Relevant outcomes are OS, symptoms, functional outcomes, QOL, and treatment-related mortality and morbidity. The body of evidence for TAHs as destination therapy is too limited to draw conclusions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Percutaneous Ventricular Assist Device

For individuals with cardiogenic shock who receive a pVAD, the evidence includes RCTs, observational studies, and a systematic review. Relevant outcomes are OS, symptoms, morbid events, functional outcomes, QOL, and treatment-related mortality and morbidity. Four RCTs of pVAD versus intra-aortic balloon pump for patients in cardiogenic shock failed to exhibit a mortality benefit and reported higher complication rates with pVAD use. Comparative observational studies and a long-term follow-up study were consistent with the RCT evidence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who undergo high-risk cardiac procedures who receive a pVAD, the evidence includes RCTs, observational studies, and systematic reviews of these trials. Relevant outcomes are OS, symptoms, morbid events, functional outcomes, QOL, and treatment-related mortality and morbidity. Randomized controlled trials, controlled and uncontrolled observational studies, and systematic reviews of these studies have not demonstrated a benefit of pVAD used as ancillary support for patients undergoing high-risk cardiac procedures. Additionally, two non-randomized studies have compared VT ablation with pVAD or IABP. Both studies verified that patients who had pVAD support spent less time in unstable VT than patients without pVAD support. However, the current evidence does not support conclusions about the use of pVAD for VT ablation. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with cardiogenic shock refractory to intra-aortic balloon pump therapy who receive a pVAD, the evidence includes case series. Relevant outcomes are OS, symptoms, morbid events, functional outcomes, QOL, and treatment-related mortality and morbidity. Case series of patients with cardiogenic shock refractory to intra-aortic balloon pump have reported improved hemodynamic parameters following pVAD placement. However, these uncontrolled series do not provide evidence that pVADs improve mortality, and high rates of complications have been reported with pVAD use. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Implantable Aortic Counter-Pulsation Ventricular Assist Systems 

For individuals with advanced heart failure who are treated with a permanently implantable aortic counterpulsation ventricular assist device the current data is limited in scope. There are scarce published, peer-reviewed scientific literature regarding its safety and effectiveness. This device is being studied for acute and chronic heart failure as a bridge to recovery. The current evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Association for Thoracic Surgery/International Society for Heart and Lung Transplantation

In 2020, the American Association for Thoracic Surgery and the International Society for Heart and Lung Transplantation published guidelines on selected topics in mechanical circulatory support, including recommendations on the use of pVADs. The guideline authors noted, "Compared with IABP, contemporary percutaneous circulatory support devices provide a significant increase in cardiac index and mean arterial pressure; however, reported 30-day outcomes are similar."

Table 1. 2020 Guidelines on Mechanical Circulatory Support

Recommendation

COE

LOE

"Percutaneous LV to aorta pumps of appropriate size should be considered for cardiogenic shock from primary LV failure."

IIA

B

COE: class of evidence; LOE: level of evidence; LV: left ventricular.

American College of Cardiology Foundation et al

The American College of Cardiology Foundation, American Heart Association (AHA), and Heart Failure Society of American (2017) published a focused update of the 2013 recommendations released by the American College of Cardiology Foundation and AHA.  Left ventricular assist device was one of several treatment options recommended for patients with refractory New York Heart Association class III or IV heart failure (stage D). If symptoms were not improved after guidelines directed management and therapy, which included pharmacologic therapy, surgical management and/or other devices, then left ventricular assist device would be an additional treatment option.

The 2017 update focused on changes in sections regarding biomarkers, comorbidities, and prevention of heart failure, while many of the previous recommendations remained unchanged. The American College of Cardiology Foundation and AHA (2013) released guidelines for the management of heart failure that included recommendations related to the use of mechanical circulatory support (MCS), including both durable and nondurable MCS devices. The guidelines categorized pVADs and extracorporeal ventricular assist devices (VADs) as nondurable MCS devices. Since the 2017 update, these guidelines have been updated regularly, with the most recent update occurring in 2022. Table 2 provides recommendations on MCS devices from the most recently updated guideline iteration.

Table 2. AHA/ACC/HFSA Guidelines on Mechanical Circulatory Support

Recommendation

COEa

LOEb

"In select patients with advanced HFrEF with NYHA class IV symptoms who are deemed to be dependent on continuous intravenous inotropes or temporary MCS, durable LVAD implantation is effective to improve functional status, QOL, and survival."

I

A

"In select patients with advanced HFrEF who have NYHA class IV symptoms despite GDMT, durable MCS can be beneficial to improve symptoms, improve functional class, and reduce mortality."

IIA

B-R

"In patients with advanced HFrEF and hemodynamic compromise and shock, temporary MCS, including percutaneous and extracorporeal ventricular assist devices, are reasonable as a 'bridge to recovery' or 'bridge to decision”

IIA

B-NR

 

American Heart Association

In 2012, the AHA published recommendations for the use of MCS. These guidelines defined nondurable MCS as IABPs, extracorporeal membrane oxygenation, extracorporeal VADs, and pVADs. Table 3 lists recommendations made on indications for the use of MCS, including durable and nondurable devices.

Table 3. 2012 Guidelines on Mechanical Circulatory Support

Recommendation

COE

LOE

"MCS for BTT indication should be considered for transplant-eligible patients with end-stage HF who are failing optimal medical, surgical, and/or device therapies and at high risk of dying before receiving a heart transplantation."

I

B

"Implantation of MCS in patients before the development of advanced HF … is associated with better outcomes. Therefore, early referral of HF patients is reasonable."

IIA

B

"MCS with a durable, implantable device for permanent therapy or DT is beneficial for patients with advanced HF, high 1-year mortality resulting from HF, and the absence of other life-limiting organ dysfunction; who are failing medical, surgical, and/or device therapies; and who are ineligible for heart transplantation."

I

B

"Elective rather than urgent implantation of DT can be beneficial when performed after optimization of medical therapy in advanced HF patients who are failing medical, surgical, and/or device therapies."

IIA

C

"Urgent nondurable MCS is reasonable in hemodynamically compromised HF patients with end-organ dysfunction and/or relative contraindications to heart transplantation/durable MCS that are expected to improve with time and restoration of an improved hemodynamic profile." "These patients should be referred to a center with expertise in the management of durable MCS and patients with advanced HF."

IIA
I

C
C

"Patients who are ineligible for heart transplantation because of pulmonary hypertension related to HF alone should be considered for bridge to potential transplant eligibility with durable, long-term MCS."

IIA

B

BTT: bridge to transplant; COE: class of evidence; DT: destination therapy; HF: heart failure; LOE: level of evidence; MCS: mechanical circulatory support.

Society for Cardiovascular Angiography and Interventions et al

In 2015, the Society for Cardiovascular Angiography and Interventions, the Heart Failure Society of America, the Society of Thoracic Surgeons, and the American College of Cardiology published a joint clinical expert consensus statement on the use of percutaneous MCS devices in cardiovascular care. This statement addressed IABPs, left atrial-to-aorta assist device (eg, TandemHeart), left ventricle-to-aorta assist devices (e.g., Impella), extracorporeal membrane oxygenation, and methods of right-sided support. Specific recommendations were not made, but the statement reviews the use of MCS in patients undergoing high-risk percutaneous intervention, those with cardiogenic shock, and those with acute decompensated heart failure.

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

Ventricular assist device, biventricular support, BIVAD, cardiac support, heart transplantation (transplant), LVAD, VAD, destination therapy, HeartWare®, Impella LV®, Impella 2.5, Impella 2.5 circulatory assist device, DeBakey, percutaneous ventricular assist device, pVAD, TandemHeart®, Berlin Heart EXCOR®, Impella RP, Carmat, bioprosthetic artificial heart, HeartMate III™, Total Artificial Heart, TAH, CardioWest™ Total Artificial Heart, HeartMate II®, SynCardia artificial heart, Right Ventricular Assist Device, RVAD, PediMag®, short-term continuous flow ventricular assist devices, STCF-VADs, intraluminal axial support, HeartAssist 5 Pediatric Ventricular Assist Device; NuPulseCV iVAS; Symphony Heart Assist System; CentriMag® Blood Pump; Implantable Aortic Counterpulsation Ventricular Assist Devices;  Intravascular Ventricular Assist Systems; iVAS); C-Pulse, CardioVAD

APPROVED BY GOVERNING BODIES:

A number of mechanical circulatory support devices have received approval or clearance for marketing by FDA. These devices are summarized in Table 4, and described further in the sections below.

Table 4: Available Mechanical Circulatory Support Devices

Device

Manufacturer

Approval Date

 FDA Clearance

PMA, HDE, or

      510(k) No.

Indication

Thoratec® IVAD

Thoratec

Aug 2004

PMA supplement

P870072

Bridge to transplant and postcardiotomy

DeBakey VAD® Child

 

MicroMed

Feb 2004

HDE

H030003

Bridge to transplant in children 5-16 years of age

HeartMate II®

Thoratec

Apr 2008

PMA

P060040

Bridge to transplant and destination therapy

Centrimag®

Thoratec

Dec 2019

PMA

P170038

 

Postcardiotomy,

bridge to decision

 

Berlin Heart EXCOR®

Pediatric VAD

Berlin

June 2017

PMA

P160035

 

Bridge to transplant

HeartMate III™

Left Ventricular Assist System

 

 

HeartWare

Aug 2017

    Oct 2018

PMA

P160054

P160054/S008

Bridge to transplant, and destination therapy; PMA for Pediatric patients in 2020

FDA: Food and Drug Administration; HDE: humanitarian device exemption; PMA: premarket approval

*Note: Current FDA-approved pediatric VADs include the Berlin Heart EXCOR Pediatric Ventricular Assist Device (for children aged 16 years or younger) and the HeartAssist 5 Pediatric Ventricular Assist Device (for children aged 5 to 16 years). The EXCOR Pediatric VAD can be used in children up to 60 kg body weight. The HeartAssist 5 Pediatric VAD can be used in children with a BSA greater than or equal to 0.7 m2 and less than 1.5 m2).

Ventricular Assist Devices

In February 2004, the FDA approved the DeBakey VAD® Child under the HDE approval process. According to the FDA, this device is indicated under HDE for both home and hospital use for children who are between ages 5 and 16 years and who have end-stage ventricular failure requiring temporary mechanical blood circulation until a heart transplant is performed.

In April 2008, continuous flow device HeartMate II® LVAS (Thoratec, Pleasanton, CA) was approved by the FDA through the premarket approval process for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The Heartmate II® LVAS is intended for use both inside and outside the hospital. In January 2010, the device received the added indication as destination therapy for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and are not candidates for cardiac transplantation.

In October 2008, device Centrimag® Right Ventricular Assist Device (Levitronix, Zurich) was approved by the FDA under the HDE to provide temporary circulatory support for up to 14 days for patients in cardiogenic shock due to acute right-sided heart failure.

In December 2011, the Berlin Heart EXCOR® Pediatric VAD was approved via HDE. The indications for this device are pediatric patients with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support.

In December 2012, the FDA using the INTERMACS registry as a control approved device HeartWare® Ventricular Assist System (HeartWare, Inc., Framingham, Mass.)  INTERMACS registry was established in 2005 as a joint effort involving the FDA, National Heart, Lung and Blood Institute (NHLBI), Centers for Medicare and Medicaid Services (CMS), clinicians, scientists, and industry.  This was the first time the FDA approved an LVAD using registry data as a control.  The University of Alabama at Birmingham manages INTERMACS.

In September 2017, HeartWare® Ventricular Assist System (HeartWare, Inc., Framingham, Mass.) was approved by the FDA for providing long-term hemodynamic support (e.g., destination therapy) in patients with advanced heart failure.

In August 2017, the FDA for providing short-term hemodynamic support (e.g., bridge to transplant) or bridge to myocardial recovery in patients with advanced refractory left ventricular heart failure approved the HeartMate™ 3 Left Ventricular Assist System (Thoratec Corp., Pleasanton, CA).

In October 2018, the HeartMate™ 3 Left Ventricular Assist System (Thoratec Corp., Pleasanton, CA) was approved by the FDA for providing long-term hemodynamic support (e.g., destination therapy) in patients with advanced heart failure.

Total Artificial Heart

In 2004, FDA approved the temporary CardioWest™ Total Artificial Heart (SynCardia Systems) through the premarket approval process for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. This device is also intended for use inside the hospital. In 2010, FDA approved a name change to SynCardia Temporary Total Artificial Heart. FDA product code: LOZ.

In 2006, FDA approved the AbioCor® Implantable Replacement Heart System (Abiomed) through the humanitarian device exemption (H040006) process in severe biventricular end-stage heart disease patients who are not cardiac transplant candidates and who:

  • Are younger than 75 years of age;
  • Require multiple inotropic support;
  • Are not treatable by left VAD destination therapy; and
  • Are not weanable from biventricular support if on such support.

In addition to meeting other criteria, patients who are candidates for the AbioCor® TAH must undergo a screening process to determine if their chest volume is large enough to hold the device.  The device is too large for about 90% of women and for many men.

**NOTE: The Carmat bioprosthetic total artificial heart has not been FDA approved.

Percutaneous VADs (Circulatory Assist Devices)

Table 3. Available Mechanical Circulatory Support Devices

 

Device

 

Manufacturer

 

Approval

Date

 

FDA

Clearance

PMA,

510(k) No.

 

                  Indication

TandemHeart®

Cardiac Assist

Sep 2005

510(k)

K110493

Temporary left ventricular bypass of ≤6 h

Impella® Recover LP 2.5

Abiomed

May 2008

510(k)

K063723

Partial circulatory support using extracorporeal bypass control unit for ≤6 h

Impella® 2.5 System

Abiomed

Mar 2015

PMA

P140003

Temporary ventricular support for ≤6 h

FDA: U.S. Food and Drug Administration; PMA: premarket approval.

Comparative Efficacy of Left VAD Devices

The mechanism of operation of left VADs has changed since their introduction. The earliest devices were pulsatile positive displacement pumps. These pumps have been largely replaced by axial continuous-flow pumps. More recently centrifugal continuous-flow pumps have also been introduced.

The evidence of the comparative efficacy of centrifugal continuous-flow vs axial continuous-flow devices consists of two randomized controlled trials of two different centrifugal continuous-flow devices. The MOMENTUM 3 trial compared HeartMate III™ centrifugal continuous-flow device with the HeartMate II® axial continuous-flow device in patients indicated for circulatory support as a bridge to transplant or destination therapy. HeartMate III™ received PMA approval in August 2017 but was recalled in April 2018. The ENDURANCE trial compared HeartWare® centrifugal continuous-flow device with the HeartMate II® axial continuous-flow device in patients indicated for circulatory support as destination therapy. HeartWare® is FDA-approved as a bridge to transplantation device. Both trials found the centrifugal device to be noninferior to the axial device for the primary, composite outcome including measures of survival, freedom from disabling stroke, and freedom from device failure. While there are fewer device failures with the centrifugal devices without a significant increase in disabling stroke, the HeartWare® device was associated with increased risk of any stroke over a period of 2 years.

The evidence on the comparative efficacy of continuous-flow vs pulsatile-flow devices consists of a randomized controlled trial and several nonrandomized comparative studies. The randomized controlled trial reported fairly large differences in a composite outcome measure favoring the continuous-flow devices, with increases in revision and reoperation rates for the pulsatile device group being the largest factor driving the difference in outcomes. Other nonrandomized comparative studies, including a database study with large numbers of patients, have not reported important differences in clinical outcomes between devices.

Percutaneous Ventricular Assist Devices (circulatory assist devices)

The Impella® Recover LP 2.5 Percutaneous Cardiac Support System (Abiomed, Aachen, Germany) received FDA 510(k) approval in May 2008 for short-term (less than six hours) use in patients requiring circulatory support.

In March 2015, the Impella® 2.5 System received approval through the PMA process for temporary ventricular support during high-risk percutaneous coronary interventions.

The TandemHeart® (Cardiac Assist, Pittsburgh) received a similar 510(k) approval for short-term circulatory support in September 2005.

Several other devices are in clinical trials or awaiting FDA review.

Permanently implantable aortic counterpulsation ventricular assist devices

Permanently implantable aortic counterpulsation ventricular assist devices are being studied, as a bridge to recovery for patients with acute or chronic heart failure. Various devices are being investigated but presently no device has obtained FDA approval. Examples of devices in development or in clinical trials include, but may not be limited to, the following: CardioVAD (LVAD Technology, Detroit, MI), Symphony device (Abiomed Inc, Danvers, MA), and the C-Pulse device (CHF Solutions Inc, Eden Prairie, MN) (Kontogiannis, et al., 2016; Gafoor, et al., 2015). There are limited data in the published, peer-reviewed literature regarding the safety and effectiveness of implantable aortic counterpulsation VADs for the treatment of heart failure.

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 contracts: 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:   

33927

Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy (Effective 01/01/18)

33928

Removal and replacement of total replacement heart system (artificial heart) (Effective 01/01/18)

33929

Removal of a total replacement heart system (artificial heart) for heart transplantation (List separately in addition to code for primary procedure) (Effective 01/01/18)

33975

Implantation of ventricular assist device; extracorporeal, single ventricle

33976

Implantation of ventricular assist device; extracorporeal, biventricular

33977

Removal of ventricular assist device; extracorporeal single ventricle

33978

Removal of ventricular assist device; extracorporeal, biventricular

33979

Insertion of ventricular assist device, implantable intracorporeal, single ventricle

33980

Removal of ventricular assist device, implantable intracorporeal, single ventricle

33981

Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump

33982

Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass

33983

Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass

33990

Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, arterial access only (Revised 01/01/21)

33991

Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, both arterial and venous access, with transseptal puncture (Revised 01/01/21)

33992

Removal of percutaneous left heart ventricular assist device, arterial or arterial and venous cannula(s), at separate and distinct session from insertion (Revised 01/01/21)

33993

Repositioning of percutaneous right or left heart ventricular assist device with imaging guidance at separate and distinct session from insertion (Revised 01/01/21)

33995

Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; right heart, venous access only (Effective 01/01/21)

33997

Removal of percutaneous right heart ventricular assist device, venous cannula, at separate and distinct session from insertion (Effective 01/01/21)

33999

Unlisted procedure, cardiac surgery

93750           

Interrogation of ventricular assist device (VAD), in person, with physician or other qualified health care professional analysis of device parameters (e.g., drivelines, alarms, power surges), review of device function (e.g., flow and volume status, septum status, recovery), with programming, if performed, and report

 

HCPCS Codes:                       

L8698

Miscellaneous component, supply or accessory for use with total artificial heart system (Effective 01/01/2019)

PREVIOUS CODING:

Aortic Counterpulsation Ventricular Assist Devices

0451T

Insertion or replacement of a permanently implantable aortic counterpulsation ventricular assist system, endovascular approach, and programming of sensing and therapeutic parameters; complete system (counterpulsation device, vascular graft, implantable vascular hemostatic seal, mechano-electrical skin interface and subcutaneous electrodes)

(Deleted 12/31/21)

0452T

Insertion or replacement of a permanently implantable aortic counterpulsation ventricular assist system, endovascular approach, and programming of sensing and therapeutic parameters; aortic counterpulsation device and vascular hemostatic seal

(Deleted 12/31/21)

0453T

Insertion or replacement of a permanently implantable aortic counterpulsation ventricular assist system, endovascular approach, and programming of sensing and therapeutic parameters; mechano-electrical skin interface  (Deleted 12/31/21)

0454T

Insertion or replacement of a permanently implantable aortic counterpulsation ventricular assist system, endovascular approach, and programming of sensing and therapeutic parameters; subcutaneous electrode  (Deleted 12/31/21)

0455T

Removal of permanently implantable aortic counterpulsation ventricular assist system; complete system (aortic counterpulsation device, vascular hemostatic seal, mechano-electrical skin interface and electrodes) (Deleted 12/31/21)

0456T

Removal of permanently implantable aortic counterpulsation ventricular assist system; aortic counterpulsation device and vascular hemostatic seal  (Deleted 12/31/21)

 

0457T

Removal of permanently implantable aortic counterpulsation ventricular assist system; mechano-electrical skin interface  (Deleted 12/31/21)

0458T

Removal of permanently implantable aortic counterpulsation ventricular assist system; subcutaneous electrode  (Deleted 12/31/21)

0459T

Relocation of skin pocket with replacement of implanted aortic counterpulsation ventricular assist device, mechano-electrical skin interface and electrodes

Repositioning of previously implanted aortic counterpulsation ventricular assist device; subcutaneous electrode  (Deleted 12/31/21)

0460T

Repositioning of previously implanted aortic counterpulsation ventricular assist device; subcutaneous electrode  (Deleted 12/31/21)

0461T

Repositioning of previously implanted aortic counterpulsation ventricular assist device; aortic counterpulsation device  (Deleted 12/31/21)

0462T

Programming device evaluation (in person) with iterative adjustment of the implantable mechano-electrical skin interface and/or external driver to test the function of the device and select optimal permanent programmed values with analysis, including review and report, implantable aortic counterpulsation ventricular assist system, per day (Deleted 12/31/21)

 

0463T

Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter, implantable aortic counterpulsation ventricular assist system, per day (Deleted 12/31/21)

0051T

Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy (Deleted 12/31/17)

0052T

Replacement or repair of thoracic unit of a total replacement heart system (artificial heart) (Deleted 12/31/17)

0053T

Replacement or repair of implantable component or components of total replacement heart system (artificial heart) excluding thoracic unit (Deleted 12/31/17)

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  59. Rogers JG, Butler J, Lansman SL, et al. Chronic mechanical circulatory support for Inotrope-dependent heart failure patients who are not transplant candidates- Results of the INTREPID Trial. J Am Coll Cardiol. 2007; 50(8):741-747.
  60. Rogers JG, Pagani FD, Tatooles AJ, et al. Intrapericardial left ventricular assist device for advanced heart failure. N Engl J Med. Feb 02 2017; 376(5):451-460.
  61. Romeo F, Acconcia MC, Sergi D, et al. Percutaneous assist devices in acute myocardial infarction with cardiogenic shock: Review, meta-analysis. World J Cardiol. Jan 26 2016; 8(1):98-111.
  62. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-state heart failure. The New England Journal of Medicine, November 2001, Vol. 345, No. 20: 1435-43.
  63. Schafer A, Werner N, Burkhoff D, et al. Influence of Timing and Predicted Risk on Mortality in Impella-Treated Infarct-Related Cardiogenic Shock Patients. Front Cardiovasc Med. 2020; 7: 74. 
  64. Schreiber T, Wah Htun W, Blank N, et al. Real-world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella Registry. Catheter Cardiovasc Interv. Apr 18 2017; 90(4):576-581.
  65. Seyfarth M, Sibbing D, Bauer I, et al. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol. Nov 4 2008; 52(19):1584-1588.
  66. Shuhaiber JH, Hur K, Gibbons R. The influence of preoperative use of ventricular assist devices on survival after heart transplantation: propensity score matched analysis. BMJ 2010; 340:c392.
  67. Sieweke JT, Berliner D, Tongers J, et al. Mortality in patients with cardiogenic shock treated with the Impella CP microaxial pump for isolated left ventricular failure. Eur Heart J Acute Cardiovasc Care. Mar 2020; 9(2): 138-148.
  68. Slaughter MS, Pagani FD, McGee EC, et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant. Jul 2013; 32(7):675-683.
  69. Starling RC, Estep JD, Horstmanshof DA, et al. Risk Assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: The ROADMAP Study 2-year results. JACC Heart Fail. Jul 2017; 5(7):518-527.
  70. Struber M, Sander K, Lahpor J et al. HeartMate II left ventricular assist device; early European experience. Eur J Cardiothorac Surg 2008; 34(2):289-94.
  71. Strueber M, O'Driscoll G, Jansz P et al. Multicenter evaluation of an intrapericardial left ventricular assist system. J Am Coll Cardiol 2011; 57(12):1375-82.
  72. TEC Assessment Program. Left ventricular assist devices as destination therapy for end-stage heart failure. 2002;Volume 17;Tab 19.
  73. TEC Assessment Program. Ventricular assist devices in bridging to heart transplantation. 1996;Volume 11;Tab 26.
  74. Thiele H, Sick P, Boudriot E, et al. Randomized comparison of intra-aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock. Eur Heart J. Jul 2005; 26(13):1276-1283.
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  76. Torregrossa G, Morshuis M, Varghese R, et al. Results with SynCardia total artificial heart beyond 1 year. ASAIO J. Nov-Dec 2014; 60(6):626-634.
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  78. Wehman B, Stafford KA, Bittle GJ, et al. Modern outcomes of mechanical circulatory support as a bridge to pediatric heart transplantation. Ann Thorac Surg. Jun 2016; 101(6):2321-2327.
  79. Wever-Pinzon O, Drakos SG, McKellar SH, et al. Cardiac recovery during long-term left ventricular assist device support. J Am Coll Cardiol. Oct 04 2016; 68(14):1540-1553.
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POLICY HISTORY:

TEC, March 1999

Medical Policy Administration Committee, February 2002

Medical Review Committee, March 2004

Medical Policy Group, May 2004 (1)

Medical Review Committee, May 2004

Medical Policy Administration Committee, June 2004

Available for comment June 28-August 11, 2004

Medical Policy Group, March 2006 (1)

Medical Policy Group, April 2008 (2)

Medical Policy Group, August 2009 (1)

Medical Policy Administration Committee, September 2009

Available for comment September 4-October 19, 2009

Medical Policy Group, October 2010 (1): Description, Key Points and Governing Body Approval updated

Medical Policy Group, November 2010 Reference Update

Medical Policy Administration Committee November 2010

Available for comment November 4 – December 20, 2010

Medical Policy Group, September 2011 (1): Update to Description, Key Points and References; Entire policy reformatted, no changes to policy statements

Medical Policy Group, December 2011 (3): Update to Approved by Governing Bodies & References (FDA Approval of EXCORE)

Medical Policy Group, March 2012 (3): Updated coverage for total artificial heart for bridge to transplant. Added other specialty recommendations and references.

Medical Policy Administration Committee March 2012

Available for comment March 15 – April 30, 2012

Medical Policy Group, November 2012 (3): 2012 Update to Key Points, Governing Bodies, and References

Medical Policy Group, November 2012: 2013 Coding Update-Added Codes 33990 - 33993; deleted Codes 0048T & 0050T effective 1/1/2013

Medical Policy Group, December 2012 (3):  Update to Approved by Governing Bodies & References (FDA Approval of HeartWare) 

Medical Policy Group, December 2012 (3): 2013 Coding update – Verbiage change to Code 93750-added “or other qualified health care professional”

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (3):  Updated policy statement on children – amended age range from 5-16 years to 0-16 reflecting approval of the BERLIN heart EXCOR device for pediatric patients age 0-16; and clarified info on Medicare-approved heart transplant facility requirement for total artificial hearts; and Medicare-approved heart transplant facility OR Medicare-approved VAD destination facility requirement for VADs

Medical Policy Administration Committee March 2013

Available for comment March 12 through April 25, 2013

Medical Policy Group, August 2013 (4):  Added verbiage to BTT policy section “Or a patient who is undergoing evaluation to determine candidacy for heart transplantation.

Medical Policy Administration Committee August 2013.

Available for comment August 22 through October 5, 2013

Medical Policy Group, February 2014 (5):  Added ICD-9 and ICD-10-CM diagnosis under Coding; no change to policy statement.

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (4): Updated description.  NO changes to the policy statement.

Medical Policy Group, March 2015 (4): Added Impella RP to Key Words and Approved Governing Bodies. 

Medical Policy Panel, May 2015

Medical Policy Group, May 2015 (4): Updates to Key Points, Approved Governing Bodies, and References.  Added policy statements to include total artificial hearts and pVADs are considered investigational for all other indications.  Also, rearranged policy statements for ease of reading. Policy statement intents unchanged.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (4): Updates to Description, Key Points, Key Words, Approved Governing Bodies and References. No change to current policy statement. Removed policy statement section for “effective dates prior to February 2012”.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References.  No change to policy statement.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Added new codes 33927 – 33929 effective 01/01/18 to Current Coding.  Moved deleted codes 0051T – 0053T to Previous Coding.

Medical Policy Group, April 2018 (4): corrected typo.

Medical Policy Panel, August 2018

Medical Policy Group, August 2018 (3): Updates to Title, Description, Key Points, References, Approved By Governing Bodies, and Key Words; added: AbioCor® Total Artificial Heart, CardioWest™ Total Artificial Heart, HeartMate II®, SynCardia® Artificial Heart, Right Ventricular Assist Device, RVAD, PediMag®, Short-Term Continuous Flow Ventricular Assist Devices, STCF-VADs, intraluminal axial support, Impella® LV, and BIVAD. No changes to policy statement or intent.

Medical Policy Group, October 2018 (3): Updated to reflect the FDA approval of the HeartMate III™  device and the HeartWare® Ventricular Assist System for providing long-term hemodynamic support (e.g., destination therapy) in patients with advanced heart failure.

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added HCPC code L8698 to the Current coding section.

Medical Policy Panel, August 2019

Medical Policy Group, September 2019 (3): 2019 Updates to Key Points. No changes to policy statement or intent.

Medical Policy Panel, August 2020

Medical Policy Group, September 2020 (3): 2020 Updates to Key Points, Approved by Governing Bodies, Practice Guidelines and Position Statements, and References. No changes to policy statement or intent.

Medical Policy Group, November 2020: Annual Coding Update.  Added new CPT codes 33995 and 33997.  Revised CPT codes 33990-33993 to clarify left or right heart.

Medical Policy Group, April 2021 (3): Off-cycle update related to CMS changes to patient criteria related to the use of left ventricular assist devices. Updates to Description, Key Points, Approved by Governing Bodies, References and Key Words: added: HeartAssist 5 Pediatric Ventricular Assist Device; NuPulseCV iVAS; Symphony Heart Assist System; CentriMag® Blood Pump; Implantable Aortic Counterpulsation Ventricular Assist Devices;  Intravascular Ventricular Assist Systems; iVAS); C-Pulse, CardioVAD. Policy statement removed requiring heart transplant listing to be part of criteria for coverage. Added policy statements related to the use of RVAD’s. Added policy statements to include peak VO2 as a criteria point for coverage. Added clarification language related to aortic counterpulsation ventricular assist devices that are considered investigational. Reduced the number of days required for IABP support from 14 to 7 days. No other changes to policy statement or intent. Coding updated to include CPT codes for Implantable Aortic Counterpulsation Ventricular Assist Devices (0451T-0463T).

Medical Policy Administration Committee, April 2021

Available for comment April 14, 2021- May 29, 2021

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (3): 2021 Updates to Key Points, Approved by Governing Bodies, Practice Guidelines and Position Statements, and References. Policy statement revised to remove outdated eligibility criteria for short and long-term therapy.

Medical Policy Administration Committee, September 2021

Available for comment August 19, 2021 - October 3, 2021

Medical Policy Group, December 2021: 2022 Annual Coding Update. Moved CPT codes from Current coding section.  Updated Previous Coding section to include codes 0451T, 0452T, 0453T, 0454T, 0455T, 0456T, 0457T, 0458T, 0459T, 0460T, 0461T, and 0462T. Added unlisted CPT Code 33999 to Current Coding section. CPT Code 33999 will be used to report permanently Implantable Aortic Counterpulsation Ventricular Assist Devices after 01/01/2022.

Medical Policy Panel, August 2022

Medical Policy Group, September 2022 (3): 2022 Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No changes to policy statement or intent. 

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.