BlueCross and BlueShield of Montana Medical Policy/Codes
Ventricular Assist Devices and Total Artifical Hearts
Chapter: Transplant
Current Effective Date: November 26, 2013
Original Effective Date: November 07, 2008
Publish Date: November 26, 2013
Revised Dates: March 1, 2010; January 18, 2012; November 12, 2012; October 30, 2013
Description

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.

Background

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, 5, and 10 years of 88%, 74%, and 55%, respectively. (1) The supply of donor organs has leveled off, while candidates for transplants are increasing, compelling the development of mechanical devices.

Initial research into mechanical assistance for the heart focused on the total artificial heart, a biventricular device which 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 heart must be removed, failure of the device is synonymous with cardiac death.

Left ventricular assist devices (LVADs). Implantable VAD 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. More recent devices may utilize a pump, which provides continuous flow. Continuous devices may move blood in rotary or axial flow.

Surgically-implanted VADs 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.

Devices in which the majority of the system’s components are external to the body are for short-term use (6 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).

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 <2.0 L/min/m while receiving maximal medical support. Patients with VADs are classified by the United Network for Organ Sharing (UNOS) as Status I, that is, persons who are most ill and are considered the highest priority for transplant.

Contraindications for bridge to transplant VADs and TAH 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 TAH, implantation is also contraindicated in patients with uncorrected valvular disease. See medical policy SUR703.005 Heart Transplant for further discussion of heart transplant candidacy.

In addition, individuals 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 individuals 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 CT scan.

Percutaneous ventricular assist devices (pVADs). pVADs have been developed for short-term use in patients who require acute circulatory support. These devices are placed through the femoral artery. Two different pVADs have been developed, the TandemHeart™ (Cardiac Assist™, Pittsburgh, PA), and the Impella® device (AbioMed™, Aachen, Germany). In the TandemHeart™ system, a catheter is introduced through the femoral artery 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 also 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.

There are several situations in which pVAD may offer possible benefits: 1) cardiogenic shock that is refractory to medications and intra-aortic balloon pump (IABP), 2) cardiogenic shock, as an alternative to IABP, and 3) high-risk patients undergoing invasive cardiac procedures who need circulatory support.

Regulatory Approval

Total Artificial Heart

In October 2004, device CardioWest™ Temporary Total Artificial Heart (SynCardia Systems, Inc., Tucson, AZ) was approved by the U.S. Food and Drug Administration (FDA) 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. Also, the temporary CardioWest™ Total Artificial Heart (TAH-t) is intended for use inside the hospital. In April 2010, the FDA approved a name-change to Syncardia Temporary Total Artificial Heart.

In September 2006, device AbioCor® Implantable Replacement Heart System (AbioMed, Inc., Danvers MA) was approved by the FDA through the Humanitarian Device Exemption (HDE) process for use in severe biventricular end-stage heart disease individuals who are not cardiac transplant candidates and who:

  • Are younger than 75 years of age;
  • Require multiple inotropic support;
  • Are not treatable by left ventricular assist devices (LVAD) 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 approximately 90% of women and for many men. The FDA is requiring the company to provide a comprehensive patient information package to patients and families. To further refine and improve the use of this artificial heart technology, AbioMed will conduct a postmarketing study of 25 additional patients. The postmarketing study was recommended by the Circulatory Systems Devices Panel, a part of the FDA's Medical Devices Advisory Committee.

Ventricular Assist Devices

In December 1995, device Thoratec® Ventricular Assist Device System (Thoratec Corp., Pleasanton, CA) was approved by the FDA through the premarket approval process for use as a bridge to transplantation in patients suffering from end-stage heart failure. The patient should meet all of the following criteria:

  1. Candidate for cardiac transplantation,
  2. Imminent risk of dying before donor heart procurement, and
  3. Dependence on, or incomplete response to, continuous vasopressor support.

In May 1998, supplemental approval for the above device was given for the indication for postcardiotomy patients who are unable to be weaned from cardiopulmonary bypass. In June 2001, supplemental approval was given for a portable external driver to permit excursions within a 2-hour travel radius of the hospital in the company of a trained caregiver. In November 2003, supplemental approval was given to market the device as Thoratec® Paracorporeal VAD. In August 2004, supplemental approval was given to a modified device to be marketed as the Thoratec® Implantable VAD for the same indications. In January 2008, supplemental approval was given to delete Paracorporeal VAD use.

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 IIÒ 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.

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

The table is not an “all inclusive” list. Refer to the FDA web site at www.fda.gov for new devices.

Device

FDA Approved

Type

Approved Use

AbioCor® Implantable Replacement Heart

H04006

September 2006

Humanitarian Device Exception

Pneumatic

Long-term implantable heart replacement unit serving as a TAH. First completely self-contained TAH.

Device indicated for use in severe biventricular end stage heart disease patients who are not cardiac transplant candidates and who:

  • are less than 75 years old
  • require multiple inotropic support
  • are not treatable by LVAD destination therapy
  • cannot be weaned from biventricular support if currently -on such support.

AbioMed ®  BVS ® 5000 Bi-Ventricular Support System

P900023

Jan. 1996

Ventricular Assist Bypass

Short-term assistance in post-cardiotomy support as a bridge to transplant or bridge to recovery. Left, right, or both ventricles to be used to temporarily support blood circulation in the post-cardiotomy setting and requires inpatient monitoring.

AbioMed ® i-Pulse Circulatory Support System

P900023/S047

Dec. 2007

Intra-aortic Balloon Pump

A unit that will support patients in need of full circulatory support using the BVS 5000 blood pump or the AB5000 Ventricle, or partial ventricular assist using the approved intra-aortic balloon pump (IABP). The device console, as modified, will be marketed under the trade name iPulse Circulatory Support System and is indicated for use in conjunction with the ABIOMED® AB 5000™ ventricle and the BVS 5000® Blood Pump.

AbioMed ® AB5000 Circulatory Support System

RECALLED

12/16/2009

Gravitational Force with Vacuum Assistance

Short-term assistance for left, right, or both ventricles as a bridge to recovery.

BioMedicus, Sarns, Lifestream (Bio-Pump) Pump

K872033

12/07/1987

Centrifugal Non-pulsatile Pump

Short-term assistance in post-cardiotomy support, cardiopulmonary bypass, or as a bridge to transplant for patient who can not be weaned from the device.

DeBakey ® VAD Child LVAS

H030003

February 2004 Humanitarian Device Exception

Electromagnetic Spin Blood Propellant

Miniaturized LVAD short-term assistance for children ages 5 to 16 who are awaiting a heart transplant.

TCI Heartmate® 1000A IP LVAD

P920014

September 1994

Pneumatic Pulsatile Pump

Long-term left ventricular support as a bridge to transplant.

HeartMate ® XVE LVAS

P920014/S014

May 2001

Titanium Blood Pump within a Blood Chamber

Long-term left ventricular support for destination therapy or as a bridge to transplant. Easily maintained and monitored on an outpatient basis.

Levitronix CentriMag® RVAS

H070004

HDE 1/29/2007 FDA 10/7/2008

 

Centrifugal Non-pulsatile Pump

Levitronix Centrimag RVAS is indicated for temporary circulatory support for up to 14 days for patients in cardiogenic shock due to right ventricular failure.

Novacor ® N100PCq LVAS

P980012/S005

1/2/2004

Pneumatic (air powered) Pulsatile Pump or Electrical Pulsatile Pump

Long-term left ventricular support as a bridge to transplant. Can be used on an outpatient basis.

Syncardia Temporary  CardioWest TAH-t)

P030011

10/15/2004

Pneumatic

Temporary implantable artificial heart for use as bridge to transplant for use only in the hospital.

TandemHeart PTVA Controller

K991783

November 2000

Centrifugal Non-pulsatile Pump

Short-term assistance in post cardiotomy cardiogenic shock or ventricular support in bridge to transplant.

TandemHeart Transseptal Cannula Set-EF Cannula

K052570

January 2006

Catheter cannula

Intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

Thoratec HeartMate ® Sutures Not Applied (SNAP) Vented Electric LVAS

P920014/S016

November 2002

Electrical Pulsatile Pump

Long-term support for patients with severe end-stage congestive heart failure who are not eligible for heart transplants (destination therapy) or as a bridge to transplant.

Thoratec HeartMate ® II LVAS

P060040

April 2008

 

Axial Flow Blood Pump

The HeartMate II LVAS is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure (long-term support). It is intended for use both inside and outside the hospital, or for transportation of ventricular assist device patients via ground ambulance, fixed-wing aircraft, or helicopter.

Thoratec® VAD System

December 1995

Pneumatic Pulsatile Pump

Short-term assistance in post-cardiotomy support as a bridge to transplant or bridge to recovery. Long-term left or both ventricles as a support for a bridge to transplant. Requires impatient monitoring.

Jarvik 2000 FlowMaker

In Clinical Trials – not FDA approved

Non-pulsatile Axial/Rotary Flow Blood Pump (Turbine-driven)

Long-term left ventricular support for destination therapy

Berlin Heart EXCOR® Pediatric VAD

December 2011

HDE

Paracorporeal Pulsatile

EXCOR® Pediatric is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients.

Ventracor VentrAssist™ LVAD

In clinical Trials – not FDA approved

patented hydrodynamicaly suspended impeller

Designed as a permanent alternative to heart transplants for patients suffering heart failure.

Can also be used as a bridge to heart transplant and possibly as a bridge to recovery, where it may allow a deteriorating heart an opportunity to recuperate.

HeartWare ®   VAS

November 2012

centrifugal blood pump

Indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

Impella® 

pVAD

May 2008 

510(k) 

Pump, Blood, Cardiopulmonary Bypass, non roller

Partial circulatory support using an extracorporeal bypass control unit. for periods up to 6 hours 

C-Pulse™     Inflatable Cuff

Yet to start clinical trials in US– not FDA approved

Pulsatile

It is a non-blood contacting implantable counterpulsation therapy designed to treat moderate heart failure.

MiTiHeart™  LVAD

Yet to start clinical trials – not FDA approved

Centrifugal pump

For the treatment of congestive heart failure.

DuraHeart®  LVAS

Yet to start clinical trials – not FDA approved

Centrifugal pump

To provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure.

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

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

 Post-Cardiotomy Setting/Bridge to Recovery

Implantable ventricular assist devices (VAD) with U.S. Food and Drug Administration (FDA) approval or clearance may be considered medically necessary in the post-cardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass.

Bridge to Transplantation

Implantable VAD with FDA approval or clearance may be considered medically necessary as a bridge to heart transplantation for patients who:

  • Are not expected to survive until a donor heart can be obtained AND
  • Are currently listed as heart transplantation candidates or are undergoing evaluation to determine candidacy for heart transplantation.

Ventricular assist devices with FDA approval or clearance, including humanitarian device (HDE) exemptions, may be considered medically necessary as a bridge to heart transplantation for patients in the pediatric population who:

  • Are not expected to survive until a donor heart can be obtained AND
  • Are currently listed as heart transplantation candidates or are undergoing evaluation to determine candidacy for heart transplantation.

Total artificial hearts (TAH) with FDA-approved devices may be considered medically necessary as a bridge to heart transplantation for patients with biventricular failure who have no other reasonable medical or surgical treatment options, who 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.

Destination Therapy

Implantable ventricular assist devices with FDA approval or clearance may be considered medically necessary as destination therapy for end-stage heart failure patients who are:

  • Ineligible for human heart transplant and who meet the following “REMATCH Study” criteria:

1.   New York Heart Association (NYHA) Class IV heart failure for >60 days, OR

2.   Patients in NYHA Class III/IV for 28 days, received >14 days’ support with intra-aortic balloon pump or dependent on IV inotropic agents, with 2 failed weaning attempts; AND

  • Are not candidates for human heart transplant for 1 or more of the following reasons:

1.    Age >65 years; OR

2.    Insulin-dependent diabetes mellitus with end-organ damage; OR

3.    Chronic renal failure (serum creatinine >2.5 mg/dL for >90 days; OR

4.    Presence of other clinically significant condition

Other Indications

Other applications of implantable ventricular devices or total artificial hearts are considered experimental, investigational and unproven, including, but not limited to, the use of total artificial hearts as destination therapy.

The use of non-FDA approved or cleared implantable ventricular assist devices or total artificial hearts is considered experimental, investigational and unproven.

Percutaneous ventricular assist devices (pVADs) that are FDA approved may be considered medically necessary for the following FDA approved indications:

  • Impella®-Partial Circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours OR;
  • TandemHeart®-Temporary left ventricular bypass of 6 hours or less.

Xenotransplantion/heterotransplantation (a graft transplantation between different species) of a baboon heart OR porcine/swine (pig) heart is considered experimental, investigational and unproven as bridge to transplantation.

Policy Guidelines

CPT Codes 0048T and 0050T specifically describe the Tandem Heart device.

The table of devices listed in the description section of this policy is not an “all inclusive” list.  New devices that are not FDA cleared are being put to use on an ongoing basis.  To ensure up to date information is reviewed, refer to the FDA web site at www.fda.gov .

Rationale

Literature Review

This policy was created in 2008 and regularly updated with searches of the MEDLINE database. The most recent literature search was performed for the period from July 2011 through July 2012. The literature review focuses on 3 types of devices: 1) left ventricular assist devices (LVAD), 2) total artificial hearts (TAH), and 3) percutaneous ventricular assist devices (pVAD). The literature review addresses short-term use of the devices as a bridge to recovery or transplantation. The LVADs and TAHs are also evaluated as longer-term destination therapy for patients who are not transplant candidates. Following is a summary of the key literature to date.

Left ventricular assist devices (LVADs)

LVADs as Bridge to Recovery: Post-cardiotomy Setting

Five studies of the Centrimag Right Ventricular Assist Device (RVADs) included between 12 and 32 patients, the majority of whom received biventricular devices. (2-4) Indications (and numbers of patients) in these 5 studies were: support for post-cardiotomy cardiogenic shock (bridge to recovery, n=53), bridge to long-term device implantation (n=9), treatment of right heart failure in patients who previously received left ventricular assist devices (LVADs) (n=15), bridge to later decision when neurologic status is clarified (n=16), and acute donor graft failure (n=6). The mean time on mechanical circulatory support ranged from 9.4 days to 46.9 days. The 30-day mortality rates were between 17% and 63%. The proportion of patients discharged from the hospital was between 30% and 83%. Major complications included bleeding requiring reoperation, sepsis, and stroke. No device failures were observed in these studies.

LVADs as Bridge to Transplant

A 1996 TEC Assessment concluded that left ventricular assist devices (LVADs) can provide an effective bridge to transplantation. (5) Goldstein and colleagues published a more recent review. (6) It should be recognized that LVADs do not change the number of patients undergoing heart transplantation due to the fixed number of donor hearts. However, the VAD will categorize its recipient as a high-priority heart transplant candidate.

Published studies continue to report that the use of a VAD does not compromise the success of a subsequent heart transplant and, in fact, may improve post-transplant survival, thus improving the use of donor hearts. (7-10) Currently available implantable LVADs consist of pulsatile devices that require stiff power vent lines that perforate the skin and implantable pump chambers, as well as non-pulsatile axial flow systems of smaller size and lower noise levels. (11)

In 5 reports, with samples ranging from 32 to 279 patients, most participants received the continuous-flow device as a bridge to transplantation. (12-16) Survival rates at 6 months were between 67% and 87%, and between 50% and 80% at 1 year. These rates are similar to those observed in a recent report of a federal circulatory support device registry. (17) A study by Patel and colleagues compared HeartMate I and HeartMate II recipients at a single center, finding the same 1-year survival and similar rates of subsequent development of right heart failure. (15) Serious adverse events occurring after HeartMate II-implantation include bleeding episodes requiring reoperation, stroke, infection, and device failure.

A systematic review published in 2012 examined the evidence on the effect of LVADs on post-transplant outcomes. (18) This review included 31 observational studies that compared outcomes of transplant in patients who did and did not have pre-transplant LVAD. Survival at one year was more likely in patients who had LVAD treatment, but this benefit was confined to patients who received an intra-corporeal device (relative risk [RR]: 1.8, 95% confidence interval [CI]: 1.53-2.13). For patients treated with an extracorporeal device, the likelihood of survival was not different from patients who were not treated with an LVAD (RR: 1.08, 95% CI: 0.95-1.22). There was no difference in the risk of rejection between patients who did and did not receive LVAD treatment.

There is a U.S. Food and Drug Administration (FDA)-approved device, via the Humanitarian Device Exemption (HDE) process, available for use as a bridge to cardiac transplant in children. This HDE approval was based on data from children who were a part of the initial clinical studies of this device. (19) Publications have reported positive outcomes for children using ventricular assist devices (VADs) as a bridge to transplantation. Using the United Network for Organ Sharing (UNOS) database, Davies et al. reported on use of VADs in pediatric patients undergoing heart transplantation. (20) Their analysis concluded that pediatric patients requiring a pretransplantation VAD have similar long-term survival to those not receiving mechanical circulatory support.

In 2011, Strueber et al. (21) published a case series of 50 patients awaiting heart transplantation treated with a newer generation HeartWare® VAD. This device was smaller than previous versions and implanted within the pericardial space. Patients were followed until transplantation, myocardial recovery, device explant, or death. The median duration of time on the LVAD was 322 days. Nine patients died; 3 from sepsis, 3 from multiple organ failure, and 3 from hemorrhagic stroke. At the end of follow-up, 20 patients had undergone transplant (40%), 4 had the pump explanted (8%), and the remaining 17 continued on pump support (34%). The most common complications were infection and bleeding. A total of 21 patients had infections (42%), and 5 patients had sepsis (10%). Bleeding complications occurred in 15 patients (30%), 10 of whom (20%) required surgery for bleeding.

Conclusions 

The evidence on the efficacy of LVADs as bridge to transplant consists of numerous uncontrolled trials of patients who have no other treatment options. These studies report that substantial numbers of patients survive to transplant in situations in which survival would not be otherwise expected. Despite the lack of high-quality controlled trials, this evidence is sufficient to determine that outcomes are improved in patients who have no other options for survival. The impact of pre-transplant LVADs on survival from transplant is uncertain, with some studies reporting worse survival in patients receiving LVADs, but other studies reporting similar or improved survival.

LVADs as Destination Therapy

The policy regarding LVADs as destination therapy is based on a 2002 TEC Assessment (22) that offered the following observations and conclusions:

  • The available evidence comes from a single, well-designed and rigorously conducted randomized trial, known as the REMATCH study. (23) The study was a cooperative effort of Thoratec, Columbia University, and the National Institutes of Health.
  • The randomized trial found that patients with end-stage heart failure who are not candidates for cardiac transplantation have significantly better survival on a VAD compared with treatment by optimal medical therapy. Median survival was improved by approximately 8.5 months. Serious adverse events were more common in the VAD group, but these appear to be outweighed by this group’s better outcomes on function; New York Heart Association (NYHA) class was significantly improved, as was quality of life among those living to 12 months.
  • VAD patients spend a greater relative proportion of time inside the hospital than medical management patients do, but the survival advantage would mean a longer absolute time outside the hospital.

Park and colleagues published an extended 2-year follow-up of patients in the REMATCH trial, which found that survival and quality-of-life benefits were still apparent. In addition, this study and other case series suggest continuing improvement in outcomes related to ongoing improvements in the device and in patient management. (24, 25) However, the durability of the HeartMate device used in the REMATCH trial is a concern; for example, at one participating institution, all 6 long-term survivors required device change-outs. Next generation devices consisting of smaller continuous flow devices are eagerly anticipated.

Conclusions 

The main piece of evidence on the efficacy of LVADs as destination therapy in patients who are not transplant candidates is from a multicenter randomized controlled trial (RCT), the REMATCH study. This trial reported that the use of LVADs led to improvements in survival, quality of life, and functional status. This evidence is sufficient to establish that health outcomes are improved for this patient population.

Comparative efficacy of continuous flow versus pulsatile flow devices

In December 2009, Slaughter and colleagues published data from an unblinded randomized multicenter trial comparing a continuous flow device with a pulsatile device. (26) Subjects were randomly assigned to continuous-flow or pulsatile-flow devices on a 2:1 block-randomization basis. The primary outcome measured was a composite endpoint of 2-year survival, free of disabling stroke or need for device replacement. Continuous-flow patients (n=134) reached the primary outcome at a rate of 46% (95% CI: 38-55) compared to pulsatile-flow patients’ (n=66) rate of 11% (95% CI: 3-18), which was a significant difference (p<0.001). Analysis of constituent factors indicated that a lower rate of devices needing replacement in the continuous-flow group had the largest effect on the composite endpoint; 2-year death rate also favored this device (58% vs. 24%, respectively; p=0.008). Stroke and death (within 2 years of implantation) were similar in the 2 groups (stroke rate 12% and death rate 36%). Quality-of-life scores were also similar in the 2 groups. Although unblinded, this randomized trial adds to the evidence favoring continuous-flow devices.

Nativi et al. (27) published a non-randomized comparison of pulsatile versus continuous flow devices using data from the registry of the International Society for Heart and Lung Transplantation on 8,557 patients undergoing transplant. Comparisons were made among patients receiving a pulsatile LVAD, a continuous flow LVAD, and no LVAD. Two time periods were used for analysis, the first was pre-2004, when nearly all LVADs were pulsatile devices, and post-2004 when continuous use devices began to be used in clinical care. Comparing the first time period to the second time period, there was a significantly greater risk of mortality in the first time period compared to the second time period (relative risk [RR]: 1.30, 95% CI 1.03-1.65, p=0.03). When analysis was confined to the second time period, there was no significant improvement in survival for the continuous group compared to the pulsatile group (RR: 1.25, 95% CI: 1.03-1.65, p=0.03).

Other non-randomized studies that have compared outcomes from different types of LVADs have been smaller and/or focused on physiologic outcomes. (28-31) In some of these studies, the continuous flow devices exhibit greater improvement in physiologic measures, but none of these studies have reported significant differences between devices in clinical outcomes.

Conclusions 

The evidence on the comparative efficacy of different devices consists of one RCT and several non-randomized comparative studies. The RCT 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 non-randomized comparative studies, including one database study with large numbers of patients, have not reported important differences between devices on clinical outcomes.

Total Artificial Heart

TAH as Bridge to Transplant

The FDA approval of the CardioWest TAH was based on the results of a nonrandomized, prospective study of 81 patients. (32) 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.

Other case series have been reported on outcomes of the TAH as a bridge to transplant. For example, Copeland et al. (33) reported on 101 patients treated with the SynCardia artificial heart as a bridge to transplant. All patients either met established criteria for mechanically assisted circulatory support, or were failing medical therapy on multiple inotropic drugs. The mean support time was 87 days, with a range of 1-441 days. Survival to transplant was 68.3% (69/101). Of the 32 deaths prior to transplant, 13 were due to multiple organ failure, 6 were due to pulmonary failure, and 4 were due to neurologic injury. Survival after transplant at 1, 5, and 10 years, respectively, was 76.8%, 60.5%, and 41.2%.

TAH as Destination Therapy

Data concerning the artificial heart are available from information concerning the FDA approval (34) and from a published article describing results for the first 7 patients. (35) 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 neurologic events. Device-related infection was "non-existent."

This device shows technological progress, and these initial results are encouraging; however, a number of questions remain. These questions may be answered once the results of the 14-patient study are published, or data on a larger group of patients may be needed. One issue is to further analyze relevant patient outcomes (complications, quality of life, survival, etc.). Therefore, based on current information, this device is considered experimental, investigational and unproven.

Conclusions 

There is a smaller amount of evidence on the use of TAH as a bridge to transplantation, or as destination therapy, compared to the use of LVADs. The type of evidence on bridge to transplant is similar to that for LVADs, i.e., case series reporting substantial survival rates in patients without other alternatives. Therefore, this evidence is sufficient to conclude that TAH improves outcomes for these patients similar to LVADs, and is a reasonable alternative for patients who require bridge to transplantation but who are ineligible for other types of support devices. There is insufficient evidence on the use of TAH as destination therapy to support conclusions.

Percutaneous ventricular assist devices (pVADs)

pVADs as an alternative to intra-aortic balloon pump (IABP) in cardiogenic shock

Three RCTs have been published that compare percutaneous ventricular assist device (pVAD) to IABP for patients with cardiogenic shock, (36-38) along with a systematic review and meta-analysis of these 3 trials. (39) The meta-analysis was published in 2009 by Chen et al. The 3 RCTs enrolled a total of 100 patients, 53 treated with a pVAD and 47 treated with an IABP. All 3 study populations included patients with acute myocardial infarction (MI) and cardiovascular shock; one of the trials (32) restricted this population to patients who were post revascularization in the acute MI setting. The primary outcomes reported were 30-day mortality, hemodynamic measures of left ventricular (LV) pump function, and adverse events.

All 3 trials reported an improvement in LV hemodynamics in the pVAD group. On combined analysis, there was a mean increase in cardiac index of 0.35 L/min/m2 for the pVAD group, an increase in mean arterial pressure of 12.8 mm Hg (95% CI: 3.6-22.0, p<0.001), and a decrease in pulmonary capillary wedge pressure of 5.3 mm Hg (95% CI: 1.2-9.4, p<0.05).

pVADS as Bridge to recovery in cardiogenic shock refractory to IABP

Case series of patients with cardiogenic shock refractory to IABP who were treated with pVAD have also been published. In the largest series, Kar et al. (41) treated 117 patients who had severe, refractory cardiogenic shock with the TandemHeart® System. Eighty patients had ischemic cardiomyopathy and 37 had nonischemic cardiomyopathy. There were significant improvements in all hemodynamic measures following LVAD placement. For example, cardiac index increased from 0.52±0.8 L/min/m2 to 3.0±0.9 L/min/m2 (p<0.001), and the systolic blood pressure (BP) increased from 75±15 mm Hg to 100±15 mm Hg (p<0.001). The authors concluded that pVAD rapidly reversed the terminal hemodynamic compromise noted in patients with severe refractory cardiogenic shock refractory to IABP and vasopressor support.

pVADs ancillary support in high-risk patients undergoing invasive cardiovascular procedures.

The PROTECT trial intended to evaluate whether the Impella® 2.5 system improved outcomes for patients undergoing high-risk percutaneous coronary intervention (PCI) procedures. PROTECT I (42) was a feasibility study of 20 patients who had left main disease or last patent coronary conduit that required revascularization but who were not candidates for coronary artery bypass graft (CABG) surgery. High-risk PCI was performed using the Impella® system for circulatory support. All of the procedures were completed successfully without any hemodynamic compromise during the procedures. There were 2 patient deaths within 30 days (10%), and 2 patients had a periprocedural MI (10%). An additional 2 patients had evidence of hemolysis, which was transient and resolved without sequelae.

The PROTECT II trial was a prospective, randomized clinical trial to compare the Impella® system with IABP in patients undergoing high-risk PCI procedures. Four hundred fifty two symptomatic patient with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function were randomly assigned to either    IABP) (n=226) or Impella 2.5 (n=226) during nonemergent high-risk percutaneous coronary intervention. The authors noted in their results that Impella 2.5 provided superior hemodynamic support in comparison with IABP, with maximal decrease in cardiac power output from baseline of -0.04±0.24 W in comparison with -0.14±0.27 W for IABP (P=0.001). The authors also noted in their conclusions that at 90 days, trends for improved outcomes were observed for Impella 2.5-supported patients. (43) 

A few other case series have described pVAD use in high-risk patients undergoing an invasive cardiac procedure. Sjauw et al. (44) performed a retrospective analysis of 144 consecutive patients undergoing high-risk PCI with pVAD support (Impella® system) from a European registry. Endpoints included successful device function and incidence of adverse events at 30 days. The device was successfully implanted in all 144 patients. There was one periprocedural death. The mortality rate was 5.5% at 30 days. Bleeding requiring transfusion or surgery occurred in 6.2% of patients, and vascular access site complications occurred in 4.0%. There was one stroke (0.7%) and no MIs were reported.

Kar et al. (45) reported on 5 patients who were treated with pVAD support during PCI. All patients were ineligible for CABG because of severe comorbidities. In 4 of 5 patients, the procedure was performed successfully and the pVAD removed within several hours. In the fifth patient, persistent cardiogenic shock precluded removal of the pVAD for more than 48 hours, and the patient eventually died of progressive heart failure 10 days after pVAD was discontinued. Giombolini et al. (46) treated 6 patients with pVAD who were undergoing a high-risk cardiac procedure. Three cases were performed on an emergency basis, and 3 were performed on an elective basis. There were no deaths, and all 6 procedures were successfully completed. The authors concluded the TandemHeart, a percutaneous transseptal ventricular assist device, can be easily and rapidly deployed either in emergency or in elective high-risk PCI to achieve complete cardiac assistance.

Summary

There is a substantial body of evidence from clinical trials and observational studies supporting implantable ventricular assist devices as a bridge to transplant in patients with end-stage heart failure, possibly improving mortality as well as quality of life. A well-designed clinical trial, with 2 years of follow-up data, demonstrates an advantage of implantable ventricular assist devices as destination therapy for patients who are ineligible for heart transplant. Despite an increase in adverse events, both mortality and quality of life appear to be improved for these patients. Therefore, LVADs may be considered medically necessary as a bridge to transplant and as destination therapy in patients who are not transplant candidates.

The evidence for total artificial heart in these settings is less robust. However, given the limited evidence from case series and the lack of medical or surgical options for these patients, 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 an LVAD. TAH may be considered medically necessary for this purpose. There is insufficient evidence on the use of TAH as destination therapy, and TAH is considered experimental, investigational and unproven for this purpose.

The evidence on percutaneous ventricular assist devices (pVADs) indicates improved hemodynamic support in comparison with IABP therefore, pVADs that are FDA approved may be considered medically necessary when following the FDA approved indications.

Practice Guidelines and Position Statements

The American College of Cardiology/American Heart Association (ACC/AHA) released a guideline to the management of end-stage heart failure in 2005 (48); a 2009 focused update did not change any recommendations regarding the technologies covered in this policy. (49) The group has stated that left ventricular assist devices may be indicated in a highly select group of patients who are not candidates for heart transplantation and are likely to have a 1-year survival rate of less than 50% with medical therapy alone. The short-term use of any form of mechanical ventricular support is mentioned as an area of research interest. No recommendations are made regarding this indication.

The Heart Failure Society of America published guidelines in 2010 on surgical approaches to the treatment of heart failure. (50) The following recommendations were made regarding left ventricular assist devices:

  • Patients awaiting heart transplantation who have become refractory to all means of medical circulatory support should be considered for a mechanical support device as a bridge to transplant. (Strength of Evidence = B)
  • Permanent mechanical assistance using an implantable assist device may be considered in highly selected patients with severe HF [heart failure] refractory to conventional therapy who are not candidates for heart transplantation, particularly those who cannot be weaned from intravenous inotropic support at an experienced HF center. (Strength of Evidence = B)
  • Patients with refractory HF and hemodynamic instability, and/or compromised end-organ function, with relative contraindications to cardiac transplantation or permanent mechanical circulatory assistance expected to improve with time or restoration of an improved hemodynamic profile should be considered for urgent mechanical circulatory support as a "bridge to decision." These patients should be referred to a center with expertise in the management of patients with advanced HF. (Strength of Evidence = C)

The European Society of Cardiology published guidelines in 2008 for the diagnosis and treatment of acute and chronic heart failure. (19) A focused update was published in 2010. (51) These guidelines included the following statements about LVADs:

  • Current indications for LVADs and artificial hearts include bridging to transplantation and managing patients with acute, severe myocarditis (Class IIa recommendation, level of evidence C).
  • LVAD may be considered as destination therapy to reduce mortality in patients with severe heart failure who are ineligible for transplant. (Class IIb recommendation, level of evidence B).

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

37.52, 37.53, 37.54, 37.62, 37.63, 37.65, 37.66, 37.68, 398.91, 402.01, 402.11, 404.01, 404.03, 404.11, 428.0

ICD-10 Codes

I09.81, I11.0, I13.0, I13.2, I50.1, I50.2, I50.20, I50.21, I50.22, I50.23, I50.30, I50.31, I50.32, I50.33, I50.40, I50.41, I50.42, I50.43, I50.9, I97.0, 02HA0QZ, 02HA3QZ, 02HA3RZ, 02HA4QZ, 02RK0JZ, 02RK4JZ, 02RL0JZ, 02RL4JZ

Procedural Codes: 33967, 33968, 33970, 33971, 33973, 33974, 33975, 33976, 33977, 33978, 33979, 33980, 33981, 33982, 33983, 33990, 33991, 33992, 33993, 93750, 0051T, 0052T, 0053T, Q0478, Q0479, Q0480, Q0481, Q0482, Q0483, Q0484, Q0485, Q0486, Q0487, Q0488, Q0489, Q0490, Q0491, Q0492, Q0493, Q0494, Q0495, Q0496, Q0497, Q0498, Q0499, Q0500, Q0501, Q0502, Q0503, Q0504, Q0505, Q0506, Q0507, Q0508, Q0509
References
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History
January 2012 Policy updated with literature search. Percutaneous VADs added to policy statement and rationale. References 22, 30-39, 42, 43 added
November 2012 Policy updated with literature search. References 18, 27-31, 33, 40, 47. Clause added to policy statement on TAH that says “…or are undergoing evaluation to determine candidacy for heart transplantation…”
November 2013 Policy formatting and language revised.  Title changed from "Total Artificial Hearts and Implantable Ventricular Assist Devices" to "Ventricular Assist Devices and Total Artificial Hearts".  Added medically necessary criteria for percutaneous ventricular assist devices to the policy statement.  Previously investigational.
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Ventricular Assist Devices and Total Artifical Hearts