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MP 7.03.11 Total Artificial Hearts and Implantable Ventricular Assist Devices

Medical Policy    
Section
Surgery
 
Original Policy Date
11/30/96
Last Review Status/Date
Reviewed with literature search/2:2013
Issue
2:2013
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


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 (LVAD). 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. More recent devices may utilize a pump, which provides continuous flow. Continuous devices may move blood in rotary or axial flow.

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.

Percutaneous ventricular assist devices (pVAD). 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). The pVADs 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.

Intra-aortic balloon pumps are outside the scope of this policy.

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 U.S. Food and Drug Administration (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® 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.

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.

VAD Device Manufacturer Date of Initial
Approval
Method of FDA clearance Indication
Thoratec®
IVAD
Thoratec August 2004 PMA Supplement Bridge to Transplant and Post-
Cardiotomy
DeBakey
VAD®  Child
MicroMed April 2004 Humanitarian Device
Exemption
Bridge to Transplant in children
5-16 years
HearMate
II®
 
Thoratec April 2008 PMA Bridge to Transplant and
Destination
Centrimag®  Levitronix October 2008 HDE Post-Cardiotomy
pVAD Device Manufacturer Date of Initial
Approval
Method of FDA clearance Indication
Impella®  Abiomed May 2008 510(k) Partial circulatory support using an
extracorporeal bypass control unit.
for periods up to 6 hours
TandemHeart®  Cardiac Assist September 2005 510(k) Temporary left ventricular bypass of
6 hours or less

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


Policy

Post-cardiotomy Setting/Bridge to Recovery

Implantable ventricular assist devices with 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 ventricular assist devices with FDA approval or clearance may be considered medically necessary as a bridge to heart transplantation for patients 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 transplantation.

Implantable ventricular assist devices with FDA approval or clearance, including humanitarian device exemptions, may be considered medically necessary as a bridge to heart transplantation in children 16 years old or younger 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 transplantation.

Total artificial hearts 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 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 with end-stage heart failure patients who are ineligible for human heart transplant and who meet the following “REMATCH Study” criteria:

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

In addition, patients must not be candidates for human heart transplant for 1 or more of the following reasons:

  • Age >65 years; OR
  • Insulin-dependent diabetes mellitus with end-organ damage; OR
  • Chronic renal failure (serum creatinine >2.5 mg/dL for >90 days; OR
  • Presence of other clinically significant condition

Other Indications

Other applications of implantable ventricular devices or total artificial hearts are considered investigational, 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 investigational.

Percutaneous ventricular assist devices (pVADs) are considered investigational for all indications.


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 (HDE) process. The DeBakey VAD is indicated for use in children ages 5 to 16 years who are awaiting a heart transplant, i.e., as 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 ventricular assist devices (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.

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

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 policy No. 7.03.09 (heart transplantation) 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 [computed tomography] scan.

Coding

Effective in 2013, the following category I codes were introduced:

33990: Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; arterial access only

33991: both arterial and venous access, with transseptal puncture

33992: Removal of percutaneous ventricular assist device at separate and distinct session from insertion

In 2003, several category III CPT codes were introduced to describe axial VADs and total artificial hearts as follows:

CPT codes 0048T, 0050T specifically describe the TandemHeart (these were deleted at the end of 2012).

CPT codes 0051T-0053T specifically describe artificial hearts.


Benefit Application
BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity.

Removal of the device prior to heart transplantation (CPT codes 33977-33978) is considered part of the global fee and incidental to the heart transplant.


Rationale 

Literature Review

This policy was created in 1996 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 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 one 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 investigational.

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 (pVAD)

pVADs as an Alternative to Intra-aortic Balloon Pump (IABP) in Cardiogenic Shock

Three randomized controlled trials (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 postrevascularization in the acute MI setting. The primary outcomes reported were 30-day mortality, hemodynamic measures of left ventricular (LV) pump function, and adverse events.

None of the 3 trials reported an improvement in mortality associated with pVAD use. The combined analysis estimated the relative risk for death in pVAD patients as 1.06 (95% CI: 0.68-1.66, p=0.80). 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). Complications were more common in the pVAD group. On combined analysis, patients in the pVAD group had a significantly increased likelihood of bleeding events with a relative risk of 2.35 (95% CI: 1.40-3.93). Leg ischemia was also more common in the pVAD group, but this difference did not meet statistical significance (relative risk [RR]: 2.59, 95% CI: 0.75-8.97, p=0.13).

Case series of patients treated with pVADs as an alternative to IABP in cardiogenic shock have been published, (40) and report high success rates as a bridge to alternative therapies. However, these studies do not add much to the evidence on efficacy that is reported from the RCTs.

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). Complications were common post-LVAD implantation. Thirty-four patients had bleeding around the cannula site (29.1%), and 35 developed sepsis during the hospitalization (29.9%). Groin hematoma occurred in 6 patients (5.1%); limb ischemia in 4 patients (3.4%); femoral artery dissection or perforation in 2 patients (1.7%); stroke in 8 patients (6.8%); coagulopathy in 13 patients (11.0%).

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 planned as an RCT to compare the Impella® system with IABP in patients undergoing high-risk PCI procedures. Enrollment was planned for 654 patients from 50 clinical centers. The primary endpoint was the composite of 10 different complications occurring within 40 days of the procedure, with the authors hypothesizing a 10% absolute decrease in the complication rate for patients in the pVAD group. The trial was discontinued prematurely in late 2010 due to futility, after an interim analysis revealed that the primary endpoint could not be reached. At this point, approximately half the planned patients had been enrolled. Interim results were presented at the 2011 American College of Cardiology (ACC) scientific meeting. (43) These results reported composite adverse event rates of 38% in the pVAD group compared to 43% in the IABP group (p=0.40).

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 and 8 deaths at 30 days for a mortality rate of 5.5%. 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 myocardial infarctions (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.

Conclusions. pVADs have been tested in RCTs and uncontrolled studies of patients with cardiogenic shock and in patients undergoing high-risk cardiac interventions. The RCTs do not report a benefit for use of pVADs. In addition, both the RCTs and case series report high rates of adverse events that may outweigh any potential benefits. As a result, the evidence on pVADs does not support an improvement in health outcomes for patients with cardiogenic shock or in patients undergoing high-risk cardiac interventions.

Ongoing trials (all devices)

The BERLIN Heart EXCOR IDE study (47) is a prospective multicenter, single-arm trial of the EXCOR device in small children aged 0-16 years with severe heart failure meeting the criteria for transplantation. This is the only device that is FDA-approved for children younger than 5 years of age. The primary efficacy endpoint of this trial is survival to recovery or heart transplant, and the primary safety endpoint is the incidence of serious adverse events. A total of 48 children are planned to be enrolled. The study population will be compared to historical controls treated with extra-corporeal membrane oxygenation (ECMO).

Summary

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. 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 investigational for this purpose.

The evidence on percutaneous ventricular assist devices (pVADs) does not support that these devices improve health outcomes. Three randomized controlled trials of pVAD versus intra-aortic balloon pump (IABP) for patients in cardiogenic shock failed to demonstrate a mortality benefit and reported higher complications associated with pVAD use, and a fourth RCT was terminated early due to futility. Case series of patients with cardiogenic shock refractory to IABP have reported improved hemodynamic parameters following pVAD placement. However, these uncontrolled series cannot determine if pVAD improves mortality, and high rates of complications are reported with pVAD use. Because of the lack of demonstrated benefits in clinical trials, and the high complication rates reported, the use of pVAD for all indications is considered investigational.

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).

Medicare National Coverage

Medicare has a national coverage policy regarding bridge-to-transplant LVADs, mandating coverage for the following conditions:

  • The VAD is used according to FDA labeling
  • The patient is approved and listed as a heart transplant candidate
  • The VAD is implanted in a Medicare-approved heart transplant center or has received written permission from the Medicare-approved heart transplant center under which the patient is listed prior to implantation of the VAD.

Medicare also has an affirmative national coverage decision regarding VADs as destination therapy when performed at a Joint Commission-approved facility:

The VADs are covered for patients who have chronic end-stage heart failure (New York Heart Association Class IV end-stage left ventricular failure for at least 90 days with a life expectancy of less than 2 years), are not candidates for heart transplantation, and meet all of the following conditions:

  1. The patient’s Class IV heart failure symptoms have failed to respond to optimal medical management, including dietary salt restriction, diuretics, digitalis, beta-blockers, and ACE [angiotensin-converting enzyme] inhibitors (if tolerated) for at least 60 of the last 90 days;
  2. The patient has a left ventricular ejection fraction (LVEF) of less than 25%;
  3. The patient has demonstrated functional limitation with a peak oxygen consumption of less than 12 mL/kg/min; or the patient has a continued need for intravenous inotropic therapy owing to symptomatic hypotension, decreasing renal function, or worsening pulmonary congestion; and,
  4. The patient has the appropriate body size (greater than 1.5 m²) to support the VAD implantation.

As of August 2010, CMS was accepting comments on further changes to the coverage decision.

In 2008, the Centers for Medicare and Medicaid Services (CMS) announced a national Medicare coverage decision for artificial hearts under their coverage with evidence development (CED) program. Beginning in May 2008, Medicare will provide coverage for artificial hearts as bridge to transplant or destination therapy when the patient is enrolled in a CMS-approved clinical trial that meets the criteria outlined in the Medicare policy and that answers one of the following questions:

  • Were there unique circumstances such as expertise available in a particular facility or an unusual combination of conditions in particular patients that affected their outcomes?
  • What will be the average time to device failure when the device is made available to larger numbers of patients?
  • Do results adequately give a reasonable indication of the full range of outcomes (both positive and negative) that might be expected from more wide spread use?

CMS maintains a list of their approved artificial heart studies on their website available online at:

http://www.cms.hhs.gov/MedicareApprovedFacilitie/06_artificialhearts.asp. As of August 10, 2010, there are 2 studies listed:

Study Title: A Post-approval Study to Monitor the Clinical Performance of the AbioCor® in Severe End-stage Heart Disease

Sponsor: Abiomed, Inc.

ClinicalTrials.gov Number: NCT00669357

CMS Approval Date: 5/14/08

Study Title: The SynCardia CardioWest™ TAH-t Postmarket Surveillance Study

Sponsor: SynCardia Systems, Inc.

ClinicalTrial.gov Number: NCT00614510

CMS Approval Date: 5/14/08

References:

  1. US Department of Health and Human Services. U.S. Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry of Transplant Recipients (SRTR). 2008 OPTN/SRTR Annual Report 1998-2007. Available online at http://optn.transplant.hrsa.gov/ar2008/.
  2. Shuhaiber JH, Jenkins D, Berman M et al. The Papworth experience with the Levitronix CentriMag ventricular assist device. J Heart Lung Transplant 2008; 27(2):158-64.
  3. De Robertis F, Birks EJ, Rogers P et al. Clinical performance with the Levitronix Centrimag short-term ventricular assist device. J Heart Lung Transplant 2006; 25(2):181-6.
  4. De Robertis F, Rogers P, Amrani M et al. Bridge to decision using the Levitronix CentriMag short-term ventricular assist device. J Heart Lung Transplant 2008; 27(5):474-8.
  5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Ventricular assist devices in bridging to heart transplantation. TEC Assessments 1996; Volume 11, Tab 26.
  6. Goldstein DJ, Oz MC, Rose EA. Implantable left ventricular assist devices. N Engl J Med 1998; 339(21):1522-33.
  7. Aaronson KD, Eppinger MJ, Dyke DB et al. Left ventricular assist device therapy improves utilization of donor hearts. J Am Coll Cardiol 2002; 39(8):1247-54.
  8. Frazier OH, Rose EA, McCarthy P et al. Improved mortality and rehabilitation of transplant candidates treated with a long-term implantable left ventricular assist system. Ann Surg 1995; 222(3):327-36; discussion 36-8.
  9. Bank AJ, Mir SH, Nguyen DQ et al. Effects of left ventricular assist devices on outcomes in patients undergoing heart transplantation. Ann Thorac Surg 2000; 69(5):1369-74; discussion 75.
  10. 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.
  11. Wieselthaler GM, Schima H, Lassnigg AM et al. Lessons learned from the first clinical implants of the DeBakey ventricular assist device axial pump: a single center report. Ann Thorac Surg 2001; 71(3 Suppl):S139-43; discussion S44-6.
  12. Frazier OH, Gemmato C, Myers TJ et al. Initial clinical experience with the HeartMate II axial-flow left ventricular assist device. Tex Heart Inst J 2007; 34(3):275-81.
  13. John R, Kamdar F, Liao K et al. Improved survival and decreasing incidence of adverse events with the HeartMate II left ventricular assist device as bridge-to-transplant therapy. Ann Thorac Surg 2008; 86(4):1227-34; discussion 34-5.
  14. Miller LW, Pagani FD, Russell SD et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med 2007; 357(9):885-96.
  15. Patel ND, Weiss ES, Schaffer J et al. Right heart dysfunction after left ventricular assist device implantation: a comparison of the pulsatile HeartMate I and axial-flow HeartMate II devices. Ann Thorac Surg 2008; 86(3):832-40; discussion 32-40.
  16. 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.
  17. Kirklin JK, Naftel DC, Stevenson LW et al. INTERMACS database for durable devices for circulatory support: first annual report. J Heart Lung Transplant 2008; 27(10):1065-72.
  18. Alba AC, McDonald M, Rao V et al. The effect of ventricular assist devices on long-term post-transplant outcomes: a systematic review of observational studies. Eur J Heart Fail 2011; 13(7):785-95.
  19. Dickstein K, Cohen-Solal A, Filippatos G et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J 2008; 29(19):2388-442.
  20. Davies RR, Russo MJ, Hong KN et al. The use of mechanical circulatory support as a bridge to transplantation in pediatric patients: an analysis of the United Network for Organ Sharing database. J Thorac Cardiovasc Surg 2008; 135(2):421-7, 27 e1.
  21. 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.
  22. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Left ventricular assist devices as destination therapy for end-stage heart failure. TEC Assessments 2002; Volume 17, Tab 19.
  23. Rose EA, Gelijns AC, Moskowitz AJ et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med 2001; 345(20):1435-43.
  24. Park SJ, Tector A, Piccioni W et al. Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 2005; 129(1):9-17.
  25. Long JW, Kfoury AG, Slaughter MS et al. Long-term destination therapy with the HeartMate XVE left ventricular assist device: improved outcomes since the REMATCH study. Congest Heart Fail 2005; 11(3):133-8.
  26. Slaughter MS, Rogers JG, Milano CA et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009; 361(23):2241-51.
  27. Nativi JN, Drakos SG, Kucheryavaya AY et al. Changing outcomes in patients bridged to heart transplantation with continuous- versus pulsatile-flow ventricular assist devices: an analysis of the registry of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant 2011; 30(8):854-61.
  28. Pruijsten RV, Lok SI, Kirkels HH et al. Functional and haemodynamic recovery after implantation of continuous-flow left ventricular assist devices in comparison with pulsatile left ventricular assist devices in patients with end-stage heart failure. Eur J Heart Fail 2012; 14(3):319-25.
  29. Lim KM, Constantino J, Gurev V et al. Comparison of the effects of continuous and pulsatile left ventricular-assist devices on ventricular unloading using a cardiac electromechanics model. J Physiol Sci 2012; 62(1):11-9.
  30. Kato TS, Chokshi A, Singh P et al. Effects of continuous-flow versus pulsatile-flow left ventricular assist devices on myocardial unloading and remodeling. Circ Heart Fail 2011; 4(5):546-53.
  31. Ventura PA, Alharethi R, Budge D et al. Differential impact on post-transplant outcomes between pulsatile- and continuous-flow left ventricular assist devices. Clin Transplant 2011; 25(4):E390-5.
  32. Copeland JG, Smith RG, Arabia FA et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med 2004; 351(9):859-67.
  33. Copeland JG, Copeland H, Gustafson M et al. Experience with more than 100 total artificial heart implants. J Thorac Cardiovasc Surg 2012; 143(3):727-34.
  34. FDA information: AbioCor clinical results. Available online at http://www.accessdata.fda.gov/cdrh_docs/pdf4/H040006b.pdf. Last accessed August 2010.
  35. Dowling RD, Gray LA, Jr., Etoch SW et al. Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg 2004; 127(1):131-41.
  36. Burkhoff D, Cohen H, Brunckhorst C et al. A randomized multicenter clinical study to evaluate the safety and efficacy of the TandemHeart percutaneous ventricular assist device versus conventional therapy with intraaortic balloon pumping for treatment of cardiogenic shock. Am Heart J 2006; 152(3):469 e1-8.
  37. 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 2008; 52(19):1584-8.
  38. 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 2005; 26(13):1276-83.
  39. Cheng JM, den Uil CA, Hoeks SE et al. Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock: a meta-analysis of controlled trials. Eur Heart J 2009; 30(17):2102-8.
  40. Griffith BP, Anderson MB, Samuels LE et al. The RECOVER I: A multicenter prospective study of Impella 5.0/LD for postcardiotomy circulatory support. J Thorac Cardiovasc Surg 2012 [Epub ahead of print].
  41. Kar B, Gregoric ID, Basra SS et al. The percutaneous ventricular assist device in severe refractory cardiogenic shock. J Am Coll Cardiol 2011; 57(6):688-96.
  42. Dixon SR, Henriques JP, Mauri L et al. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv 2009; 2(2):91-6.
  43. PROTECT II study halted for futility: Abiomed explanation meets skepticism. 2010. Available online at: http://www.theheart.org/article/1161463.do. Last accessed 8/17/11.
  44. Sjauw KD, Konorza T, Erbel R et al. Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry. J Am Coll Cardiol 2009; 54(25):2430-4.
  45. Kar B, Forrester M, Gemmato C et al. Use of the TandemHeart percutaneous ventricular assist device to support patients undergoing high-risk percutaneous coronary intervention. J Invasive Cardiol 2006; 18(3):93-6.
  46. Giombolini C, Notaristefano S, Santucci S et al. Percutaneous left ventricular assist device, TandemHeart, for high-risk percutaneous coronary revascularization. A single centre experience. Acute Card Care 2006; 8(1):35-40.
  47. Almond CS, Buchholz H, Massicotte P et al. Berlin Heart EXCOR Pediatric ventricular assist device Investigational Device Exemption study: study design and rationale. Am Heart J 2011; 162(3):425-35 e6.
  48. Hunt SA, Abraham WT, Chin MH et al. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation 2005; 112(12):e154-235.
  49. Hunt SA, Abraham WT, Chin MH et al. 2009 focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation 2009; 119(14):e391-479.
  50. Lindenfeld J, Albert NM, Boehmer JP et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010; 16(6):e1-194.
  51. Dickstein K, Vardas PE, Auricchio A et al. 2010 Focused Update of ESC Guidelines on device therapy in heart failure: an update of the 2008 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC guidelines for cardiac and resynchronization therapy. Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association. Eur Heart J 2010; 31(21):2677-87.

Codes

Number

Description

CPT  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 or ventricular assist device, implantable intracorporeal, single ventricle
  33980 Removal of ventricular assist device, implantable intracorporeal, single ventricle
  33990 Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; arterial access only (new code 1/1/13)
  33991 ;both arterial and venous access, with transseptal puncture (new code 1/1/13)
  33992 Removal of percutaneous ventricular assist device at separate and distinct session from insertion (new code 1/1/13)
  33993 Repositioning of percutaneous ventricular assist device with imaging guidance at separate and distinct session from insertion
  33999 Unlisted procedure, cardiac surgery
   0048T  Implantation of a ventricular assist device, extracorporeal, percutaneous, transseptal access, single or dual cannulation 
   0049T  Prolonged extracorporeal percutaneous transseptal ventricular assist device, greater than 24 hours, each subsequent 24-hour period (discontinued 12/31/08)
   0050T  Removal of a ventricular assist device, extracorporeal, percutaneous transseptal access, single or dual cannulation 
   0051T  Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy 
   0052T  Replacement or repair of thoracic unit of a total replacement heart system (artificial heart) 
   0053T  Replacement or repair of implantable component or components of total replacement heart system (artificial heart) excluding thoracic unit 
ICD-9 Procedure  37.52 Implantation of total replacement heart system (artificial heart) 
  37.53 Replacement or repair of thoracic unit of total replacement heart system
  37.54 Replacement or repair of other implantable component of total replacement heart system
  37.63 Repair of heart assist system (includes replacement of parts of an existing VAD)
  37.66  Implant of an implantable, pulsatile heart-assist system (ventricular assist device) 
   37.68 Insertion of percutaneous external heart assist device (includes pVADs)
ICD-9 Diagnosis  398.91  Rheumatic heart failure (congestive) 
   402.01  Malignant hypertensive heart disease with congestive heart failure 
   402.11  Benign hypertensive heart disease with congestive heart failure 
   404.01  Malignant hypertensive heart and renal disease with congestive heart failure 
   404.03  Malignant hypertensive heart and renal disease with congestive heart failure and renal failure 
   404.11  Hypertensive heart and renal disease with congestive heart failure and renal failure 
   428.0  Congestive heart failure 
HCPCS Q0480 Driver for use with pneumatic ventricular assist device, replacement only
   Q0481 Microprocessor control unit for use with electric ventricular assist device, replacement only
   Q0482 Microprocessor control unit for use with electric/pneumatic combination ventricular assist device, replacement only
   Q0483 Monitor/display module for use with electric ventricular assist device, replacement only
   Q0484 Monitor/display module for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0485 Monitor control cable for use with electric ventricular assist device, replacement only
   Q0486 Monitor control cable for use with electric/pneumatic ventricular assist device, replacement only
   Q0487 Leads (pneumatic/electrical) for use with any type electric/pneumatic ventricular assist device, replacement only
   Q0488 Power pack base for use with electric ventricular assist device, repalcement only
   Q0489 Power pack base for use with electric/pneumatic ventricular assist device, replacement only
   Q0490 Emergency power source for use with electric ventricular assist device, replacement only
   Q0491 Emergency power source for use with electric/pneumatic ventricular assist device, replacement only
   Q0492 Emergency power supply cable for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0493 Emergency power supply cable for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0494 Emergency hand pump for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0495 Battery/power pack charger for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0496 Battery for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0497 Battery clips for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0498 Holster for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0499 Belt/vest for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0500 Filters for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0501 Shower cover for use with electric or electric/pneumatic ventricular assist device, replacement only
   Q0502 Mobility cart for pneumatic ventricular assist device, replacement only
   Q0503 Battery for pneumatic ventricular assist device, replacement only, each
   Q0504 Power adapter for pneumatic ventricular assist device, replacement only, vehicle type
   Q0505  Miscellaneous supply or accessory for use with ventricular assist device  
   Q0506 Battery, lithium-ion, for use with electric or electric/phuematic ventricular assist device, replacement only
ICD-10-CM (effective 10/1/14)  I09.81 Rheumatic heart failure  
  I11.0 Hypertensive heart disease with heart failure  
    I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease  
  I13.2 Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease  
   I50.1-I50.9 Heart failure code range  
  I97.0 Postcardiotomy syndrome  
ICD-10-PCS (effective 10/1/14)  02RK0JZ + 02RL0JZ Total artificial heart is reported with a “cluster” of 2 codes for open replacement with synthetic substitute of the right and left ventricles  
  02HA0QZ, 02HA3QZ, 02HA4QZ Surgical, heart and great vessels, insertion, heart, implantable heart assist system; open, percutaneous and percutaneous endoscopic approach codes  
  02HA3RZ Surgical, heart and great vessels, insertion, heart, percutaneous, external heart assist system  
  02RK0JZ, 02RK4JZ, 02RL0JZ, 02RL4JZ Surgical, heart and great vessels, replacement, ventricle, synthetic substitute; codes for left and right, and open and percutaneous endoscopic approaches 
Type of Service  Surgery 
Place of Service  Inpatient 

Index

Artificial Heart
Assist Devices, Ventricular
Devices, Ventricular Assist, as a Bridge to Heart Transplantation
Total Artificial Heart
Ventricular Assist Devices as a Bridge to Heart Transplantation


Policy History

Date Action Reason
11/30/96 Add to Surgery section New policy
03/15/99 Replace policy Policy updated to include new FDA-approved devices
07/12/02 Replace policy Policy reviewed: Rationale section expanded, references added. Policy statement on use of VADs in patients who are not transplant candidates deleted; this topic will be addressed in a separate policy. Policy statement otherwise unchanged
12/18/02 Replace policy Policy statement revised to include 2002 TEC Assessment conclusions regarding VADs in patients who are not transplant candidates, i.e., “destination” therapy”
10/9/03 Replace policy Policy statement revised to limit medically necessary indications to FDA-approved devices. Policy statement added regarding investigational status of total artificial hearts. Additional 2003 category III CPT codes added
04/1/05 Replace policy Policy statement revised to indicate that a total artificial heart may be considered medically necessary as a bridge to transplant, based on FDA approval for that indication
06/27/05 Replace policy Policy statement for total artificial heart corrected (language removed that was erroneously left in the policy)
04/25/06 Replace policy Policy updated with literature review; policy statement unchanged. Reference numbers 10 and 11 added. HCPCS codes for replacement parts and accessories added to code table
10/10/06 Replace policy Policy updated with FDA approval of total artificial heart. Policy statements unchanged; total artificial hearts are investigational. Reference numbers 13, 14, 16, and 17 added. ICD-9 procedure code for total heart added.
04/09/08 Replace policy  Policy updated with literature search; no change in policy statements. Specific information added to Policy Guidelines about VADs that have FDA-approval for use in children. Reference numbers 15, 16, and 18 added.
08/13/09 Replace policy Policy updated with literature search; references 20 through 31 added. No change to policy statements
09/16/10 Replace policy Policy updated with literature search; References 1, 10, 19, 29 and 30 added. Extensive editing completed. Policy statements revised to address only implantable VADs and total artificial hearts.
09/01/11 Replace policy Policy updated with literature search. Percutaneous VADs added to policy statement and rationale. References 22, 30-39, 42, 43 added.
09/13/12 Replace policy 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…”
11/8/12 replace policy - coding update only CPT codes updated
2/14/13 Replace policy Policy statement on children amended; age range changed from 5-16 to 0-16, reflecting the approval of the BERLIN heart EXCOR device for pediatric patients aged 0-16
3/14/13 Replace policy- correction only First paragraph in the Policy Guidelines revised to include the Berlin Heart EXCOR Pediatric VAD.
4/11/13 Replace policy- correction only Description section revised to remove statement that pVADs are outside the scope of this policy.