| Coverage Policy Manual | |
| Policy #: | 1998108 |
| Category: | Surgery |
| Initiated: | August 2017 |
| Last Review: | August 2023 |
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| Ventricular Assist Devices | |
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| 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. The VAD has also been used as a bridge to recovery in patients with reversible conditions affecting cardiac output.
Background
According to a 2022 report from the American Heart Association and based on data collected from 2015 to 2018, roughly 6 million Americans ages 20 years or older had heart failure during that time frame (Tsao, 2022). Prevalence of heart failure is projected to affect more than 8 million people 18 years of age and older by the year 2030. Between 2015 and 2018, the prevalence of heart failure was highest in non-Hispanic Black males. Based on data from the Multi-Ethnic Study of Atherosclerosis (MESA), in those without baseline cardiovascular disease, Black individuals had the highest risk of developing heart failure (4.6 per 1000 person-years), followed by Hispanic (3.5 per 1000 person-years), White (2.4 per 1000 person-years), and Chinese individuals (1.0 per 1000 person-years) (Lewsey, 2021). Similar findings were demonstrated in the Atherosclerosis Risk in Communities (ARIC) Community Surveillance data, in which Black men and women had the highest burden of new-onset heart failure cases and the highest-age adjusted 30-day case fatality rate in comparison to White men and women. Higher risk reflected differential prevalence of hypertension, diabetes, and low socio-economic status.
Heart failure may be the consequence of a number of 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 91%, 85%, and 78%, respectively. (OPTN, 2018) The supply of donor organs has leveled off, while candidates for transplants are increasing, compelling the development of mechanical devices.
Devices and Regulatory Status
A number of implantable ventricular assist devices (VADs) and artificial heart systems have been U.S. Food and Drug Administration (FDA) FDA approved through a Humanitarian Device Exemption, 510(k), or premarket approval regulatory pathway. This section discusses currently marketed devices.
FDA maintains a list of recent device recalls at https://www.fda.gov/medical-devices/medical-device-recalls/2021-medical-device-recalls
Ventricular Assist Devices
Implantable ventricular assist devices are attached to the native heart, which may have enough residual capacity to withstand a device failure in the short term. In reversible heart failure conditions, 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.
The intent of treatment may evolve over the course of treatment; for example, there is not necessarily a strict delineation between bridge to transplant and destination therapy, and transplant eligibility can change.
Below is a list of VADs currently available in the US. The HeartWare VAD System was discontinued in June 2021 due to evidence from observational studies demonstrating a higher frequency of neurological adverse events and mortality with the system compared to other commercially available left VADs.
Available Ventricular Assist Devices
Percutaneous Ventricular Assist Devices
Some circulatory assist devices are placed percutaneously, i.e., are not implanted. These may be referred to as percutaneous VADs (pVADs). Two different pVADs have been developed, the TandemHeart™ and the Impella® device. 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. Devices in which most 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. 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.
Available Percutaneous Ventricular Assist Devices:
Related Policy: 2015006 Extracorporeal Membrane Oxygenation for Adult Conditions
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Policy/ Coverage: |
Effective June 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Long-Term Devices
Destination Therapy
Implantable Ventricular Assist Devices (VADs) with U.S. Food and Drug Administration (FDA) approval or clearance meet member benefit certificate Primary Coverage Criteria as destination therapy for patients who meet the following criteria:
Short-Term Devices
Bridge to Transplantation
Implantable Ventricular Assist Devices (VADs) with FDA approval or clearance meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness as a bridge to heart transplantation for patients:
Postcardiotomy Setting/Bridge to Recovery
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of percutaneous ventricular assist devices (e.g., Impella®, TandemHeart®) for any indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of percutaneous ventricular assist devices for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Any other use of a ventricular assist device does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, any other use of a ventricular assist device is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective prior to June 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Ventricular assist devices meet member benefit certificate Primary Coverage Criteria for their FDA approved indications as a bridge to heart transplantation for patients who are considered appropriate heart transplant candidates but who are unlikely to survive the wait period until a human heart is available. This coverage policy is based on demonstrated ability of the VAD to provide an effective bridge to transplantation.
FDA approved ventricular assist devices meet member benefit certificate Primary Coverage Criteria in the post-cardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass.
Ventricular assist devices that have FDA approval as destination devices meet member benefit certificate Primary Coverage Criteria as destination therapy for patients who meet the following criteria:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of percutaneous ventricular assist devices (e.g., Impella®, TandemHeart®) for any indication does not meet member benefit certificate primary coverage criteria.
For members with contracts without primary coverage criteria, the use of percutaneous ventricular assist devices for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Any other use of a ventricular assist device does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
Any other use of a ventricular assist device is considered investigational. Investigational services are an exclusion in the member benefit certificate.
Effective, August 2009 – March 2016
Ventricular assist devices meet member benefit certificate Primary Coverage Criteria for their FDA approved indications as a bridge to heart transplantation for patients who are considered appropriate heart transplant candidates but who are unlikely to survive the wait period until a human heart is available. This coverage policy is based on demonstrated ability of the VAD to provide an effective bridge to transplantation.
FDA approved ventricular assist devices meet member benefit certificate Primary Coverage Criteria in the post-cardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass.
Ventricular assist devices that have FDA approval as destination devices meet member benefit certificate Primary Coverage Criteria as destination therapy for patients who meet the following criteria:
Any other use of a ventricular assist device does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
Any other use of a ventricular assist device is considered investigational. Investigational services are an exclusion in the member benefit certificate.
Effective, July 2005
Ventricular assist devices are covered as a bridge to heart transplantation for patients who are considered appropriate heart transplant candidates but who are unlikely to survive the wait period until a human heart is available.
Ventricular assist devices are covered in the post-cardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass.
Ventricular assist devices are covered as destination therapy for patients with end stage heart failure who are ineligible for human heart transplant and who meet the following criteria:
Effective, February 2003
Ventricular assist devices are covered as a bridge to heart transplantation for patients who are considered appropriate heart transplant candidates but who are unlikely to survive the wait period until a human heart is available.
Ventricular assist devices are covered in the post-cardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass.
Ventricular assist devices are covered as destination therapy for patients with end stage heart failure who are ineligible for human heart transplant and who meet the
following criteria:
1) New York Heart Association (NYHA) class IV heart failure for 60 days or longer OR NYHA class III/IV for 28 days who have received 14 or more days support with intraaortic balloon pump or dependent on IV inotropic agents, with two failed weaning attempts; AND
2) Peak O2 consumption less than or equal to 14 ml/kg.
Patients must not be candidates for human heart transplant for one or more of the following reasons: Age more than 65 years; Insulin dependent diabetes mellitus with end-organ damage; Chronic renal failure (serum creatinine higher than 2.5 mg/ dL for more than three months) and Presence of other clinically significant condition.
Effective, February 1998
Ventricular assist devices in bridging the time until a heart transplant are considered medically necessary for patients with severe congestive heart failure approved as heart transplant candidates who are in imminent risk of dying before donor heart procurement, are on optimal inotropic support, and, if possible, are on an intra-aortic balloon pump (IABP).
Ventricular assist devices are considered investigational and are not covered when used as a permanent alternative to heart transplantation.
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| Rationale: |
Bridge to Transplant LVADs
The policy was initiated in 1998 because of developing evidence that left ventricular assist devices can provide an effective bridge to transplantation.
Around the time this policy was initiated, Goldstein and colleagues published a review (Goldstein,1998). It should be recognized that left ventricular assist devices cannot 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 utilization of donor hearts. Currently available LVADs consist of pulsatile devices that require stiff power vent lines that perforate the skin and bulky implantable pump chambers. There is considerable research interest in developing non-pulsatile axial flow systems that have the potential for small size and low noise levels (Wieselthaler, 2001)
The HeartMate II was FDA approved in April 2008 for use as a bridge to transplant. This is a continuous-flow device with smaller size and hopefully better durability and lower risk of infection. The HeartMate II was evaluated as a bridge to transplantation in a multi-center study of 133 patients with end-stage heart failure on the cardiac transplant list. The duration of cardiac support ranged from 1-600 days (median 126 days. The survival rate during support was 68 percent at one year. At three months, there were significant improvements in NYHA functional class, six minute walk, and quality of life. Adverse events included bleeding, heart failure, stroke and lead infection.
LVADs as Destination Therapy
The policy regarding LVADs as destination therapy was initially based on increasing interest in the use of destination therapy.
Park and colleagues published a further follow-up of patients in the REMATCH trial, which found that survival and quality of life benefits were still apparent with extended 2-year follow-up (Park, 2005). In addition, this study and other case series suggest continuing improvement in outcomes related to ongoing improvements in the device and patient management (Long, 2005). 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.
The American College of Cardiology assigns a IIa recommendation (weight of evidence/opinion in favor of usefulness/efficacy) to the use of a LVAD as permanent or “destination” therapy reasonable in highly selected patients with refractory end-stage heart failure and an estimated 1-year mortality over 50% with medical therapy. (level of evidence B – data derived from a single randomized or nonrandomized trials).
Data regarding use of VADs in pediatric patients were reviewed for this policy update. There is one FDA-approved device (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 (FDA, 2008) Publications have reported positive outcomes for children using VADs as a bridge to transplantation. Using the UNOS database, Davies reported on use of VADs in pediatric patients undergoing heart transplantation (Davies, 2008) Their analysis concluded that pediatric patients requiring a pretransplantation VAD have similar long-term survival to those not receiving mechanical circulatory support.
2012 Update
A search of the MEDLINE database through September 2012 did not reveal any new information that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
LVADs as Bridge to Transplant
A systematic review published in 2012 examined the evidence on the effect of LVADs on post-transplant outcomes (Alba, 2011). 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.
In 2011, Strueber et al. published a case series of 50 patients awaiting heart transplantation treated with a newer generation HeartWare® VAD (Strueber, 2011). 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.
Comparative efficacy of continuous flow versus pulsatile flow devices
Nativi et al. 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 (Nativi, 2011). 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 (Pruiksten, 2012; Lim, 2012; Kato, 2011; Ventura, 2011). 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.
The Heart Failure Society of America published guidelines in 2010 on surgical approaches to the treatment of heart failure (Lindenfeld, 2010). The following recommendations were made regarding left ventricular assist devices:
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement.
2014 Update
A literature search conducted through February 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
LVADs may have a role in bridging patients to recovery, particularly if there is reverse remodeling of the left ventricle. A number of relatively small, noncomparative studies have evaluated LVADs as bridge-to-recovery therapy. In a 2006 study, a series of 15 patients with severe heart failure due to nonischemic cardiomyopathy underwent implantation of LVADs, along with medical management designed to enhance myocardial recovery. Eleven of 15 patients had enough myocardial recovery to undergo LVAD explantation; 2 patients died after explantation. Among those who survived, the cumulate rate of freedom from recurring heart failure was 100% and 88.9%, respectively, at 1 and 4 years postexplantation. The same group subsequently reported results of their LVAD explantation protocol among patients with severe heart failure due to nonischemic cardiopathy who had nonpulsatile LVADs implanted (Birks, 2011). They included 20 patients who received a combination of angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and adosterol antagonists followed by the β2-agonist clenbuterol. One patient was lost to follow-up and died after 240 days of support. Of the remaining 19 patients, 12 (63.2%) were successfully explanted after a mean 286 days; estimated survival without heart failure recurrence was 83.3% at 1 and 3 years. In a prospective multicenter study to assess myocardial recovery in patients with LVAD implantation as a bridge to transplant, Maybaum et al evaluated 67 patients with heart failure who had undergone LVAD implantation for severe heart failure (Maybaum, 2007). After 30 days, patients demonstrated significant improvements compared with pre-LVAD state in left ventricular ejection fraction (17.1% vs 34.12%, p<0.001), left ventricular end-diastolic diameter (7.1 cm vs 5.1 cm, p<0.001), and left ventricular mass (320 g vs 194 g, p<0.001). However, only 9% of patients demonstrated enough recovery to have their LVAD explanted.
The current evidence is insufficient to allow the identification of other heart failure patient populations who might benefit from the use of an LVAD as a specific bridge-to-recovery treatment strategy. Ongoing research studies are addressing this question, along with protocols for transitioning patients off LVAD use.
A report from INTERMACS comparing the HeartMate II with other LVAD devices for patients who received them with a bridge to transplantation indication reported that 91% and 80% of HeartMate II and other LVAD patients, respectively, reached transplant, cardiac recovery, or ongoing LVAD support by 6 months (Starling, 2011).
In 2012, Aaronson et al reported results of a multicenter, prospective study of a newer generation LVAD, the HeartWare®, which is a smaller, continuous flow centrifugal device that is implanted in the pericardial space (Aaronson, 2012). The study enrolled 140 patients who were awaiting heart transplantation who underwent HeartWare® implantation. A control group of 499 subjects comprised patients drawn from the INTERMACS database, which collects data on patients who receive FDA-approved durable mechanical circulatory support devices. The study’s primary outcome was defined as survival on the originally implanted device, transplantation, or explantation for ventricular recovery at 180 days. Secondary outcomes were comparisons of survival between groups and functional, quality of life, and adverse event outcomes in the HeartWare® group. Success occurred in 90.7% of the HeartWare® group and 90.1% of controls (p<0.001, noninferiority with a 15% margin). Serious adverse events in the HeartWare® group included, most commonly, bleeding, infections, and perioperative right heart failure.
In 2013, Slaughter et al reported combined outcomes for patients included in the HeartWare® bridge-to-transplant study previously described and a continued-access protocol granted by FDA (Slaughter, 2013). The study included 322 patients with heart failure, eligible for heart transplant, who received the HeartWare® (140 patients from the original study; 190 patients in the continue-access protocol who were monitored to outcome or had completed 180 days of follow-up at the time of this analysis). Survival at 60, 180, and 360 days was 97%, 91%, and 84%, respectively. The most common adverse events were respiratory dysfunction, arrhythmias, sepsis, and driveline exit site infections. Patients generally had improvements in quality-of-life measures.
Following the FDA approval, Fraser et al evaluated the EXCOR device among 48 children, aged 16 or younger with 2-ventricle circulation, who had severe heart failure, despite optimized treatment and were listed for heart transplant (Fraser, 2012). Patients were divided into 2 groups based on body surface area. A historic control group of children receiving circulatory support with extracorporeal membrane oxygenation (ECMO) from the Extracorporeal Life Support Organization registry, matched in a 2:1 fashion with study participants based on propensity-score matching. For participants in cohort 1 (body surface area, <0.7 m2), the median survival time had not been reached at 174 days, while in the matched ECMO comparison group, the median survival was 13 days (p<0.001). For participants in cohort 2 (body surface area, 0.7 to <1.5 m2), the median survival was 144 days, compared with 10 days in the matched ECMO group (p<0.001).Rates of adverse events were high in both EXCOR device cohorts, including major bleeding (in 42% and 50% of cohort 1 and cohort 2, respectively), infection (in 63% and 50% of cohort 1 and cohort 2, respectively), and stroke (in 29% of both cohorts).
In 2013, Almond et al reported results from a prospective, multicenter registry to evaluate outcomes in children who received the Berlin Heart EXCOR device as a bridge to transplant (Almond, 2013). This study included a broader patient population than the Fraser et al study. All patients were followed up from the time of EXCOR implantation until transplantation, death, or recovery. The study included 204 children, 67% of whom received the device under compassionate use. Survival at 12 months on EXCOR support was 75%, including 64% who survived to transplantation, 6% who recovered (device explanted and patient survived 30 days), and 5% alive with the device in place.
After publication of the REMATCH study results, Rogers et al published results from a prospective, nonrandomized clinical trial comparing LVAD as destination therapy with optimal medical therapy for patients with heart failure who were not candidates for heart transplant (Rogers, 2007). Fifty-five patients who had NYHA functional class IV symptoms and who failed weaning from inotropic support were offered a Novacor LVAD; 18 of these did not receive a device due to preference or device unavailability and acted as a control group. The LVAD-treated patients had superior survival rates at 6 months (46% vs 22%, p=0.03) and 12 months (27% vs 11%, p=0.02), along with fewer adverse events.
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 end point was the composite of 10 different complications occurring within 30 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 of the first 327 patients enrolled revealed that the primary end point could not be reached. At the point that the data safety and monitoring board stopped the study, 452 patients had been enrolled, of whom 3 withdrew consent and 1 died. Results were published by O’Neill et al in 2012 (O’Neil, 2012). The study’s primary analysis was intention to treat and included all 448 patients randomly assigned to the Impella® system (n=225) or IABP (n=223). The primary composite end point of major adverse effects at 30 days occurred in 35.1% of Impella® patients and in 40.1% of the IABP patients (p=0.277). There was no significant difference in the occurrence of in-hospital death, stroke, or MI between the Impella® patients and the IABP patients.
A few other case series have described pVAD use in high-risk patients undergoing an invasive cardiac procedure. Sjauw et al (Sjauw, 2009) 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 1 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 1 stroke (0.7%) and no MIs were reported. Maini et al (Maini, 2012) performed a similar retrospective analysis of 175 patients undergoing high-risk PCI with pVAD support with the Impella® 2.5 circulatory support system. The primary safety end point was the incidence of major adverse cardiac events at 30 days. Secondary end points included device safety and efficacy and patient outcomes at 30 days and 12 months. Angiographic revascularization was successful in 99% of patients. At 30-day follow up, the major adverse cardiac event rate was 8%; survival was 96%, 91%, and 88% at 30 days, 6 months, and 12 months, respectively. Secondary safety end points occurring most frequently included acute renal dysfunction (2.8%), hypotension on support (3.4%), ventricular tachycardia, or cardiopulmonary resuscitation (2.8%); other vascular complications such as vessel dissection and arteriovenous fistula (3.4%), hematomas ipsi- or contralateral to the device insertion site (8.6%), infection (5.1%), and blood transfusion (9.7%).
2015 Update
A literature review conducted using the MEDLINE database revealed one new relevant publication. In 2014 a reanalysis of the PROTECT II trial was published (Dangas, 2014), using a different definition of myocardial infarction and with additional multivariable analysis. The initial study had used a rise in CK-MB rise to >3x normal as the MI definition. The reanalysis used a CK-MB rise to >8x normal as the MI definition, based on previous validation of this level as predictive of subsequent mortality. It was postulated that CK-MB rises in the Impella group were driven in part by more aggressive intervention, including rotational atherectomy, based on the comfort level of the operator to pursue more complete revascularization. There was a decrease in some events in the Impella (vs IABP) group, with the difference driven largely by the rate of repeat revascularization. While some 90-day outcomes were improved with Impella in this reanalysis, it was noted that longer-term follow-up would be needed to determine whether Impella might afford a survival benefit compared with IABP. This analysis presents promising suggestions that outcomes might be improved by the Impella device, but as a post hoc analysis it “should be considered hypothesis generating.” Results of this analysis do not prompt a change in the coverage statement.
2016 Update
This policy is being updated with results from a literature search on percutaneous ventricular assist device used for the following three indications: 1) alternative to intra-aortic balloon pump in cardiogenic shock; 2) bridge to recovery in cardiogenic shock refractory to IABP; 3) ancillary support in high-risk patients undergoing invasive cardiovascular procedures.
pVADs as an Alternative to Intra-Aortic Balloon Pump in Cardiogenic Shock
Three RCTs have been published that compare pVADs with intra-aortic balloon pumps (IABPs) for patients with cardiogenic shock (Burkhoff, 2006; Seyfarth, 2008; Thiele, 2005), along with a systematic review and meta-analysis of these 3 trials (Cheng, 2009). The meta-analysis was published in 2009 by Cheng 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; 1 of the trials 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 LV pump function, and adverse events.
None of the three 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 to 1.66; p=0.80). All three 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 to 22.0; p<0.001), and a decrease in pulmonary capillary wedge pressure of 5.3 mm Hg (95% CI, 1.2 to 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 to 3.93). Leg ischemia was also more common in the pVAD group, but this difference did not meet statistical significance (RR=2.59; 95% CI, 0.75 to 8.97; p=0.13).
O’Neill et al compared outcomes for patients with acute MI complicated by cardiogenic shock who received pVAD support pre‒percutaneous coronary intervention (PCI) with those who received pVAD support post-PCI using data from 154 consecutive patients enrolled in a multicenter registry (O’Neill, 2014). Patients who received pVAD support pre-PCI had higher survival to discharge compared with those who received pVAD support post-PCI (65.1% vs 40.7%; p=0.003). In multivariable analysis, receiving pVAD support pre-PCI was associated with in-hospital survival (odds ratio [OR], 0.37; 95% CI, 0.17 to 0.79; p=0.01). However, the potential for underlying differences in patient groups other than the use of pVAD support makes the study’s implications uncertain.
Case series of patients treated with pVADs as an alternative to IABP in cardiogenic shock have been published (Griffith, 2012; Lemaire, 2014) and report high success rates as a bridge to alternative therapies. However, given the availability of RCT evidence, these studies add a limited amount to the body of evidence on the efficacy of pVADs for the management of cardiogenic shock.
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 (Kar, 2011) 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 systolic blood pressure 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 as 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 PCI procedures. PROTECT I (Dixon, 2009) 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 surgery. High-risk PCI was performed using the Impella® system for circulatory support. All of the procedures were successfully completed 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 end point was the composite of 10 different complications occurring within 30 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 of the first 327 patients enrolled revealed that the primary end point could not be reached. At the point that the data safety and monitoring board stopped the study, 452 patients had been enrolled, 3 of whom withdrew consent and 1 who died. Results were published by O’Neill et al in 2012.60 The study’s
primary analysis was intention to treat and included all 448 patients randomly assigned to the Impella® system (n=225) or IABP (n=223). The primary composite end point of major adverse effects at 30 days occurred in 35.1% of Impella® patients and in 40.1% of the IABP patients (p=0.277). There was no significant difference in the occurrence of in-hospital death, stroke, or MI between the Impella® patients and the IABP patients.
In a prespecified subgroup analysis of the PROTECT II trial, Kovacic et al compared outcomes for the Impella system compared with IABP among 325 patients with 3-vessel disease with LVEF less than or equal to 30%.61 In the 3-vessel disease subgroup, 167 subjects were randomized to PCI with Impella support and 158 to PCI with IABP support. PCI characteristics differed in that rotational atherectomy was more aggressively used in the Impella-support group, with more passes per patient (5.6 vs 2.8, p=0.002) and more passes per coronary lesion (3.4 vs 1.7, p=0.001). Acute procedural revascularization results did not differ between groups. At 30 days, the major adverse event rate did not differ significantly between groups (32.9% of Impella patients vs 42.4% of IABP patients, p=0.078). At 90 days, Impella patients had a significantly lower major adverse event rate compared with IABP patients (39.5% vs 51.0%, p=0.039).
The 90-day event rates for the individual components of the composite major adverse event score differed only for severe hypotension requiring treatment, which was more common in patients treated with IABP (7.6% vs 2.4%, p=0.029).
In a post hoc analysis, results of the PROTECT II trial were reanalyzed by Dangas et al, using a revised definition of MI in the determination of patients with major adverse events and major adverse cardiac and cerebral events (Dangas, 2014). In contrast to the original trial, which used a cutoff of 3 times the upper limit of normal for biomarker elevation to define periprocedural MI, the authors used a cutoff of 8 times the upper limit of normal for biomarker elevation or the presence of Q waves to define periprocedural MI. In multivariable analysis, compared with IABP, treatment with the Impella system was associated with freedom from 90-day major adverse events (OR=0.75; 95% CI, 0.61 to 0.92; p=0.007) and major adverse cardiac and cerebral events (OR=0.76; 95% CI, 0.61 to 0.96; p=0.020).
A few other case series have described pVAD use in high-risk patients undergoing an invasive cardiac procedure. Sjauw et al (Sjauw, 2009) performed a retrospective analysis of 144 consecutive patients undergoing high-risk PCI with pVAD support (Impella® system) from a European registry. End points included successful device function and incidence of adverse events at 30 days. The device was successfully implanted in all 144 patients. There was 1 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 1 stroke (0.7%), and no MIs were reported. Maini et al (Maini, 2012) performed a similar retrospective analysis of 175 patients undergoing high-risk PCI with pVAD support with the Impella® 2.5 circulatory support system. The primary safety end point was the incidence of major adverse cardiac events at 30 days. Secondary end points included device safety and efficacy and patient outcomes at 30 days and 12 months. Angiographic revascularization was successful in 99% of patients. At 30-day follow-up, the major adverse cardiac event rate was 8%; survival was 96%, 91%, and 88% at 30 days, 6 months, and 12 months, respectively. Secondary safety end points occurring most frequently included acute renal dysfunction (2.8%), hypotension on support (3.4%), ventricular tachycardia, or cardiopulmonary resuscitation (2.8%); other vascular complications such as vessel dissection and arteriovenous fistula (3.4%), hematomas ipsi- or contralateral to the device insertion site (8.6%), infection (5.1%), and blood transfusion (9.7%).
Reddy et al reported outcomes for a series of 66 patients enrolled in a prospective, multicenter registry who underwent ventricular tachycardia (VT) ablation with a pVAD or IABP (Reddy, 2014). Twenty-two patients underwent ablation with IABP assistance, while 44 underwent ablation with either the TandemHeart or Impella pVAD device (non-IABP group). Compared with patients who received support with an IABP, those who received support with a pVAD had greater numbers of unstable VTs that could be mapped and ablated (1.05 vs 0.32, p<0.001), greater numbers of VTs that could be terminated by ablation (1.59 vs 0.91, p=0.001), and fewer numbers of VTs that were terminated with rescue shocks (1.9 vs 3.0, p=0.049). More pVAD-supported patients could undergo entrainment/activation mapping (82% vs 59%, p=0.046). Mortality and VT recurrence did not differ over the study follow-up period (average, 12 months).
In a retrospective study, Aryana et al reported procedural and clinical outcomes for 68 consecutive unstable patients with scar-mediated epicardial or endocardial VT who underwent ablation with or without pVAD support (Aryana, 2014). Thirty-four patients had hemodynamic support peri-procedurally with a pVAD. pVAD- and non-pVAD-supported patients were similar at baseline, with no differences in procedural success rates between groups. Compared with non-pVAD-supported patients, patients in the pVAD group had a longer maximum time in unstable VT (27.4 vs 5.3 min, p<0.001), a greater number of VT ablations per procedure (1.2 vs 0.4, p<0.001), a shorter radiofrequency ablation time (53 vs 68 seconds, p=0.022), and a shorter hospital length of stay (4.1 vs 5.4 days, p=0.013). Over a follow-up period of 19 months, rates of VT recurrence did not differ between groups.
Summary
The evidence on percutaneous VADs (pVADs) does not support that these devices improve health outcomes. Three randomized controlled trials (RCTs) of pVAD versus IABP for patients in cardiogenic shock failed to demonstrate a mortality benefit and reported higher complications associated with pVAD use. A fourth RCT comparing pVAD with IABP as an adjunct to high-risk percutaneous coronary interventions was terminated early due to futility; analysis of enrolled subjects did not demonstrate significant improvements in the pVAD group. 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. Observational studies have evaluated the use of pVAD support as an adjunct to ventricular tachycardia ablation procedures. While these studies show some differences in procedural specifics and hospital length of stay, no differences in long-term ablation success or mortality were reported.
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
At least one VAD system has been developed that is miniaturized and generates an artificial pulse, the
HeartMate 3 LVAS (St. Jude Medical, Pleasanton, California) (Netuka, 2015).
In 2016, Acharya and colleagues reported on patients who underwent VAD placement in the setting of acute myocardial infarction (AMI) who were enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry, a prospective national registry of FDA-approved durable mechanical circulatory support devices (Acharya, 2016). Patients who had an AMI as the admitting diagnosis or a major myocardial infarction (MI) as a hospital complication that resulted in VAD implantation (n=502) were compared with patients who underwent VAD implantation for non-AMI indications (n=9727). Patients in the AMI group were generally sicker at baseline, with higher rates of smoking, severe diabetes, and peripheral vascular disease, but had fewer cardiac surgeries and recent cardiovascular hospitalizations. Most AMI patients (53.8%) were implanted with a “bridge-to-candidacy” strategy. At 1 month post-VAD, 91.8% of the AMI group was alive with the device in place. At 1 year post-VAD, 52% of the AMI group were alive with the device in place, 25.7% had received a transplant, 1.6% had their VAD explanted for recovery, and 20.7% died with the device in place.
Data from the United Network for Organ Sharing, reported by Grimm and colleagues, suggests that patients bridged to transplant with an LVAD have better outcomes than those bridged with TAH or biventricular assist devices (Grimm, 2016).
In 2016, Blume and colleagues published the first analysis of the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS), which is a prospective, multicenter registry which collects data on patients who are under age 19 at the time of implant, and includes patients implanted with either durable or temporary VADs (Blume, 2016).At the time of analysis, the registry included 241 patients; of these, 41 were implanted with a temporary device only, leaving 200 patients implanted with VADs for the present study. Most patients (73%) had an underlying diagnosis of cardiomyopathy. At the time of implantation, 64% were listed for transplant, while an additional 29% were implanted with a “bridge to candidacy” strategy. A total of 7% were implanted with a destination therapy strategy. Actuarial survival at both 6 months and 1 year was 81%. At 6 months, 58% of patients were transplanted.
Also in 2016, Wehman and colleagues reported on post-transplant survival outcomes for pediatric patients who received a VAD, extracorporeal membrane oxygenation (ECMO), or no mechanical circulatory support (MCS), in the pre-transplant period (Wehman, 2016). The study included 2777 pediatric patients who underwent heart transplant from 2005 to 2012 who were identified through the United Network for Organ Sharing Database, of whom 428 were bridged with VADs and 189 were bridged with ECMO. In unadjusted analysis, the actuarial 5-year survival was highest in the direct-to-transplant group (77%), followed by the VAD group (49%) and then the ECMO group (35%). In a proportional hazards model to predict time to death, restricted to the first 4 months post-transplant, ECMO bridging was significantly associated with higher risk of death (adjusted hazard ratio [HR] 2.77 vs direct-to-transplant, 95% CI 2.12 to 3.61, P<0.0001). However, a model to predict time to death excluding deaths in the first 4 months post-transplant, the bridging group was not significantly associated with risk of death.
Chen and colleagues reported on a retrospective, single-center series of pediatric patients with continuous flow VADs, with a focus on outpatient experiences (Chen, 2016). The series included 17 children implanted with an intracorporeal device from 2010 to 2014. Eight of those patients (47%) were discharged from the hospital after a median hospitalization duration post-implant of 49 days. Adverse events were common in outpatients, most frequently major device malfunction (31%, 5/16 events) and cardiac arrhythmias (31%, 5/16 events). At the time of analysis, 4 patients had received an orthotopic heart transplant, 2 were on ongoing support, and 1 each was transferred or died.
Another retrospective, single-center series of pediatric patients reported on outcomes for patients treated with short-term continuous flow VADs, which including the Thoratec PediMag or CentriMag, or the Maquet RotaFlow (Conway, 216). From 2015 to 2014, 27 children were supported with one of these devices, most commonly for congenital heart disease (42%). The median duration of support was 12 days, and 67% of all short term continuous flow VAD runs (19 of 28 runs) lead to hospital discharge.
A prospective observational study comparing LVAD support (n=97) with optimal medical therapy (n=103) for patients with heart failure not requiring inotropes also reported superior survival and health-related quality of life in LVAD-treated patients (Estep, 2015). Twelve-month survival was 80% in the LVAD group, compared with 63% in the best medical therapy group (P=0.022).
Romeo and colleagues reported on a systematic review and meta-analysis which evaluated a variety of percutaneous mechanical support methods, including pVADs, for patients with cardiogenic shock due to acute myocardial infarction who were undergoing revascularization (Romeo, 2016). This review included the 3 RCTs described above, comparing pVADs with IABP, along with 3 observational studies. In the analysis of the comparison of pVADs with IABP, the authors found that in-hospital mortality, the primary outcome of the analysis, was nonsignificantly increased in the pVAD group.
Briasoulis and colleagues reported on a meta-analysis of pVAD devices as an adjunct to high-risk PCI (Briasoulis, 2016). The authors included RCTs and cohort studies, and identified 18 nonrandomized observational studies and 1 RCT. The single RCT identified was the PROTECT II trial described in more detail below. In the observational studies, the sample sizes ranged from 7 to 637. In pooled analysis, the 30-day mortality rate following Impella-assisted high-risk PCI was 3.5% (95% CI 2.2 to 4.8%; I2 20%), while that for TandemHeart-assisted high-risk PCI was 8% (95% CI 2.9 to 13.1%; I2 55%). The pooled vascular complication rates were 4.9% (95% CI 2.3 to 7.6%) and 6.5% (95% CI 3.2% to 9.9%) for the Impella and the TandemHeart, respectively.
Summary of Evidence
For individuals who have end stage heart failure who receive VADs as bridge to transplant, the evidence includes single arm clinical trials and observational studies. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. There is a substantial body of evidence from clinical trials and observational studies supporting implantable VADs as a bridge to transplant in patients with end stage heart failure, possibly improving mortality, as well as quality of life. These studies report that substantial numbers of patients survive to transplant in situations in which survival would not be otherwise expected. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.
For individuals who have end stage heart failure who receive VADs as destination therapy, the evidence includes one clinical trial and multiple single arm studies. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. A well-designed clinical trial, with 2 years of follow-up data, demonstrates an advantage of implantable VADs 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. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome
For individuals who have end stage heart failure who receive total artificial hearts (TAHs) as bridge to transplant, the evidence includes case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. Compared with VADs, the evidence for TAH 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. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome. For individuals who have end stage heart failure who receive TAHs as destination therapy, the evidence includes 2 case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. The body of evidence for TAHs as destination therapy is very limited. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals with cardiogenic shock or who are undergoing high-risk percutaneous coronary intervention who receives percutaneous ventricular assist devices (pVADs), the evidence includes RCTs. Relevant outcomes are overall survival, symptoms, morbid events, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. Three RCTs 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. A fourth RCT comparing pVAD with IABP as an adjunct to high-risk percutaneous coronary interventions was terminated early due to futility; analysis of enrolled subjects did not demonstrate significant improvements in the pVAD group. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals with cardiogenic shock refractory to IABP who receive pVADs, the evidence includes case series. Relevant outcomes are overall survival, symptoms, morbid events, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. 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. The evidence is insufficient to determine the effects of the technology on health outcomes.
2018 Update
A literature search was conducted through November 2018. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Retrospective Studies
Agrawal et al conducted a retrospective cohort study evaluating the 30-day readmissions of 2510 patients undergoing LVAD implantation (Agrawal, 2018). Of the patients who met the inclusion criteria, 788 (31%) were readmitted within 30 days after surviving initial index hospitalization. Cardiac causes accounted for 23.8% of readmissions, 13.4% due to heart failure, and 8.1% to arrhythmias. Infection (30.2%), bleeding (17.6%), and device-related causes (8.2%) comprised the 76.2% of noncardiovascular causes for readmission.
VADs as Bridge to Heart Transplant
Aissaoui et al published an observational study comparing 224 patients in Germany and France with end-stage heart failure who received VAD (group I, n=83) or heart transplantation or medical therapy as first treatment options (group II, n=141) (Aissaoui, 2018). The estimated 2-year survival was 44% for group I and 70% for group II (p<0.001).
Registry Studies
Bulic et al identified all U.S. children between 1 and 21 years of age at heart transplant between 2006 and 2015 who had dilated cardiomyopathy and were supported with an LVAD or vasoactive infusions alone at the time of transplant from the Organ Procurement and Transplant Network registry (n=701) (Bulic, 2017). Functional status as measured by the median Karnofsky Performance Scale score at heart transplant was higher for children receiving LVAD (6) compared with vasoactive infusion (5; p<0.001) and children receiving LVAD were more likely to be discharged from the hospital at the time of transplant. The percentage of children having a stroke at the time of transplant was higher in those receiving LVAD (3% vs 1%, p=0.04).
2019 Update
A literature search was conducted through August 2019. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
VADs as destination therapy for end-stage heart failure
The destination therapy indication was based on 2-year results from MOMENTUM 3, which showed superiority of the HeartMate 3 device compared to HeartMate II on the composite primary outcome, survival at 2 years free of disabling stroke or reoperation to replace a malfunctioning device (RR 0.84; 95% CI 0.78–0.91, p<0.001).[85] Prevalence of stroke at 2 years was lower in the HeartMate 3 than the HeartMate 2 group (10.1% versus 19.2%; P=0.02).[86] Measures of functional capacity and Health-Related Quality of Life did not differ between the two devices at 6 months (Cowger, 2017).
VADs as Bridge to Heart Transplant
Two reports from registries of patients who received the HeartMate 3 device have been published recently. Schmitto et al reported 2-year outcomes in 50 patients who received the device as a bridge to transplant (Schmitto, 2017). Survival rates at 6 months, one year, and two years were 92%, 81%, and 74%, respectively, and the total stroke rate over 2 years was 24%. Gustafsson et al reported 6-month outcomes of 482 patients; 66% of of patients received the VAD as a bridge to transplant, 26% as destination therapy, 2% as bridge to recovery, and 6% as bridge to transplant candidacy or decision. Results were not separately reported by indication (Gustafasson, 2018). The 6-month survival rate was 82% (95% CI 79% to 85%). Three patients received a transplant. The incidence of stroke was 6.1%.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Results of a recent comparative observational study conducted by Schrage et al were consistent with previous evidence in showing no mortality benefit for pVAD over IABP (Schrage, 2018). Using registry data, the researchers retrospectively identified 237 patients who had been treated with the Impella device and matched them to patients who had received IABP as part of an RCT. There was no significant difference between groups in 30-day all-cause mortality (48.5% vs 46.4%, P=0.64). Severe or life-threatening bleeding (8.5% vs 3.0%, P<0.01) and peripheral vascular complications (9.8% vs 3.8%, P=0.01) occurred significantly more often in the Impella group.
Two recent systematic reviews have evaluated pVAD as ancillary support for patients undergoing high-risk PCI. Only one RCT (PROTECT II) was included in both reviews. In addition to PROTECT II, Ait Ichou et al included 3 RCTs in patients who received emergent PCI post-MI: IMPRESS, IMPRESS in STEMI, and ISAR-SHOCK. Ait Ichou et al conducted a systematic review of the Impella device compared to IABP for high-risk patients undergoing PCI (Ait Ichou, 2017). The researchers included 4 RCTs, 2 controlled observational studies, and 14 uncontrolled observational studies published between 2006 and 2016, with a total of 1287 patients. Individual study results were reported with no pooled analyses.
Case series of patients treated with pVADs as an alternative to IABP in cardiogenic shock have reported high success rates as a bridge to alternative therapies (Sieweke, 2020; Schafer, 2020; Griffith, 2013; Lemaire, 2014; and Lauten, 2013). However, given the availability of RCT evidence, these studies add little to the body of evidence on the efficacy of pVADs for the management of cardiogenic shock.
In 2020, the American Association for Thoracic Surgery and the International Society for Heart and Lung Transplantation published guidelines on selected topics in mechanical circulatory support, including recommendations on the use of pVADs (Kirklin, 2020). The guideline authors noted, "Compared with IABP, contemporary percutaneous circulatory support devices provide a significant increase in cardiac index and mean arterial pressure; however, reported 30-day outcomes are similar.”
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A prespecified subgroup analysis of MOMENTUM 3 published in 2020 did not find differences in outcomes based on preoperative categories of bridge to transplant, bridge to transplant candidacy, or destination therapy (Goldstein, 2020).
Pagani et al (2021) used Medicare claims data to analyze survival outcomes in patients who received different LVADs between January 2014 and December 2018, with followup through December 2019 (Pagani, 2021). Of 4195 patients who received implants, there were 117 (14.3%) deaths among 821 Heartmate3 patients, 375 (20.4%) deaths among 1840 Heartmate II patients, and 375 (24.5%) deaths among 1534 patients with other VADs. The adjusted hazard ratio for mortality at 1-year (confirmed in a propensity score matched analysis) for the HeartMate 3 versus HeartMate II was 0.64 (95% CI; 0.52 to 0.79, p<.0001).
Medicare has a national coverage determination (NCD) for VADs (CMS, 2020). The NCD mandates coverage for VADs for the following indications:
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
After the randomized trial phase of MOMENTUM 3 was completed, a post-pivotal trial continuous access protocol was initiated as a single-arm prospective study to assess the reproducibility of HeartMate 3 LVAD outcomes across centers (Mehra, 2021). Of the 516 patients initially randomized to HeartMate 3 in the MOMENTUM 3 pivotal trial, 515 comprised the pivotal cohort. Starting in October 2017, bridge to transplant patients were excluded from continuous access phase enrollment. In the continuous access phase cohort, 1685 patients were ultimately included. The primary outcomes for this extended study were survival to transplant, recovery, or ongoing LVAD support, free of disabling stroke or reoperation to replace or remove a malfunctioning pump, at 2 years post-implant. At 2 years post-implant, a similar proportion of patients in the continuous access group versus the pivotal cohort achieved the composite endpoint (76.7% vs 74.8%; adjusted HR, 0.87; 95% CI, 0.71 to 1.08; p=.21). Pump exchange rates were low in both cohorts with 98.4% of the continuous access cohort and 96.9% of the pivotal cohort being free of pump replacement at 2 years. Overall survival at 2 years was 81.2% in the continuous access cohort compared to 79% in the pivotal cohort. After controlling for baseline demographics between cohorts, the adjusted HR for continuous access versus pivotal cohort was 0.84 (95% CI, 0.67 to 1.06; p=.15). Survival based on whether the HeartMate was used a bridge to transplant or as destination therapy was also similar between the continuous access and pivotal trial cohorts (bridge to transplant adjusted HR, 0.70; 95% CI, 0.43 to 1.14; p=.15; destination therapy adjusted HR, 0.89; 95% CI, 0.68 to 1.16; p=.38). This additional trial in a larger cohort reproduced similar results to the initial MOMENTUM 3 study, especially in individuals using VADs as destination therapy. Five-year outcomes are forthcoming from the MOMENTUM 3 pivotal trial study.
Long-term follow-up of the IMPRESS trial outcomes were published by Karami et al (Karami, 2021). For this 5-year assessment, all-cause mortality, functional status, and occurrence of major adverse cardiac and cerebrovascular events were studied. Ultimately, there was no difference between groups in terms of 5-year mortality; in patients who received pVADs, 5-year mortality was 50% (12/24) and 63% (15/24) in patients who received IABP (RR, 0.87; 95% CI, 0.47 to 1.59; p=.65). Major adverse cardiac and cerebrovascular events, including death, myocardial re-infarction, repeat PCI, coronary artery bypass grafting, and stroke, occurred in 50% of the patients who received pVAD versus 79% of the IABP patients (p=.07). All survivors except for 1 were NYHA class I or II (pVAD n=10 [91%] and IABP n=7 [100%]; p=1.0) and no patients had residual angina. There were no differences in left ventricular ejection fraction between the 2 groups, supporting previously published data from the original IMPRESS trial.
Since the 2017 guideline update by the American College of Cardiology Foundation, American Heart Association (AHA), and Heart Failure Society of American, these guidelines have been updated regularly, with the most recent update occurring in 2022 (Heidenreich, 2022). Below is a list of recommendations on MCS devices from the most recently updated guideline iteration. class IIA guidelines on MCS devices.
AHA/ACC/HFSA Guidelines on Mechanical Circulatory Support
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Mehra et al reported 5-year observational outcomes from the MOMENTUM 3 study comparing the HeartMate 3 centrifugal continuous-flow device with the HeartMate II axial continuous-flow device (Mehra, 2022). The per-protocol population initially included in the MOMENTUM 3 RCT was 1020 patients. A total of 477 patients of 536 patients still receiving LVAD support at 2 years contributed to the extended-phase analysis. At 5 years, 141 patients in the HeartMate 3 group and 85 in the HeartMate II group had completed follow-up. The composite of 5-year survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump occurred in336/515 patients (65.2%) in the HeartMate 3 group versus 240/505 patients (47.5%) in the HeartMate II group. The Kaplan-Meier estimates of event-free survival at 5 years were 54% in the HeartMate 3 group and 29.7% in the HeartMate II group (HR, 0.55; 95% CI, 0.45 to 0.67; p<.001). The overall survival rates were 58.4% in the HeartMate 3 group and 43.7% in the HeartMate II group (HR, 0.72; 95% CI, 0.58 to 0.89; p=.003). In a post-hoc analysis, there were consistent survival findings in the destination therapy-specific subgroup, with a 5-year survival rate of 54.8% in the HeartMate 3 group and 39.4% in the HeartMate II group (HR, 0.70; 95% CI, 0.55 to 0.90; p=.005).Rates for device thrombosis (0.010 vs 0.108 events/patient-years), stroke (0.050 vs 0.136 events/patient-years), and bleeding (0.430 vs 0.765 events/patient-years) were significantly lower in the HeartMate 3 group compared to the HeartMate II group over 5 years, respectively. Infection, cardiac arrhythmias, and right ventricular failure were similar between groups. These 5-year outcomes demonstrate that the HeartMate 3 was associated with a better composite outcome and a higher likelihood of survival at 5years.
The International Society for Heart and Lung Transplantation (ISHLT) and the Heart Failure Society of America (HFSA) released a guideline on acute MCS in 2023 (Bernhardt, 2023). The guideline focuses on timing, patient, and device selection of acute MCS, and periprocedural and postprocedural care for cardiogenic and pulmonary shock. They provide specific recommendations depending on which MCS device is chosen. Below summarizes relevant recommendations for timing of acute MCS made in the guidelines. Additional recommendations related to specific devices is related to procedural considerations.
ISHLT/HFSA Guideline on Acute MCS
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