Medical Policy

Policy Num:       02.002.003
Policy Name:    Total Artificial Hearts and Implantable Ventricular Assist Devices
Policy ID:          [02.002.003]  [Ac / B / M+ / P-]  [7.03.11]

Last Review:      September 18, 2024
Next Review:      September 20, 2025
 

Related Policies:

07.003.009 - Heart/Lung Transplant
07.003.007 - Heart Transplant
08.001.039 - Extracorporeal Membrane Oxygenation for Adult Conditions

Total Artificial Hearts and Implantable Ventricular Assist Devices

summary

Description

A ventricular assist device (VAD) is 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. The VAD has also been used as a bridge to recovery in patients with reversible conditions affecting cardiac output.

Summary of Evidence

Ventricular Assist Device

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

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

Total Artificial Heart

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

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

Percutaneous Ventricular Assist Device

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

For individuals who undergo high-risk cardiac procedures who receive a pVAD, the evidence includes RCTs, observational studies, and systematic reviews of these trials. Relevant outcomes are OS, symptoms, morbid events, functional outcomes, QOL, and treatment-related mortality and morbidity. Randomized controlled trials, controlled and uncontrolled observational studies, and systematic reviews of these studies have not demonstrated a benefit of pVAD used as ancillary support for patients undergoing high-risk cardiac procedures. Additionally, 2 nonrandomized studies have compared ventricular tachycardia (VT) ablation with pVAD or IABP. Both studies demonstrated that patients who had pVAD support spent less time in unstable VT than patients without pVAD support. However, the current evidence does not support conclusions about the use of pVAD for VT ablation. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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

Additional Information

Not applicable.

OBJECTIVE

The objective of this evidence review is to determine whether ventricular assist devices and total artificial hearts improve the net health outcome in individuals with end-stage heart failure or cardiogenic shock.

POLICY statement

Destination Therapy

Implantable ventricular assist devices (VADs) with U.S. Food and Drug Administration (FDA) approval or clearance may be considered medically necessary as destination therapy for adult individuals with end-stage heart failure who meet the following criteria:

• New York Heart Association (NYHA) Class III heart failure with dyspnea upon mild physical activity or NYHA Class IV;

• Left ventricular ejection fraction ≤25%;

• Inotrope-dependent; OR cardiac index <2.2 liters/min/m², while not on inotropes and also meeting one of the following:

  • On optimal medical management, based on current heart failure practice guidelines for at least 45 of the last 60 days and are failing to respond, OR

  • Advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for ≥7 days.

Bridge to Transplantation

Implantable VADs with FDA approval or clearance may be considered medically necessary as a bridge to heart transplantation for individuals 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 VADs 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 (TAHs) with FDA approved devices may be considered medically necessaryas a bridge to heart transplantation for individuals with biventricular failure who:

• Have no other reasonable medical or surgical treatment options, are ineligible for other univentricular or biventricular support devices, and are currently listed as heart transplantation candidates, OR

• Have no other reasonable medical or surgical treatment options, are ineligible for other univentricular or biventricular support devices, are undergoing evaluation to determine candidacy for heart transplantation, and not expected to survive until a donor heart can be obtained.

Postcardiotomy Setting/Bridge to Recovery

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

Other Indications

Other applications of implantable ventricular assist devices (VADs) or total artificial hearts (TAHs) are considered investigational, including, but not limited to, the use of TAHs as destination therapy. The use of non-FDA-approved or cleared implantable VADs or TAHs is considered investigational.

Percutaneous VADs are considered investigational for all indications.

POLICY GUIDELINES

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

Some ventricular assist devices (VADs) have approval from the U.S. Food and Drug Administration (FDA) for the pediatric population. The DeBakey® VAD Child device and the Berlin Heart EXCOR Pediatric VAD have FDA approval through the humanitarian device exemption process. The DeBakey VAD is indicated for use in children ages 5 to 16 years who are awaiting a heart transplant (ie, 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. The HeartMate3™ received approval for expanded approval for pediatric patients with advanced refractory left ventricular heart failure in 2020.

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

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

Contraindications for bridge to transplant VADs and total artificial hearts include conditions that would generally exclude individuals for heart transplant. Such conditions are chronic irreversible hepatic, renal, or respiratory failure; systemic infection; coagulation disorders, and inadequate psychosocial support. Due to potential problems with adequate function of the VAD or total artificial heart, implantation is also contraindicated in individuals with uncorrected valvular disease. See evidence review 7.03.09 (heart transplantation) for further discussion of heart transplant candidacy.

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

The team must include, at a minimum:

• At least 1 physician with cardiothoracic surgery privileges and individual experience implanting at least 10 durable, intracorporeal, left ventricular assist devices over the course of the previous 36 months with activity in the last year.

• At least 1 cardiologist trained in advanced heart failure with clinical competence in medical- and device-based management including VADs, and clinical competence in the management of patients before and after placement of a VAD.

• A VAD program coordinator.

• A social worker.

• A palliative care specialist.”

Coding

See the Codes table for details.

BENEFIT APPLICATION

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

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

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BACKGROUND

Heart Failure

According to a 2024 report from the American Heart Association and based on data collected from 2017 to 2020 , roughly 6.7 million Americans ages 20 years or older had heart failure during that time frame.^1, 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).^2, Similar findings were demonstrated in the Atherosclerosis Risk in Communities (ARIC) Community Surveillance data, in which Black men and women had the highest burden of new-onset heart failure cases and the highest-age adjusted 30-day case fatality rate in comparison to White men and women. Higher risk reflected differential prevalence of hypertension, diabetes, and low socio-economic status.

Heart failure may be the consequence of a number of etiologies, including ischemic heart disease, cardiomyopathy, congenital heart defects, or rejection of a heart transplant. The reduction of cardiac output is considered to be severe when systemic circulation cannot meet the body's needs under minimal exertion. Heart transplantation improves quality of life and had a reported survival rate of nearly 92% or transplants performed in 2022.^3, The number of candidates for transplants exceeds the supply of donor organs; thus the interest in 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) 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-safety/medical-device-recalls.

Ventricular Assist Devices

Implantable VADs 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. VADs 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 use a pump, which provides continuous flow. Continuous devices may move blood in a rotary or axial flow.

Surgically implanted VADs represent a method of providing mechanical circulatory support for patients not expected to survive until a donor heart becomes available for transplant or for whom transplantation is contraindicated or unavailable. VADs 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 the left ventricle, a pulmonary artery for the right ventricle). A small portion of the 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.

Table 1 lists the 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. The HeartMate II and HeartMate 3 left VAD systems were recalled in April 2024 due to extrinsic outflow graft obstruction that can obstruct the device making it less effective. The recall was a corrective recall, and the devices remain on the market.^4,

Table 1. Available Ventricular Assist Devices

FDA: U.S. Food and Drug Administration; HDE: humanitarian device exemption; PMA: premarket approval; VAD: ventricular assist device.

Total Artificial Heart

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

Currently the Syncardia Temporary Total Artificial Heart (Syncardia Systems) is the only Total Artificial Heart available in the US (Table 2). The AbioCor Total Artificial Heart was FDA approved under the Humanitarian Device Exemption program in 2006, but is no longer being marketed or in development.

Table 2. Available Total Artificial Heart

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

Percutaneous Ventricular Assist Devices

Some circulatory assist devices are placed percutaneously (i.e., are not implanted). They may be referred to as percutaneous VADs (pVADs). Two different pVADs have been developed, the TandemHeart and the Impella device (Table 3). In the TandemHeart System, a catheter is introduced through the femoral vein and passed into the left atrium via transseptal puncture. Oxygenated blood is then pumped from the left atrium into the arterial system via the femoral artery. The Impella device is introduced through a femoral artery catheter. In this device, a small pump is contained within the catheter 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, stroke, and arrhythmias.

Table 3. Available Percutaneous Ventricular Assist Devices

FDA: U.S. Food and Drug Administration; PCI: percutaneous coronary intervention; PMA: premarket approval.

RATIONALE

This evidence review was created in November 1996 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through June 24, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

This literature review assesses 3 devices: (1) ventricular assist devices (VADs), (2) total artificial hearts (TAHs), and (3) percutaneous VADs (pVADs). This review addresses the short-term use of the devices as a bridge to recovery or transplantation. Left VADs (LVADs) and TAHs are also evaluated as longer-term destination therapies for patients who are not transplant candidates.

Population Reference No. 1 & 2 

Ventricular Assist Devices

Clinical Context and Therapy Purpose

The purpose of VADs in individuals who have end-stage heart failure is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with end-stage heart failure.

Interventions

The therapy being considered is a VAD.

There are 4 categories of use for VADs. However, these categories may overlap, as the intent of using a VAD may evolve over the course of treatment. Recently the concept of short and long term mechanical circulatory support has been used to describe the overlap across these indications.

• Bridge to transplant: Use of a VAD to sustain life until a donor heart becomes available.

• Destination therapy: Permanent use of the device, typically for patients ineligible for transplantation.

• Bridge to recovery: Use of a VAD results in restoration of myocardial function, sufficient that heart transplant is not needed.

• Bridge to decision: Use of a VAD in an attempt to reverse secondary organ dysfunction that is a contraindication to transplant. However, these cases are often characterized as destination therapy rather than bridge to decision.

Comparators

The comparator of interest is optimal medical management, including use of an intra-aortic balloon pump when indicated.

Outcomes

The general outcomes of interest are overall survival (OS), survival to transplant, transplant outcomes, device malfunction or replacement, infection, and QOL.

Time-to-transplant is of interest as a short-term outcome ranging from 30 days to 1 year.

When VAD is used as destination therapy, the time of interest ranges from 6 months to 2 years following implantation.

Study Selection Criteria

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow up and/or larger populations were sought.

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample size studies and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Ventricular Assist Devices as Bridge to Heart Transplant in Adults

The insertion of a VAD will categorize its recipient as a high-priority heart transplant candidate. The available evidence on the efficacy of VADs in bridging patients with refractory heart failure to transplant includes single-arm series, which generally have reported high success rates in bridging to transplant.

Systematic Reviews

Older systematic reviews concluded that VADs can provide an effective bridge to transplantation.^5,6,

Randomized Controlled Trial

The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) trial compared HeartMate 3 centrifugal continuous-flow device with the HeartMate II axial continuous-flow device in patients indicated for circulatory support as a bridge to transplant or destination therapy; inclusion criteria included: 1) New York Heart Association (NYHA) Class III heart failure with dyspnea upon mild physical activity or NYHA Class IV; 1) left ventricular ejection fraction ≤ 25%; 3) inotrope-dependent OR cardiac index < 2.2 liters/min/m² while not on inotropes plus on optimal medical management for at least 45 of the last 60 days and failing to respond or with advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for ≥7 days. HeartMate 3 received premarket approval (PMA) as a bridge to transplant therapy in August 2017 and as destination therapy in October 2018. 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 (relative risk [RR], 0.84; 95% confidence interval [CI], 0.78 to 0.91, p<.001).^7, Prevalence of stroke at 2 years was lower in the HeartMate 3 than the HeartMate II group (10.1% vs 19.2%; p=.02).^8, Measures of functional capacity and Health-Related QOL did not differ between the 2 devices at 6 months.^9,

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. ^10,

Nonrandomized Studies

Slaughter et al (2013) reported combined outcomes for patients included in the HeartWare bridge to transplant study and a continued-access protocol granted by the U.S. Food and Drug Administration (FDA). ^11, The study included 322 patients with heart failure, eligible for a heart transplant, who received the HeartWare (140 patients from the original study; 190 patients in the continue-access protocol who were monitored to the outcome or had completed 180-day follow-up at the time of analysis). Survival rates at 60, 180, and 360 days were 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 QOL measures. (Note: 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 LVADs.)

Strueber et al (2011) published a case series of 50 patients awaiting heart transplantation treated with HeartWare Ventricular Assist System, which is a smaller, continuous-flow centrifugal device implanted in the pericardial space.^12, Patients were followed until transplantation, myocardial recovery, device explant, or death. The median duration of time on the VAD was 322 days. Nine patients died: 3 from sepsis, 3 from multiple organ failure, and 4 from hemorrhagic stroke. At the end of follow-up, 20 (40%) patients had undergone transplant, 4 (8%) had had the pump explanted, and the remaining 17 (34%) continued on pump support. The most common complications were infection and bleeding: 21 (42%) patients had infections, 5 (10%) had sepsis, while 15 (30%) patients had bleeding complications, 10 (20%) of whom required surgery. (Note: 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 LVADs.)

Aaronson et al (2012) reported on results of a multicenter, prospective study of the HeartWare device.^13, The study enrolled 140 patients awaiting heart transplantation who underwent HeartWare implantation. A control group of 499 subjects comprised patients drawn from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database, which collects data on patients who receive FDA approved durable mechanical circulatory support (MCS) 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, functional status, QOL, and adverse event outcomes in the HeartWare group. Success on the primary outcome occurred in 90.7% of the HeartWare group and 90.1% of controls (p<.001, noninferiority with a 15% margin). Serious adverse events in the HeartWare group included, most commonly, bleeding, infections, and perioperative right heart failure. (Note: 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 LVADs.)

In 5 reports published from 2007 to 2008, with sample sizes ranging from 32 to 279 patients, most participants received the continuous-flow device as a bridge to transplantation.^{14,15,16,17,18,} Survival rates at 6 months ranged between 67% and 87%, and between 50% and 80% at 1 year. These rates were similar to those reported from the INTERMACS registry.^19, A study by Patel et al (2008) compared HeartMate I with HeartMate II recipients at a single-center, finding similar rates of 1 year survival and subsequent development of right heart failure.^17, Serious adverse events occurring after HeartMate II implantation included bleeding episodes requiring reoperation, stroke, infection, and device failure.

Aissaoui et al (2018) published an observational study comparing 224 patients in Germany and France with end-stage heart failure who received a VAD (group I, n=83) or heart transplantation or medical therapy as first treatment options (group II, n=141).^20, The estimated 2-year survival was 44% for group I and 70% for group II (p<.001).

Reports from registries of patients who received the HeartMate 3 device have been published recently. Schmitto et al (2019) reported 2-year outcomes in 50 patients who received the device as a bridge to transplant.^21, Survival rates at 6 months, 1 year, and 2 years were 92%, 81%, and 74%, respectively, and the total stroke rate over 2 years was 24%. Gustafsson et al (2018) reported 6-month outcomes of 482 patients; 66% of patients received the VAD as a bridge to transplant, 26% as destination therapy, 2% as a bridge to recovery, and 6% as a bridge to transplant candidacy or decision. Results were not separately reported by indication.^22, The 6-month survival rate was 82% (95% CI, 79% to 85%). Three patients received a transplant. The incidence of stroke was 6.1%. 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 follow-up through December 2019.^23, 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 (HR) 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) and for the HeartMate 3 versus other-VADs was 0.51 (95% CI, 0.42 to 0.63; p<.0001).

Additionally, 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.^24, Full results are described below.

Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure in Adults

Systematic Reviews

The evaluation of VADs as destination therapy was informed by a TEC Assessment (2002) that offered the following observations and conclusions^25,:

• The available evidence comes from a single, well-designed and rigorously conducted randomized trial, Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure, known as the REMATCH study.^26, The trial was a cooperative effort of Thoratec, Columbia University, and the National Institutes of Health.

• The trial found that patients with end-stage heart failure who are not candidates for cardiac transplantation had 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 they appear to be outweighed by this group's better outcomes on function; New York Heart Association functional class was significantly improved, as was the QOL among those living to 12 months.

• VAD patients spent a greater relative proportion of time inside the hospital than medical management patients did but the survival advantage would mean a longer absolute time outside the hospital.

Park et al (2005) published reports on the extended 2-year follow-up of patients from the REMATCH trial, which found that survival and QOL benefits were still apparent.^27,28, In addition, their reports and other case series have suggested continuing improvement in outcomes related to ongoing improvements in the device and patient management. However, the durability of the HeartMate device used in the REMATCH trial was a concern (eg, at a participating institution, all 6 long-term survivors required device change-outs).

Randomized Controlled Trials

The MOMENTUM 3 trial compared HeartMate 3 centrifugal continuous-flow device with the HeartMate II axial continuous-flow device in patients indicated for circulatory support as a bridge to transplant or destination therapy; inclusion criteria included 1) NYHA Class III heart failure with dyspnea upon mild physical activity or NYHA Class IV; 1) left ventricular ejection fraction ≤25%; 3) inotrope-dependent OR cardiac index <2.2 liters/min/m² while not on inotropes plus on optimal medical management for at least 45 of the last 60 days and failing to respond or with advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for ≥7 days. HeartMate 3 received PMA approval as a bridge to transplant therapy in August 2017 and as destination therapy in October 2018. 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 to 0.91, p<.001).^7, Prevalence of stroke at 2 years was lower in the HeartMate 3 than the HeartMate 2 group (10.1% vs 19.2%; p=.02).^8, Measures of functional capacity and Health-Related QOL did not differ between the 2 devices at 6 months.^9,

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. Additionally, nearly 15% of those initially deemed transplant ineligible were eventually transplanted within 2 years of follow-up, supporting that clinical categorizations based on transplant eligibility should no longer be used.^10,

The ENDURANCE trial compared the HeartWare centrifugal continuous-flow device with the HeartMate II axial continuous-flow device in patients indicated for circulatory support as destination therapy.^29, Both trials found the centrifugal device to be noninferior to the axial device for the primary, composite outcome including measures of survival, freedom from disabling stroke, and freedom from device failure. While there are fewer device failures with the centrifugal devices without a significant increase in disabling stroke, the HeartWare device was associated with increased risk of any stroke over a period of 2 years. (Note: 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 LVADs.)

Nonrandomized Studies

A prospective observational study called the Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP) study, reported by Estep et al (2015), compared LVAD support (n=97) with optimal medical therapy (n=103) for patients with heart failure not requiring inotropes and found superior survival and health-related QOL in LVAD-treated patients.^30, Twelve-month, as-treated, event-free actutimes survival was 80% in the LVAD group and 63% in the best medical therapy group (p=.022). Two-year results were reported by Starling et al (2017).^31, At the end of 2 years, 35 (34%) medical therapy patients and 60 (62%) LVAD patients were alive on their original therapy; 23 medical management patients received LVADs during the 2 years. The LVAD-treated patients continued to have higher as-treated, event-free actutimes survival (70% vs 41%, p<.001), although there was no statistical difference in intention-to-treat survival (70% vs 63%, p=.31).

In an FDA required, post-approval study of the HeartMate II device for destination therapy,^32, which included the first 247 HeartMate II patients identified as eligible for the device as destination therapy, Jorde et al (2014) found that outcomes and adverse events did not differ significantly from those of the original trial, which compared patients who received the HeartMate II with earlier-generation devices. Survival rates in the post-approval cohort were 82% and 69% at 1 and 2 years postoperatively, respectively.

After the release of the REMATCH trial results, Rogers et al (2007) published results from a prospective, nonrandomized trial comparing LVAD as destination therapy with optimal medical therapy for patients with heart failure who were not candidates for a heart transplant.^33, Fifty-five patients who had NYHA functional class IV symptoms and who failed to wean from inotropic support were offered a Novacor LVAD; 18 did not receive a device due to preference or device unavailability and served as a control group. The LVAD-treated patients had superior survival rates at 6 months (46% vs 22%; p=.03) and 12 months (27% vs 11%; p=.02), along with fewer adverse events.

Arnold et al (2016) analyzed 1638 patients receiving LVADs as destination therapy between May 2012 and September 2013.^34, Results were selected from the INTERMACS registry and assessed for poor outcomes. Poor outcome was defined as death or mean Kansas City Cardiomyopathy Questionnaire overall score less than 45 throughout the year after implantation. Analyses included inverse probability weighting to adjust for missing data. About 22.4% of patients died within the first year after implantation, and an additional 7.3% had persistently poor QOL; 29.7% met the definition of poor outcome. Poor outcomes were more common in those patients having higher body mass indices, lower hemoglobin levels, previous cardiac surgery, history of cancer, severe diabetes, and poorer QOL preimplant.

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.^24, 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.

Mehra et al (2022) 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.^35, 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 in 336/515 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 5 years.

Ventricular Assist Devices as Bridge to Recovery in Adults

Nonrandomized Studies

VADs may have a role in bridging patients to recovery, particularly if there is reverse remodeling of the left ventricle. Several studies have investigated the role of VADs in bridging patients to decision for transplant eligibility. One clearly defined population in which the potential for myocardial recovery exists is in the postcardiotomy setting.

Acharya et al (2016) reported on patients who underwent VAD placement for acute myocardial infarction (AMI) who were enrolled in the INTERMACS registry, a prospective national registry of FDA approved durable MCS devices.^36, 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 were 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.

Two additional 2016 publications from the INTERMACS registry reported on cardiac recovery in patients implanted with LVADs. Wever-Pinzon et al (2016) included adults registered between March 2006 and June 2015 excluding those who had a right VAD only, TAH, or prior heart transplant (N=15,138).^37, One hundred twenty-five of these patients had an a priori bridge to recovery LVAD strategy. Cardiac recovery occurred in 192 (1.3%) of the LVAD patients overall and in 14 (11.2%) of the bridge to recovery patients. Topkara et al (2016) reported a similar analysis of 13,454 INTERMACS adults with implants between June 2006 and June 2015 without TAH or pulsatile-flow LVAD or heart transplant.^38, Device explant rates for cardiac recovery were 0.9% at 1-year, 1.9% at 2-year, and 3.1% at 3-year follow-up. An additional 9% of patients demonstrated partial cardiac recovery.

In a prospective multicenter study to assess myocardial recovery in patients with LVAD implantation as a bridge to transplant, Maybaum et al (2007) evaluated 67 patients with heart failure who had LVAD implantation for severe heart failure.^39, After 30 days, patients demonstrated significant improvements compared with their pre-LVAD state in left ventricular ejection fraction (17.1% vs 34.12%, p<.001), left ventricular end-diastolic diameter (7.1 cm vs 5.1 cm, p<.001), and left ventricular mass (320 g vs 194 g, p<.001), respectively. However, only 9% of patients recovered sufficiently to have their LVAD explanted.

Agrawal et al (2018) conducted a retrospective cohort study evaluating the 30-day readmissions of 2510 patients undergoing LVAD implantation.^40, 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.

Ventricular Assist Devices in Pediatric Patients

The FDA-approved EXCOR Pediatric VAD is available for use as a bridge to cardiac transplant in children. The FDA approval was based on data from children who were part of the initial clinical studies of this device.^41, Publications have reported positive outcomes for children using VADs as a bridge to transplantation.

Comparative Studies

Bulic et al (2017) 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).^42, 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<.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=.04).

Wehman et al (2016) reported on posttransplant survival outcomes for pediatric patients who received a VAD, extracorporeal membrane oxygenation (ECMO), or no MCS, in the pretransplant period.^43, 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 actutimes 5-year survival rate 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 posttransplant, ECMO bridging was significantly associated with a higher risk of death (adjusted HR, 2.77 vs direct-to-transplant; 95% CI, 2.12 to 3.61; p<.001). However, a model to predict time to death excluding deaths in the first 4 months posttransplant, the bridging group was not significantly associated with risk of death.

Fraser et al (2012) evaluated the EXCOR device among 48 children, ages 16 or younger, with 2-ventricle circulation who had severe heart failure, despite optimized treatment, and were listed for a heart transplant.^44, Patients were divided into 2 groups based on body surface area; a historical control group of children receiving circulatory support with ECMO from the Extracorporeal Life Support Organization registry were 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<.001). For participants in cohort 2 (body surface area range, 0.7 to <1.5 m²), the median survival was 144 days compared with 10 days in the matched ECMO group (p<.001). Rates of adverse events were high in both EXCOR device cohorts, including major bleeding (cohort 1, 42%; cohort 2, 50%), infection (cohort 1, 63%; cohort 2, 50%), and stroke (29% of both cohorts).

Noncomparative Studies

Blume et al (2016) published the first analysis of the Pediatric Interagency Registry for Mechanical Circulatory Support, which is a prospective, multicenter registry that collects data on patients who are under age 19 years at the time of implant, and includes those implanted with either durable or temporary VADs.^45, At analysis, the registry included 241 patients; of them, 41 were implanted with a temporary device only, leaving 200 patients implanted with VADs for this study. Most patients (73%) had an underlying diagnosis of cardiomyopathy. At the time of implantation, 64% were listed for transplant, while 29% were implanted with a "bridge to candidacy" strategy. A total of 7% were implanted with a destination therapy strategy. Actutimes survival at both 6 months and 1 year was 81%. By 6 months, 58% of patients had received transplants.

Almond et al (2013) reported results from a prospective, multicenter registry to evaluate outcomes in children who received the EXCOR device as a bridge to transplant.^46, This study included a broader patient population than the Fraser et al (2012) study (discussed above). All patients were followed 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 the patient survived 30 days), and 5% who were alive with the device in place. In a follow-up study that evaluated 204 children from the same registry, Jordan et al (2015) reported relatively high rates of neurologic events in pediatric patients treated with the EXCOR device (29% of patients), typically early in the course of device use.^47,

Chen et al (2016) reported on a retrospective, single-center series of pediatric patients with continuous-flow VADs, with a focus on outpatient experiences.^48, The series included 17 children implanted with an intracorporeal device from 2010 to 2014. Eight (47%) patients were discharged after a median postimplant hospitalization duration 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 had been transferred or died.

Another retrospective, single-center series of pediatric patients, conducted by Conway et al (2016), reported on outcomes with short-term continuous-flow VADs, including the Thoratec, PediMag, CentriMag, or the Maquet RotaFlow.^49, From 2005 to 2014, 27 children were supported with 1 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) led to hospital discharge.

Effects of Pretransplant Ventricular Assist Devices on Transplant Outcomes

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 posttransplant survival, thus improving the use of donor hearts.^13,50,51,52, A systematic review by Alba et al (2011) examined the evidence on the effect of VADs on posttransplant outcomes.^53, Reviewers included 31 observational studies that compared transplant outcomes in patients who did and did not have pretransplant VAD. Survival at 1 year was more likely in patients who had VAD treatment, but this benefit was specific to patients who received an intracorporeal device (RR, 1.8; 95% CI, 1.53 to 2.13). For patients treated with an extracorporeal device, the likelihood of survival did not differ from patients not treated with a VAD (RR, 1.08; 95% CI, 0.95 to 1.22). There was no difference in the risk of rejection rates between patients who did and did not receive LVAD treatment.

Deo et al (2014) reported no significant differences in outcomes for 37 bridge to transplant patients with a VAD and 70 patients who underwent a heart transplant directly.^54, Data from the United Network for Organ Sharing Network, reported by Grimm et al (2016), suggested that patients bridged to transplant with an LVAD have better outcomes than those bridged with TAHs or biventricular assist devices.^55, Using the United Network for Organ Sharing database, Davies et al (2008) reported on the use of VADs in pediatric patients undergoing heart transplantation.^56, Their analysis concluded that pediatric patients requiring a pretransplantation VAD have long-term survival similar to those not receiving MCS.

Section Summary: Ventricular Assist Devices

In adults, the evidence on the efficacy of VADs as a bridge to transplant consists of controlled trials comparing different VADs, uncontrolled trials, registry studies, and case series.

The highest-quality evidence on the efficacy of LVADs as destination therapy in patients who are not transplant candidates is the REMATCH trial. This multicenter RCT reported that the use of LVADs led to improvements in survival, QOL, and functional status. A more recent trial comparing VADs has broader inclusion criteria and supports that criteria move away from use of transplant ineligibility, as treatment may evolve over the course of treatment. This evidence supports that health outcomes are improved with LVADs in this patient population.

Questions remain about defining and identifying the population most likely to experience cardiac recovery with VAD placement. One clearly defined population in which the potential for myocardial recovery exists is in the postcardiotomy setting. The current evidence is insufficient to identify other heart failure patient populations that might benefit from the use of an LVAD as a specific bridge to recovery treatment strategy.

The evidence in children, mainly from registry studies, demonstrates the effectiveness of pediatric devices as a bridge to heart transplant.

Summary of Evidence

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

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

Population Reference No. 3 & 4

Total Artificial Heart

Clinical Context and Therapy Purpose

The purpose of a TAH in individuals who have end-stage heart failure is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with end-stage heart failure.

Interventions

The therapy being considered is a TAH used as a bridge to heart transplant or as destination therapy.

Comparators

The comparator of interest is optimal medical therapy without a TAH.

Outcomes

The general outcomes of interest are OS, survival to transplant, transplant outcomes, device malfunction or replacement, infection, and quality of life.

Time-to-transplant is of interest as the short-term outcome ranging from 30 days to 1 year.

When TAH is used as destination therapy, the time of interest ranges from 6 months to 2 years following implantation.

Study Selection Criteria

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow up and/or larger populations were sought.

• Consistent with a best available evidence approach, within each category of study design, studies with larger sample size studies and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Total Artificial Heart as a Bridge to Transplant for End-Stage Heart Failure

Nonrandomized Studies

The FDA approval of the CardioWest TAH was based on the results of a nonrandomized, prospective study of 81 patients.^57, Patients had failed inotropic therapy, had a biventricular failure, and thus were not considered appropriate candidates for an LVAD. Of the patients included, 88% were male. Race and ethnicity were not described. The rate of survival to transplant was 79%, which was considered comparable with 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.

Case series have been reported on outcomes for the TAH as a bridge to transplant. For example, Copeland et al (2012) reported on 101 patients treated with the SynCardia artificial heart as a bridge to transplant.^58, All patients either met established criteria for MCS or were failing medical therapy on multiple inotropic drugs. Mean support time was 87 days (range, 1 to 441 days). The rate of survival to transplant was 68.3% (69/101). Of the 32 deaths before the transplant, 13 were due to multiorgan failure, 6 were due to pulmonary failure, and 4 were due to neurologic injury. Survival rates after transplant at 1, 5, and 10 years, respectively, were 76.8%, 60.5%, and 41.2%.

Total Artificial Heart as Destination Therapy for End-Stage Heart Failure

Case Series

Data on the artificial heart are available from the FDA approval information^59, and from a published article describing results for the first 7 patients.^60, The FDA indicated that its decision on the AbioCor implantable heart was based on the manufacturer's (Abiomed) laboratory and animal testing and on a small clinical study of 14 patients conducted by Abiomed. Study participants had a 1-month survival prognosis of not more than 30%, were ineligible for cardiac transplants, and were not projected to benefit from VAD therapy. The study showed that the device was safe and likely to benefit people with severe heart failure whose death was imminent and for whom no alternative treatments were available. Of the 14 patients studied, 12 survived the 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. No device-related infections were reported.

Torregrossa et al (2014) reported on 47 patients who received a TAH at 10 worldwide centers and had the device implanted for more than 1 year.^61, Patients were implanted for dilated cardiomyopathy (n=23), ischemic cardiomyopathy (n=15), and "other" reasons (n=9). Over a median support time of 554 days (range, 365 to 1373 days), 34 (72%) patients were successfully transplanted, 12 (24%) patients died while on device support, and 1 (2%) patient was still supported. Device failure occurred in 5 (10%) patients. Major complications were common, including systemic infection in 25 (53%) patients, driveline infections in 13 (27%) patients, thromboembolic events in 9 (19%) patients, and hemorrhagic events in 7 (14%) patients. Two of the deaths occurred secondary to device failure.

Section Summary: Total Artificial Heart

There is less evidence on the use of TAH as a bridge to transplant compared with the use of LVADs. The type of evidence on a bridge to transplant is similar to that for LVADs (ie, case series reporting substantial survival rates in patients without other alternatives). Therefore, similar to LVADs, this evidence is sufficient to conclude that TAH improves outcomes for these patients and TAH is a reasonable alternative for patients who require a bridge to transplantation but who are ineligible for other types of life-prolonging support devices.

There is less evidence on the use of TAH as destination therapy compared with the use of LVADs. Although TAHs show promise as destination therapy in patients who have no other treatment options, the available data on their use is extremely limited. Currently, the evidence base is insufficient to support conclusions about TAH efficacy in this setting.

Summary of Evidence

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

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

Population Reference No. 5 

Percutaneous Ventricular Assist Devices for Cardiogenic Shock

Clinical Context and Therapy Purpose

The purpose of percutaneous ventricular assist devices (pVADs) in individuals who have cardiogenic shock is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest are individuals with cardiogenic shock.

Interventions

The therapy being considered is pVADs.

Comparators

The comparator of interest is intra-aortic balloon pump (IABP).

Outcomes

The general outcomes of interest are OS, device malfunction, heart failure, respiratory dysfunction, arrhythmias, and infection.

Timing of interest ranges from perioperative events to 30-day mortality outcomes.

Study Selection Criteria

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow up and/or larger populations were sought.

• Consistent with a best available evidence approach, within each category of study design, studies with larger sample size studies and longer duration were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Romeo et al (2016) reported on a systematic review and meta-analysis that evaluated various percutaneous mechanical support methods, including pVADs, for patients with cardiogenic shock due to AMI who were undergoing revascularization (Tables 4 and 5).^62, Reviewers included 3 RCTs (described below) comparing pVADs with IABPs, along with 3 comparative observational studies. A major limitation noted by the review authors was the small sample size of the RCTs. Observational studies were included in meta-analyses, with subgroup analyses by study design reported (see Table 4). In the comparison of pVADs with IABP, reviewers found that in-hospital mortality (the primary outcome of the analysis) had a nonsignificant increase in the pVAD group. Subgroup analysis did not find significant differences in estimates from RCTs and observational studies, and CIs overlapped. There was no significant heterogeneity within RCTs or observational studies. The relative risk reduction was -17.23%, translating to 8 more deaths per every 100 patients treated with pVADs instead of IABP.

Table 4. Characteristics of a Systematic Review Evaluating pVADs vs IABPs for Cardiogenic Shock

IABP: intra-aortic balloon pump; pVAD: percutaneous ventricular assist device; RCT: randomized controlled trial.

Table 5. Results of a Systematic Review Evaluating pVADs vs IABPs for Cardiogenic Shock

CI: confidence interval; IABP: intra-aortic balloon pump; N: sample size; NNH: number needed to harm; pVAD: percutaneous ventricular assist device; RCT: randomized controlled trial.

Randomized Controlled Trials

A total of 4 RCTs have compared pVADs with IABPs for patients who had cardiogenic shock; 3 were included in the Romeo et al (2016) systematic review described above^63,64,65, and 1 was published after Romeo et al (2016).^66, The 4 RCTs enrolled a total of 148 patients, 77 treated with a pVAD and 71 treated with an IABP. All 4 trial populations included patients with AMI and cardiovascular shock; 1 trial restricted its population to patients who were post-revascularization in the AMI setting. The primary outcomes reported were 30-day mortality, hemodynamic measures of left ventricle pump function, and adverse events. The trials are summarized in Tables 6 and 7. Some trials reported improvements in hemodynamic and metabolic parameters but none found any reductions in 30-day mortality. The IMPella versus IABP Reduces mortality in STEMI patients treated with primary percutaneous coronary intervention (PCI) in Severe cardiogenic SHOCK (IMPRESS) trial reported 6-month mortality outcomes and also found no difference between groups. Bleeding events and leg ischemia were more common in the pVAD groups.

Table 6. Characteristics of RCTs Evaluating pVADs and IABPs for Cardiogenic Shock

AMI: acute myocardial infarction; CS: cardiogenic shock; IABP: intra-aortic balloon counterpulsation; IMPRESS: IMPella versus IABP Reduces mortality in STEMI patients treated with primary PCI in Severe cardiogenic SHOCK; ISAR-SHOCK: Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock; MI: myocardial infarction; PCI: percutaneous coronary intervention; pVAD: percutaneous ventricular assist device; RCT; randomized controlled trial.

Table 7. Results of RCTs Evaluating pVADs and IABPs for Cardiogenic Shock

CI: confidence interval; HR: hazard ratio; IABP: intra-aortic balloon counterpulsation; IMPRESS: IMPella versus IABP Reduces mortality in STEMI patients treated with primary PCI in Severe cardiogenic SHOCK; ISAR-SHOCK: Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock; pVAD: percutaneous ventricular assist devices; RCT: randomized controlled trial.

Long-term follow-up of the IMPRESS trial outcomes were published by Karami et al (2021).^67, 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.

Nonrandomized Studies

Results of a recent comparative observational study conducted by Schrage et al (2019) were consistent with previous evidence in showing no mortality benefit for pVAD over IABP.^68, 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=.64). Severe or life-threatening bleeding (8.5% vs 3.0%; p<.01) and peripheral vascular complications (9.8% vs 3.8%; p=.01) occurred significantly more often in the Impella group.

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.^{69,70,71,72,73,74,} 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.

Section Summary: Percutaneous Ventricular Assist Devices for Cardiogenic Shock

Four RCTs comparing pVAD with IABP in patients with cardiogenic shock failed to demonstrate a mortality benefit for pVAD use and reported higher complication rates associated with pVAD use. Comparative observational studies and a long-term follow-up study were consistent with the RCT evidence.

Summary of Evidence

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

Population Reference No. 6 

Percutaneous Ventricular Assist Devices for High-Risk Cardiac Procedures

Clinical Context and Therapy Purpose

The purpose of pVADs in individuals who undergo high-risk cardiac procedures is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals undergoing high-risk cardiac procedures.

Interventions

The therapy being considered is pVADs.

Comparators

The comparator of interest is intra-aortic balloon pump (IABP).

Outcomes

The general outcomes of interest are OS, device malfunction, heart failure, respiratory dysfunction, arrhythmias, and infection.

Timing of interest ranges from perioperative events to 30-day mortality outcomes.

Study Selection Criteria

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Consistent with a best available evidence approach, within each category of study design, studies with larger sample size studies and longer duration were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Percutaneous Ventricular Assist Devices as Ancillary Support for High-Risk Percutaneous Coronary Intervention

Systematic Reviews

Two recent systematic reviews have evaluated pVAD as ancillary support for patients undergoing high-risk PCI. Table 8 shows a comparison of the RCTs included in each. Only 1 RCT (PROTECT II) was included in both reviews. In addition to PROTECT II, Ait Ichou et al (2018) included 3 RCTs in patients who received emergent PCI post-MI: IMPRESS, IMPRESS in STEMI, and ISAR-SHOCK. Ait Ichou et al (2018) conducted a systematic review of the Impella device compared to IABP for high-risk patients undergoing PCI (Tables 8 and 9).^75, 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.

Iannaccone et al (2024) conducted direct and network meta-analyses comparing pVAD-supported PCI with either coronary artery bypass grafting (CABG) or PCI without pVAD support in patients with severely reduced ejection fraction.^76, A total of 15 studies were identified (N=17,841; n=2584 treated with PCI with pVAD [Impella]). Only 1 RCT comparing pVAD-supported PCI with PVAD was identified (Table 8). Characteristics and results relevant to pVAD-supported PCI compared with PCI are summarized in Tables 9 and 10, respectively. Results of the network MA identified reduced one-year mortality pVAD-supported PCI compared with CABG (RR, 0.75; 95% CI, 0.59 to 0.94).

Table 8. Comparison of RCTs Included in SRs Evaluating pVAD as Ancillary Support for High-Risk PCI

IMPRESS: IMPella versus IABP Reduces mortality in STEMI patients treated with primary PCI in Severe cardiogenic SHOCK; ISAR-SHOCK: Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock; PCI: percutaneous coronary intervention; pVAD: percutaneous ventricular assist device; RCT: randomized controlled trial; SR: systematic review.

The range of results identified in the controlled and uncontrolled studies as reported by Ait Ichou et al (2018) are summarized in Table 10. The RCTs found similar rates of all-cause mortality between the Impella device and IABP. One RCT reported higher rates among patients randomized to Impella (7.6% vs 5.9%) but the difference was not statistically significant (p=.47). Two of the 3 controlled observational studies found higher 30-day mortality rates in patients receiving Impella but the differences were not statistically significant. There was a reduction in major cardiovascular adverse events at 90 days with the Impella device reported in 1 RCT (odds ratio vs IABP, 0.79; 95% CI, 0.64 to 0.96). Among uncontrolled studies, the rates of all-cause mortality and adverse events were heterogeneous due to differences in study populations and their underlying cardiovascular risk.

Risk of bias assessment determined that 3 of the 4 RCTs were at a low-risk of bias, but they had insufficient power to detect a difference in clinical outcomes. One RCT (IMPRESS in STEMI) was rated as a high-risk of bias due to early termination and widening of inclusion criteria over time. The 2 controlled observational studies had methodological limitations leading to a serious risk of bias, and the other observational studies were at a high-risk of bias due to their uncontrolled study design. After exclusion of low-quality studies, the rates of 30-day mortality, major bleeding, and MI did not change substantially. However, in the group of low-risk of bias studies, the vascular complication rate was higher.

An earlier systematic review and meta-analysis conducted by Briasoulis et al (2016) included studies of both Impella and TandemHeart.^77, Reviewers identified 18 nonrandomized observational studies and a single RCT (PROTECT II).^78,. Results are shown in Table 9. In the observational studies, the sample sizes ranged from 7 to 637 patients. In a pooled analysis of the observational trial data, 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. This meta-analysis did not compare pVAD to IABP or other interventions.

Table 9. Characteristics of SRs Evaluating pVAD as Ancillary Support for High-Risk PCI

EF: ejection fraction; N: sample size; NR: not reported; PCI: percutaneous coronary intervention; pVAD: percutaneous ventricular assist device; RCT: randomized controlled trial; SR: systematic review.

Table 10. Results of SRs Evaluating pVAD as Ancillary Support for High-Risk Percutaneous Coronary Intervention

CI: confidence interval; IABP: intra-aortic balloon pump; IQR: interquartile range; pVAD: percutaneous ventricular assist device; SR: systematic review.

High-Risk Ventricular Tachycardia Ablation

Reddy et al (2014) reported on outcomes for a series of 66 patients enrolled in a prospective, multicenter registry who underwent ventricular tachycardia (VT) ablation with a pVAD or IABP.^80, Twenty-two patients underwent ablation with IABP assistance, while 44 underwent ablation with 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 more unstable VTs that could be mapped and ablated (1.05 vs 0.32; p<.001), more VTs than could be terminated by ablation (1.59 vs 0.91; p=.001), and fewer VTs terminated with rescue shocks (1.9 vs 3.0; p=.049). More pVAD-supported patients could undergo entrainment/activation mapping (82% vs 59%; p=.046). Mortality and VT recurrence did not differ over the study follow-up (average, 12 months).

In a retrospective study, Aryana et al (2014) 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.^81, Thirty-four patients had hemodynamic support periprocedurally with a pVAD. Percutaneous VAD- and non-pVAD-supported patients had similar procedural success rates. Compared with non-pVAD-supported patients, patients in the pVAD group had a longer maximum time in unstable VT (27.4 minutes vs 5.3 minutes; p<.001), more VT ablations per procedure (1.2 vs 0.4; p<.001), shorter radiofrequency ablation time (53 seconds vs 68 seconds; p=.022), and a shorter hospital length of stay (4.1 days vs 5.4 days; p=.013). Over a follow-up of 19 months, rates of VT recurrence did not differ between groups.

Section Summary: Percutaneous Ventricular Assist Devices for High-Risk Cardiac Procedures

Evidence from RCTs, controlled and uncontrolled observational studies, and systematic reviews of these studies have generally not demonstrated a benefit of pVAD used as ancillary support for patients undergoing high-risk PCI. The key RCT identified in all 3 systematic reviews did not find reduced major adverse events with pVAD at 30 days; however, a recent meta-analysis did find improved one-year mortality with pVAD in patients with reduced ejection fractions undergoing PCI. Additional, well-designed RCTs are needed.

Two nonrandomized studies have compared VT ablation with pVAD or IABP. In both studies, patients who had pVAD support spent less time in unstable VT than patients without pVAD support. Rates of recurrence of VT was comparable between groups for both studies. The current evidence does not support conclusions about the use of pVAD for VT ablation.

Summary of Evidence

For individuals who undergo high-risk cardiac procedures who receive a pVAD, the evidence includes RCTs, observational studies, and systematic reviews of these trials. Relevant outcomes are OS, symptoms, morbid events, functional outcomes, QOL, and treatment-related mortality and morbidity. Randomized controlled trials, controlled and uncontrolled observational studies, and systematic reviews of these studies have generally not demonstrated a benefit of pVAD used as ancillary support for patients undergoing high-risk cardiac procedures. Additionally, 2 nonrandomized studies have compared ventricular tachycardia (VT) ablation with pVAD or IABP. Both studies demonstrated that patients who had pVAD support spent less time in unstable VT than patients without pVAD support. However, the current evidence does not support conclusions about the use of pVAD for VT ablation. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 7 

Percutaneous Ventricular Assist Devices for Cardiogenic Shock Refractory to Intra-Aortic Balloon Pump Therapy

Clinical Context and Therapy Purpose

The purpose of pVADs in individuals who have cardiogenic shock refractory to IABP therapy is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with cardiogenic shock refractory to IABP therapy.

Interventions

The therapy being considered is pVADs.

Comparators

The comparator of interest is optimal medical therapy without IABP and other MCS.

Outcomes

The general outcomes of interest are OS, device malfunction, heart failure, respiratory dysfunction, arrhythmias, and infection.

Timing of interest ranges from perioperative events to 30-day mortality outcomes.

Study Selection Criteria

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow up and/or larger populations were sought.

• Consistent with a best available evidence approach, within each category of study design, studies with larger sample size studies and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Nonrandomized Studies

In a large series, Kar et al (2011) treated 117 patients who had severe, refractory cardiogenic shock with the TandemHeart System.^82, Eighty patients had ischemic cardiomyopathy and 37 had nonischemic cardiomyopathy. There were significant improvements in all hemodynamic measures following LVAD placement. For example, the cardiac index increased from 0.52 L/min/m² to 3.0 L/min/m² (p<.001), and systolic blood pressure increased from 75 mm Hg to 100 mm Hg (p<.001). Complications were common after LVAD implantation. Thirty-four (29.1%) patients had bleeding around the cannula site, and 35 (29.9%) developed sepsis during hospitalization. Groin hematoma occurred in 6 (5.1%) patients; limb ischemia in 4 (3.4%) patients; femoral artery dissection or perforation in 2 (1.7%) patients; stroke in 8 (6.8%) patients; and coagulopathy in 13 (11.0%) patients.

Section Summary: Percutaneous Ventricular Assist Devices for Cardiogenic Shock Refractory to Intra-Aortic Balloon Pump Therapy

Percutaneous VADs have been assessed in uncontrolled studies of patients with cardiogenic shock including those refractory to IABP therapy. The case series have reported high rates of adverse events that may outweigh any potential benefits. As a result, the evidence on pVADs does not demonstrate that the use of VADs is associated with improvements in health outcomes for patients with cardiogenic shock refractory to IABP therapy.

Summary of Evidence

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

SUPPLEMENTAL INFORMATION

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2014 Input

In response to requests, input was received from 2 physician specialty societies and 5 academic medical centers while this policy was under review in 2014. Vetting focused on the use of percutaneous ventricular assist devices (pVADs) under the American Heart Association and American College of Cardiology guidelines (2013) and on the use of the total artificial heart as destination therapy. All providing input supported the use of implantable VADs as destination therapy subject to the guidelines in the policy statements. Most providing input considered total artificial hearts to be investigational for destination therapy; reviewers noted that there are limited clinical trial data to support the use of total artificial hearts as destination therapy.

Most providing input considered pVADs to be investigational as a "bridge to recovery" or "bridge to decision" and for all other indications. Some reviewers noted that pVADs may improve patients' hemodynamics better than other alternatives, such as an intra-aortic balloon pump, but are associated with more complications. Some noted that, despite a lack of evidence to indicate that pVADs improve overall outcomes, there may be cases when pVADs may be considered to support intervention or treatment for a life-threatening condition.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Association for Thoracic Surgery et al

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 (Table 11).^83, The guideline authors noted, "Compared with IABP [intraaortic balloon pump], contemporary percutaneous circulatory support devices provide a significant increase in cardiac index and mean arterial pressure; however, reported 30-day outcomes are similar."

Table 11. 2020 Guidelines on Mechanical Circulatory Support

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

American College of Cardiology Foundation et al

In 2017, the American College of Cardiology Foundation, American Heart Association (AHA), and Heart Failure Society of American published a focused update of the 2013 recommendations released by the American College of Cardiology Foundation and AHA.^84, Left ventricular assist device was 1 of several treatment options recommended for patients with refractory New York Heart Association class III or IV heart failure (stage D). If symptoms were not improved after guideline-directed management and therapy, which included pharmacologic therapy, surgical management and/or other devices, then a left ventricular assist device would be an additional treatment option.

The 2017 update focused on changes in sections regarding biomarkers, comorbidities, and prevention of heart failure, while many of the previous recommendations remained unchanged. The American College of Cardiology Foundation and AHA (2013) released guidelines for the management of heart failure that included recommendations related to the use of mechanical circulatory support (MCS), including both durable and nondurable MCS devices.^85, The guidelines categorized pVADs and extracorporeal ventricular assist devices (VADs) as nondurable MCS devices. Since the 2017 update, these guidelines have been updated regularly, with the most recent update occurring in 2022.^86, Table 12 provides recommendations on MCS devices from the most recently updated guideline iteration.

Table 12. AHA/ACC/HFSA Guidelines on Mechanical Circulatory Support

ACC: American College of Cardiology; AHA: American Heart Association; COE: class of evidence; GDMT: guideline-directed medical therapy; HFrEF: heart failure with reduced ejection fraction; HFSA: Heart Failure Society of America; LOE: level of evidence; LVAD: left ventricular assist device; MCS: mechanical circulatory support; NYHA: New York Heart Association; QOL: quality of life; RCT: randomized controlled trial. aI: Strong; IIa: Moderate.bA: high quality evidence from more than 1 RCT; B-R: Moderate-quality evidence from 1 or more RCTs; B-NR: Moderate-quality evidence from 1 or more well-designed, well-executed nonrandomized studies, observational studies, or registry studies.

American Heart Association

In 2012, the AHA published recommendations for the use of MCS.^87, These guidelines defined nondurable MCS as IABPs, extracorporeal membrane oxygenation, extracorporeal VADs, and pVADs. Table 13 lists recommendations made on indications for the use of MCS, including durable and nondurable devices.

Table 13. 2012 Guidelines on Mechanical Circulatory Support

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

International Society for Heart and Lung Transplantation

The International Society for Heart and Lung Transplantation and the Heart Failure Society of America released a guideline on acute MCS in 2023.^88, 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. Table 14 summarizes relevant recommendations for timing of acute MCS made in the guidelines. Additional recommendations related to specific devices is related to procedural considerations.

Table 14. ISHLT/HFSA Guideline on Acute MCS

COR: class of recommendation; CS: cardiogenic shock; HFSA: Heart Failure Society of America; ISHLT: International Society for Heart and Lung Transplantation; LOE: level of evidence; MCS: mechanical circulatory support

Society for Cardiovascular Angiography and Interventions et al

In 2015, the Society for Cardiovascular Angiography and Interventions, the Heart Failure Society of America, the Society of Thoracic Surgeons, and the American College of Cardiology published a joint clinical expert consensus statement on the use of percutaneous MCS devices in cardiovascular care.^89, This statement addressed IABPs, left atrial-to-aorta assist device (eg, TandemHeart), left ventricle-to-aorta assist devices (eg, Impella), extracorporeal membrane oxygenation, and methods of right-sided support. Specific recommendations were not made, but the statement reviews the use of MCS in patients undergoing high-risk percutaneous intervention, those with cardiogenic shock, and those with acute decompensated heart failure.

U.S. Preventive Services Task Force Recommendations

Not applicable.

medicare advantage

Medicare has a national coverage determination (NCD) for VADs.^90, The NCD mandates coverage for VADs for the following indications:

• For support of blood circulation in the post cardiotomy setting, defined as the period following open-heart surgery.

  • If the VAD has U.S. Food and Drug Administration (FDA) approval for that purpose and are used according to the FDA-labeled indication

• For short-term (e.g., bridge-to-recovery and bridge-to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support for patients who meet the following criteria:

  • Have New York Heart Association (NYHA) Class IV heart failure; and

  • Have a left ventricular ejection fraction (LVEF) ≤25%; and

  • Are inotrope dependent

    OR

    have a cardiac index <2.2 L/min/m2, while not on inotropes, and also meet 1 of the following:

    • Are on optimal medical management, based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; OR

    • Have advanced heart failure for at least 14 days and are dependent on an IABP or similar temporary mechanical circulatory support for at least 7 days.

"Beneficiaries receiving VADs for DT [destination therapy] must be managed by an explicitly identified cohesive, multidisciplinary team of medical professionals with the appropriate qualifications, training, and experience.... The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD."

"Facilities must be credentialed by an organization approved by the Centers for Medicare & Medicaid Services."

Effective December 1, 2020, Artificial Hearts has been removed from the NCD Manual. Coverage determinations for artificial hearts and related devices shall be made by the Medicare Administrative Contractors.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 15.

Table 15. Summary of Key Trials

 NCT: national clinical trial.a Denotes industry-sponsored or cosponsored trial.

REFERENCES

1. Martin SS, Aday AW, Almarzooq ZI, et al. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. Feb 20 2024; 149(8): e347-e913. PMID 38264914
2. Lewsey SC, Breathett K. Racial and ethnic disparities in heart failure: current state and future directions. Curr Opin Cardiol. May 01 2021; 36(3): 320-328. PMID 33741769
3. Organ Procurement and Transplantation Network. National Heart Patient and Graft Survival as of June 21, 2024. https://insights.unos.org/OPTN-metrics/. Accessed June 27, 2024.
4. Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction. U.S. Food & Drug Administration website. Updated April 15, 2024. Accessed June 24, 2024. https://www.fda.gov/medical-devices/medical-device-recalls/abbottthoratec-corp-recalls-heartmate-ii-and-heartmate-3-left-ventricular-assist-system-lvas-due
5. TEC Assessment Program. Ventricular assist devices in bridging to heart transplantation. 1996;Volume 11;Tab 26.
6. Goldstein DJ, Oz MC, Rose EA. Implantable left ventricular assist devices. N Engl J Med. Nov 19 1998; 339(21): 1522-33. PMID 9819452
7. Mehra MR, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report. N Engl J Med. Apr 25 2019; 380(17): 1618-1627. PMID 30883052
8. Colombo PC, Mehra MR, Goldstein DJ, et al. Comprehensive Analysis of Stroke in the Long-Term Cohort of the MOMENTUM 3 Study. Circulation. Jan 08 2019; 139(2): 155-168. PMID 30586698
9. Cowger JA, Naka Y, Aaronson KD, et al. Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients. J Heart Lung Transplant. Jan 2018; 37(1): 15-24. PMID 29153637
10. Goldstein DJ, Naka Y, Horstmanshof D, et al. Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial. JAMA Cardiol. Apr 01 2020; 5(4): 411-419. PMID 31939996
11. Slaughter MS, Pagani FD, McGee EC, et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant. Jul 2013; 32(7): 675-83. PMID 23796152
12. Strueber M, O'Driscoll G, Jansz P, et al. Multicenter evaluation of an intrapericardial left ventricular assist system. J Am Coll Cardiol. Mar 22 2011; 57(12): 1375-82. PMID 21414534
13. Aaronson KD, Eppinger MJ, Dyke DB, et al. Left ventricular assist device therapy improves utilization of donor hearts. J Am Coll Cardiol. Apr 17 2002; 39(8): 1247-54. PMID 11955839
14. 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. PMID 17948075
15. 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. Oct 2008; 86(4): 1227-34; discussion 1234-5. PMID 18805167
16. Miller LW, Pagani FD, Russell SD, et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med. Aug 30 2007; 357(9): 885-96. PMID 17761592
17. 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. Sep 2008; 86(3): 832-40; discussion 832-40. PMID 18721570
18. Strüber M, Sander K, Lahpor J, et al. HeartMate II left ventricular assist device; early European experience. Eur J Cardiothorac Surg. Aug 2008; 34(2): 289-94. PMID 18571932
19. Kirklin JK, Naftel DC, Stevenson LW, et al. INTERMACS database for durable devices for circulatory support: first annual report. J Heart Lung Transplant. Oct 2008; 27(10): 1065-72. PMID 18926395
20. Aissaoui N, Morshuis M, Maoulida H, et al. Management of end-stage heart failure patients with or without ventricular assist device: an observational comparison of clinical and economic outcomes. Eur J Cardiothorac Surg. Jan 01 2018; 53(1): 170-177. PMID 28950304
21. Schmitto JD, Pya Y, Zimpfer D, et al. Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure-two-year results from the HeartMate 3 CE Mark Study. Eur J Heart Fail. Jan 2019; 21(1): 90-97. PMID 30052304
22. Gustafsson F, Shaw S, Lavee J, et al. Six-month outcomes after treatment of advanced heart failure with a full magnetically levitated continuous flow left ventricular assist device: report from the ELEVATE registry. Eur Heart J. Oct 01 2018; 39(37): 3454-3460. PMID 30165521
23. Pagani FD, Mehra MR, Cowger JA, et al. Clinical outcomes and healthcare expenditures in the real world with left ventricular assist devices - The CLEAR-LVAD study. J Heart Lung Transplant. May 2021; 40(5): 323-333. PMID 33744086
24. Mehra MR, Cleveland JC, Uriel N, et al. Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants. Eur J Heart Fail. Aug 2021; 23(8): 1392-1400. PMID 33932272
25. TEC Assessment Program. Left ventricular assist devices as destination therapy for end-stage heart failure. 2002;Volume 17;Tab 19.
26. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. Nov 15 2001; 345(20): 1435-43. PMID 11794191
27. Park SJ, Tector A, Piccioni W, et al. Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg. Jan 2005; 129(1): 9-17. PMID 15632819
28. 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. PMID 15947534
29. Rogers JG, Pagani FD, Tatooles AJ, et al. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. Feb 02 2017; 376(5): 451-460. PMID 28146651
30. Estep JD, Starling RC, Horstmanshof DA, et al. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: Results From the ROADMAP Study. J Am Coll Cardiol. Oct 20 2015; 66(16): 1747-1761. PMID 26483097
31. Starling RC, Estep JD, Horstmanshof DA, et al. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results. JACC Heart Fail. Jul 2017; 5(7): 518-527. PMID 28396040
32. Jorde UP, Kushwaha SS, Tatooles AJ, et al. Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. May 06 2014; 63(17): 1751-7. PMID 24613333
33. Rogers JG, Butler J, Lansman SL, et al. Chronic mechanical circulatory support for inotrope-dependent heart failure patients who are not transplant candidates: results of the INTrEPID Trial. J Am Coll Cardiol. Aug 21 2007; 50(8): 741-7. PMID 17707178
34. Arnold SV, Jones PG, Allen LA, et al. Frequency of Poor Outcome (Death or Poor Quality of Life) After Left Ventricular Assist Device for Destination Therapy: Results From the INTERMACS Registry. Circ Heart Fail. Aug 2016; 9(8). PMID 27507111
35. Mehra MR, Goldstein DJ, Cleveland JC, et al. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. Sep 27 2022; 328(12): 1233-1242. PMID 36074476
36. Acharya D, Loyaga-Rendon RY, Pamboukian SV, et al. Ventricular Assist Device in Acute Myocardial Infarction. J Am Coll Cardiol. Apr 26 2016; 67(16): 1871-80. PMID 27102502
37. Wever-Pinzon O, Drakos SG, McKellar SH, et al. Cardiac Recovery During Long-Term Left Ventricular Assist Device Support. J Am Coll Cardiol. Oct 04 2016; 68(14): 1540-53. PMID 27687196
38. Topkara VK, Garan AR, Fine B, et al. Myocardial Recovery in Patients Receiving Contemporary Left Ventricular Assist Devices: Results From the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Circ Heart Fail. Jul 2016; 9(7). PMID 27402861
39. Maybaum S, Mancini D, Xydas S, et al. Cardiac improvement during mechanical circulatory support: a prospective multicenter study of the LVAD Working Group. Circulation. May 15 2007; 115(19): 2497-505. PMID 17485581
40. Agrawal S, Garg L, Shah M, et al. Thirty-Day Readmissions After Left Ventricular Assist Device Implantation in the United States: Insights From the Nationwide Readmissions Database. Circ Heart Fail. Mar 2018; 11(3): e004628. PMID 29519902
41. 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. Oct 2008; 29(19): 2388-442. PMID 18799522
42. Bulic A, Maeda K, Zhang Y, et al. Functional status of United States children supported with a left ventricular assist device at heart transplantation. J Heart Lung Transplant. Aug 2017; 36(8): 890-896. PMID 28363739
43. Wehman B, Stafford KA, Bittle GJ, et al. Modern Outcomes of Mechanical Circulatory Support as a Bridge to Pediatric Heart Transplantation. Ann Thorac Surg. Jun 2016; 101(6): 2321-7. PMID 26912304
44. Fraser CD, Jaquiss RD, Rosenthal DN, et al. Prospective trial of a pediatric ventricular assist device. N Engl J Med. Aug 09 2012; 367(6): 532-41. PMID 22873533
45. Blume ED, Rosenthal DN, Rossano JW, et al. Outcomes of children implanted with ventricular assist devices in the United States: First analysis of the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS). J Heart Lung Transplant. May 2016; 35(5): 578-84. PMID 27009673
46. Almond CS, Morales DL, Blackstone EH, et al. Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation. Apr 23 2013; 127(16): 1702-11. PMID 23538380
47. Jordan LC, Ichord RN, Reinhartz O, et al. Neurological complications and outcomes in the Berlin Heart EXCOR® pediatric investigational device exemption trial. J Am Heart Assoc. Jan 22 2015; 4(1): e001429. PMID 25613996
48. Chen S, Lin A, Liu E, et al. Outpatient Outcomes of Pediatric Patients with Left Ventricular Assist Devices. ASAIO J. 2016; 62(2): 163-8. PMID 26720740
49. Conway J, Al-Aklabi M, Granoski D, et al. Supporting pediatric patients with short-term continuous-flow devices. J Heart Lung Transplant. May 2016; 35(5): 603-9. PMID 27009672
50. 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. Sep 1995; 222(3): 327-36; discussion 336-8. PMID 7677462
51. Bank AJ, Mir SH, Nguyen DQ, et al. Effects of left ventricular assist devices on outcomes in patients undergoing heart transplantation. Ann Thorac Surg. May 2000; 69(5): 1369-74; discussion 1375. PMID 10881807
52. 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. Feb 10 2010; 340: c392. PMID 20147346
53. 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. Jul 2011; 13(7): 785-95. PMID 21551162
54. Deo SV, Sung K, Daly RC, et al. Cardiac transplantation after bridged therapy with continuous flow left ventricular assist devices. Heart Lung Circ. Mar 2014; 23(3): 224-8. PMID 23954004
55. Grimm JC, Sciortino CM, Magruder JT, et al. Outcomes in Patients Bridged With Univentricular and Biventricular Devices in the Modern Era of Heart Transplantation. Ann Thorac Surg. Jul 2016; 102(1): 102-8. PMID 27068177
56. 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. Feb 2008; 135(2): 421-7, 427.e1. PMID 18242279
57. Copeland JG, Smith RG, Arabia FA, et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med. Aug 26 2004; 351(9): 859-67. PMID 15329423
58. Copeland JG, Copeland H, Gustafson M, et al. Experience with more than 100 total artificial heart implants. J Thorac Cardiovasc Surg. Mar 2012; 143(3): 727-34. PMID 22245242
59. Food and Drug Administration. Summary of Safety and Probable Benefit - H040006: AbioCor Implantable Replacement Heart. 2006; https://www.accessdata.fda.gov/cdrh_docs/pdf4/H040006b.pdf. Accessed July 1, 2024.
60. Dowling RD, Gray LA, Etoch SW, et al. Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg. Jan 2004; 127(1): 131-41. PMID 14752423
61. Torregrossa G, Morshuis M, Varghese R, et al. Results with SynCardia total artificial heart beyond 1 year. ASAIO J. 2014; 60(6): 626-34. PMID 25158888
62. Romeo F, Acconcia MC, Sergi D, et al. Percutaneous assist devices in acute myocardial infarction with cardiogenic shock: Review, meta-analysis. World J Cardiol. Jan 26 2016; 8(1): 98-111. PMID 26839661
63. 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. Sep 2006; 152(3): 469.e1-8. PMID 16923414
64. Seyfarth M, Sibbing D, Bauer I, et al. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol. Nov 04 2008; 52(19): 1584-8. PMID 19007597
65. Thiele H, Sick P, Boudriot E, et al. Randomized comparison of intra-aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock. Eur Heart J. Jul 2005; 26(13): 1276-83. PMID 15734771
66. Ouweneel DM, Eriksen E, Sjauw KD, et al. Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. Jan 24 2017; 69(3): 278-287. PMID 27810347
67. Karami M, Eriksen E, Ouweneel DM, et al. Long-term 5-year outcome of the randomized IMPRESS in severe shock trial: percutaneous mechanical circulatory support vs. intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction. Eur Heart J Acute Cardiovasc Care. Dec 06 2021; 10(9): 1009-1015. PMID 34327527
68. Schrage B, Ibrahim K, Loehn T, et al. Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock. Circulation. Mar 05 2019; 139(10): 1249-1258. PMID 30586755
69. Sieweke JT, Berliner D, Tongers J, et al. Mortality in patients with cardiogenic shock treated with the Impella CP microaxial pump for isolated left ventricular failure. Eur Heart J Acute Cardiovasc Care. Mar 2020; 9(2): 138-148. PMID 29405734
70. Schäfer A, Werner N, Burkhoff D, et al. Influence of Timing and Predicted Risk on Mortality in Impella-Treated Infarct-Related Cardiogenic Shock Patients. Front Cardiovasc Med. 2020; 7: 74. PMID 32478095
71. 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. Feb 2013; 145(2): 548-54. PMID 22405676
72. Lemaire A, Anderson MB, Lee LY, et al. The Impella device for acute mechanical circulatory support in patients in cardiogenic shock. Ann Thorac Surg. Jan 2014; 97(1): 133-8. PMID 24090575
73. Lauten A, Engström AE, Jung C, et al. Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry. Circ Heart Fail. Jan 2013; 6(1): 23-30. PMID 23212552
74. Ouweneel DM, de Brabander J, Karami M, et al. Real-life use of left ventricular circulatory support with Impella in cardiogenic shock after acute myocardial infarction: 12 years AMC experience. Eur Heart J Acute Cardiovasc Care. Jun 2019; 8(4): 338-349. PMID 30403366
75. Ait Ichou J, Larivée N, Eisenberg MJ, et al. The effectiveness and safety of the Impella ventricular assist device for high-risk percutaneous coronary interventions: A systematic review. Catheter Cardiovasc Interv. Jun 2018; 91(7): 1250-1260. PMID 28941078
76. Iannaccone M, Barbero U, Franchin L, et al. Comparison of mid-term mortality after surgical, supported or unsupported percutaneous revascularization in patients with severely reduced ejection fraction: A direct and network meta-analysis of adjusted observational studies and randomized-controlled. Int J Cardiol. Feb 01 2024; 396: 131428. PMID 37820779
77. Briasoulis A, Telila T, Palla M, et al. Meta-Analysis of Usefulness of Percutaneous Left Ventricular Assist Devices for High-Risk Percutaneous Coronary Interventions. Am J Cardiol. Aug 01 2016; 118(3): 369-75. PMID 27265673
78. O'Neill WW, Kleiman NS, Moses J, et al. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. Oct 02 2012; 126(14): 1717-27. PMID 22935569
79. Ouweneel DM, Engstrom AE, Sjauw KD, et al. Experience from a randomized controlled trial with Impella 2.5 versus IABP in STEMI patients with cardiogenic pre-shock. Lessons learned from the IMPRESS in STEMI trial. Int J Cardiol. Jan 01 2016; 202: 894-6. PMID 26476989
80. Reddy YM, Chinitz L, Mansour M, et al. Percutaneous left ventricular assist devices in ventricular tachycardia ablation: multicenter experience. Circ Arrhythm Electrophysiol. Apr 2014; 7(2): 244-50. PMID 24532564
81. Aryana A, Gearoid O'Neill P, Gregory D, et al. Procedural and clinical outcomes after catheter ablation of unstable ventricular tachycardia supported by a percutaneous left ventricular assist device. Heart Rhythm. Jul 2014; 11(7): 1122-30. PMID 24732372
82. Kar B, Gregoric ID, Basra SS, et al. The percutaneous ventricular assist device in severe refractory cardiogenic shock. J Am Coll Cardiol. Feb 08 2011; 57(6): 688-96. PMID 20950980
83. Kirklin JK, Pagani FD, Goldstein DJ, et al. American Association for Thoracic Surgery/International Society for Heart and Lung Transplantation guidelines on selected topics in mechanical circulatory support. J Heart Lung Transplant. Mar 2020; 39(3): 187-219. PMID 31983666
84. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. Aug 08 2017; 136(6): e137-e161. PMID 28455343
85. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. Oct 15 2013; 62(16): e147-239. PMID 23747642
86. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. May 03 2022; 145(18): e876-e894. PMID 35363500
87. Peura JL, Colvin-Adams M, Francis GS, et al. Recommendations for the use of mechanical circulatory support: device strategies and patient selection: a scientific statement from the American Heart Association. Circulation. Nov 27 2012; 126(22): 2648-67. PMID 23109468
88. Bernhardt AM, Copeland H, Deswal A, et al. The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support. J Heart Lung Transplant. Apr 2023; 42(4): e1-e64. PMID 36805198
89. Rihal CS, Naidu SS, Givertz MM, et al. 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care: Endorsed by the American Heart Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention. J Am Coll Cardiol. May 19 2015; 65(19): e7-e26. PMID 25861963
90. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Ventricular Assist Devices (20.9.1). 2020; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=360&ncdver=2&keyword=ventricular%20assist&keywordType=starts&areaId=all&docType=NCD&contractOption=all&sortBy=relevance&bc=AAAAAAQAAAAA&KeyWordLookUp=Doc&KeyWordSearchType=Exact. Accessed June 27, 2024.

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