Description
A ventricular assist device (VAD) is a mechanical support attached to the native heart and vessels to augment cardiac output. The total artificial heart (TAH) replaces the native ventricles and is attached to the pulmonary artery and aorta; the native heart is typically removed. Both the VAD and TAH may be used as a bridge to heart transplantation or as destination therapy in those not candidates for transplantation. 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 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.

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.  

Background   
Heart Failure
According to a 2025 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.^1,2 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).³ 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 2022.⁴ 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 DeBakey VAD Child received FDA Humanitarian Device Exemption (HDE) approval in 2004, offering a temporary lifeline for pediatric patients with end-stage heart failure as they awaited heart transplantation. However, this device was replaced by the HeartAssist 5 VAD which is not currently available for use as it was an investigational device that was discontinued.

• As of April 15, 2024, both the HeartMate II and HeartMate 3 devices have been placed under a Class I FDA recall in response to the accumulation of biological material within the devices, an issue that can result in serious obstructions and significantly increase the risk of severe injury or death. In April 2025, Abbott further removed the HeartMate Mobile Power Unit, which is used with both the HeartMate II and HeartMate 3, following reports of sudden and unexpected power loss.⁵

• The Abbott CentriMag Circulatory Support System received FDA approval in 2019 to provide longer-term life support to critically ill patients. In 2023, it was approved for longer-term use in adults when extracorporeal membrane oxygenation.⁶

Table 1. Available Ventricular Assist Devices

Device	Manufacturer	Approval Date	FDA Clearance	PMA, HDE, or 510(k) No.	Indication
HeartMate II	Thoratec (Abbott)	Apr 2008	PMA	P060040	Bridge to transplant and destination
CentriMag	Thoratec (Abbott)	Dec 2019	PMA	P170038	Postcardiotomy, bridge to decision
Berlin Heart EXCOR Pediatric VAD	Berlin	Jun 2017	PMA	P160035	Bridge to transplant or recovery
HeartMate 3 Left Ventricular Assist System	Thoratec (Abbott)	Aug 2017 Oct 2018	PMA PMA	P160054 P160054/S008	Bridge to transplant and destination

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

Device	Manufacturer	Approval Date	FDA Clearance	PMA No.	Indication
SynCardia Temporary Total Artificial Heart (Formerly CardioWest Total Artificial Heart and Jarvik Total Artificial Heart)	SynCardia Systems	2004	510(k)	P030011	Bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

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. LivaNova, the company that acquired CardiacAssist Inc. (the original developer of the TandemHeart), announced plans to wind down its Advanced Circulatory Support business, including the TandemHeart, in 2024. However, it is possible that some components, such as cannulas, may still be available for purchase.⁷

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. As of June 5, 2023, the FDA has issued a Class I recall for specific Impella 5.5 devices due to purge fluid leaks.⁸ On October 10, 2025, the FDA issued an alert on the automated Impella controller correction due to a cybersecurity issue.⁹

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

Device	Manufacturer	Approval Date	FDA Clearance	PMA, 510(k) No.	Indication
TandemHeart	Cardiac Assist (LivaNova)	Sep 2011	510(k)	K110493	Temporary left ventricular bypass of ≤6 h
Impella CP	Abiomed	Nov 2016	PMA	P140003	Temporary (≤6 hours) ventricular support devices indicated for use during high-risk PCI Temporary ventricular support for ≤4 days in cardiogenic shock
Impella 5.5	Abiomed	Nov 2016	PMA	P140003	Temporary ventricular support for ≤14 days in cardiogenic shock

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

Related Policies
70308 Heart/Lung Transplant
70309 Heart Transplant

Policy
Long-Term Devices
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
  • Advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for ≥ 7 days

Short-Term Devices
Bridge to Transplantation
Implantable 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 NECESSARY as a bridge to heart transplantation for individuals with biventricular failure who have no other reasonable medical or surgical treatment options, who are ineligible for other univentricular or biventricular support devices, and are currently listed as heart transplantation candidates or are undergoing evaluation to determine candidacy for heart transplantation, and not expected to survive until a donor heart can be obtained.

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 VADs or 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 and/ or unproven and therefore considered NOT MEDICALLY NECESSARY.

PERCUTANEOUS Ventricular Assist Devices:

The Impella RP System is considered MEDICALLY NECESSARY for up to 14 days in a child or adult with a BSA> 1.5m2 for the treatment of acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open heart surgery.

The TandemHeart PTVA System, the Impella Recover LP 2.5 Percutaneous Cardiac Support System, Impella 5.0Catheters, or Impella 2.5 Plus are considered MEDICALLY NECESSARY for the treatment of cardiogenic shock for up to six hours.

The TandemHeart PTVA System, the Impella REcover LP2.5 Percutaenous Cardiac Support System, Impella 5.0 Catheters, or Impella 2.5 Plus for any other indication is considered experimental, investigational or unproven and therefore NOT MEDICALLY NECESSARY.

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.

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 August 25, 2025.

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.

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.

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.^10,11

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).¹² Prevalence of stroke at 2 years was lower in the HeartMate 3 than the HeartMate II group (10.1% vs 19.2%; p=.02).¹³ Measures of functional capacity and Health-Related QOL did not differ between the 2 devices at 6 months.¹⁴

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. ¹⁵

The VAD‐DZHK3 trial is an ongoing multi-center German RCT (N=102 patients; NCT02387112) evaluating whether elective LVAD implantation improves outcomes in end‐stage heart failure (HF) patients listed for heart transplantation compared with the current therapeutic strategy of medical heart failure therapy and assist device implantation after clinical deterioration.¹⁶ The primary endpoint is survival free from urgent transplantation, disabling stroke or HF hospitalization. This event‐driven trial aims to define optimal timing for LVAD therapy in high‐risk transplant candidates (see Table 12. Summary of Key Trials).

Nonrandomized Studies
In 5 reports published from 2007 to 2008 on the HeartMate device, with sample sizes ranging from 32 to 279 patients, most participants received the continuous-flow device as a bridge to transplantation.^{17,18,19,20,21} 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.²² 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.²⁰ 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).²³ 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.²⁴ 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.²⁵ 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 2019.²⁶ 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.²⁷ Full results are described below.

Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure in Adults
Systematic Reviews
Khoufi (2025) conducted a meta-analysis to synthesize evidence on the survival rates, complications, and QOL improvements associated with LVADs used as destination therapy in patients with end-stage heart failure.²⁸ Data from 12 studies (6 RCTs and 6 observational studies published through April 2024) were extracted and analyzed using a random-effects model. Survival rates, complications (e.g., infection and bleeding), and QOL measures were the primary outcomes evaluated. The analysis showed significant improvements in survival, with a pooled effect size of 0.848 (95% CI, 0.306 to 1.390, p =.002). Complication rates varied, with infections and bleeding being the most common adverse events. QOL also improved post-LVAD implantation, with a standardized mean difference (SMD) of 0.78 (95% CI, 0.65 to 0.91).

Park et al (2005) published reports on the extended 2-year follow-up of patients from the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial,²⁹ which found that survival and QOL benefits were still apparent.^30,31 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 and ENDURANCE RCTs represent the primary studies evaluating the HeartMate device as a destination therapy for adults with end-stage heart failure. These pivotal trials were both incorporated into the Khoufi (2025) meta-analysis above.

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).¹² Prevalence of stroke at 2 years was lower in the HeartMate 3 than the HeartMate 2 group (10.1% vs 19.2%; p=.02).¹³ Measures of functional capacity and Health-Related QOL did not differ between the 2 devices at 6 months.¹⁴

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.¹⁵

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.³² 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.³³ 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).³⁴ 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,³⁵ 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.

Arnold et al (2016) analyzed 1638 patients receiving LVADs as destination therapy between May 2012 and September 2013.³⁶ 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.²⁷ 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.³⁷ 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.⁸ 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).³⁸ 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.³⁹ 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.⁴⁰ 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.⁴¹ 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.⁴² 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).⁴³ 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.⁴⁴ 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.⁴⁵ 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.⁴⁶ 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.⁴⁷ 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.⁴⁸

Chen et al (2016) reported on a retrospective, single-center series of pediatric patients with continuous-flow VADs, with a focus on outpatient experiences.⁴⁹ 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.⁵⁰ 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.^51,52,53,54 A systematic review by Alba et al (2011) examined the evidence on the effect of VADs on posttransplant outcomes.⁵⁵ 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.⁵⁶ 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.⁵⁷ Using the United Network for Organ Sharing database, Davies et al (2008) reported on the use of VADs in pediatric patients undergoing heart transplantation.⁵⁸ 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.

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 (now SynCardia temporary Total Artificial Heart) was based on the results of a nonrandomized, prospective study of 81 patients.⁵⁹ 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.⁶⁰ 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 information⁶¹ and from a published article describing results for the first 7 patients.⁶² 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.⁶³ 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.

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
Tariq et al (2025) conducted a meta-analysis to evaluate the safety and efficacy of the Impella device in the treatment of AMI-associated cardiogenic shock.⁶⁴ The primary outcome was 6-month all-cause mortality. Secondary outcomes included 30-day mortality, major bleeding, limb ischemia, sepsis, and left ventricular ejection fraction. Four RCTs (N=440 patients), published through June 2024, were included in this meta-analysis (Table 4). The pooled analysis showed that the odds of 6-month all-cause mortality were significantly lower with Impella compared to standard of care (odds ratio [OR], 0.64, 95% CI, 0.43 to 0.95; p =.03). However, 30-day mortality reported no statistically significant difference between the 2 groups (OR, 1.03; 95% CI, 0.43 to 2.48; p =.95). The analysis found that the use of impella is associated with a statistically significant increase in the odds of major bleeding (OR, 3.61; 95% CI, 1.14 to 11.40; p =.03), limb ischemia (OR, 4.91; 95% CI, 1.37 to 17.59; p =.01), and sepsis (OR, 2.75; 95% CI, 1.25 to 6.08; p =.01). No statistical significance was found in left ventricular ejection fraction at follow-up between the 2 groups (SMD, -0.35; 95% CI, −0.78 to 0.07; p =.11).

Table 4. Characteristics of RCTs in the Tariq et al (2025) meta-analysis⁶⁴

Study (Registration)	Countries	Sites (patients)	Dates	pVAD	Control	Inclusion Criteria
Ouweneel et al (2017)65 IMPRESS (NTR3450)	Netherlands, Norway	2 (48)	2012-2015	Impella CP	IABP	Patients presented with an AMI with ST segment elevation complicated by severe CS in the setting of immediate percutaneous coronary intervention (PCI). Severe CS was defined as a systolic blood pressure <90mm Hg for longer than 30min or the need for inotropes or vasopressors to maintain a systolic blood pressure > 90mm Hg.
Seyfarth et al (2008)66 ISAR-SHOCK (NCT00417378)	Germany	2 (25)	2004-2007	Impella LP 2.5	IABP	Patients with: AMI < 48 h, confirmed by ischemic symptoms for at least 30min with elevated cardiac markers or ST-segment elevation or left bundle branch block. An AMI was suspected when patients were resuscitated, and cardiac markers and/or electrocardiographic changes met criteria for AMI/acute coronary syndrome; CS was defined using both clinical and hemodynamic criteria as previously described in the SHOCK trial.
Bochaton et al (2020)67 IMPELLA-STIC	France	2 (12)	2010-2013	Impella LP5.0	IABP	Patients admitted with CS-AMI, who had been treated with primary angioplasty within 24 h of the index AMI, and required inotropic drugs and an IABP, were eligible for inclusion.
Møller et al (2024)68 DanShock (NCT01633502)	Denmark, Germany, United Kingdom	13 (355)	2013-2021	Impella CP	ECMO/IABP	Patients 18 years of age or older with STEMI and car- diogenic shock. Cardiogenic shock was defined as hypotension (systolic blood pressure below 100mm Hg or an ongoing need for vasopressor support), end-organ hypoperfusion with an arterial lactate level of 2.5 mmol per liter or greater, and a left ventricular ejection fraction of less than 45%.

AMI: acute myocardial infarction; CS: cardiogenic shock; ECMO: Extracorporeal membrane oxygenation; 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; DanShock: Danish Cardiogenic Shock Trial; IMPELLA-STIC: Impella Programme de Soutien aux Techniques Innovantes et Couteuses; PCI: percutaneous coronary intervention; pVAD: percutaneous ventricular assist device; RCT; randomized controlled trial; STEMI: ST elevation myocardial infarction.

Randomized Controlled Trials
No additional RCTs were identified beyond those included in the Tariq et al (2025) meta-analysis above.

Long-term follow-up of the IMPRESS trial outcomes were published by Karami et al (2021).⁶⁹ 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.

Section Summary: Percutaneous Ventricular Assist Devices for Cardiogenic Shock
A meta-analysis of four RCTs found pVAD use in AMI-related cardiogenic shock reduced 6-month mortality but not 30-day mortality. pVADs were associated with significantly increased risks of major bleeding, limb ischemia, and sepsis, with no improvement in left ventricular ejection fraction compared to standard care. Comparative observational studies and a long-term follow-up study were consistent with the RCT evidence.

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 5 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 5 and 6).⁷⁰ 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.⁷¹ 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 5). 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 5. Comparison of RCTs Included in SRs Evaluating pVAD as Ancillary Support for High-Risk PCI

Study	Iannaccone et al (2024)71	Ait Ichou et al (2018)70	Briasoulis et al (2016)72
O'Neill et al (2012)73 PROTECT II	⚫	⚫	⚫
Ouweneel et al 2017 65 IMPRESS		⚫
Ouweeneel et al (2016)74IMPRESS in STEMI		⚫
Seyfarth et al (2008)66 ISAR-SHOCK		⚫

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 7. 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.⁷² Reviewers identified 18 nonrandomized observational studies and a single RCT (PROTECT II, comparing the Impella 2.5 device to IABP therapy).⁷³ Results are shown in Table 6. 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 6. Characteristics of SRs Evaluating pVAD as Ancillary Support for High-Risk PCI

Study	Dates	Trials	Participants	Devices Included	N (Range)	Design	Duration
Ait Ichou et al (2018)70	Inception-2016	20	High-risk patients undergoing PCI	Impella	1287 (10 to 225)	4 RCT, 2 controlled observational, 14 uncontrolled observational	1 to 42 months
Briasoulis et al (201672	Inception-2016	Impella: 12 TandemHeart::8	High-risk patients undergoing PCI	Impella and TandemHeart	Impella: 1350 (10 to 637) TandemHeart: 252 (7 to 68)	Impella: 11 cohort studies, 1 RCT TandemHeart: 8 cohort studies	NR
Iannaccone et al (2024)71	Inception-2023	15	Patients with reduced EF undergoing revascularization	Impella	17,841 (134 to 4794)	CABG vs PCI: 11 (observational) PCI vs PCI with pVAD: 4 (1 RCT; 3 observational)	NR

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

Study	All-Cause Mortality (30 days)	All-Cause Mortality (3 months)	All-Cause Mortality (12 months)	Stroke (30 days)	Stroke (3 months)	Stroke (12 months)	Major Adverse Events (30 days)	Major Adverse Events (3 months)	Major Adverse Events (12 months)	Vascular Complications
Ait Ichou et al (2018)70
Range of effect (controlled studies)
Impella	7.6% to 46%	12.1% to 50%	15.3% to 26%	0%	0.9% to 8%	8%	15% to 35.1%	26% to 40.6%	37%
IABP	0% to 46%	8.7% to 50%	11% to 25.8%	0% to 1.8%	0% to 4%	0%	40% to 40.1%	33% to 49.3%	47%
Range of effect (uncontrolled studies)
Impella	0% to 74%	--	10% to 45.5%	0% to 2%	--	--	0% to 20%	--	30%
Briasoulis et al (2016)72							Major bleeding
Impellla	54/1346						126/1346			89/1346
Pooled effect (95% CI)	0.35 (0.022 to 0.048)						0.71 (0.043 to 0.99)			0.049 (0.023 to 0.076)
I2 (p)	20% (.243)						63% (.002)			78% (<.001)
TandemHeart	22/212						11/205			15/205
Pooled effect (95% CI)	0.080 (0.029 to 0.131)						0.036 (0.011 to 0.061)			0.065 (0.032 to 0.099)
I2 (p)	55% (.030)						0% (.581)			0% (.865)
Iannaccone et al (2024)71
Impella			9.45 % (IQR, 5.7 to 12.5)
non-supported PCI			10.6% (IQR, 8.9 to 10.7)
Pooled effect (95% CI)			0.77 (0.6 to 0.89)

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.⁷⁵ 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.⁷⁶ 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.

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.⁷⁷ 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.

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
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 (MCS), including recommendations on the use of pVADs (Table 8).⁷⁸ 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 8. 2020 Guidelines on Mechanical Circulatory Support

Recommendation	COE	LOE
"Percutaneous LV to aorta pumps of appropriate size should be considered for cardiogenic shock from primary LV failure."	IIA	B

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

American College of Cardiology Foundation et al
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.⁷⁹ 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 MCS , including both durable and nondurable MCS devices.⁸⁰ 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 2022.⁸¹ Table 9 provides recommendations on MCS devices from the most recently updated guideline iteration.

Table 9. AHA/ACC/HFSA Guidelines on Mechanical Circulatory Support

Recommendation	COEa	LOEb
"In select patients with advanced HFrEF with NYHA class IV symptoms who are deemed to be dependent on continuous intravenous inotropes or temporary MCS, durable LVAD implantation is effective to improve functional status, QOL, and survival."	I	A
"In select patients with advanced HFrEF who have NYHA class IV symptoms despite GDMT, durable MCS can be beneficial to improve symptoms, improve functional class, and reduce mortality."	IIA	B-R
"In patients with advanced HFrEF and hemodynamic compromise and shock, temporary MCS, including percutaneous and extracorporeal ventricular assist devices, are reasonable as a 'bridge to recovery' or 'bridge to decision'"	IIA	B-NR

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.⁸² These guidelines defined nondurable MCS as IABPs, extracorporeal membrane oxygenation, extracorporeal VADs, and pVADs. Table 10 lists recommendations made on indications for the use of MCS, including durable and nondurable devices.

Table 10. 2012 Guidelines on Mechanical Circulatory Support

Recommendation	COE	LOE
"MCS for BTT indication should be considered for transplant-eligible patients with end-stage HF who are failing optimal medical, surgical, and/or device therapies and at high risk of dying before receiving a heart transplantation."	I	B
"Implantation of MCS in patients before the development of advanced HF … is associated with better outcomes. Therefore, early referral of HF patients is reasonable."	IIA	B
"MCS with a durable, implantable device for permanent therapy or DT is beneficial for patients with advanced HF, high 1-year mortality resulting from HF, and the absence of other life-limiting organ dysfunction; who are failing medical, surgical, and/or device therapies; and who are ineligible for heart transplantation."	I	B
"Elective rather than urgent implantation of DT can be beneficial when performed after optimization of medical therapy in advanced HF patients who are failing medical, surgical, and/or device therapies."	IIA	C
"Urgent nondurable MCS is reasonable in hemodynamically compromised HF patients with end-organ dysfunction and/or relative contraindications to heart transplantation/durable MCS that are expected to improve with time and restoration of an improved hemodynamic profile." "These patients should be referred to a center with expertise in the management of durable MCS and patients with advanced HF."	IIA I	C C
"Patients who are ineligible for heart transplantation because of pulmonary hypertension related to HF alone should be considered for bridge to potential transplant eligibility with durable, long-term MCS."	IIA	B

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

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 2023.⁸³ 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 11 summarizes relevant recommendations for timing of acute MCS made in the guidelines. Additional recommendations related to specific devices is related to procedural considerations.

Table 11. ISHLT/HFSA Guideline on Acute Mechanical Circulatory Support

Recommendation	COR	LOE
"Acute MCS should be initiated as soon as possible in patients with CS who fail to stabilize or continue to deteriorate despite initial interventions."	I	B
"The use of acute MCS should be considered in patients with multiorgan failure to allow successful optimization of clinical status and neurologic assessment before placement of durable MCS or organ transplantation."	II	C

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.⁸⁴ 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.

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 12.

Table 12. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT01627821a	Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study	350	Mar 2025 (last updated Mar 2024)
NCT02387112	Early Versus Emergency Left Ventricular Assist Device Implantation in Patients Awaiting Cardiac Transplantation	102	Dec 2024 (last updated Oct 2023)
NCT04768322	Left Ventricular Assist Device (LVAD) Versus Guideline Recommended Medical Therapy in Ambulatory Advanced Heart Failure Patients (GDMT)	92	Feb 2029
Unpublished

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

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42. 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
43. 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
44. 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
45. 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
46. 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
47. 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
48. 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
49. 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
50. 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
51. 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
52. 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
53. 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
54. 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
55. 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
56. 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
57. 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
58. 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
59. 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
60. 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
61. 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.
62. 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
63. 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
64. Tariq MD, Jain H, Khan AM, et al. Efficacy and safety of percutaneous mechanical circulatory support in patients with cardiogenic shock following acute myocardial infarction: A meta-analysis of randomized controlled trials. Medicine (Baltimore). Nov 15 2024; 103(46): e40595. PMID 39560531
65. 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
66. 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
67. Bochaton T, Huot L, Elbaz M, et al. Mechanical circulatory support with the Impella® LP5.0 pump and an intra-aortic balloon pump for cardiogenic shock in acute myocardial infarction: The IMPELLA-STIC randomized study. Arch Cardiovasc Dis. Apr 2020; 113(4): 237-243. PMID 31740272
68. Møller JE, Engstrøm T, Jensen LO, et al. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. Apr 18 2024; 390(15): 1382-1393. PMID 38587239
69. 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
70. 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
71. 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
72. 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
73. 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
74. 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
75. 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
76. 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
77. 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
78. 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
79. 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
80. 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
81. 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
82. 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
83. 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
84. 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
85. 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 October 13, 2025.

Coding Section

Codes	Number	Description
CPT	33975	Insertion of ventricular assist device; extracorporeal, single ventricle
	33927-33929	Total Heart System code range
	33976	Insertion of ventricular assist device; extracorporeal, biventricular
	33977	Removal of ventricular assist device; extracorporeal, single ventricle
	33978	Removal of ventricular assist device; extracorporeal, biventricular
	33979	Insertion of ventricular assist device, implantable intracorporeal, single ventricle
	33980	Removal of ventricular assist device, implantable intracorporeal, single ventricle
	33990	Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; arterial access only
	33991	; both arterial and venous access, with transseptal puncture
	33992	Removal of percutaneous left heart ventricular assist device, arterial or arterial and venous cannula(s), at separate and distinct session from insertion
	33993	Repositioning of percutaneous right or left heart ventricular assist device with imaging guidance at separate and distinct session from insertion
	33995	Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; right heart, venous access only
	33997	Removal of percutaneous right heart ventricular assist device, venous cannula, at separate and distinct session from insertion
	0451T- 0463T	Placement and maintenance of permanent aortic counterpulation ventricular assistance devices code range (deleted eff 12/31/2021)
HCPCS	Q0478-Q0509	Code range for replacement LVAD parts and accessories
	L8698	Miscellaneous component, supply or accessory for use with total artificial heart system
ICD-10-CM	I09.81	Rheumatic heart failure
	I11.0	Hypertensive heart disease with heart failure
	I13.0	Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease
	I13.2	Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease
	I50.1-I50.9	Heart failure code range
	I97.0	Postcardiotomy syndrome
ICD-10-PCS	02RK0JZ + 02RL0JZ	Total artificial heart is reported with a “cluster” of 2 codes for open replacement with synthetic substitute of the right and left ventricles
	02HA0QZ, 02HA3QZ, 02HA4QZ	Surgical, heart and great vessels, insertion, heart, implantable heart assist system; open, percutaneous and percutaneous endoscopic approach codes
	02HA3RZ	Surgical, heart and great vessels, insertion, heart, percutaneous, external heart assist system
	02RK0JZ, 02RK4JZ, 02RL0JZ, 02RL4JZ	Surgical, heart and great vessels, replacement, ventricle, synthetic substitute; codes for left and right, and open and percutaneous endoscopic approaches
Type of service	Surgery
Place of service	Inpatient

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

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2024 Forward     

03/01/2026	Annual review, updating background, rationale and references.
03/01/2025	Annual review, no change to policy intent. Updating summary of evidence, background policy guidelines, rationale, table #15, and references.
03/27/2024	Annual review, no change to policy intent.
01/01/2024	New Policy.