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CurrentAetnaPolicy 0654

Ventricular Assist Devices

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Defines Aetna's medical necessity, investigational indications, and coding guidance for FDA‑approved ventricular assist devices (including implantable, percutaneous, pediatric, and right VADs) for members receiving circulatory support or awaiting transplant.

Policy Summary

PayerAetna

PolicyVentricular Assist Devices

Policy CodePolicy 0654

Change TypeNo material change

Effective DateMar 25, 2003

Last ReviewDec 6, 2023

Next Review DateJul 11, 2024

Key ActionObtain prior authorization confirming device FDA approval and that the patient meets destination therapy clinical criteria (NYHA Class IV, LVEF <25%, failed optimal medical therapy or dependence criteria, peak VO2 ≤14 ml/kg/min).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Multipledistinct device groups

>=20codes referenced

5 elementsdestination therapy thresholds

30 daysRVAD time limit

n=129REMATCH trial size

Coverage Criteria for Ventricular Assist Devices

Destination therapy (implantable VAD)

Covered when ALL of the following are met for implantable VAD destination therapy

Destination therapy criteria: 1) Device has received FDA approval for a destination therapy indication; 2) Member has NYHA Class IV end-stage ventricular heart failure and is not a candidate for heart transplant; 3) Member has failed to respond to optimal medical management (including beta-blockers and ACE inhibitors if tolerated) for at least 45 of the last 60 days, OR has been balloon pump dependent for 7 days, OR has been IV inotrope dependent for 14 days; 4) Left ventricular ejection fraction (LVEF) less than 25%; 5) Demonstrated functional limitation with a peak oxygen consumption (peak VO2) less than or equal to 14 ml/kg/min. Note: The peak VO2 requirement may be waived in persons who are balloon pump or IV inotrope dependent or are otherwise unable to perform exercise stress testing.see node text

Criteria may be waived in specified circumstances.

FDA‑approved indications (implantable, pVAD, pediatric, RVAD, Impella RP)

Covered when ANY of the following FDA‑approved indications apply

Policy Summary

PayerAetna

PolicyVentricular Assist Devices

Policy CodePolicy 0654

Change TypeNo material change

Effective DateMar 25, 2003

Last ReviewDec 6, 2023

Next Review DateJul 11, 2024

SourceLink

On This Page

FDA‑approved indications: 1) Bridge to transplant when the device has FDA approval for bridge-to-transplant use; 2) Destination therapy when all destination therapy criteria are met (see Destination therapy criteria); 3) FDA‑approved percutaneous VAD (pVAD) for short-term circulatory support in cardiogenic shock; 4) FDA‑approved pVAD use as prophylactic or rescue support during high‑risk percutaneous coronary intervention (PCI) in appropriately selected high‑risk anatomy/low EF patients (device-specific indications and anatomic/EF criteria apply); 5) FDA‑approved pediatric VAD for pediatric patients as a bridge to transplant when child has documented end‑stage ventricular failure and an age/size‑appropriate VAD will be used until donor heart available; 6) FDA‑approved RVAD for temporary right-sided support (device labeling/duration and anticoagulation ability required); 7) Impella RP per FDA labeling for temporary right‑sided support up to the labeled duration (e.g., up to 14 days) with body‑size considerations per device labeling.device FDA approval and device-specific clinical criteria

Clinical specifics and duration vary by device and indication; document FDA approval and indication for the chosen device.

Destination therapy (durable LVAD)

Destination therapy with a durable LVAD is covered when ALL of the following are met:

Destination therapy eligibility: 1. The device to be implanted has received FDA approval for a destination therapy indication; 2. Patient has NYHA Class IV end-stage ventricular heart failure and is not suitable for heart transplantation; 3. Patient has failed to respond to optimal medical management (including beta-blockers and ACE inhibitors if tolerated) for at least 45 of the last 60 days, OR is balloon pump dependent for 7 days, OR is IV inotrope dependent for 14 days; 4. Patient has a left ventricular ejection fraction (LVEF) less than 25%; 5. Patient has demonstrated functional limitation with a peak oxygen consumption (peak VO2) less than or equal to 14 ml/kg/min.see text

CMS removed prior BSA >1.5 m2 requirement; peak VO2 threshold increased from 12 to 14 ml/kg/min.

Short-term percutaneous/extracorporeal VAD support

Short-term percutaneous or extracorporeal VADs may be considered for temporary hemodynamic support in specified situations (bridge-to-recovery, high-risk PCI, cardiogenic shock):

Indications for short-term percutaneous/extracorporeal VAD support: Use of percutaneous or extracorporeal VADs (pVADs, TandemHeart, Impella systems, or temporary extracorporeal pumps) for short‑term bridge‑to‑recovery; prophylactic or rescue hemodynamic support during high‑risk PCI in patients with severely reduced LV function and appropriate anatomic considerations; or temporary circulatory support for cardiogenic shock when indicated. Note: Device selection and maximum intended duration depend on device labeling (e.g., Impella periprocedural use measured in hours for high‑risk PCI; Impella RP and CentriMag intended for temporary right‑sided support with labeled short‑term durations).device-dependent

Document indication, device model, and intended short-term duration per FDA labeling and clinical justification.

The policy identifies several procedures as experimental and investigational. Specifically, concomitant mitral valve surgery performed at the time of LVAD implantation for the purpose of treating mitral regurgitation is listed as investigational. In addition, permanently implantable aortic counter‑pulsation VAD systems (for example, the NuPulseCV iVAS and the Symphony Heart Assist System) are considered not medically established and therefore investigational. Mesenchymal precursor cell therapy used adjunctively in VAD recipients is also listed as investigational.

The Centers for Medicare & Medicaid Services (CMS) reviewed destination therapy eligibility and declined to expand coverage to NYHA Class IIIb patients because the pivotal trial evidence contained only a small proportion of Class IIIb patients (about 20%) with no subgroup results reported and because the Class IIIb subclassification is not broadly accepted or reliably identifiable in routine practice. The policy cites these CMS findings when describing why destination therapy coverage remains focused on patients meeting the policy’s NYHA Class IV and other defined thresholds.

The policy notes important limitations in the current evidence base. Many comparative and device-outcome data come from observational registries and retrospective analyses that lack granular hemodynamic details (for example, right heart catheterization values, vasopressor use, lactate) at the time of device selection. These sources are susceptible to residual confounding and selection bias, reducing certainty about device-specific benefits. Systematic reviews and meta-analyses of micro-axial LVADs report heterogenous observational data and call for randomized trials to clarify effectiveness and safety.

The policy records device-specific contraindications drawn from manufacturer labeling and regulatory summaries. The HeartWare™ HVAD™ System is explicitly noted as contraindicated in patients who cannot tolerate anticoagulation therapy, and the policy cites the device labeling to support this safety-related restriction.

Renal disease is highlighted as a major prognostic consideration for LVAD candidacy. The policy references reviews reporting that an estimated GFR below 30 ml/min/1.73 m2 (stage 4 CKD) is a general contraindication, and that patients on chronic dialysis (end-stage renal disease) have been treated as an absolute contraindication in some reports due to markedly worse outcomes.

Aetna considers use of VADs, including implantable LVADs, percutaneous VADs (pVADs), pediatric VADs, and RVADs, for indications that do not meet the policy’s specific FDA‑approved or stated clinical criteria to be experimental and investigational. Such uses do not meet the medical‑necessity standards in this policy and may be denied when submitted for coverage.

The policy does not support routine use of percutaneous LVADs as the first-line mechanical strategy for cardiogenic shock. Meta-analysis and large registry studies show improved hemodynamics but do not demonstrate improved early survival compared with intra-aortic balloon pump (IABP). Observational data have shown higher in-hospital mortality and bleeding with intra‑vascular micro‑axial LVADs versus IABP in AMI complicated by cardiogenic shock, leading the policy to conclude that pVADs are not supported as first‑line therapy based on current evidence.

Comparative-effectiveness evidence summarized in the policy indicates that micro‑axial LVADs have not demonstrated a mortality benefit relative to extracorporeal membrane oxygenation (ECMO) or intra‑aortic balloon pump (IABP). Systematic reviews and large observational studies report similar or higher short‑term mortality and higher complication rates (including bleeding) with micro‑axial devices versus IABP, and the authors conclude that current evidence is insufficient to establish superiority of micro‑axial LVADs over ECMO or IABP.

Coding and Clinical Thresholds

Covered CPT CodesCPTCovered

33975	Insertion of ventricular assist device; extracorporeal, single ventricle.
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 ventricular.
33981	Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump.
33982	Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass.
33983	Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass.
33990	Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; arterial access only.

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CPT Codes Not Covered (aortic counterpulsation devices)CPTNot Covered

0451T	Insertion or replacement of a permanently implantable aortic counterpulsation ventricular assist system, endovascular approach, and programming of sensing and therapeutic parameters.
0452T	Insertion or replacement of a permanently implantable aortic counterpulsation ventricular assist system, endovascular approach, and programming of sensing and therapeutic parameters. (series 0451T-0454T)
0455T	Removal of permanently implantable aortic counterpulsation ventricular assist system.
0459T	Relocation of skin pocket with replacement of implanted aortic counterpulsation ventricular assist device, mechano-electrical skin interface and electrodes.

Covered HCPCS Codes (supplies/accessories)HCPCSCovered

Q0477	Power module patient cable for use with electric or electric/pneumatic ventricular assist device, replacement only.
Q0478	Power adapter for use with electric or electric/pneumatic ventricular assist device, vehicle type.
Q0479	Power module for use with electric or electric/pneumatic ventricular assist device, replacement only.
Q0480	Driver for use with pneumatic ventricular assist device, replacement only.
Q0481	Microprocessor control unit for use with electric ventricular assist device, replacement only.
Q0482	Microprocessor control unit for use with electric/pneumatic combination ventricular assist device, replacement only.
Q0483	Monitor/display module for use with electric ventricular assist device, replacement only.
Q0484	Monitor/display module for use with electric or electric/pneumatic ventricular assist device, replacement only.
Q0485	Monitor control cable for use with electric ventricular assist device, replacement only.
Q0486	Monitor control cable for use with electric/pneumatic ventricular assist device, replacement only.

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Covered ICD-10 CodesICD-10Covered

I23.0 - I23.9	Certain current complications following ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction (within the 28 day period).
I50.1 - I50.9	Heart failure.
I97.0	Postcardiotomy syndrome.
I97.110	Postprocedural cardiac insufficiency following cardiac surgery.
R57.0	Cardiogenic shock.
Z76.82	Awaiting organ transplant status [awaiting heart transplant].
Z95.811	Presence of heart assist device.

ICD-10 Codes Not Covered for Indications ListedICD-10Not Covered

I05.1	Rheumatic mitral insufficiency [mitral repair].
I34.0	Nonrheumatic mitral (valve) insufficiency [mitral repair].

FDA PMA/HDE/510(k) references citedmixed

P100047	HeartWare Ventricular Assist System PMA No. P100047
P140003	Impella 2.5 System PMA No. P140003
K016723	Impella Recover LP 2.5 510(k) K016723
H140001	Impella RP System HDE No. H140001
H070004	CentriMag Right Ventricular Assist System HDE No. H070004
H100004	EXCOR Pediatric VAD Humanitarian Use Device H100004
P160054	Thoratec HeartMate 3 PMA No. P160054
P060040	Thoratec HeartMate II PMA No. P060040
K083111	Impella 5.0 510(k) K083111

inv-20: Peak oxygen consumption (peak VO2) — clinical threshold

Peak VO2 threshold<= 14 ml/kg/min (functional limitation criterion for destination therapy); may be waived if balloon pump or IV inotrope dependent or unable to perform exercise testing.

Alternate waived conditionsPeak VO2 requirement may be waived for patients who are balloon pump dependent or IV inotrope dependent, or unable to complete exercise testing.

CMS adjustment noteCMS increased peak VO2 threshold from 12 to 14 ml/kg/min in destination therapy criteria.

inv-21: Left ventricular ejection fraction (LVEF) — clinical threshold

LVEF thresholdLess than 25% required for destination therapy eligibility.

Role in criteriaOne of five required destination therapy elements (device FDA approval, NYHA IV, failed medical therapy, LVEF <25%, peak VO2 ≤14 ml/kg/min).

CMS phrasingStated as 'left ventricular ejection fraction (LVEF) less than 25%'.

inv-22: RVAD duration — clinical/time limit

RVAD maximum durationUp to 30 days for temporary circulatory support in cardiogenic shock due to acute right ventricular failure.

Anticoagulation requirementMember must be willing and able to be treated with heparin or an appropriate alternative anticoagulant during RVAD support.

Example deviceCentriMag Right Ventricular Assist System cited as FDA-approved for temporary use up to 14 days (note: policy text specifies RVADs up to 30 days as medically necessary when criteria met).

inv-23: Impella RP support duration and BSA — duration and body-surface-area requirement

Impella RP maximum durationUp to 14 days of temporary circulatory support.

Body surface area requirementIntended for use in individuals with body surface area (BSA) ≥ 1.5 m2.

IndicationsUse for right heart failure or decompensation following LVAD implantation, MI, heart transplant, or open heart surgery.

inv-24: Failed optimal medical management duration — required trial durations before LVAD

Required trial durationFailed optimal medical management for at least 45 of the last 60 days is required prior to destination therapy implantation.

Alternative dependence criteriaCriterion can be met instead by balloon pump dependence for 7 days or IV inotrope dependence for 14 days.

Medical therapy componentsOptimal medical management includes beta-blockers and ACE inhibitors if tolerated.

inv-25: Peak oxygen consumption (peak VO2) duplicate threshold entry

Peak VO2 duplicate entryPeak oxygen consumption ≤ 14 ml/kg/min is required for destination therapy (duplicate threshold entry consistent with primary criterion).

Waiver conditions notedMay be waived for balloon pump or IV inotrope dependent patients or those unable to perform exercise testing.

CMS threshold changeThreshold increased from 12 to 14 ml/kg/min per CMS policy adjustments.

inv-26: Left ventricular ejection fraction (LVEF) duplicate threshold entry

LVEF duplicate entryLeft ventricular ejection fraction < 25% repeated as a required destination therapy threshold.

Context in criteria setOne of the five mandatory elements for durable LVAD destination therapy eligibility.

Documentation requirementLVEF <25% should be documented in prior authorization/medical record to support device implantation.

inv-27: Temporary support duration — up to 14 days

Temporary support upper limitTemporary VADs (e.g., CentriMag, Impella RP) are described for intended use up to 14 days.

Device examplesCentriMag (extracorporeal centrifugal pump) and Impella RP (right percutaneous device) cited in context of temporary support durations.

Policy distinctionSome RVAD policy language allows up to 30 days for RVADs when criteria are met; shorter device-specific approvals (e.g., CentriMag/Impella RP up to 14 days) are also noted.

inv-28: eGFR threshold for LVAD contraindication — eGFR < 30 ml/min/1.73 m2 noted as general contraindication

eGFR contraindication thresholdEstimated GFR less than 30 ml/min/1.73 m2 (stage 4 CKD) is noted as a general contraindication to LVAD implantation in the literature.

Dialysis/ESRD considerationPatients on dialysis (ESRD) are reported in some studies as an absolute contraindication to LVAD implantation.

Prognostic implicationPoor prognosis in LVAD recipients with ESRD may affect appropriateness determinations and require shared decision-making.

Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for VAD procedures and supplies when medical necessity criteria are being claimed. Prior authorization requests should confirm FDA approval for the chosen device and that the member meets the applicable clinical criteria (e.g., destination therapy labeling, NYHA class, prior medical management, LVEF, peak VO2 or documented dependence on balloon pump/IV inotropes). Failure to document FDA approval status and alignment with labeled indications may affect coverage determination.

Prior authorization required for listed VAD procedure and supply codes when medical necessity is claimed (see CPT/HCPCS code lists).
Confirm device has FDA approval for the requested indication (bridge to transplant, destination therapy, temporary support, pediatric indication, etc.).

Prior Authorization

Prior Authorization: Temporary VADs (up to 14 days)

Temporary-use VADs intended for short-term circulatory support (examples: CentriMag, Impella RP) are described for use up to 14 days for indicated acute right ventricular failure or post-operative support. Prior authorization should reflect the temporary nature and the FDA-labeled duration of use.

CentriMag: FDA HDE approved for temporary support up to 14 days for cardiogenic shock due to acute RV failure.
Impella RP: intended for temporary support up to 14 days for adults/pediatrics (BSA ≥ 1.5 m2) in specified settings.

Prior Authorization

Authorization Aligned with FDA Indications

Authorization decisions must align with FDA-approved indications for devices. Use of devices or indications not approved by the FDA or not listed in this policy should be considered experimental/investigational and are not covered.

Examples: Destination therapy and bridge-to-transplant indications require device-specific FDA labeling (e.g., HeartMate 3, HeartMate II).
Off-label use of pVADs or pediatric VADs outside specified medically necessary criteria is considered experimental/investigational.

Documentation Required

Concomitant Aortic Valve Procedures Require Documented Justification

When a concomitant aortic valve procedure is planned at the time of LVAD implantation, documentation must justify the indication for the valve procedure and include evidence of discussion of increased perioperative risk and alternative approaches. Concurrent aortic valve procedures have been associated with higher short-term mortality and reduced long-term survival compared with isolated LVAD implantation.

Document the specific indication for the aortic valve procedure (repair, replacement, closure) and pre-procedure aortic insufficiency severity.
Document that risks and benefits, including higher short-term mortality and longer cardiopulmonary bypass time, were discussed with the patient/caregiver.

Note

Prior Authorization — Not Specified in This Section

This section does not specify additional separate prior authorization pathways beyond the requirement to consult the main policy and applicable plan/program provisions. Providers should consult the main policy, plan disclosures, and program provisions for operational details (submission portals, timelines, and local plan rules).

If in doubt, submit clinical documentation with the authorization request per the main policy guidance and plan-specific instructions.
Refer to plan disclosures and program provisions for member-specific coverage rules.

Note

Prior Authorization — See Main Policy

Providers should consult the main VAD policy and plan documents for full prior authorization instructions, submission checklists, and any network- or plan-specific requirements.

See main policy and plan disclosures for how to initiate prior authorization and for any state- or product-specific exceptions.

Denial Risk

Use of a VAD for Indications Other Than FDA‑Approved/Policy‑Listed

Use of a VAD for indications other than FDA‑approved or policy-listed indications is considered experimental and investigational and is not covered due to insufficient evidence.

Off-label uses lacking peer-reviewed evidence are not covered.
Provide clinical trial identifiers or strong evidence if pursuing coverage for novel indications; otherwise, expect denial as investigational.

Documentation Required

Observational Data Limitations May Trigger Review

Observational and registry data have limitations (residual confounding, limited granular hemodynamic/lab data, device heterogeneity) that may prompt additional review or requests for more detailed documentation to support medical necessity.

Registry/retrospective studies may not capture the clinical status at decision time (vasopressor use, lactate, right heart cath measurements).
Be prepared to provide detailed hemodynamics, timing of device placement, and rationale when observational evidence is used to support requests.

Note

HVAD Safety / Market Withdrawal

The HeartWare (HVAD) system distribution and sale were stopped by the manufacturer due to safety concerns (increased neurological adverse events and mortality) and device-specific pump failure risks. Providers must account for this market withdrawal when requesting authorization and should document device availability and safety considerations.

Medtronic stopped distribution/sale of the HeartWare HVAD System (August 2021) due to increased risk of neurologic events and mortality.
If HVAD or other withdrawn devices are proposed, include justification and mention alternative FDA‑approved devices.

Documentation Required

LVAD in ESRD — Prognostic Consideration

For members with end-stage renal disease (ESRD) being considered for LVAD placement, document the poor prognosis and engage in shared decision-making; the markedly increased early mortality may affect appropriateness and coverage considerations.

Studies report very high early mortality in ESRD patients after LVAD placement (median time to death often measured in days; significantly higher in-hospital mortality).
Document counseling regarding prognosis and treatment goals when ESRD is present.

Note

No Denial Triggers Are Specified in This Section

No specific denial triggers are enumerated in this section beyond the general statements that non–FDA‑approved or investigational uses are not covered. Providers should recognize that absence of required documentation or failure to meet stated clinical criteria may result in denial.

There are no additional explicit provider-level denial triggers listed here; however, lack of required documentation or nonalignment with FDA/policy criteria may prompt denial.
If coverage is denied, providers can appeal with supplemental clinical evidence aligning to policy criteria.

Note

No Denial Triggers or Authorization Requirements in Additional-Information Sections

Similarly, no separate denial triggers or additional authorization requirements are listed in the Additional Information sections; operational or plan-level requirements should be confirmed with the main policy and plan documents.

Check plan disclosures and program provisions for any member- or product-specific denial or authorization rules.

Documentation Required

Documentation Should Support FDA Approval and Clinical Status

Documentation submitted with authorization requests should explicitly support FDA approval status and demonstrate the member meets clinical criteria: NYHA class, LVEF, duration and failure of optimal medical management, peak VO2 results or objective dependence on inotropes/balloon pump, and device model and indication.

Document NYHA functional class, LVEF (%) and peak VO2 (ml/kg/min) if available.
If exercise testing not possible, document inotrope or balloon pump dependence with duration (e.g., 7 days for balloon pump, 14 days for IV inotropes).
Confirm and document device model and its FDA-labeled indication.

Documentation Required

Recommended Clinical Documentation Elements

Recommended clinical documentation elements to include with prior authorization: detailed hemodynamics, vasopressor/inotrope use and duration, lactate, right-heart catheterization measurements, device model, timing of device placement, and peri-procedural details.

Right heart cath values (RAP, PAP, PCWP, cardiac index), PAPi and other RV failure predictors.
Timing of events (onset of shock, device insertion date), vasopressor doses and duration, lactate trends, and prior ECMO/renal replacement therapy if applicable.

Documentation Required

Device Trial Documentation

When authorization is supported by device trial data, provide trial-supported indications and relevant cohort characteristics (including pediatric cohorts and body-surface-area groups) to demonstrate applicability to the member.

Include IDE or post-approval study identifiers and outcomes if relying on trial evidence (e.g., Excor pediatric IDE cohorts by BSA).
Document how the member’s characteristics align with trial cohorts (age, BSA, severity).

Documentation Required

Pre-Implant RV Failure Risk Documentation

Pre-implant assessment should document risk factors for post-LVAD right ventricular failure (RVF) — include INTERMACS profiles, need for pre-op ECMO or renal replacement therapy, severe tricuspid regurgitation, prior cardiac surgery, and hemodynamic predictors (elevated RAP, low PAPi, low stroke volume).

Report INTERMACS profile, pre-op support (ECMO, IABP), renal replacement therapy status, and echocardiographic/tricuspid regurgitation findings.
Provide calculated PAPi and other RVF risk indices where available.

Note

No Documentation Requirements Are Specified Beyond Those Listed

This section does not specify separate or additional documentation requirements beyond the clinical items listed above; submit those standard elements with authorization requests.

If specific plan or state rules impose additional documentation requirements, include those per main policy guidance.

Documentation Required

Medical Therapy Trial

Prior to LVAD implantation for destination therapy, members must have failed optimal medical management (including beta-blockers and ACE inhibitors if tolerated) for at least 45 of the last 60 days, or meet alternative dependency criteria (7 days balloon pump, 14 days IV inotropes). Evidence of attempted optimal medical therapy should be provided.

Document medication trials, doses, and durations (e.g., beta-blocker, ACE inhibitor) covering at least 45 of the last 60 days when applicable.
Alternatively document documented balloon pump or IV inotrope dependence with duration.

Step Therapy

Step Approach Recommendation — Consider IABP Before Micro-Axial LVAD (Evidence Context)

Given comparative evidence suggesting higher in-hospital mortality and bleeding with intra-vascular micro-axial LVADs versus IABP in some AMI/CS cohorts, consider a step approach (e.g., IABP before micro-axial LVAD) where clinically appropriate; document rationale for device selection.

If bypassing IABP in favor of a micro-axial device (Impella), provide clinical justification and supporting hemodynamics.
Recognize observational evidence limitations and document why the selected device is optimal for the individual patient.

Step Therapy

There are no formal step-therapy sequencing requirements specified in this policy (no mandatory trials of another device prior to approval), but clinical judgement and documentation supporting device choice are expected.

Providers should document rationale if an alternative device or escalation was not attempted.
Authorization reviewers may request additional justification when step choices deviate from common practice.

Documentation Required

Pediatric Anti-Thrombotic Plan

For pediatric durable VAD candidates, include a planned anti-thrombotic regimen and monitoring plan in the documentation due to high bleeding and thrombotic event rates and variability in practice.

Document perioperative and long-term anticoagulation strategy (e.g., unfractionated heparin transitioning to LMWH/warfarin) and antiplatelet plan (aspirin, dipyridamole where applicable).
Include monitoring plans and laboratory targets given pediatric monitoring challenges.

Background and Context

Ventricular assist devices (VADs) are mechanical pumps that support the left or right ventricle. Implantable left ventricular assist devices (LVADs) provide long‑term circulatory support and are used as a bridge to transplant or as destination therapy in patients not eligible for transplant. Percutaneous VADs (pVADs) such as TandemHeart and Impella are catheter‑delivered, short‑term devices intended for temporary circulatory support (for example, during cardiogenic shock or high‑risk PCI). Temporary extracorporeal RVADs and percutaneous right‑sided devices (e.g., Impella RP) are described for short durations (up to 14 to 30 days depending on device) to manage acute right ventricular failure.

Definitions and Device Types

inv-59: Left ventricular assist device (LVAD) — definition

LVAD definitionA mechanical pump that assists or replaces left ventricular function to provide blood flow throughout the body; commonly implantable and used as bridge to transplant or destination therapy.

Variants describedDevices vary by pump type (centrifugal vs pulsatile), location (extracorporeal vs implantable), and intended duration (short-term vs long-term).

Common usesUsed for reversible cardiac dysfunction, bridge to transplant, or permanent support in end-stage heart failure (destination therapy).

inv-60: Percutaneous VAD (pVAD) — definition

pVAD definitionA short-term, catheter-delivered circulatory support device placed via vascular access without open-chest surgery, e.g., Impella and TandemHeart.

Placement approachCan be placed via cardiac catheterization and may use trans-septal access to the left ventricle, avoiding open-chest surgery.

Typical useUtilized for short-term bridge-to-recovery, support in cardiogenic shock, or as adjunct during high-risk PCI.

inv-61: Percutaneous ventricular assist device (pVAD) examples — catheter-delivered devices

Catheter-delivered examplesImpella 2.5, Impella 5.0, Impella CP, Impella Recover LP 2.5, and TandemHeart PTVA System cited as examples of pVADs.

FunctionalityProvide temporary hemodynamic support; Impella devices use an intravascular micro-axial pump to aspirate blood from the LV and expel into the aorta.

Clinical contextsUsed for short-term bridge-to-recovery, massive MI, sudden heart failure, or as bridge to further interventions or transplantation.

inv-62: Destination therapy definition — permanent implantation for non-transplant candidates

Destination therapy (DT) definitionPermanent implantation of an LVAD for patients with end-stage heart failure who are not candidates for heart transplantation.

FDA examplesDevices such as HeartMate II and HeartWare HVAD historically listed as destination therapy devices in FDA approvals and trials referenced.

Policy contextDestination therapy coverage requires meeting all specified clinical thresholds (NYHA Class IV, failed medical therapy, LVEF <25%, peak VO2 ≤14 ml/kg/min, device FDA approval).

inv-63: Temporary VAD duration — devices like CentriMag and Impella RP up to 14 days

Temporary VAD duration standardDevices such as CentriMag and Impella RP are described as intended for temporary circulatory support for up to 14 days.

Device typesCentriMag is an extracorporeal centrifugal pump; Impella RP is a percutaneous right-sided device for temporary support.

Use casesIndicated for cardiogenic shock due to acute right ventricular failure or post-operative decompensation as temporary support.

inv-64: Excor Pediatric VAD (HDE) — pediatric device under HDE

Excor Pediatric VAD statusEXCOR Pediatric VAD approved under Humanitarian Device Exemption (HDE) for pediatric patients with severe isolated left or biventricular dysfunction awaiting transplant.

Cohort sizingIDE trial divided patients into cohorts by BSA (cohort 1 <0.7 m2; cohort 2 0.7 to <1.5 m2) with 24 patients in each group.

Adverse events observedReported serious adverse events included major bleeding, infection, and stroke in pediatric cohorts.

inv-65: Destination therapy (DT) — policy context for implantable VAD as permanent therapy

DT policy contextImplantable VAD used as permanent therapy in patients not eligible for transplant; coverage contingent on meeting the full destination therapy criteria.

FDA approval linkageDevice must have FDA approval for destination therapy (policy cites HeartMate II, HeartMate 3 among examples).

Coverage elementsRequired documentation includes NYHA class, LVEF, peak VO2, and failed medical management duration as part of authorization review.

inv-66: Bridge to transplantation (BTT) — definition and context

Bridge to transplantation (BTT) definitionUse of a VAD to provide hemodynamic support until a patient can undergo heart transplantation.

Device examplesMultiple devices (e.g., Abiomed AB5000, HeartMate series, EXCOR Pediatric VAD) cited as FDA-approved for bridge-to-transplant indications.

Clinical purposeImproves survival to transplantation and functional status prior to transplant surgery.

inv-67: NYHA functional classes — brief class definitions

NYHA Class INo symptoms and no limitation in ordinary physical activity.

NYHA Class IIMild symptoms and slight limitation during ordinary activity.

NYHA Class IIIMarked limitation in activity due to symptoms; comfortable only at rest.

NYHA Class IVSevere limitations; experiences symptoms at rest (primary functional class for destination therapy).

inv-68: Pulmonary artery pulsatility index (PAPi) — hemodynamic parameter for RV function risk assessment

PAPi purposePulmonary artery pulsatility index (PAPi) is a hemodynamic parameter used to assess right ventricular function and predict post-LVAD RV failure.

Predictive valueLower pre-operative PAPi is associated with higher risk of right ventricular failure after LVAD implantation (systematic review findings).

Recommended usePAPi should be used alongside other hemodynamic parameters when risk-stratifying LVAD candidates for RV failure risk.