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CurrentAetnaPolicy 0791

Cardiac Devices and Procedures for Occlusion of the Left Atrial Appendage

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Defines Aetna's medical necessity, experimental/investigational exclusions, provider and site requirements, and coding guidance for left atrial appendage closure (LAAC) devices and procedures in patients with non-valvular atrial fibrillation.

Policy Summary

PayerAetna

PolicyCardiac Devices and Procedures for Occlusion of the Left Atrial Appendage

Policy CodePolicy 0791

Change TypeMinorno material clinical or coverage changes

Effective DateJul 24, 2009

Last ReviewJan 9, 2024

Next Review DateSep 12, 2024

Key ActionObtain and document formal shared decision-making with an independent non-interventional physician prior to LAAC.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CHADS2 >=2 or CHA2DS2-VASc >=3stroke risk threshold

>=25min transseptal procedures

>=12LAAC volume (2 yrs)

45 daysshort-term anticoagulation

Watchman; Amplatzer AmuletFDA-referenced devices

07/24/2009policy effective

Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following are met:

Coverage criteria for LAAC (NVAF): 1) Device has FDA PMA for the device's FDA-approved indication; AND 2) Member has CHADS2 >= 2 OR CHA2DS2-VASc >= 3; AND 3) Documented formal shared decision-making interaction with an independent non-interventional physician using an evidence-based decision tool, recorded in the medical record; AND 4) Member is suitable for short-term dual antiplatelet therapy or warfarin for 45 days and long-term aspirin but is deemed unable to take long-term oral anticoagulation for one or more specified reasons (thromboembolism while on therapeutic OAC; major bleed while on therapeutic OAC; HAS-BLED >=3; or other absolute contraindication to long-term anticoagulation); AND 5) Member (pre- and post-op) is under the care of a cohesive multidisciplinary team; AND 6) Procedure is furnished in a hospital with an established structural heart disease and/or electrophysiology program; AND 7) Procedure is performed by interventional cardiologist(s), electrophysiologist(s), or cardiovascular surgeon(s) who: a) received manufacturer training on device use; b) have performed >=25 interventional cardiac procedures involving transseptal puncture through an intact septum; AND c) continue to perform >=25 such procedures, of which at least 12 are LAAC, over a two-year period.

Coverage-related candidate selection

Consider device-based LAA occlusion when ALL of the following are met (per trial populations and expert commentary):

Policy Summary

PayerAetna

PolicyCardiac Devices and Procedures for Occlusion of the Left Atrial Appendage

Policy CodePolicy 0791

Change TypeMinorno material clinical or coverage changes

Effective DateJul 24, 2009

Last ReviewJan 9, 2024

Next Review DateSep 12, 2024

Key ActionObtain and document formal shared decision-making with an independent non-interventional physician prior to LAAC.

SourceLink

On This Page

Patient selection: Non-valvular atrial fibrillation (NVAF) with elevated stroke risk (eg, prior stroke/TIA, congestive heart failure, diabetes, hypertension, or age >=75) or CHADS2/CHA2DS2-VASc scores consistent with trial enrollmentas in Holmes et al and observational cohorts

supported by trial enrollment criteria

Indication rationale: Either: (1) patient is ineligible for long-term oral anticoagulation because of bleeding risk/contraindication OR (2) patient meets trial-equivalent indication and accepts procedural risk as an alternative to warfarin

randomized trials enrolled warfarin-eligible patients while many registries enrolled warfarin-ineligible patients

Center/operator requirements: Procedure to be performed at centers with operator experience and appropriate imaging support (TEE/fluoroscopy) due to significant learning curve and procedure-related complication rates

Maisel and other series noted higher complications at less-experienced centers

Imaging confirmation and follow-up: Baseline and serial imaging (intra-procedural TEE, 45-day and later TEE/CTA) to document device position and residual peri-device leak; ongoing surveillance as per study protocols

multiple studies used TEE at set intervals

Coverage rationale and considerations

Covered when ALL of the following are met (clinical context supported by cited studies and guidance):

Patient selection

Anticoagulation suitability: Either patient is a candidate for anticoagulation but seeks an alternative to long-term warfarin OR patient has contraindication/intolerance to long-term oral anticoagulationas described in ASAP and expert statements
Documented in trials and reviews

ref":"b0_3","title":"Coverage conditions (evidence-informed)"},{

citations":["72","73","74","75","84"],"intro":"Evidence-based considerations and groups described in the document","nodes":["{\"operator\":\"all\",\"label\":\"Devices with RCT support (Watchman)\",\"text\":\"Use of the Watchman device is supported by randomized trials (PROTECT AF, PREVAIL) showing comparable stroke prevention to warfarin and reductions in hemorrhagic stroke and bleeding in longer-term follow-up.\",\"children\":[]}","{\"operator\":\"all\",\"label\":\"Devices with limited RCT data (Amplatzer ACP/Amulet, Lariat)\",\"text\":\"Evidence for Amplatzer Cardiac Plug, Amplatzer Amulet, and Lariat devices is primarily from non-randomized registries and observational series; comparative RCT data are limited.\",\"children\":[]}","{\"operator\":\"all\",\"label\":\"Surgical LAAO during concomitant cardiac surgery\",\"text\":\"Concomitant surgical LAA occlusion during cardiac surgery has been associated in meta-analysis with lower risk of embolic events and stroke without significant increase in perioperative complications, but further RCTs are needed.\",\"children\":[]}","{\"operator\":\"all\",\"label\":\"Applicability caveats\",\"text\":\"Trial populations required ability to tolerate short-term OAC and post-implant anticoagulation; therefore trial results may not generalize to patients with true contraindications to OAC and comparisons versus NOACs are limited.\",\"children\":[]}","{\"operator\":\"all\",\"label\":\"Imaging and procedural considerations\",\"text\":\"Pre-procedure TEE/CT imaging is used to assess LAA anatomy and device suitability; device-related leaks and device-related thrombosis are recognized complications detectable on CT/TEE and relate to device positioning and anatomy.\",\"children\":[]}"],"ref":"b0_4","title":"Evidence-based coverage considerations"},{

citations":["122","109","117"],"intro":"Coverage-aligned clinical considerations and evidence elements reported in this section include:","nodes":["{\"operator\":\"all\",\"label\":\"General coverage-aligned considerations\",\"text\":\"Patient has non-valvular atrial fibrillation and is at increased risk for stroke (eg, elevated CHADS2 or CHA2DS2-VASc score); device therapy considered when patient has an appropriate rationale for a non-pharmacologic alternative and is suitable for short-term anticoagulation as per device indications. Contraindications include intracardiac thrombus, active endocarditis/bacteremia, or anatomic interference with intracardiac/intravascular structures.\",\"children\":[]}","{\"operator\":\"any\",\"label\":\"Situations supported by evidence where LAAO may be preferred\",\"text\":\"Patients with absolute or relative contraindications to long-term oral anticoagulation, or those with prior major bleeding, where percutaneous LAAO offers an alternative to reduce stroke risk, supported by registry and meta-analysis data in selected cohorts.\",\"children\":[]}","{\"operator\":\"all\",\"label\":\"Expected follow-up and outcomes evidence\",\"text\":\"Post-implant TEE follow-up (commonly at 1–3 months) to assess residual leak (<3 mm jet defined as adequate occlusion) and to evaluate for device-related thrombus; registry data report high implant success and adequate occlusion rates in short-term follow-up.\",\"children\":[]}"],"ref":"b0_5","title":"Coverage considerations and evidence summary"}]}{

INVALID JSON

Aetna considers exclusion of the left atrial appendage (LAA) performed alone during open heart surgery (for example, clip, excision, stapling, ligation, oversewing, or plication performed as a standalone procedure) to be experimental and investigational for stroke prevention in atrial fibrillation. This determination does not apply when an FDA‑approved percutaneous LAA closure device is used in conjunction with cardiac surgery for treatment of non‑valvular atrial fibrillation; however, standalone surgical exclusion without supporting evidence is not covered.

Percutaneous left atrial appendage closure using devices other than the Amplatzer Amulet or the Watchman device (for example, the Amplatzer Cardiac Plug, AtriClip, or Lariat Suture Delivery Device) is considered experimental and investigational and is not supported for coverage based on the available evidence and device approvals.

Routine use of LAA occlusion techniques outside of controlled research or special arrangements is not recommended until longer‑term safety and effectiveness are established. Multiple reviewers and commentators have highlighted major safety concerns, incomplete data, and the need for larger randomized trials before substituting device‑based LAA occlusion for standard anticoagulation in broad populations.

For primary stroke prevention in patients who are eligible for and tolerating anticoagulation, percutaneous LAA closure lacks convincing randomized controlled trial evidence of benefit versus anticoagulation; major assessments have concluded that RCT data do not demonstrate clear noninferiority or superiority to anticoagulation for patients without contraindications. Therefore, device therapy should not routinely replace anticoagulation in patients who can receive and tolerate medical therapy.

Devices used off‑label for LAA occlusion (for example, the LARIAT system) do not have FDA approval specifically for LAA closure and have documented safety concerns reported by regulatory agencies and in the literature. Use of such off‑label devices for LAAO is considered investigational and may be excluded from coverage.

Results from randomized trials (e.g., Watchman PROTECT AF/PREVAIL) enrolled patients who were able to tolerate short‑term oral anticoagulation and therefore do not necessarily generalize to patients with true contraindications to long‑term anticoagulation. Caution is warranted when extrapolating trial findings to patients who could not have met the original trial eligibility criteria.

Evidence is insufficient to evaluate the efficacy and safety of surgically implanted LAA clips (for example, AtriClip) as a substitute for anticoagulation. Systematic reviews and health‑technology assessments report heterogeneous techniques, variable success rates, and limited high‑quality comparative data; therefore, surgical clipping for stroke prevention lacks sufficient evidence to support routine coverage as a primary therapy.

Device placement is contraindicated and would likely preclude coverage when there is evidence of intracardiac thrombus, active endocarditis or other infections producing bacteremia, or when placement would interfere with other intracardiac or intravascular structures; these contraindications are specified for the Amplatzer Amulet device labeling.

Current guidelines do not recommend interventional or surgical LAA occlusion as a management strategy specifically for patients with documented NOAC failure; the role of occlusion in the setting of NOAC failure remains uncertain and requires further study and guideline development.

The provided excerpt does not list additional explicit coverage exclusions beyond those already stated, and notes that some authoritative reviews (for example, an UpToDate review) do not mention the AtriClip/clipping device as a standard management option.

A published statement in the literature emphasizes that left atrial appendage occlusion does not eliminate the need for warfarin; device‑based strategies should not be assumed to obviate anticoagulation without careful consideration of the evidence and clinical context.

Cardiac devices and procedures for occlusion of the left atrial appendage that do not meet the stated medical necessity criteria are considered experimental and investigational. This includes technologies and indications beyond those explicitly identified as FDA‑approved (Watchman, Amplatzer Amulet) and supported by trial evidence.

Overall, LAA occlusion is not supported as a routine alternative to warfarin by conclusive long‑term evidence for most patients and remains investigational except in carefully selected patients (for example, those with contraindications to long‑term anticoagulation) or within clinical trials. Ongoing and future randomized studies are needed to define the role of LAAO versus contemporary anticoagulants.

Routine adoption of novel LAA occlusion techniques without randomized comparative evidence and longer‑term outcome data is not supported. Case series are subject to selection bias and limited follow‑up; safety signals and procedural complications underscore the need for randomized trials before broad dissemination of new techniques.

For Medicare beneficiaries, routine percutaneous LAA closure is considered not reasonable and necessary outside approved clinical trials per the CMS National Coverage Determination; CMS allows coverage only under specified clinical trial (CED) conditions given current evidence limitations.

Evidence is limited regarding LAAO use in patients who are completely contraindicated to oral anticoagulation; registries and observational series suggest potential benefit but are insufficient to support broad application without more robust studies specifically enrolling this population.

Incomplete or variable surgical LAA closure techniques (for example, stapler exclusion and some suture methods) have demonstrated high failure rates and may be associated with continued stroke risk; procedures with known low success rates are considered unsupported until better evidence or technique standardization is available.

Use of AtriClip and other epicardial clipping devices is not consistently mentioned in authoritative reviews and guidelines as a standard management option; therefore, routine use outside of established indications or trials is not supported by this policy excerpt.

The excerpted policy text included in this section does not explicitly state any additional interventions as not medically necessary beyond the investigational and not medically necessary determinations already described.

Billing and Coding

CPT codes (covered if selection criteria met)CPTCovered

33267	Exclusion of left atrial appendage, open, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) [not covered for open heart surgery]
33268	Exclusion of left atrial appendage, open, performed at the time of other sternotomy or thoracotomy procedure(s), any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) (List separately) [not covered for open heart surgery]
33269	Exclusion of left atrial appendage, thoracoscopic, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) [not covered for open heart surgery]
33340	Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation
93318	Echocardiography, transesophageal (TEE) for monitoring purposes, including probe placement, real time 2-dimensional image acquisition and interpretation

HCPCS / supply codesHCPCS

C1760	Closure device, vascular (implantable/insertable)
C1817	Septal defect implant system, intracardiac
C2628	Catheter, occlusion

ICD-10 codes (covered if selection criteria met)ICD-10Covered

I48.0	Paroxysmal atrial fibrillation
I48.11	Persistent atrial fibrillation
I48.19	Other persistent atrial fibrillation
I48.20	Chronic atrial fibrillation
I48.21	Permanent atrial fibrillation
I48.91	Unspecified atrial fibrillation

ICD-10 codes (not covered for CPB indications)ICD-10Not Covered

I63.30-I63.9	Cerebral infarction [stroke] (listed as not covered for indications in the CPB)
I66.01-I66.9	Occlusion and stenosis of cerebral arteries, not resulting in cerebral infarction [stroke] (listed as not covered for indications in the CPB)

No explicit billing codes in this segmentmixed

No codes listed

Stroke risk score thresholds

CHADS2 thresholdCHADS2 >= 2

CHA2DS2-VASc thresholdCHA2DS2-VASc >= 3

Context for useApplies to NVAF patients considered for FDA‑approved LAAC devices as part of medical necessity criteria

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required for Listed Codes: Prior authorization is required for the CPT/HCPCS codes listed in this policy. CPT codes (for example, 33340 and related procedure codes) are covered only when all applicable selection and medical necessity criteria in this policy are met.

Prior authorization required for listed CPT/HCPCS codes
CPT codes covered only if policy selection criteria are met

Prior Authorization

Prior Authorization and Center/Operator Expertise

Prior authorization should document facility and operator expertise. Devices and procedures for LAA occlusion carry significant procedural risks and have a learning curve; prior authorization should confirm that the procedure will be performed at a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program and by operators who meet manufacturer training and minimum procedure-volume expectations.

Procedure furnished in hospital with established SHD and/or EP program
Operator has manufacturer-prescribed training
Operator meets volume criteria (≥25 transseptal procedures and ≥12 LAAC procedures over 2 years)

Prior Authorization

Preauthorization — Evidence and Trial Considerations

Preauthorization should reflect the current evidence base and ongoing trials. Given limited definitive randomized trial evidence and ongoing large trials (eg, LAAOS III, PREVAIL/PROTECT AF meta-analyses, Amplatzer Amulet trials), prior authorization should document indications, prior anticoagulation history, and whether the patient would meet trial criteria or CMS coverage-with-evidence-development requirements.

Document prior anticoagulation trials, contraindications, and rationale for device therapy
Note ongoing trials (LAAOS III, Amulet trial, PRAGUE-17, ASAP-TOO) and CMS clinical trial/CED status

Prior Authorization

Prior Authorization / Coverage Confirmation Recommended

Confirm payer/CMS coverage policies before scheduling. Coverage for LAA closure devices may be restricted (eg, CMS NCD limits routine coverage and allows coverage only in certain trials/CED); obtain prior authorization or confirm trial eligibility when applicable.

CMS NCD may limit routine coverage — coverage may be allowed only within qualifying trials or CED
Obtain payer prior authorization/coverage confirmation before scheduling

Prior Authorization

Prior Authorization — Ability to Tolerate Short-term OAC

Document ability to tolerate short-term oral anticoagulation when indicated. Many pivotal trials required that patients be able to tolerate short-term OAC (eg, warfarin for 45 days followed by antiplatelet therapy); preauthorization should document the patient’s ability to tolerate required short-term anticoagulation or provide justification if not possible.

Document capacity to tolerate short-term OAC (eg, warfarin for initial weeks) when indicated by device instructions or trial regimens
If unable, provide clinical justification and reference to relevant evidence/trial enrollment

Prior Authorization

Prior Authorization for LAAO Device Procedures

Prior authorization for LAAO device procedures should include device type, indication (NVAF with specified risk scores or contraindication to long-term OAC), documentation of shared decision-making, and imaging suitability (TEE/CTA).

Specify device to be implanted (eg, Watchman, Amplatzer Amulet)
Document CHADS2/CHA2DS2-VASc and HAS-BLED scores
Attach shared decision-making documentation and MDT note
Include pre-procedure imaging demonstrating suitable LAA anatomy (TEE/CTA)

Prior Authorization

Prior Authorization — Amplatzer Amulet (Confirm Indication/Contraindications)

Amplatzer Amulet specific prior authorization considerations: confirm that the patient meets FDA-indicated criteria (NVAF, increased stroke risk by CHADS2/CHA2DS2-VASc, suitable for short-term anticoagulation, seeking non-pharmacologic alternative) and that contraindications are absent.

Confirm FDA indication: NVAF, increased stroke risk, suitable for short-term anticoagulation, and rationale to seek non-pharmacologic alternative
Contraindications to exclude: presence of intra-cardiac thrombus; active endocarditis or bacteremia; where device placement would interfere with intra-cardiac or intra-vascular structures

Documentation Required

Pre-procedure Multidisciplinary Selection and Documentation

Pre-procedure multidisciplinary selection and documentation is required. The member must be under care of a cohesive multidisciplinary team (MDT), and a formal shared decision-making interaction with an independent non-interventional physician using an evidence-based tool must be documented.

Document MDT involvement (cardiology, electrophysiology, cardiac surgery, imaging specialists as applicable)
Document formal shared decision-making using evidence-based tool and independent non-interventional physician note

Note

Prior Authorization — Administrative Details

Prior authorization specifics not specified in excerpt: Some administrative prior authorization requirements (exact forms, submission portals, and code-specific instructions) are not detailed in the provided excerpts; follow payer-specific prior authorization instructions and coding guides.

Follow Aetna prior authorization submission processes and include clinical documentation as outlined above
See full policy/coding appendix for exact CPT/HCPCS grouping and billing guidance

Denial Risk

Denial Triggers

Triggers for Denial: Lack of required clinical documentation, failure to meet risk-score thresholds, absence of documented shared decision-making, inability to demonstrate MDT care or facility/operator requirements, missing imaging, or unaddressed contraindications can result in denial.

Denial risk if CHADS2/CHA2DS2-VASc or HAS-BLED thresholds not met
Denial risk if shared decision-making not documented
Denial risk if facility/operator qualifications not documented
Denial risk if pre-procedure imaging or evidence of contraindications absent

Denial Risk

Incomplete LAA Exclusion — Denial/Harm Risk

Incomplete LAA exclusion and low rates of echocardiographic-confirmed occlusion have been associated with uncertain or potentially harmful outcomes. Prior authorization and documentation should address technical feasibility and imaging plans to minimize incomplete exclusion.

Document pre-procedure imaging and plan to confirm complete exclusion (intra-procedural TEE/fluoroscopy and post-procedure TEE/CTA)
Acknowledge risk of incomplete occlusion and plan for follow-up imaging and management

Denial Risk

Insufficient RCT Evidence May Prompt Denial

Insufficient randomized controlled trial evidence may prompt noncoverage decisions. Payers may consider there is inadequate evidence of benefit compared with anticoagulation (particularly NOACs); prior authorization should provide best-available evidence and rationale when seeking coverage.

Provide RCT and registry evidence applicable to the clinical scenario
If device is sought for patients who were excluded from trials (eg, unable to tolerate any OAC), justify applicability of existing evidence

Prior Authorization

Evidence from Trials — Patient OAC Tolerance Requirement

Evidence from pivotal trials required patients able to tolerate OAC. Many randomized trials (eg, PROTECT AF, PREVAIL) enrolled patients able to receive short-term OAC; when requesting coverage for patients truly unable to take OAC, provide specific supporting evidence or consider trial enrollment pathways.

Indicate whether patient met trial-like eligibility (ability to tolerate short-term OAC) or provide clinical rationale if not
Consider trial/CED enrollment if patient characteristics fall outside trial populations

Note

Evidence Insufficiency — Authorization Context

Evidence insufficiency noted: systematic reviews and health-technology assessments have concluded current evidence is insufficient to prove percutaneous LAAC is as effective and safe as OAC, and comparative studies versus NOACs are lacking. Use this context in authorization justification.

Cite HTA conclusions and comparative-evidence limitations when submitting request
Explain why device therapy is preferred for this patient despite evidence gaps

Denial Risk

Contraindications That Preclude Device Placement

Contraindications that preclude device placement must be documented and will preclude approval: presence of intra-cardiac thrombus, active endocarditis or bacteremia, or anatomy where device placement would interfere with intra-cardiac or intra-vascular structures.

Exclude intra-cardiac thrombus by imaging (TEE/CTA) prior to authorization
Confirm absence of active endocarditis or bacteremia
Document that device placement will not interfere with intracardiac/vascular structures

Note

Procedural Authorization — Not Specified in Excerpt

No procedural authorization rules present in the provided excerpts: The excerpts do not list specific per-procedure administrative rules (eg, prior authorization time windows, exact forms). Follow payer-specific procedural authorization instructions.

Follow Aetna administrative guides for procedural authorization and coding
Include clinical documentation described elsewhere in this section

Note

No Explicit Authorization/Denial Rules in Excerpt

No explicit authorization or denial triggers presented in some parts of the excerpt: while many clinical triggers are described, certain administrative thresholds or exception pathways are not explicit; contact medical policy or prior authorization services for clarification.

Contact Aetna medical policy/prior authorization for unclear cases or exceptions
Provide comprehensive documentation to avoid administrative denials

Documentation Required

Provider and Facility Documentation

Provider and Facility Documentation Expectations: Document provider training (manufacturer training), prior procedure counts, multidisciplinary care, facility program status (SHD/EP), and device-specific training and credentialing.

Document manufacturer-prescribed device training and operator procedural volumes (≥25 transseptal; ≥12 LAAC in 2 years)
Document hospital SHD/EP program status and MDT oversight

Documentation Required

Imaging Confirmation Required

Imaging Confirmation Required: Pre-procedure TEE and/or CTA are required to evaluate LAA anatomy and exclude intra-cardiac thrombus. Intra-procedural imaging (TEE/fluoroscopy) and scheduled post-procedure imaging (eg, 45 days, 1–3 months, and as clinically indicated) should be documented.

Pre-procedure TEE or CTA to assess anatomy and exclude thrombus
Intra-procedural TEE/fluoroscopy to confirm deployment
Post-procedure TEE/CTA at recommended intervals (eg, ~45 days, 1–3 months) to confirm occlusion and evaluate for device thrombus or leak

Documentation Required

Procedure and Follow-up Documentation

Procedure and Follow-up Documentation: Authorization requests and medical records should document device type, procedural success/complications, discharge antithrombotic regimen, and follow-up imaging/clinical visits.

Record device make/model and implant details
Record immediate procedural outcomes and any complications
Document discharge medication plan (eg, short-term OAC or antiplatelet regimen) and follow-up imaging schedule

Documentation Required

Imaging and Follow-up Documentation

Imaging and Follow-up Documentation: Trials and registries used serial imaging (TEE, CTA) to assess device position, residual leak, and device thrombus; prior authorization and follow-up care plans should include these imaging checkpoints and responsible providers.

Include plan for TEE/CTA assessments (eg, 45 days, 1–3 months, and later intervals as indicated)
Plan for managing residual leaks or device thrombus discovered on follow-up imaging

Documentation Required

Peri-procedural and TEE Follow-up Documentation

Peri-procedural and TEE Follow-up Documentation: Document intra-procedural imaging findings, peri-procedural adverse events (eg, pericardial effusion, device embolization), and core-lab or echocardiographic confirmation of occlusion at follow-up.

Document peri-procedural adverse events and interventions (eg, pericardiocentesis, surgical conversion)
Attach TEE/CTA reports showing occlusion metrics (residual jet <3 mm where applicable)

Documentation Required

Post-procedure Imaging and Anticoagulation Documentation

Post-procedure Imaging and Anticoagulation Documentation: Trials used short-term anticoagulation (eg, warfarin for initial weeks) and transition to antiplatelet therapy; document the planned and actual post-implant antithrombotic regimen and imaging confirmation prior to discontinuing OAC when applicable.

Document intended post-implant antithrombotic regimen and monitoring plan
Provide imaging confirmation (eg, 45-day TEE) before major changes to antithrombotic therapy

Documentation Required

Risk Score Documentation

Risk Score Documentation: Include CHADS2, CHA2DS2-VASc, and HAS-BLED scores in the authorization request and medical record to support stroke risk assessment and bleeding-risk rationale for LAAO.

Provide CHADS2 and/or CHA2DS2-VASc score
Provide HAS-BLED score and explanation if ≥3

Step Therapy

Step Therapy Requirement and Therapy Sequencing

Step Therapy and Therapy Sequencing Expectations: LAAC is considered a second-line therapy to oral anticoagulation. Document that first-line medical therapy (VKAs or NOACs) was considered and reasons the patient is an appropriate candidate for device therapy (eg, contraindication, major bleed, thromboembolism on anticoagulant, high HAS-BLED).

Document trial and intolerance/contraindication to long-term OAC when applicable
State that LAAC is being considered after shared decision-making and MDT review

Note

Randomized Evidence and Consideration of Medical Therapy First

Randomized Evidence and Medical Therapy Considerations: Randomized trials compared percutaneous LAA closure to warfarin; selection for device-based therapy should consider trial eligibility, comparator limitations (warfarin vs NOACs), and shared decision-making outcomes.

Acknowledge that pivotal trials compared devices to warfarin, not routinely to NOACs
Document how trial findings apply to the individual patient

Documentation Required

Post-procedure Pharmacotherapy Expectations

Post-procedure Pharmacotherapy Expectations: Trials commonly used short-term warfarin followed by dual antiplatelet therapy and then single antiplatelet therapy; authorization and discharge plans should state the expected regimen and monitoring.

Expect short-term anticoagulation (eg, warfarin for ~6 weeks) then dual antiplatelet therapy to 6 months in many trial protocols
If alternative regimens are planned (eg, antiplatelet-only), document rationale and supporting evidence

Note

Consideration of Anticoagulation and Alternatives

Consideration of Anticoagulation and Alternatives: Surgical LAAO is often adjunctive at time of cardiac surgery; evidence does not support replacing anticoagulation broadly. For surgical approaches (AtriClip), document that use is adjunctive and post-operative anticoagulation plans are specified.

Document whether LAAO is concomitant to cardiac surgery or standalone thoracoscopic procedure
For surgical AtriClip, document intraoperative confirmation and post-op anticoagulation plan

Note

No Additional Step Therapy Requirements Presented

No step therapy requirements were presented in parts of the excerpt beyond the policy statement that LAAC is second-line to oral anticoagulation; when administrative step-therapy rules are unclear, follow payer-specific prior authorization pathways.

LAAC considered second-line to OAC per policy
Follow Aetna step-therapy/prior authorization rules if present

Note

Policy History and Review Dates

Policy History and Review Dates: Document versioning and review dates when submitting or referencing policy decisions.

Effective date: 2009-07-24
Last review: 01/09/2024; Next review: 09/12/2024

Definitions and Device Glossary

LAAC (Left Atrial Appendage Closure)

DefinitionProcedures and devices intended to occlude or exclude the left atrial appendage to reduce thromboembolic stroke risk in non‑valvular atrial fibrillation

ApproachesPercutaneous transcatheter (eg, Watchman, Amplatzer/Amulet) or surgical epicardial clipping (eg, AtriClip)

Post‑implant anticoagulationWatchman requires ability to tolerate short‑term anticoagulation for ~45 days post‑procedure

Regulatory noteOnly WATCHMAN had FDA PMA historically; Amplatzer Amulet later FDA‑approved (see device specific entries)

NVAF (Non-valvular atrial fibrillation)

DefinitionAtrial fibrillation not caused by rheumatic mitral valve disease, a prosthetic heart valve, or mitral valve repair; population for which LAAC criteria are defined

RelevanceNVAF patients with elevated stroke risk are target population for LAAC device consideration

Trial populationsPROTECT AF/PREVAIL enrolled NVAF patients eligible for warfarin; many registries included NVAF with contraindication to OAC

Watchman device

Device descriptionWatchman LAA System: nitinol frame with polyester mesh implanted percutaneously to seal the LAA

ImplantationDelivered via transcatheter transeptal approach and anchored with fixation barbs; multiple sizes available

Follow‑upDevice becomes endothelialized over months; trials used regular follow‑up including TEE at ~45 days and up to 1 year

Amplatzer / ACP

Device familyAmplatzer devices (eg, Amplatzer Cardiac Plug [ACP], Amplatzer Amulet) are nitinol mesh transcatheter occluders used to occlude the LAA

Regulatory statusACP historically used off‑label for LAA; Amplatzer Amulet obtained FDA approval (see Amulet entry)

EvidenceMostly non‑randomized registries reporting high implantation success but limited RCT data compared with Watchman

Lariat device

Device descriptionLariat: percutaneous epicardial snare with pre‑tied suture that ligates the LAA from the epicardial surface

Access and techniqueRequires combined epicardial and endocardial access with TEE and fluoroscopic guidance for snare placement

Safety considerationsHigh acute success reported in series but FDA safety communications note serious procedural complications; not FDA‑approved for LAAO indication

AtriClip

Device descriptionAtriClip: a surgical epicardial clip applied to the base of the LAA to exclude the appendage during cardiac surgery or via thoracoscopic approaches

EvidenceSystematic reviews and small trials report high intra‑procedural occlusion rates (~95–98%) with short‑term durability on imaging

Regulatory noteAtriClip cleared by FDA via 510(k) for epicardial LAA occlusion; long‑term stroke prevention data limited

LARIAT

Regulatory statusLARIAT system is FDA‑cleared for soft‑tissue approximation only and has been used off‑label for LAA ligation

MechanismPercutaneous suture‑based ligation using an epicardial snare to close the LAA ostium

Safety signalsObservational series show high closure rates but FDA issued safety communications reporting cases of death and cardiac perforation

Amplatzer Amulet / Cardiac Plug (ACP)

Device identityAmplatzer Amulet: evolution of the Amplatzer Cardiac Plug designed for percutaneous LAA occlusion

PurposeTranscatheter device intended to occlude the LAA to reduce thromboembolic risk in NVAF

Evidence and trialsStudied in registries and the Amulet IDE randomized trial comparing Amulet vs Watchman (ongoing/reported cohorts)

Epicardial LAA clip

Epicardial clip definitionEpicardial LAA clip: external device applied to epicardial surface to exclude the LAA (eg, AtriClip)

Use casesApplied during open cardiac surgery or via thoracoscopic/minimally invasive approaches; reported high imaging‑confirmed occlusion rates

Evidence limitationsLong‑term comparative effectiveness for stroke prevention vs anticoagulation remains limited

LARIAT (alternate entry)

Alternate nameLARIAT (alternate entry): percutaneous suture‑based LAA ligation device used off‑label for LAAO

Approval noteApproved by FDA for tissue approximation only, not specifically for LAA closure

Reported outcomesHigh acute closure rates in single‑site series with reported access‑related complications and FDA safety warnings

Watchman (alternate entry)

Alternate entryWatchman (alternate entry): nitinol frame with polyester cover implanted percutaneously to seal the LAA

FDA approvalReceived FDA PMA (approved March 13, 2015) for stroke risk reduction in selected NVAF patients

Follow‑up protocolClinical and TEE follow‑up at 45 days, 6 months and up to 1 year reported in trials

AtriClip (alternate entry)

Alternate entryAtriClip (alternate entry): surgical epicardial clip for LAA exclusion used during cardiac surgery or thoracoscopic procedures

PerformanceStudies report >95% intra‑procedural exclusion with short‑term imaging durability

GuidanceEvidence limited; UpToDate review may not mention AtriClip as standard option

LAAC / LAAO (alternate entry)

TerminologyLAAC / LAAO: procedures/devices that exclude the left atrial appendage from systemic circulation to reduce thromboembolic risk in AF

ModalitiesIncludes percutaneous endocardial occluders (Watchman, Amulet), epicardial ligation (LARIAT), and surgical clips (AtriClip)

Clinical roleConsidered for NVAF patients at increased stroke risk who have contraindications or intolerance to long‑term anticoagulation

PROTECT AF / PREVAIL

TrialsPROTECT AF and PREVAIL: randomized trials evaluating Watchman vs warfarin for stroke prevention in AF

EnrollmentCombined enrollment ~1,114 patients with long‑term follow‑up reported

OutcomesMeta‑analysis showed comparable stroke prevention to warfarin with reductions in hemorrhagic stroke and bleeding in some analyses

LAAO devices

DefinitionLAAO devices: percutaneous devices intended to exclude the left atrial appendage from systemic circulation (examples: Watchman, Amplatzer Amulet, LARIAT)

Evidence mixDevice evidence includes RCTs for Watchman and registries/observational studies for other devices

Clinical implicationDevice‑specific outcomes and safety profiles vary; choice influenced by anatomy, operator experience, and regulatory status

1-stop procedure

Definition1‑stop procedure: combined single‑session catheter ablation for AF and left atrial appendage closure performed concomitantly

EvidenceMeta‑analyses report high procedural success (~98%) but variable rates of residual flow, bleeding, and AF recurrence; further comparative studies needed

Clinical cautionCombined procedures may increase peri‑procedural complexity and require experienced centers

LAAO (Left atrial appendage occlusion)

DefinitionLAAO (Left atrial appendage occlusion): procedures/devices that exclude or occlude the LAA to reduce thrombus formation and embolic stroke risk in AF

MethodsIncludes percutaneous occlusion, epicardial ligation, and surgical clipping depending on clinical context

Follow‑up expectationsIntra‑procedural imaging plus serial TEE/CT to assess device position, leak, and thrombus

Amplatzer Amulet indication

Indication summaryAmplatzer Amulet indicated to reduce risk of thrombus embolization from the LAA in NVAF patients at increased stroke risk who are suitable for short‑term anticoagulation and seeking a non‑pharmacologic alternative

ContraindicationsContraindicated in presence of intra‑cardiac thrombus, active endocarditis/bacteremia, or when placement would interfere with intra‑cardiac/intravascular structures

Regulatory noteFDA approved Amplatzer Amulet on August 14, 2021 for selected NVAF patients

Epicardial LAA clipping (AtriClip)

DefinitionEpicardial LAA clipping (AtriClip): external device applied to the base of the LAA to exclude the appendage from circulation, used during open cardiac surgery or thoracoscopically

PerformanceSystematic reviews report high occlusion success (~97–98%) with low device‑related adverse events in short‑term follow‑up

Clinical noteLong‑term stroke prevention data limited; trial evidence ongoing for stand‑alone minimally invasive use

Peri-device leak (PDL)

DefinitionPeri‑device leak (PDL): residual communication or contrast patency around or beyond an implanted LAA occlusion device detected on imaging (TEE or CT)

Clinical significancePDL may indicate incomplete occlusion and is associated with residual thromboembolic risk and need for follow‑up or additional therapy

Imaging assessmentCT or TEE at ~2 months or 1–3 months commonly used to evaluate for PDL in device follow‑up studies

AtriClip (alternate entry)

Alternate AtriClip entryAtriClip (alternate entry): thoracoscopic or open epicardial clip achieving high imaging‑confirmed closure rates (~95–98%) in series

Use casesEmployed as adjunct during cardiac surgery or as stand‑alone thoracoscopic procedure in selected centers

LimitationsUpToDate review may not list AtriClip as standard option; long‑term comparative outcomes remain to be established

AMPLATZER Amulet LAA Occluder

Device nameAMPLATZER Amulet LAA Occluder

Trial statusStudied in registries and the Amulet IDE randomized trial (NCT0287998) comparing against Watchman

Reported outcomesRegistry data report high implantation success (~99%) and high adequate occlusion on short‑term TEE/CT

WATCHMAN device (alternate entry)

Alternate Watchman entryWATCHMAN device (alternate entry): FDA‑approved percutaneous LAA occluder with RCT evidence (PROTECT AF/PREVAIL) and required post‑implant imaging and short‑term anticoagulation

Clinical follow‑upTrials and registries use TEE at 45 days, 6 months and serial imaging to assess sealing and device thrombus

Safety considerationsPeri‑device leak and delayed endothelialization reported; operator experience affects complication rates

Policy Dates and Revision History

2024-01-09policy_reviewLatest

Policy last reviewed on 01/09/2024; reflects current coverage criteria and supporting evidence summaries.

2009-07-24policy_effective

Policy originally became effective on 07/24/2009 establishing coverage criteria for left atrial appendage occlusion devices and procedures.

2024-01-09policy_reviewLatest

Policy last reviewed on 01/09/2024; prior authorization requirements are noted elsewhere in the full policy and are not specified in the provided excerpt.

2009-07-24policy_effective

Policy originally became effective on 07/24/2009; see full policy for coding and prior authorization details.