DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Surgical Left Atrial Appendage Occlusion Devices for Stroke Prevention in Atrial Fibrillation

Coverage guidance for use of surgical LAA occlusion devices (including the AtriClip) for stroke prevention in patients with atrial fibrillation, addressing use during concomitant open or thoracoscopic cardiac surgery and as standalone procedures; applies to Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySurgical Left Atrial Appendage Occlusion Devices for Stroke Prevention in Atrial Fibrillation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 12, 2022

Next Review DateN/A

Key ActionConfirm member-specific benefits and eligibility with the provider call center before scheduling or billing for surgical LAA occlusion procedures.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2CPT codes listed as not covered / not medically necessary

7AtriClip device versions marketed

2010AtriClip FDA clearance year

5%/yrEstimated annual stroke incidence in untreated AF

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Coverage Determinations and Policy Scope

Coverage determinations

Coverage stance by product:

Medicare Advantage - during open or thoracoscopic cardiac procedures: Use of surgical left atrial appendage (LAA) occlusion devices, including the AtriClip device, for stroke prevention in individuals with atrial fibrillation undergoing open or thoracoscopic cardiac procedures is not covered (evidence insufficient)

Medicare Advantage - stand-alone: Use of surgical LAA occlusion devices, including AtriClip, as a stand‑alone procedure for stroke prevention in individuals with atrial fibrillation is not covered

Commercial - during open or thoracoscopic cardiac procedures: Use of surgical LAA occlusion devices, including the AtriClip device, for stroke prevention in individuals with atrial fibrillation undergoing open or thoracoscopic cardiac procedures is not medically necessary (evidence insufficient)

Commercial - stand-alone: Use of surgical LAA occlusion devices, including the AtriClip device, as a stand‑alone procedure for stroke prevention in individuals with atrial fibrillation is not medically necessary (evidence insufficient)

The policy excludes the use of surgical left atrial appendage (LAA) occlusion devices, including the AtriClip, for stroke prevention. This exclusion applies to procedures performed either as a stand‑alone intervention or as an adjunct during open or thoracoscopic cardiac surgery where the evidence is judged insufficient to determine clinical benefit.

Coverage and payment are governed by the member's subscriber agreement, member certificate, or employer agreement, which supersede this medical policy. Providers should verify member‑specific benefits and eligibility by calling the provider call center; services determined to be not medically necessary or non‑covered may not be billed to the member unless a prior written agreement is obtained.

For Commercial products, use of surgical LAA occlusion devices, including the AtriClip, is considered not medically necessary for stroke prevention when performed either during open or thoracoscopic cardiac procedures or as a stand‑alone procedure, because the available evidence is insufficient to determine effects on health outcomes.

Billing and Code Status

Not covered / Not medically necessary CPT CodesCPTNot Covered

33267	Exclusion of left atrial appendage, open, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) (New code as of 1/01/2022)
33269	Exclusion of left atrial appendage, thoracoscopic, any method (eg, excision, isolation via stapling, oversewing, ligation, plication, clip) (New code as of 1/01/2022)

Provider Responsibilities, Prior Authorization, and Billing Risk

Prior Authorization

Prior Authorization and Benefits Verification

Prior authorization is not applicable for this policy.

Providers should still confirm member-specific benefits and eligibility with the plan prior to scheduling services.
For member-specific coverage determinations, call the provider call center; benefits are determined by the member's subscriber agreement or employer agreement (see plan documents). (Source chunk 22)

Denial Risk

Financial Liability Risk for Non‑Covered or Not Medically Necessary Services

If services are determined to be not medically necessary or are non‑covered benefits, providers may be financially responsible and should notify and obtain written agreement from the member before proceeding.

Providers may not bill the member unless the member has been informed and has agreed in writing in advance to pay.

Clinical Background and Rationale

Atrial fibrillation (AF) is the most common cardiac arrhythmia and substantially increases stroke risk, primarily from thromboembolism arising in the left atrial appendage (LAA), the cardiac structure where the majority of atrial thrombi form. First‑line stroke prevention in AF is long‑term anticoagulation (warfarin or direct oral anticoagulants); surgical LAA excision or occlusion has been employed as a nonpharmacologic alternative, most commonly performed incident to other cardiac surgery.

Key Terms and Device Definitions

Left atrial appendage (LAA) — definition & morphology variants

Anatomical definitionA small extension of the left atrium with variable size and shape that is the region of lowest flow in AF and the source of >90% of left atrial thrombi

Common morphologiesDescribed morphologies include chicken wing (most common), cactus, windsock, and cauliflower

Clinical significanceTarget for surgical removal or exclusion during cardiac surgery to reduce thromboembolic risk

Morphology implicationsMorphologic variation (dominant lobe presence and number of lobes) influences appearance and may affect procedural approach

Actionable pointRecognize LAA as primary thrombus source in AF (>90%) when considering stroke-prevention strategies including anticoagulation versus surgical exclusion

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySurgical Left Atrial Appendage Occlusion Devices for Stroke Prevention in Atrial Fibrillation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 12, 2022

Next Review DateN/A

Key ActionConfirm member-specific benefits and eligibility with the provider call center before scheduling or billing for surgical LAA occlusion procedures.

SourceLink

On This Page

Verify participation agreement terms for billing and balance‑billing rules.

Note

Regulatory Context and Device Versions

FDA clearance and device versions relevant to clinical use are summarized below; document device model and indication in operative notes.

AtriClip LAA Exclusion System cleared by FDA via 510(k) in June 2010 (K093679); indication: exclusion of the LAA performed under direct visualization in conjunction with other cardiac surgical procedures.
AtriClip has undergone device iterations (clip material and applicator refinements); as of 2022, AtriCure markets multiple AtriClip versions to accommodate LAA size and concomitant surgical approaches.
Document the specific AtriClip model/version used and that use was conjunctive to other cardiac surgical procedures if applicable.

AtriClip LAA Exclusion System — FDA clearance & indicated use

Device and sponsorAtriClip LAA Exclusion System (AtriCure)

FDA clearanceCleared by FDA via 510(k) K093679 in June 2010

Indicated use per clearanceIndicated for exclusion of the LAA performed under direct visualization in conjunction with other cardiac surgical procedures

Manufacturer noteMultiple iterations since 2010; as of 2022 AtriCure markets 7 device versions to match LAA size and concomitant surgery

Epicardial clip (AtriClip) — description & cited clinical reports

Device descriptionAn epicardial clip applied to the external ostium of the LAA to occlude the appendage during cardiac surgery

Clinical reportsMultiple studies and series report AtriClip use during cardiac surgery with evidence of effective occlusion and long-term stability

Selected evidence examplesReferences include observational series and analyses (eg, Kurfirst et al., Caliskan et al., multiple systematic reviews) reporting occlusion efficacy and outcomes

Typical clinical contextUsed during concomitant cardiac procedures (eg, CABG, valve surgery) as an adjunctive surgical step

Thoracoscopic stapler-and-loop technique — minimally invasive technique & outcomes

Technique descriptionMinimally invasive thoracoscopic approach using a stapler and loop to exclude/close the LAA

Reported outcomesMid-term outcomes reported in a series of 201 patients (Ohtsuka et al. 2018) and other cohort reports showing procedural feasibility and clinical/echocardiographic outcomes

Clinical roleDescribed as a standalone thoracoscopic option for LAA closure in patients with nonvalvular AF in cited literature

Evidence typeReported in observational cohort and mid-term outcome studies rather than randomized trials (per references cited)