Clinical Policy: Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention Form

CENTENE®  
Corporation  

Clinical Policy: Percutaneous Left Atrial Appendage Closure Device for Stroke  
Prevention  
Reference Number: CP.MP.147  
Date of Last Revision: 03/26  

Coding Implications  
Revision Log  

See Important Reminder at the end of this policy for important regulatory and legal  
information.  

**Description**  
Atrial fibrillation (AF), the most commonly encountered sustained tachyarrhythmia, is associated  
with a five-fold increased risk of stroke, and stroke risk increases with age.¹ Among patients with  
non-valvular AF, the vast majority of thrombus material is located within or involves the left  
atrial appendage (LAA). Most patients with AF should receive anticoagulant therapy to reduce  
the risk of systemic embolization, however, not all individuals are candidates for this therapy.  
LAA occlusion devices have been researched as an alternative to pharmacological therapy to  
reduce the risk of stroke in these individuals.  

**Policy/Criteria**  
  

II. It is the policy of health plans affiliated with Centene Corporation that current research does  
not support the use of percutaneous devices other than those noted above for occlusion of  
the LAA to reduce the risk of stroke in adults with non-valvular AF. There is a paucity of  
evidence regarding the long-term safety and efficacy of all other percutaneous devices for  
occlusion of the LAA, and at this time, no other devices are FDA approved for this  
indication.  

**Background**  
The individualized assessment of the risk-benefit balance is central to decision making regarding  
pharmacotherapy for stroke reduction in atrial fibrillation (AF). To estimate stroke risk, the  
ACC/American Heart Association/HRS Guideline for the Management of Patients With Atrial  
Fibrillation recommends the use of the CHA₂DS₂-VASc point score [Congestive heart failure,  
Hypertension, Age ≥75 years (doubled), Diabetes mellitus, prior Stroke, transient ischemic  
attack, or thromboembolism (doubled), Vascular disease, Age 65 to74 years, Sex category),  
which provides an estimate of the potential benefits of therapy. Per the guideline, oral  
anticoagulation is a class I recommendation for patients with prior stroke, transient ischemic  
attack (TIA), or a CHA₂DS₂-VASc score ≥ 2 (estimated annual stroke risk of 2.2%) in the  

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CLINICAL POLICY  
Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention  

context of shared decision making, including a discussion of risks of stroke and bleeding, and the  
patient’s preferences.²  

Some patients with AF, whose stroke risk profiles would favor anticoagulation, have relative or  
absolute contraindications to anticoagulation. Others are unable or unwilling to adhere to long-  
term anticoagulation therapy. As a result, a number of percutaneous techniques that mechanically  
prevent embolization of left atrial appendage (LAA) thrombi, often referred to as LAA exclusion  
procedures, have been studied as an alternative to pharmacological therapy to reduce the risk of  
stroke. The percutaneous devices include two broad categories: endocardial plug devices to  
occlude the ostium of the LAA and epicardial LAA ligation procedures to exclude the LAA.  

Currently, the WATCHMAN, WATCHMAN FLX, and the Amplatzer Amulet are the only  
FDA-approved percutaneous LAA closure devices.  

The WATCHMAN device is deployed percutaneously via transseptal puncture and has a  
polyethylene membrane that covers a self-expanding nitinol cage with barbs to anchor the device  
in the LAA. The early findings for the WATCHMAN device suggest noninferiority to warfarin  
for the composite endpoint of stroke, systemic embolism, and cardiovascular death; however,  
early adverse events occur in approximately 10% of patients, including pericardial bleeding.  
Longer-term follow-up of the WATCHMAN device at 1588 patient-years suggests noninferiority  
of this device to warfarin.³ A subsequent registry study demonstrated that the WATCHMAN  
device achieved noninferiority in patients who could not receive warfarin. Quality of life was  
assessed in a subset of patients (361 device and 186 warfarin patients) enrolled in the PROTECT  
AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention  
of Stroke in Patients With Atrial Fibrillation) trial at baseline and 12 months. It was reported that  
patients with non-valvular AF at risk for stroke, treated with left atrial appendage closure, had  
favorable quality of life changes at 12 months versus patients treated with warfarin.⁴  

The PREVAIL study was mandated by the US FDA to further evaluate the safety profile and  
confirm the efficacy of the WATCHMAN device for regulatory approval. This study randomly  
assigned 407 patients in a 2:1 ratio to WATCHMAN or warfarin. Results from the five-year  
outcomes of the PREVAIL trial and the PROTECT AF trial demonstrated that LAA closure with  
the WATCHMAN device provided stroke prevention in nonvalvular AF that was comparable to  
warfarin and included additional reductions in major bleeding and mortality.²⁰  

The newer-generation WATCHMAN FLX is FDA approved and is widely replacing the  
WATCHMAN device in most centers.²⁰ The WATCHMAN FLX comes in five sizes with a  
slightly broader range of dimensions than the WATCHMAN. This device has a distal rounded  
edge and double row stabilizing anchors, which improves the safety of the procedure.²⁴ A  
single-arm prospective registry of 400 patients, the PINNACLE FLX study, concluded that LAA  
closure with the WATCHMAN FLX device was associated with a low incidence of adverse  
events and a high incidence of anatomic closure.²⁰,²⁴  

The second-generation Amplatzer Cardiac Plug device, the Amulet, received FDA approval in  
2021, and includes design advances such as larger lobe size for occluding larger appendages and  
more stabilizing wires, which improves device stability. A key difference in the Amulet device is  

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the possibility for patients to be discharged without oral anticoagulation immediately after the  
device has been implanted.²⁵ A multicenter registry report including 1,088 patients showed 99%  
procedural success with 3.2% of patients having major adverse events.²⁰ The Amulet IDE trial  
included 1,878 patients with AF who were randomly assigned to receive either the Amulet or  
WATCHMAN percutaneous LAA occlusion device. Follow up at 18 months showed similar  
results between the devices with a 2.8% rate of ischemic stroke or systemic embolism.  

**National Institute for Health and Clinical Excellence (NICE)**  
Current evidence suggests that percutaneous occlusion of the LAA is efficacious in reducing the  
risk of thromboembolic complications associated with nonvalvular AF. With regard to safety,  
there is a risk of life-threatening complications from the procedure, but the incidence of these is  
low. Therefore, this procedure may be used, provided that normal arrangements are in place for  
clinical governance, consent and audit.⁵,²⁶ LAA occlusion should not be offered as an alternative  
unless anticoagulation is contraindicated or not tolerated.²⁶  

**European Society of Cardiology**  
Guidelines for the Management of Atrial Fibrillation states LAA occlusion may be considered  
for stroke prevention in patients with AF and contraindications for long-term anticoagulant  
treatment. (Class IIb recommendation-usefulness/efficacy is less well established by  
evidence/opinion.)⁸  

**American Heart Association/American College of Cardiology/ Heart Rhythm Society**  
The latest guideline for the management of patients with atrial fibrillation is a 2019 update of the  
2014 AHA/ACC/HRS guidelines. This update addresses percutaneous approaches to occlude the  
LAA and has a new recommendation that percutaneous LAA occlusion may be considered in  
patients with AF at increased risk of stroke who have contraindications to long-term  
anticoagulation. FDA approval of the WATCHMAN and clinical trial data necessitated this  
recommendation.¹  

**Coding Implications**  
This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered  
trademark of the American Medical Association. All CPT codes and descriptions are copyrighted  
2025, American Medical Association. All rights reserved. CPT codes and CPT descriptions are  
from the current manuals and those included herein are not intended to be all-inclusive and are  
included for informational purposes only. Codes referenced in this clinical policy are for  
informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage.  
Providers should reference the most up-to-date sources of professional coding guidance prior to  
the submission of claims for reimbursement of covered services.  

| CPT® Codes | Description |
|------------|-------------|
| 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 |

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CLINICAL POLICY  
Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention  

| Reviews, Revisions, and Approvals | Revision Date | Approval Date |
|----------------------------------|---------------|---------------|
| Policy adopted from Health Net NMP 376, Left Atrial Appendage Devices | 06/17 | 07/17 |
| Replaced “investigational” in II with “there is a paucity of evidence regarding the long-term safety and efficacy of all other percutaneous devices for occlusion of the LAA …” References reviewed and updated. Verbiage edits to I.B, adding contraindications of 1.-11., in addition to the note regarding Warfarin. | 04/21 | 05/21 |
| Annual Review. Updated criteria I and criteria II to include all FDA approved percutaneous devices for occlusion of the LAA (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) and removed verbiage that the WATCHMAN is the only FDA approved device. Updated background to include information on WATCHMAN FLX and Amplatzer Amulet devices with updated notation that both devices are FDA approved and removed verbiage that the WATCHMAN is the only FDA approved device. Updated AHA/ACC/HRS recommendation in background. References reviewed and updated. Changed “Review Date” in policy header to “Date of Last Revision,” and “Date” in the revision log header to “Revision Date.” Specialist reviewed. | 05/22 | 05/22 |
| Annual review completed. Minor rewording with no clinical significance. Background updated with no impact to clinical criteria. ICD-10 diagnosis code table removed. References reviewed and updated. | 05/23 | 05/23 |
| Annual review. References reviewed and updated. Reviewed by external specialist. | 05/24 | 05/24 |
| Annual review. Changed “both” to “all” of the following in criteria I. Removed contraindications I.B.1.-I.B.11. Thrombocytopenia or known coagulation… Added criteria I.C. “Ability to tolerate short-term anticoagulants”. Removed Note: Warfarin may be required… References reviewed and updated. Reviewed by internal specialist. | 03/25 | 03/25 |
| Annual review. References reviewed and updated. Reviewed by external specialist. | 03/26 | 03/26 |

  

**Important Reminder**  
This clinical policy has been developed by appropriately experienced and licensed health care  
professionals based on a review and consideration of currently available generally accepted  
standards of medical practice; peer-reviewed medical literature; government agency/program  
approval status; evidence-based guidelines and positions of leading national health professional  
organizations; views of physicians practicing in relevant clinical areas affected by this clinical  
policy; and other available clinical information. The Health Plan makes no representations and  
accepts no liability with respect to the content of any external information used or relied upon in  
developing this clinical policy. This clinical policy is consistent with standards of medical  
practice current at the time that this clinical policy was approved. “Health Plan” means a health  
plan that has adopted this clinical policy and that is operated or administered, in whole or in part,  
by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.  

The purpose of this clinical policy is to provide a guide to medical necessity, which is a  
component of the guidelines used to assist in making coverage decisions and administering  
benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage  
decisions and the administration of benefits are subject to all terms, conditions, exclusions and  
limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy,  
contract of insurance, etc.), as well as to state and federal requirements and applicable Health  
Plan-level administrative policies and procedures.  

This clinical policy is effective as of the date determined by the Health Plan. The date of posting  
may not be the effective date of this clinical policy. This clinical policy may be subject to  
applicable legal and regulatory requirements relating to provider notification. If there is a  
discrepancy between the effective date of this clinical policy and any applicable legal or  
regulatory requirement, the requirements of law and regulation shall govern. The Health Plan  
retains the right to change, amend or withdraw this clinical policy, and additional clinical  
policies may be developed and adopted as needed, at any time.  

This clinical policy does not constitute medical advice, medical treatment or medical care. It is  
not intended to dictate to providers how to practice medicine. Providers are expected to exercise  
professional medical judgment in providing the most appropriate care, and are solely responsible  

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CLINICAL POLICY  
Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention  

for the medical advice and treatment of members/enrollees. This clinical policy is not intended to  
recommend treatment for members/enrollees. Members/enrollees should consult with their  
treating physician in connection with diagnosis and treatment decisions.  

Providers referred to in this clinical policy are independent contractors who exercise independent  
judgment and over whom the Health Plan has no control or right of control. Providers are not  
agents or employees of the Health Plan.  

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and  
distribution of this clinical policy or any information contained herein are strictly prohibited.  
Providers, members/enrollees and their representatives are bound to the terms and conditions  
expressed herein through the terms of their contracts. Where no such contract exists, providers,  
members/enrollees and their representatives agree to be bound by such terms and conditions by  
providing services to members/enrollees and/or submitting claims for payment for such services.  

**Note:** For Medicaid members/enrollees, when state Medicaid coverage provisions conflict  
with the coverage provisions in this clinical policy, state Medicaid coverage provisions take  
precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to  
this clinical policy.  

**Note:** For Medicare members/enrollees, to ensure consistency with the Medicare National  
Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable  
NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria  
set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional  
information.  

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