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Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation
11.02.26c

Policy

MEDICALLY NECESSARY

The use of a US Food and Drug Administration (FDA)–​approved percutaneous left atrial appendage (LAA) closure device (i.e., Watchman™ LAA Closure Technology​; Amplatzer™ Amulet™ Left Atrial Appendage Occluder​) is considered medically necessary and, therefore, covered for the prevention of stroke in individuals with nonvalvular atrial fibrillation (AF) when all of the following criteria are met:

  • Assessment of stroke risk: There is an increased risk of stroke and systemic embolism, and long-term systemic anticoagulation therapy is recommended based on either of the following stroke risk stratification tools:
    • CHADS2 score: Risk factors of congestive heart failure, hypertension, age 75 years or greater, diabetes mellitus, and previous stroke/transient ischemic attack
    • CHA2DS2-VASc score: Risk factors of congestive heart failure, hypertension, age 75 years or greater, diabetes mellitus, previous stroke/transient ischemic attack, vascular disease, age 65 to 74, and female gender
  • Assessment of bleeding risk: There is an increased risk of major bleeding (intracranial, hospitalization, hemoglobin decrease >2 g/L, and/or transfusion) based on clinical risk factors of hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, history of actual bleeding complications on warfarin, labile international normalized ratios (INRs) (either high or low), “elderly” (age >65 years), drugs/alcohol usage (i.e., HAS-BLED score), of three or greater.
  • The individual is deemed suitable for short-term warfarin.
  • The long-term risks of systemic anticoagulation clearly outweigh the risks of a percutaneous LAA closure device implantation.
EXPERIMENTAL/INVESTIGATIONAL

All other uses for percutaneously deployed LAA closure devices are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

The use of other percutaneously deployed LAA closure devices, including but not limited to the LARIAT® Suture Delivery Device (SentreHEART, Inc., Redwood City, CA), WaveCrest Left Atrial Appendage Occlusion System (Coherex Medical Inc., Salt Lake City, UT), and Amplatzer Cardiac Plug (St. Jude Medical, Inc., St. Paul, MN) devices, for stroke prevention in individuals with AF, is considered investigational.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

Stroke risk stratification tools used to determine the level of anticoagulation therapy for individuals with nonvalvular atrial fibrillation (AF) required:

CHADS2 RISK ASSESSMENT (AHA)
SCORECHADS2 RISK CRITERIA
1 pointCongestive heart failure
1 pointHypertension
1 pointAge ≥75 years
1 point Diabetes mellitus
2 pointsStroke/transient ischemic attack
CHADS2 score of 0: recommend aspirin.
CHADS2 score of 1: recommend antithrombotic therapy with oral anticoagulation or antiplatelet therapy but preferably oral anticoagulation.
CHADS2 score of 2 or greater: recommend oral anticoagulation.

CHA2DS2-VASc RISK ASSESSMENT
SCORECHA2DS2-VASc RISK CRITERIA
1 pointCongestive heart failure
1 pointHypertension
2 pointsAge ≥75 years
1 point Diabetes mellitus
2 pointsStroke/transient ischemic attack
1 pointVascular disease
1 pointAge 65-74 years
1 pointGender category (i.e., female)
CHA2DS2-VASc score of 1: recommend antithrombotic therapy with oral anticoagulation or antiplatelet therapy but preferably oral anticoagulation.
CHA2DS2-VASc score of 2 or greater: recommend oral anticoagulation.

Risk of major bleeding stratification tool used to determine the level of caution warranted when anticoagulation therapy for individuals with nonvalvular AF is required:

HAS-BLED Risk of Major Bleeding with Anticoagulation
 CLINICAL FEATURESCORE
HHypertension (systolic blood pressure [SBP] > 160 mm Hg) 1 point
 A*Abnormal Renal Function 1 point
Abnormal Liver Function 1 point
SStroke: Previous Stroke 1 point
BBleeding: Prior Major Bleeding or Predisposition 1 point
LLabile International Normalized Ratio (INR) (<60% of time in therapeutic range) 1 point
EElderly (age >65 years) 1 point
DDrugs Predisposing to Bleeding (antiplatelet agents, nonsteroidal anti-inflammatory drugs [NSAIDs]) (concomitantly) 1 point
Excess Alcohol Use (concomitantly) 1 point
A HAS-BLED score of 3 or greater indicates that caution is warranted when prescribing oral anticoagulation, and regular review is recommended.

*Abnormal renal function is classified as the presence of chronic dialysis, renal transplantation, or serum creatinine 200 mmol/L or greater. Abnormal liver function is defined as chronic hepatic disease (e.g., cirrhosis) or biochemical evidence of significant hepatic derangement (bilirubin two to three times the upper limit of normal, in association with aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase three times the upper limit normal, etc.), history of bleeding or predisposition (anemia), labile INR (i.e., time in therapeutic range <60 percent), concomitant antiplatelets or nonsteroidal anti-inflammatory drugs, or excess alcohol.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, percutaneous left atrial appendage (LAA) closure device (i.e., Watchman™ LAA Closure Technology, Amplatzer™ Amulet™ Left Atrial Appendage Occluder) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.


US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
The Watchman LAA Closure Technology was approved by the FDA on March 13, 2015, for the prevention of stroke in individuals with AF.

The Amplatzer™ Amulet™ Left Atrial Appendage Occluder was approved by the FDA on August 14, 2021, for the prevention of stroke in individuals with AF. ​

Description

Individuals with atrial fibrillation (AF) are at increased risk of stroke due to blood clots that can form in the heart. Stroke prevention in AF is an important goal of treatment. Treatment with anticoagulant medications is the most common approach to stroke prevention. Most embolic strokes, commonly associated with AF, originate from the left atrial appendage (LAA); therefore, occlusion of the LAA offers a nonpharmacologic alternative to anticoagulant medications for the prevention of stroke in individuals with nonvalvular AF using percutaneous LAA closure devices.


In clinical practice, individuals with nonvalvular AF with high stroke risk and high bleeding risk scores are considered the most suitable candidates for percutaneous LAA closure, CHADS2, and HAS-BLED stratification tools, respectively. A commonly used stroke risk stratification tool, the CHADS2 score, assigns one point each for the presence of congestive heart failure, hypertension, age 75 years or older, diabetes, prior stroke or transient ischemic attack (TIA). The preferred, more inclusive, CHADS2-VASc score includes the presence of vascular disease, more age categories, and gender, in addition to the risk factors used in the CHADS2 score. Warfarin is the predominant anticoagulant agent in clinical use. Several newer anticoagulant medications, including dabigatran, rivaroxaban, and apixaban, have recently received US Food and Drug Administration (FDA) approval for stroke prevention in nonvalvular AF and have demonstrated noninferiority to warfarin in clinical trials and do not require frequent blood tests and dose adjustments like warfarin; however, they have not been tested against percutaneous LAA closure devices. Although anticoagulation is effective for stroke prevention, there is an increased risk of bleeding. Guidelines from the American College of Chest Physicians recommend the use of oral anticoagulation for individuals with AF who are at high risk of stroke (i.e., CHADS2 score of 2 or greater), with a more individualized choice of antithrombotic therapy in individuals with lower stroke risk. Percutaneous LAA closure devices have been developed as a nonpharmacologic alternative to anticoagulation for stroke prevention in AF. The devices may prevent stroke by occluding the LAA, thus preventing thrombus formation.

Multiple percutaneously deployed devices are being investigated for LAA closure. On March 13, 2015, an occlusion device, the Watchman™ LAA Closure Technology  (Boston Scientific Corp., Marlborough, MA), received approval from the FDA for stroke prevention in individuals with AF. The Watchman device is indicated for stroke prevention in individuals with AF who are candidates for systemic anticoagulation. The most relevant evidence comes from two industry-sponsored randomized controlled trials (RCTs) that compared the Watchman device with anticoagulation. One trial reported noninferiority on a composite outcome of stroke, cardiovascular/unexplained death, or systemic embolism after 2 years of follow-up, with continued benefits with the Watchman device after 4 years of follow-up.

The Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation (PROTECT-AF) trial, a multicenter, prospective RCT, was conducted to determine whether percutaneous LAA closure with a Watchman device was noninferior to warfarin for stroke prevention in nonvalvular AF. In the study, 707 individuals who were at least 18 years of age, with nonvalvular AF, a CHADS2 score of one or greater, and with eligibility for long-term warfarin therapy, were enlisted from 59 centers in the United States and Europe and were randomly assigned in a device-to-control ratio of two to one. Device individuals were treated with warfarin until day 45 to allow for endothelialization; thereafter, warfarin was discontinued. Individuals were followed with transesophageal echo at 45 days, 6 months, and 1 year, and were seen for clinical follow-up biannually for up to 5 years, and had regular international normalized ratio (INR) monitoring while on warfarin. Primary effectiveness composite endpoints were stroke, cardiovascular death, and systemic embolism.

The primary safety endpoints were life-threatening events, which included device embolization requiring retrieval and bleeding events such as pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitated a surgical procedure. The primary efficacy outcome occurred at a rate of 3.0 per 100 patient-years in the LAA closure group compared with 4.9 per 100 patient-years in the warfarin group. Based on these outcomes, the probability of noninferiority was greater than 99.9%. For the individual components of the primary outcome, cardiovascular/unexplained death and hemorrhagic stroke were higher in the warfarin group. In contrast, ischemic stroke was higher in the LAA closure group at 2.2 per 100 patient-years compared with 1.6 per 100 patient-years in the warfarin group. The primary safety outcome occurred more commonly in the LAA closure group, at a rate of 7.4 per 100 patient-years compared with 4.4 per 100 patient-years in the warfarin group. The excess adverse event rates of the LAA closure group were primarily the result of early adverse events associated with placement of the device. Outcomes through 4 years of follow-up were reported by Reddy et al. in 2014. The relative risk for the composite primary outcome in the Watchman group compared with anticoagulation was 0.60, which met the noninferiority criteria with a confidence interval of greater than 99.9%. Fewer hemorrhagic strokes occurred in the Watchman group, and fewer cardiovascular events occurred in the Watchman group. Rates of ischemic stroke did not differ significantly between the groups, but Watchman group individuals had lower all-cause mortality than anticoagulation group individuals.

The second multicenter, prospective RCT, the Watchman LAA Closure Device in Patients with Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL) study reported by Holmes et al. in 2014, evaluated the safety and effectiveness of the Watchman device for stroke prevention in 461 individuals with nonvalvular AF who were deemed by their professional providers to be suitable for long-term warfarin therapy with a CHADS2 score of two or greater. The study had three primary endpoints. The first primary endpoint included 18-month rates of the composite of stroke, systemic embolism, and cardiovascular or unexplained death. The second primary endpoint was the 18-month rates of ischemic stroke and systemic embolism excluding the first 7 days of postrandomization. The third primary endpoint was occurrence of death, ischemic stroke, systemic embolism, and procedure- or device-related complications requiring open cardiovascular surgery or major endovascular intervention in device-group only. In this trial, LAA occlusion was noninferior to warfarin for ischemic stroke prevention of systemic embolism events greater than 7 days postprocedure. Although noninferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety was significantly improved. This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in individuals with nonvalvular AF who do not have an absolute contraindication to short-term warfarin therapy.

In 2015, Holmes et al. reported results of a meta-analysis, which included data from the PROTECT-AF and PREVAIL trials and their respective registries, which included a total of 2406 enrolled individuals:1877 treated with the Watchman device and 382 treated with warfarin alone. With a mean follow-up of 2.69 years, individuals receiving LAA closure with the Watchman device had significantly fewer hemorrhagic strokes (0.15 vs 0.96 events per 100 patient-years); cardiovascular/unexplained death (1.1 vs 2.3 events per 100 patient-years); and nonprocedural bleeding (6% vs 11.9%) compared with warfarin. There were more ischemic strokes in the device group (1.6 vs 0.9 events per 100 patient-years). In conclusion, for individuals with nonvalvular AF at increased risk for stroke or bleeding who are candidates for long-term anticoagulation, LAA closure resulted in improved rates of hemorrhagic stroke, cardiovascular/unexplained death, and nonprocedural bleeding compared to warfarin.

Overall, the evidence from the published clinical trials is sufficient to determine that the Watchman device is efficacious in preventing stroke for individuals with nonvalvular AF who are eligible to receive systemic anticoagulation. When it is determined on an individualized basis that the long-term risk of systemic anticoagulation exceeds the procedural risk of the percutaneous LAA closure device implantation, the net health outcome will be improved.

For the use of the Watchman device for stroke prevention in patients with AF who are not candidates for systemic anticoagulation, the evidence consists of relatively small case series. The data from these studies suggest that placement of the Watchman device with the use of antiplatelet therapy is feasible, but do not provide evidence of the comparative benefit of LAA closure in preventing strokes. Thus, the published evidence is insufficient to determine that the Watchman device improves the net health outcome for individuals with AF who are not candidates for systemic anticoagulation. 


On August 14, 2021, an occlusion device, the Amplatzer™ Amulet™ Left Atrial Appendage Occluder (Abbott Medical, Plymouth, MN), received approval from the FDA for stroke prevention in individuals with AF. The Amplatzer Amulet Left Atrial Appendage Occluder  is intended to reduce the risk of thrombus embolization from the LAA in individuals who have nonvalvular AF and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a nonpharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.  The most relevant evidence comes from an industry-sponsored prospective, multicenter RCT that compared the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder to the Watchman device.


The Amplatzer Amulet LAA Occluder Trial (Amulet IDE), a multicenter worldwide prospective RCT, was conducted to evaluate the safety and effectiveness of the Amplatzer Amulet Left Atrial Appendage Occluder. In the study, 1878 individuals who were at least 18 years of age, with documented paroxysmal, persistent, or permanent nonvalvular AF, a CHADS2 score of two or greater or a CHA2DS2-VASc score of 3 or greater, and with eligibility for short-term warfarin therapy, were enlisted from 78 centers in the United States and 30 centers outside of the United States, and were randomly assigned (1:1) to undergo percutaneous implantation of an LAA occluder with the Amulet occlusion device (treatment) or Watchman LAA closure device (control). 


The primary endpoints included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months) and effectiveness (composite of ischemic stroke or systemic embolism at 18 months) and the rate of LAA occlusion at 45 days. Prespecified secondary endpoints included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the three primary endpoints. The Amulet occluder was noninferior to the Watchman device for the primary safety endpoint (14.5% vs 14.7%; difference= −0.14, 95% confidence interval [CI], −3.42 to 3.13; P<0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% vs 10.0% and 3.9% vs 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% vs 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness endpoint (2.8% vs 2.8%; difference=0.00, 95% CI, −1.55 to 1.55; P<0.001 for noninferiority), and the composite of stroke, systemic embolism, or cardiovascular/unexplained death (5.6% vs 7.7%; difference= −2.12; 95% CI, −4.45 to 0.21; P<0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% vs 12.3%; difference= −0.71; 95% CI, −3.72 to 2.31; P=0.32 for superiority). LAA occlusion was higher for the Amulet occluder compared with the Watchman device (98.9% vs 96.8%; difference=2.03, 95% CI, 0.41−3.66; P<0.001 for noninferiority; P=0.003 for superiority). The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular AF compared with the Watchman device, and superior for LAA occlusion. Procedure-related complications were higher with the Amulet device and decreased with operator experience. 

 

For the use of other LAA closure devices, including the Lariat® Suture Delivery Device (SentreHEART, Inc., Redwood City, CA), WaveCrest LAA occluder (Coherex Medical Inc., Salt Lake City, UT), and AmplatzerCardiac Plug (St. Jude Medical, Inc., St. Paul, MN) devices, for the prevention of stroke in AF, there were no controlled trials identified. Case series of these devices report high procedural success, but also numerous complications. The risks and benefits of sole open surgical LAA occlusion have not been well studied. In addition, these devices do not have FDA approval for LAA closure. Therefore, the current evidence is considered insufficient to determine that LAA closure devices other than the Watchman or Amplatzer Amulet Left Atrial Appendage Occluder devices improve the net health outcome for individuals with AF.​​

References

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Price MJ, Reddy VY, Valderrabano M, et al. Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin: A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience. JACC Cardiovasc Interv. 2015;8(15):1925-1932. 

Reddy VY, Doshi SK, Sievert H, et al. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) Trial. Circulation. 2013;127(6):720-729.

Reddy VY, Holmes D, Doshi SK, et al. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011;123(4):417-424.

Reddy VY, Möbius-Winkler S, Miller MA, et al. Left atrial appendage closure with the Watchman Device in patients with a contraindication for oral anticoagulation. The ASAP Study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013;61(25):2551-2556.

Reddy VY, Sievert H, Halperin J, et al. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988-1998.

Santoro G, Meucci F, Stolcova M, et al. Percutaneous left atrial appendage occlusion in patients with nonvalvular atrial fibrillation: implantation and up to four years follow-up of the AMPLATZER cardiac plug. EuroIntervention. 2016;11(10):1188-1194.

Sahay S, Nombela-Franco L, Rodes-Cabau J, et al. Efficacy and safety of left atrial appendage closure versus medical treatment in atrial fibrillation: a network meta-analysis from randomised trials. Heart. 2017;103(2):139-147.


Saw J, Holmes DR, Cavalcante JL, et al. SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure. J Soc Cardiovasc Angiogr Interv. 2023;2(3):100577.

Stone D, Byrne T, Pershad A. Early results with the LARIAT device for left atrial appendage exclusion in patients with atrial fibrillation at high risk for stroke and anticoagulation. Catheter Cardiovasc Interv. 2015;86(1):121-127.

Streb W, Szymala M, Kukulski T, et al. Percutaneous closure of the left atrial appendage using the Amplatzer cardiac plug in patients with atrial fibrillation: evaluation of safety and feasibility. Kardiol Pol. 2013;71(1):8-16.

Swaans MJ, Post MC, Rensing BJ, et al. Percutaneous left atrial appendage closure for stroke prevention in atrial fibrillation. Neth Heart J. 2012;20(4):161-166.

 

Takeda K, Tsuboko Y, Iwasaki K. Latest outcomes of transcatheter left atrial appendage closure devices and direct oral anticoagulant therapy in patients with atrial fibrillation over the past 5 years: a systematic review and meta-analysis. Cardiovasc Interv Ther. 2022;37(4):725-738. 

Tereshchenko LG, Henrikson CA, Cigarroa J, et al. Comparative effectiveness of interventions for stroke prevention in atrial fibrillation: a network meta-analysis. J Am Heart Assoc. 2016;5(5):e003206.

Urena M, Rodes-Cabau J, Freixa X, et al. Percutaneous left atrial appendage closure with the AMPLATZER cardiac plug device in patients with nonvalvular atrial fibrillation and contraindications to anticoagulation therapy. J Am Coll Cardiol. 2013;62(2):96-102.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Approval Letter: WATCHMAN LAA Closure Technology. Premarket Approval (PMA) Database . [FDA Web site]. 03/13/2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/p130013a.pdf. Accessed February 4, 2025.

 

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Approval Letter: Amplatzer Amulet Left Atrial Appendage Occluder. [FDA Web site]. 08/14/2021. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200049A.pdf. Accessed February 4, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). 2013 Meeting Materials of the Circulatory System Devices Panel.[FDA Web site]. 2013. Available at:
https://wayback.archive-it.org/7993/20170405193446/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm342357.htm. Accessed February 4, 2025.


Van Gelder IC, Rienstra M, Bunting KV, et al., 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3314-3414.


Viles-Gonzalez JF, Reddy VY, Petru J, et al. Incomplete occlusion of the left atrial appendage with the percutaneous left atrial appendage transcatheter occlusion device is not associated with increased risk of stroke. J Interv Card Electrophysiol. 2012;33(1):69-75.

Wei Z, Zhang X, Wu H, et al. A meta-analysis for efficacy and safety evaluation of transcatheter left atrial appendage occlusion in patients with nonvalvular atrial fibrillation. Medicine (Baltimore). 2016;95(31):e4382.

Wiebe J, Bertog S, Franke J, et al. Safety of percutaneous left atrial appendage closure with the Amplatzer cardiac plug in patients with atrial fibrillation and contraindications to anticoagulation. Catheter Cardiovasc Interv. 2014;83(5):796-802. 


Wen SN, Li SN, et al. Over 1-year efficacy and safety of left atrial appendage occlusion versus novel oral anticoagulants for stroke prevention in atrial fibrillation: A systematic review and meta-analysis of randomized controlled trials and observational studies. Heart Rhythm. 2016;13(6):1203-1214.

You JJ, Singer DE, Howard PA, et al. Antithrombotic therapy for atrial fibrillation: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2 Suppl):e531S-575S.

Coding

CPT Procedure Code Number(s)
33340
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)

I48.0 Paroxysmal atrial fibrillation

I48.11 Longstanding persistent atrial fibrillation

I48.19 Other persistent atrial fibrillation

I48.20 Chronic atrial fibrillation, unspecified

I48.21 Permanent atrial fibrillation

I48.91 Unspecified atrial fibrillation

HCPCS Level II Code Number(s)
N/A
Revenue Code Number(s)
N/A


​

Coding and Billing Requirements

Policy History

Revisions From 11.02.26c:​
​04/01/2026
​This policy has been reissued in accordance with the Company's annual review process.
04/02/2025

​This policy has been reviewed and reissued to communicate the Company’s continuing position on Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation.​
​07/10/2024
​This policy has been reviewed and reissued to communicate the Company’s continuing position on Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation.​​
​09/06/2023
​The policy has been reviewed and reissued to communicate the Company’s continuing position on Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation.​
07/18/2022

This version of the policy will become effective 07/18/2022.

​The intent of this policy remains unchanged; however, the policy criteria has been revised to include the Amplatzer™ Amulet™ Left Atrial Appendage Occluder​​ device as Medically Necessary.

​In addition, the Guidelines section of the policy has been revised n consideration of the US Food and Drug Administration (FDA) labeling for the Amplatzer™ Amulet™ Left Atrial Appendage Occluder​​. ​

The decription section of the policy was revised to include the AMPLATZER™ Amulet™​ LAA Occluder Trial​ (Amulet IDE). 

Revisions From 11.02.26b:​
​09/23/2020
​The policy has been reviewed and reissued to communicate the Company’s continuing position on Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation.​
11/20/2019This policy has been reissued in accordance with the Company's annual review process.
10/01/2019This policy has been identified for the ICD-10 code update, effective 10/01/2019.

The following ICD-10 codes has been added to this policy:

I48.11 Longstanding persistent atrial fibrillation

I48.19 Other persistent atrial fibrillation

I48.20 Chronic atrial fibrillation, unspecified

I48.21 Permanent atrial fibrillation

The following ICD-10 codes has been deleted to this policy:

I48.1 Persistent atrial fibrillation

I48.2 Chronic atrial fibrillation


Revisions From 11.02.26a:
05/09/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation.
11/22/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation.

Effective 10/05/2017 this policy has been updated to the new policy template format.
7/18/2022
7/18/2022
4/1/2026
11.02.26
Medical Policy Bulletin
Commercial
No
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