Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

Policy #:11.02.26a

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

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) 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 65-74, and female gender
  • Assessment of bleeding risk: There is an increased risk of major bleeding (intracranial, hospitalization, hemoglobin decrease, greater than 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 greater than 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), WaceCrest LAA occluder (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 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
1 pointAge > 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 atrial fibrillation is required:

HAS-BLED Risk of Major Bleeding with Anticoagulation
 CLINICAL FEATURESCORE
HHypertension (systolic blood pressure [SBP] > 160 mmHg) 1 point
AAbnormal 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, non-steroidal 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 less than 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) 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 atrial fibrillation (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. A number of newer anticoagulant medications, including dabigatran, rivaroxaban, and apixaban, have recently received 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. While 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 U.S. Food and Drug Administration (FDA) for stroke prevention in individuals with AF. The Watchman™ LAA Closure Technology 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 two years of follow-up, with continued benefits with the Watchman™ device after four years of follow-up.

PROTECT-AF, a multicenter, prospective randomized controlled trial (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 US and Europe and were randomized 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 five 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 percent. 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 four years 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 percent. 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 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 seven days of post-randomization. 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 post-procedure. 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, Homes 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 versus 0.96 events per 100 patient-years); cardiovascular/unexplained death (1.1 versus 2.3 events per 100 patient-years); and nonprocedural bleeding (6 percent versus 11.9 percent) compared with warfarin. There were more ischemic strokes in the device group (1.6 versus 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. 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 Amplatzer™Cardiac 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™ device improve the net health outcome for individuals with AF.
References


Alli O, Doshi S, Kar S, et al. Quality of life assessment in the randomized PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial of patients at risk for stroke with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2013;61(17):1790-1798.

Backer OD, Arnous S, Ihlemann N, et al. Percutaneous left atrial appendage occlusion for stroke prevention in atrial fibrillation: an update. Open Heart.2014;1(1)e000020.

Bajaj NS, Kalra R, Patel N, et al. Comparison of approaches for stroke prophylaxis in patients with non-valvular atrial fibrillation: network meta-analyses of randomized controlled trials. PLoS One. 2016;11(10):e0163608.

Bartus K, Bednarek J, Myc J, et al. Feasibility of closed-chest ligation of the left atrial appendage in humans. Heart Rhythm.2011;8(2):188-193.

Bartus K, Han FT, Bednarek J, et al. Percutaneous left atrial appendage suture ligation using the LARIAT Device in patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol. 2013;62(2):108-118.

Bayard YL, Omran H, Neuzil P, et al. PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients: results from the European PLAATO study. EuroIntervention. 2010;6(2):220-226.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous left atrial appendage closure therapy for prevention of stroke. TEC Assessments 2014; volume 29, tab 5.

Center for Medicare and Medicaid Services. National Coverage Determination (NCD) for Percutaneous Left Atrial Appendage Closure (LAAC) (20.34). [CMS Web site]. 10/03/2016. Available at:https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Main%20Menu/Tools%20&%20Resources/Policies%20and%20Protocols/Medicare%20Advantage%20Policy%20Guidelines/Percutaneous_LAAC.pdf. Accessed April 10, 2018.

Chun KR, Bordignon S, Urban V, et al. Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience. Heart Rhythm. 2013;10(12):1792-1799.

Cruz-Gonzalez I, Martin Moreiras J, Garcia E. Thrombus formation after left atrial appendage exclusion using an Amplatzer cardiac plug device. Catheter Cardiovasc Interv. 2011;78(6):970-973.

Danna P, Proietti R, Sagone A, et al. Does left atrial appendage closure with a cardiac plug system reduce the stroke risk in nonvalvular atrial fibrillation patients? A single-center case series. Pacing Clin Electrophysiol.2013;36(3):347-353.

Fuller CJ, Reisman M. Stroke prevention in atrial fibrillation: atrial appendage closure. Curr Cardiol Rep. 2011;13(2):159-166.

Gage BF, Waterman AD, Shannon W, et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001; 285(22):2864–2870.

Gloekler S, Shakir S, Doblies J, et al. Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation. Clin Res Cardiol. 2015;104(8):656-665.

Guerios EE, Schmid M, Gloekler S, et al. Left atrial appendage closure with the Amplatzer cardiac plug in patients with atrial fibrillation. Arq Bras Cardiol. 2012;98(6):528-536.

Hanif H, Belley-Cote EP, Alotaibi A, et al. Left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation: a systematic review and network meta-analysis of randomized controlled trials. J Cardiovasc Surg (Torino). 2018;59(1):128-139.

Health Technology Forecast [database online]. Plymouth Meeting (PA): ECRI Institute; 2015 May 01. [accessed 2015 August 10]. Transcatheter left atrial appendage occlusion for preventing stroke in patients with atrial fibrillation. [16 pp]. Available: http://www.ecri.org.

Hijazi ZM, Saw J. Nonpharmacologic therapy to prevent embolization in patients with atrial fibrillation. [UpToDate Web site]. 11/28/2017. Available at:https://www.uptodate.com/contents/nonpharmacologic-therapy-to-prevent-embolization-in-patients-with-atrial-fibrillation. Accessed April 10, 2018.

Holmes DR, Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation a patient-level meta-analysis. J Am Coll Cardiol. 2015;65(24):2614-2623.

Holmes DR, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64(1):1-12.

Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009;374(9689):534-542.

Horstmann S, Zugck C, Krumsdorf U, et al. Left atrial appendage occlusion in atrial fibrillation after intracranial hemorrhage. Neurology. 2014;82(2):135-138.

January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation.2014;130(23):2071-2104.

Kefer J, Vermeersch P, Budts W, et al. Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac plug: the Belgian Registry. Acta Cardiol. 2013;68(6):551-558.

Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016;18(11):1609-1678.

Lam YY, Yip GW, Yu CM, et al. Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience. Catheter Cardiovasc Interv. 2012;79(5):794-800.

Lane DA, Lip GY. Use of the CHA2DS2-VASc and HAS-BLED scores to aid decision making for thromboprophylaxis in nonvalvular atrial fibrillation. Circulation.2012;126(7):860-865.

Lopez-Minguez JR, Eldoayen-Gragera J, Gonzalez-Fernandez R, et al. Immediate and one-year results in 35 consecutive patients after closure of left atrial appendage with the Amplatzer cardiac plug. Rev Esp Cardiol.2013;66(2):90-97.

Masoudi FA, Calkins H, Kavinsky CJ, et al. 2015 ACC/HRS/SCAI left atrial appendage occlusion device societal overview. A professional societal overview from the American College of Cardiology, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2015.

Massumi A, Chelu MG, Nazeri A, et al. Initial experience with a novel percutaneous left atrial appendage exclusion device in patients with atrial fibrillation, increased stroke risk, and contraindications to anticoagulation. Am J Cardiol. 2013;111(6):869-873.

Matsuo Y, Sandri M, Mangner N, et al. Interventional Closure of the Left Atrial Appendage for Stroke Prevention. Circ J. 2014;78(3):619-624.

Meerkin D, Butnaru A, Dratva D, et al. Early safety of the Amplatzer cardiac plug for left atrial appendage occlusion. Int J Cardiol. 2013;168(4):3920-3925.

Montenegro MJ, Quintella EF, Damonte A, et al. Percutaneous occlusion of left atrial appendage with the Amplatzer Cardiac PlugTM in atrial fibrillation. Arq Bras Cardiol. 2012;98(2):143-150.

Nietlispach F, Gloekler S, Krause R, et al. Amplatzer left atrial appendage occlusion: single center 10-year experience. Catheter Cardiovasc Interv. 2013;82(2):283-289.

Park JW, Bethencourt A, Sievert H, et al. Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience. Catheter Cardiovasc Interv. 2011;77(5):700-706.

Pisters R, Lane DA, Nieuwlaat R, et al. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138(5):1093-1100.

Price MJ, Gibson DN, Yakubov SJ, et al. Early safety and efficacy of percutaneous left atrial appendage suture ligation: results from the U.S. transcatheter LAA ligation consortium. J Am Coll Cardiol. 2014;64(6):565-572.

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.October 30, 2014.

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.

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.

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).

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. [FDA Web site]. 03/13/2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/p130013a.pdf. Accessed April 10, 2018.

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 April 03, 2018.

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.Dec 11 2013.

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

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

33340


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

I48.0 Paroxysmal atrial fibrillation

I48.1 Persistent atrial fibrillation

I48.2 Chronic 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 11.02.26a:
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.

Version Effective Date: 01/01/2017
Version Issued Date: 12/30/2016
Version Reissued Date: 05/09/2018

Connect with Us        


© 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.