Print

Date Printed: June 23, 2017: 06:28 PM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-33000-36

Original Effective Date: 04/15/16

Reviewed: 04/27/17

Revised: 05/15/17

Next Review: 04/26/18

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

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Stroke is the most serious complication of atrial fibrillation (AF). Stroke associated with AF is primarily embolic in nature, tends to be more severe than the typical ischemic stroke, and causes higher rates of mortality and disability. As a result, stroke prevention is one of the main goals of AF treatment.

Stroke in AF occurs primarily as a result of thromboembolism from the left atrium. The lack of atrial contractions in AF leads to blood stasis in the left atrium, and this low flow state increases the risk for thrombosis. The area of the left atrium with the lowest blood flow in AF, and, therefore, the highest risk of thrombosis, is the left atrial appendage (LAA).

The main treatment for stroke prevention in AF is anticoagulation, which has proven efficacy. The risk for stroke among those with AF is stratified on the basis of several factors. A commonly used score, the CHADS2 score, assigns 1 point each for the presence of heart failure, hypertension, age 75 years or older, diabetes, or prior stroke or transient ischemic attack. The CHADS2-VASc score includes gender, more age categories, and the presence of vascular disease, in addition to the risk factors used in the CHADS2 score. Warfarin is the predominant agent in clinical use. A number of newer anticoagulant medications, including dabigatran, rivaroxaban, and apixaban, have demonstrated noninferiority to warfarin in clinical trials. Warfarin requires frequent monitoring and adjustments, as well as lifestyle changes. Dabigatran does not require monitoring. However, unlike warfarin, the antithrombotic effects of dabigatran are not reversible with any currently available hemostatic drugs.

Bleeding is the primary risk associated with systemic anticoagulation. A number of risk scores have been developed to estimate the risk of significant bleeding in individuals treated with systemic anticoagulation. An example is the HAS-BLED score, which has validated to assess the annual risk of significant bleeding in those with AF treated with warfarin. The score ranges from 0 to 9, based on a number of clinical characteristics, including the presence of hypertension, renal and liver function, history of stroke, bleeding, labile international normalized ratios (INRs), age, and drug/alcohol use. Scores of 3 or greater are considered to be associated with high risk of bleeding, potentially signaling the need for closer monitoring for adverse risks, closer monitoring of INRs, or differential dose selections of oral anticoagulants or aspirin.

Surgical removal, or exclusion, of the LAA is often performed in individuals with AF who are undergoing open heart surgery for other reasons. 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.

Several versions of LAA occlusion devices have been developed. The Watchman™ left atrial appendage system is a self-expanding nickel titanium device. It has a polyester covering and fixation barbs for attachment to the endocardium. Implantation is performed percutaneously through a catheter delivery system, using venous access and transseptal puncture to enter the left atrium. Following implantation, individuals are anticoagulated with warfarin or alternative agents for approximately 1 to 2 months. After this period, they are maintained on antiplatelet agents (ie, aspirin and/or clopidogrel) indefinitely. The Lariat® Loop Applicator is a suture delivery device that is intended to close a variety of surgical wounds in addition to left atrial appendage closure. The Cardioblate® closure device is currently being tested in clinical studies. The Amplatzer® cardiac plug is FDA-approved for closure of atrial septal defects but not as an LAA closure device. A second-generation device, the Amplatzer Amulet, has been developed. The Percutaneous LAA Transcatheter Occlusion device has also been evaluated in research studies but has not received FDA approval.

POSITION STATEMENT:

The use of the Watchman™ left atrial appendage system for percutaneous left atrial appendage closure meets the definition of medical necessity for the prevention of stroke in individuals with atrial fibrillation when the all of the following criteria are met:

• There is an increased risk of stroke and/or systemic embolism based on CHADS2 score( ≥ 2), or CHA2DS2-VASc score ( ≥ 2), and systemic anticoagulation therapy is recommended; AND

• The long-term risks of systemic anticoagulation outweigh the risks of the device implantation (e.g., HAS-BLED score ≥ 3)

CHADS2 Calculator for Atrial Fibrillation

Criteria

Score

Congestive heart failure (any history of CHF or LV dysfunction)

+1

Hypertension (any history of a hypertension diagnosis, regardless of severity)

+1

Age 75 years or older

+1

Diabetes mellitus (any history of a diabetes diagnosis, regardless of severity)

+1

Stroke or TIA (any history of cerebral ischemia)

+2

CHA2DS2-VASc Calculator for Atrial Fibrillation

Criteria

Score

Congestive heart failure (signs/symptoms of heart failure confirmed with objective evidence of cardiac dysfunction)

+1

Hypertension

(resting BP > 140/90 mmHg on at least 2 occasions or current antihypertensive pharmacologic treatment)

+1

Age 75 years or older

+2

Diabetes mellitus

(fasting glucose > 125 mg/dL or treatment with oral hypoglycemic agent and/or insulin)

+1

Stroke, TIA, or Thromboembolism

(includes any history of cerebral ischemia)

+2

Vascular disease

(prior MI, peripheral arterial disease, or aortic plaque)

+1

Age 65 to 74 years

+1

Gender category (female)

+1

HAS-BLED Calculator for Atrial Fibrillation

Criteria

Score

Hypertension (uncontrolled hypertension (systolic BP > 160 mmHg)

+1

Abnormal renal or liver function

[Renal: Chronic dialysis, renal transplant, serum creatinine ≥ 2.3 mg/dL (200 µmol/L)]

[Liver: Cirrhosis, bilirubin > 2x UNL with AST/ALT/AP > 3x UNL]

+1 or +2

Stroke

+1

Bleeding (bleeding history or predisposition (anemia)

+1

Labile INR (therapeutic time in range < 60%)

+1

Elderly (greater than 65 years old

+1

Drugs or alcohol

[Drugs - other antiplatelet agents or NSAIDs]

[Alcohol - more than 8 drinks per week]

+1 or +2

The use of other percutaneous left atrial appendage closure devices, including but not limited to the Cardioblate® closure device, Lariat® Loop Applicator, Amplatzer® cardiac plug, Amplatzer Amulet, and Percutaneous LAA Transcatheter Occlusion devices, for stroke prevention in atrial fibrillation is considered experimental or investigational.

BILLING/CODING INFORMATION:

None applicable.

CPT Coding:

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

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Percutaneous LEFT ATRIAL APPENDAGE Closure (LAAC) (20.34), located at cms.gov.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Watchman™ Left Atrial Appendage Closure Technology
Cardioblate® Closure Device
Lariat® Loop Applicator
Amplatzer® Cardiac Plug
Amplatzer Amulet
Percutaneous LAA Transcatheter Occlusion Device

REFERENCES:

  1. Akin I, Nienaber CA. Left atrial appendage occlusion: A better alternative to anticoagulation? World J Cardiol. 2017 Feb 26;9(2):139-146.
  2. Alli O, 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. Journal of the American College of Cardiology [2013, 61 (17):1790-1798].
  3. Alipour A, et al. Novel stroke risk reduction in atrial fibrillation: left atrial appendage occlusion with a focus on the Watchman closure device. Vasc Health Risk Manag. 2017 Mar 6;13:81-90.
  4. BlueCross BlueSHield Association Medical Policy Reference Manual. 2.02.26, Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation. May 2016.
  5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous left atrial appendage closure therapy for prevention of stroke. TEC Assessments 2014;29; Tab 5.
  6. Centers for Medicare & Medicaid Services (CMS). Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N). February 8, 2016.
  7. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Percutaneous LEFT ATRIAL APPENDAGE Closure (LAAC) (20.34). (10/03/16).
  8. Eng L, Saw J. Percutaneous left atrial appendage closure: here to stay. J Thorac Dis. 2016 Sep;8(9):2420-2423.
  9. Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H, Valderrabano M, Reddy VY. 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 Jun 23;65(24):2614-23.
  10. U.S. Food and Drug Administration (FDA). Approval Letter (P130013a) : WATCHMAN LAA Closure Technology. March 2015. Accessed at http://www.accessdata.fda.gov/cdrh_docs/pdf13/p130013a.pdf.
  11. 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. Jul 8 2014;64(1):1-12.
  12. Huang WP, et al. Efficacy and Safety of the WATCHMAN Left Atrial Appendage System for Stroke Prevention in Chinese Patients with Nonvalvular Atrial Fibrillation: A Single-center, Prospective, Observational Study. Chin Med J (Engl). 2017 Feb 20;130(4):434-438.
  13. January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2014;64:2246–80.
  14. Jazayeri MA, et al. Five years of keeping a watch on the left atrial appendage-how has the WATCHMAN fared? J Thorac Dis. 2016 Dec;8(12):E1726-E1733.
  15. Matsuo Y, et al. Interventional closure of the left atrial appendage for stroke prevention. Circ J. 2014;78(3):619-24.
  16. Reddy VY, et al. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98.
  17. National Guideline Clearinghouse. Guideline Summary NGC-10473: Atrial fibrillation: the management of atrial fibrillation. National Clinical Guideline Centre. London (UK): National Institute for Health and Care Excellence (NICE); 2014 Jun.
  18. National Institute for Health and Care Excellence (NICE). Interventional Procedure Guidance (IPG) 349: Percutaneous occlusion of the left atrial appendage in non-valvular atrial fibrillation for the prevention of thromboembolism. June 2010. Accessed at http://www.nice.org.uk/guidance/ipg349/.
  19. Reddy VY, Möbius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. 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 Jun 25;61(25):2551-6.
  20. Suradi HS, Hijazi ZM. Left atrial appendage closure: outcomes and challenges. Neth Heart J. 2017 Feb;25(2):143-151.
  21. U.S. Food and Drug Administration (FDA). Approval Letter (P130013a) : WATCHMAN LAA Closure Technology. March 2015. Accessed at http://www.accessdata.fda.gov/cdrh_docs/pdf13/p130013a.pdf.
  22. You JJ, 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 Feb;141(2 Suppl):e531S-75S.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/27/17.

GUIDELINE UPDATE INFORMATION:

04/15/16

New Medical Coverage Guideline.

01/01/17

Annual CPT/HCPCS update. Added 33340. Deleted 0281T.

05/15/17

Scheduled review. Position statement maintained. Reformatted guideline. Updated references.

Date Printed: June 23, 2017: 06:28 PM