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Stroke prevention in atrial fibrillation is an important goal of treatment. Treatment with anticoagulant medications is the most common approach to stroke prevention. Most embolic strokes originate from the left atrial appendage; therefore, occlusion of the left atrial appendage may offer a nonpharmacologic alternative to anticoagulant medications for the prevention of stroke in patients with atrial fibrillation. Multiple percutaneously deployed devices are being investigated for left atrial appendage closure. There is one left atrial appendage (LAA) occlusion device with approval from the U.S. Food and Drug Administration (FDA) for stroke prevention in patients with atrial fibrillation, the Watchman™ device.
Stroke is the most serious complication of atrial fibrillation. The estimated incidence of stroke in non-treated patients with atrial fibrillation is 5% per year. Stroke associated with atrial fibrillation 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 atrial fibrillation treatment.
Stroke in atrial fibrillation occurs primarily as a result of thromboembolism from the left atrium. The lack of atrial contractions in atrial fibrillation 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 atrial fibrillation, and, therefore, the highest risk of thrombosis, is the left-atrial appendage (LAA). It has been estimated that 90% of left-atrial thrombi occur in the LAA.
The main treatment for stroke prevention in atrial fibrillation is anticoagulation, which has proven efficacy. The risk for stroke among patients with atrial fibrillation is stratified on the basis of several factors. A commonly used score, the CHADS2 score, assigns one 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 sex, 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 recently received U.S. Food and Drug Administration (FDA) approval for stroke prevention in nonvalvular atrial fibrillation and have demonstrated noninferiority to warfarin in clinical trials. While anticoagulation is effective for stroke prevention, there is an increased risk of bleeding. Also, 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. Guidelines from the American College of Chest Physicians recommend the use of oral anticoagulation for patients with atrial fibrillation who are at high risk of stroke (ie, CHADS2 score ≥2), with more individualized choice of antithrombotic therapy in patients with lower stroke risk.
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 patients treated with systemic anticoagulation. An example is the HAS-BLED score, which has validated to assess the annual risk of significant bleeding in patients with atrial fibrillation 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 of the patient 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 patients with atrial fibrillation 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 atrial fibrillation. 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 (Boston Scientific, Maple Grove, MN) 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 transeptal puncture to enter the left atrium. Following implantation, patients are anticoagulated with warfarin or alternate agents for approximately 1-2 months. After this period, patients are maintained on antiplatelet agents (i.e., aspirin and/or clopidrogel) 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 developed by Medtronic is currently being tested in clinical studies. The Amplatzer® cardiac plug (St. Jude Medical, Minneapolis, MN), is FDA-approved for closure of atrial septal defects, but not LAA closure device. A second-generation device, the Amplatzer Amulet, has been developed. The Percutaneous LAA Transcatheter Occlusion device (eV3, Plymouth, MN) has also been evaluated in research studies but has not received FDA approval.
In 2009, the Watchman Left Atrial Appendage Closure Technology (Boston Scientific, Marlborough, MA) was originally considered by the U.S. Food and Drug Administration (FDA) approval based on the results of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients with Atrial Fibrillation (PROTECT-AF) randomized controlled trial. The device underwent three panel reviews before it was approved by FDA through the premarket approval process on March 13, 2015.
This device is indicated to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation who:
FDA product code: NGV.
At least two other devices have been studied for LAA occlusion, but are not approved in the United States for percutaneous closure of the LAA. In 2006, the Lariat® Loop Applicator device (SentreHEART, Redwood City, CA), a suture delivery system, was cleared for marketing by the FDA through the 510(k) process. The intended use is to facilitate suture placement and knot tying in surgical applications where soft tissues are being approximated or ligated with a pretied polyester suture. The Amplatzer Amulet® device (St. Jude Medical, Plymouth, MN) has a CE approval in Europe for LAA closure, but is not currently approved in the United States for any indication.
The use of a device with U.S. Food and Drug Administration (FDA) approval for percutaneous left atrial appendage closure (eg, the Watchman) may be considered medically necessary for the prevention of stroke in patients with atrial fibrillation when the following criteria are met:
The use of a device with FDA approval for percutaneous left atrial appendage closure (eg, the Watchman) for stroke prevention in patients who do not meet the above criteria is considered investigational.
The use of other percutaneous left atrial appendage closure devices, including but not limited to the Lariat, PLAATO, and Amplatzer devices, for stroke prevention in patients with atrial fibrillation is considered investigational.
The balance of risks and benefits associated with implantation of the Watchman device for stroke prevention, as an alternative to systemic anticoagulation with warfarin, must be made on an individual basis.
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 patients treated with systemic anticoagulation. An example is the HAS-BLED score, which has validated to assess the annual risk of significant bleeding in patients with atrial fibrillation treated with warfarin. The score ranges from 0 to 9, based on a number of clinical characteristics (see the table below).
Clinical Components of the HAS-BLED Bleeding Risk Score
Patients with scores of 3, 4, and 5 have been reported to have a risk of major bleeding of 3.74/100 patient years, 8.70/100 patient years, and 12.5/100 patient years, respectively. Scores of 3 or greater are considered to be associated with high risk of bleeding, potentially signaling the need for closer monitoring of the patient for adverse risks, closer monitoring of international normalized ratio, or differential dose selections of oral anticoagulants or aspirin.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/29/2011: Approved by Medical Policy Advisory Committee.
04/26/2012: Policy reviewed; added "percutaneous" to the policy title and policy statement.
07/19/2013: Policy reviewed; no changes to policy statement. Added CPT code 0281T to the Code Reference section.
09/15/2014: Policy reviewed; no changes.
08/18/2015: Code Reference section updated for ICD-10.
02/01/2016: Policy description updated regarding anticoagulant medications and devices. Added policy statement that the use of a device with FDA approval for percutaneous left atrial appendage closure may be considered medically necessary for the prevention of stroke in patients with atrial fibrillation when certain criteria are met. Added policy statement that the use of an FDA-approved device for patients not meeting the criteria is considered investigational. Policy statement revised to state that the use of other percutaneous left atrial appendage closure devices, including but not limited to the Lariat, PLAATO, and Amplatzer devices, for stroke prevention in patients with atrial fibrillation is considered investigational. Policy guidelines updated regarding clinical components of the HAS-BLED bleeding risk score. Added medically necessary and investigative definitions. Code Reference section updated to change "Investigational Codes" to "Medically Necessary Codes." Code Reference section updated to add CPT code 33999 and ICD-10 diagnosis codes I48.0, I48.1, I48.2, and I48.91.
06/06/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.26
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Medically Necessary Codes