mp-490 - Medical Policies - Alabama
Left-Atrial Appendage Closure or Clipping
Policy Number: MP-490
Latest Review Date: June 2020
Policy Grade: B
Effective for Dates of Service on and after June 10, 2019:
The use of a device with U.S. Food and Drug Administration (FDA) approval for percutaneous left atrial appendage closure (e.g., the Watchman) may be considered medically necessary for the prevention of stroke in patients with atrial fibrillation when the following criteria are met:
- There is an increased risk of stroke and systemic embolism based on CHA2DS2 or CHA2DS2-VASc score and systemic anticoagulation therapy is recommended; and
- The long-term risks of systemic anticoagulation outweigh the risks of the device implantation.
The use of a device with FDA approval for percutaneous left atrial appendage closure (e.g., 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 and Amplatzer devices, for stroke prevention in patients with atrial fibrillation is considered investigational.
Effective for Dates of Service prior to June 10, 2019:
Left-atrial appendage closure devices performed via thoracotomy, percutaneously or with concomitant procedure are considered not medically necessary and investigational.
Epicardial clipping of the left atrial appendage is considered not medically necessary and investigational, including but not limited to, atrial fibrillation and all other indications.
DESCRIPTION OF PROCEDURE OR SERVICE:
Stroke prevention in patients with atrial fibrillation (AF) is an important goal of treatment. Treatment with anticoagulant medications is the most common approach to stroke prevention. Because most embolic strokes originate from the left atrial appendage, occlusion of the left atrial appendage may offer a non-pharmacologic alternative to anticoagulant medications to lower the risk of stroke. Multiple percutaneously-deployed devices are being investigated for left atrial appendage closure. One left atrial appendage device (the Watchman device) has approval from the U.S. Food and Drug Administration for stroke prevention in patients with AF.
Atrial Fibrillation and Stroke
AF is the most common type of irregular heartbeat, affecting at least 2.7 million people in the U. S. Stroke is the most serious complication of AF. The estimated incidence of stroke in nontreated patients with AF is 5% per year. Stroke associated with AF is primarily embolic, tends to be more severe than the typical ischemic stroke, and causes higher rates of mortality and disability. As a result, stroke prevention is a main goal of AF treatment.
Stroke in AF 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 AF is anticoagulation, which has proven efficacy. The risk for stroke among patients with AF is evaluated using several factors. Two commonly used scores, the CHADS2 score, and the CHA2DS2-VASc score are described in Table 1. 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 AF and have demonstrated non-inferiority 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 (2018, updated from 2012) recommend that CHA2DS2VASc be used to evaluate stroke risk, and patients initially identified as having a low stroke risk should not be given antithrombotic therapy. In addition, they recommend bleeding risk assessments be given to every patient at every patient contact and that “potentially modifiable bleeding risk factors” should be the initial focus.
Table 1. CHA2DS2 and CHA2DS2-VASc Scores to Predict Ischemic Stroke Risk in Patients With Atrial Fibrillation
Congestive heart failure (signs/symptoms of heart failure confirmed with objective evidence of cardiac dysfunction)
Hypertension (resting blood pressure >140/90 mmHg on at least 2 occasions or current antihypertensive pharmacologic treatment)
Age ≥75 y
Diabetes (fasting glucose >125 mg/dL or treatment with oral hypoglycemic agent and/or insulin)
Stroke or transient ischemic attack (includes any history of cerebral ischemia)
Vascular disease (prior myocardial infarction, peripheral arterial disease, or aortic plaque)
Age 65-74 y
Sex category of female (female sex confers higher risk)
Adapted from Lip et al (2018), and January et al (2014).
Bleeding is the primary risk associated with systemic anticoagulation. 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 AF treated with warfarin. The score ranges from zero to nine, 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 three 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 the devices have been developed. The PLAATO system (ev3 Endovascular) was the first device to be approved by the FDA for LAA occlusion. The device was discontinued in 2007 for commercial reasons, and intellectual property was sold to manufacturers of the Watchman system. 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, utilizing venous access and transseptal puncture to enter the left atrium. Transesophageal echocardiography and fluoroscopy are used to guide the procedure. Following implantation, patients are anticoagulated with warfarin or alternate agents for approximately one-two months. After this period, patients are maintained on antiplatelet agents (i.e., aspirin and/or clopidogrel) indefinitely. The Amplatzer cardiac plug (St. Jude Medical, Minneapolis, MN), is FDA-approved for closure of atrial septal defects but not for LAA closure. A second-generation device, the Amplatzer Amulet, has been developed for the specific indication of LAAC, but currently does not have the FDA approval. The Amplatzer Amulet consists of a nitinol mesh disc to seal the ostium of the LAA and a nitinol mesh distal lobe, to be positioned within the LAA. The device is preloaded within a delivery sheath. The Percutaneous LAA Transcatheter Occlusion (PLATTO) device (eV3, Plymouth MN) has also been studied for this purpose but has not received FDA approval. The Occlutech® (Occlutech, Sweden) Left Atrial Appendage Occluder (has received a CE mark for coverage in Europe. The Cardioblate® closure device (Medtronic) is currently being tested in clinical studies.
The Lariat Loop Applicator is a suture delivery device approved by the FDA, intended to close a variety of surgical wounds. It is not specifically approved for LAAC. While the Watchman and other devices are implanted in the endocardium, the Lariat is a non-implant epicardial device.
The optimal study design for evaluating the efficacy of percutaneous LAAC for the prevention of stroke in AF is a randomized controlled trial that includes clinically relevant measures of health outcomes. The rate of ischemic stroke during follow-up is the primary outcome of interest, along with rates of systemic embolization, cardiac events, bleeding complications, and death. For the LAAC devices, the appropriate comparison group could be oral anticoagulation, no therapy (for patients who have prohibitive risk for oral anticoagulation), or open surgical repair.
Although the Watchman device and other LAAC devices would ideally represent an alternative to oral anticoagulation for the prevention of stroke in patients with AF, during the postimplantation period, the device may be associated with increased thrombogenicity and, therefore, anticoagulation is used during the periprocedural period. Most studies evaluating the Watchman device have included patients who are eligible for anticoagulation.
The most recent update with literature review covers the period of through March 9, 2020.
For individuals who have AF who are at increased risk for embolic stroke who receive the Watchman percutaneous LAAC device, the evidence includes two RCTs and meta-analyses of these trials. The relevant outcomes are overall survival, morbid events, and treatment-related morbidity. The most relevant evidence comes from two industry-sponsored RCTs that compared the Watchman device with anticoagulation alone. 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. The second trial did not demonstrate noninferiority for the same composite outcome but did demonstrate noninferiority of the Watchman device to warfarin for late ischemic stroke and systemic embolization. Patient-level meta-analyses at five-year follow-up for the two trials reported that the Watchman device is noninferior to warfarin on the composite outcome of stroke, systemic embolism, and cardiovascular death. Also, the Watchman was associated with lower rates in major bleeding, particularly hemorrhagic stroke, and mortality over the long-term. The evidence also indicates that the Watchman device is efficacious in preventing stroke in the subset of patients with AF who are at increased risk for embolic stroke. Among patients in which the long-term risk of systemic anticoagulation exceeds the procedural risk of device implantation, the net health outcome will be improved. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
For individuals who have AF who are at increased risk for embolic stroke who receive a percutaneous LAAC device other than the Watchman device (e.g., the Lariat, Amplatzer), the evidence includes several nonrandomized comparator studies and uncontrolled case series. The relevant outcomes are overall survival, morbid events, and treatment-related morbidity. One nonrandomized study which compared outcomes among patients undergoing LAAC with the Lariat device with patients receiving anticoagulant or antiplatelet therapy, reported fewer thromboembolic events in the group receiving the Lariat device. Two nonrandomized studies compared the Amplatzer cardiac plug with the Amplatzer amulet. While the amulet may be technically easier to implant, clinical outcomes were similar between the two groups. The remaining evidence consists of case series of these devices which report high procedural success but also numerous complications. In addition, these devices do not have the FDA approval for LAAC. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
American Heart Association
The American Heart Association, in collaboration with the American College of Cardiology and the Hearth Rhythm Society (2019) published an update of their guideline for the management of patients with atrial fibrillation. A new recommendation in the guideline states: "Percutaneous LAA occlusion may be considered in patients with AF at increased risk of stroke who have contraindications to long-term anticoagulation." The class of recommendation is IIb and the level of evidence is B-NR (moderate quality of evidence, non-randomized). No other LAA closure devices are mentioned in the guideline.
Andrade et al (2017) provided the following summary (see Table 2) comparing guidelines by American, Canadian, and European societies on left atrial appendage exclusion and closure for the management of atrial fibrillation.
Table 2. Comparison of American, Canadian, and European Guidelines on LAA Exclusion/Closure
Surgical LAA closure (excision or obliteration of LAA)
May be considered in patients undergoing cardiac surgery (IIb)
Should be considered as part of surgical ablation of AF associated with mitral, aortic valve, or coronary artery bypass surgery
• May be considered in patients undergoing cardiac surgery (IIb)
• More data needed to confirm safety and efficacy of thoracoscopic exclusion
Percutaneous LAA exclusion
Not be used, except in research or in systematically documented use protocols in patients at high risk of stroke (CHADS2 ≥2) and antithrombotic therapy precluded
May be considered in patients with contraindications for long term anticoagulant treatment (IIb)
Adapted from Andrade et al (2017).
ACC: American College of Cardiology; AF: atrial fibrillation; AHA: American Heart Association; CCS: Canadian Cardiovascular Society; CHADS2: Congestive Heart Failure, Hypertension, Age, Diabetes, Stroke/Transient Ischemic Attack; ESC: European Society of Cardiology; HRS: Heart Rhythm Society; LAA: left atrial appendage.
U.S. Preventive Services Task Force Recommendations
LAA closure devices are not preventive services and are therefore not included in the U.S. Preventive Task Force Recommendations for preventive services.
Left Atrial Appendage Closure Device, WATCHMAN®, LARIAT®, AMPLATZER®, PLATTO, LAA
APPROVED BY GOVERNING BODIES:
In 2002, the PLAATO system (ev3 Endovascular) was the first device to be approved by the U.S. Food and Drug Administration (FDA) for LAA occlusion. The device was discontinued in 2007 for commercial reasons and intellectual property was sold to manufacturers of the Watchman system.
In 2015, the Watchman™ Left Atrial Appendage Closure Technology (Boston Scientific) was approved by the FDA through the premarket approval process by the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients with Atrial Fibrillation randomized controlled trial. This device is indicated to reduce the risk of thromboembolism from the LAA in patients with nonvalvular AF who:
- Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;
- Are deemed by their physicians to be suitable for warfarin; and
- Have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared with warfarin.
Other devices are being evaluated for LAA occlusion, but are not approved in the U.S. for percutaneous closure of the LAAC. The Lariat® Loop Applicator device (SentreHEART, Inc, Redwood City, CA) is a suture delivery system that received 510(k) marketing clearance from FDA in 2006. The intended use is to facilitate suture placement and knot tying in surgical applications where soft tissues are being approximated or ligated with a pre-tied polyester suture. The Amplatzer Amulet® device (St. Jude Medical, Plymouth, MN) and WaveCrest® (Coherex Medical) have CE approval in Europe for left atrial appendage closure, but are not currently approved in the U.S. for this indication.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity
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. (Effective 01/01/17)
Percutaneous transcatheter closure of the left atrial appendage with implant, including fluoroscopy, transseptal (Deleted 12/31/16)
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- 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): 161-6.
- 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. May 20 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.
- 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). Aug 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 2013.
- 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-75S.
Medical Policy Group, December 2011 (3)
Medical Policy Administration Committee, December 2011
Available for comment December 14, 2011 through January 27, 2012
Medical Policy Group, March 2012 (3): 2012 Updates to Description, Key Points & References
Medical Policy Panel, March 2013
Medical Policy Group, June 2013 (4): 2013 Updates to Description, Key Points, Key Words & References; no change in policy statement
Medical Policy Panel, July 2014
Medical Policy Panel, July 2014 (4): Updated Description, updated Key Points to include Practice Guidelines, updated Approved Governing Bodies and References. There were no changes to the policy at this time.
Medical Policy Group, May 2015 (4): Update to Approved Governing Bodies
Medical Policy Panel, October 2015
Medical Policy Group, December 2015 (4): Updates to Description, Key Points, Approved Governing Bodies, and References. No change to policy statement.
Medical Policy Panel, May 2016
Medical Policy Group, June 2016 (4): Updates to Key Points and References. No change to policy statement.
Medical Policy Group, December 2016: 2017 Annual Coding Update. Created Previous Coding section and moved deleted code 0281T to this section. Added new CPT code 33340 to Current Coding.
Medical Policy Panel, May 2017
Medical Policy Group, May 2017 (4): Updates to Description, Key Points, Key Words and References. No change to policy statement.
Medical Policy Panel, 2018
Medical Policy Group, May 2018 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to policy statement.
Medical Policy Group June 2018: Clarified policy statement to include other devices and routes.
Medical Policy Administration Committee, June 2018
Available for comment June 14 through July 28, 2018
Medical Policy Panel, May 2019
Medical Policy Group, June 2019 (4): Updates to Description, Policy, Key Points, and References. Updated policy statements to allow coverage for FDA approved LAAs with criteria.
Medical Policy Administrative Committee: June 2019
Available for Comment: June 11, 2019 through July 29, 2019
Medical Policy Panel, May 2020
Medical Policy Group, June 2020 (4): Updates to Key Points and References. No change to policy statements.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.