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Percutaneous Endovascular Left-Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

Policy Number: MP-490

Latest Review Date: May 2024

Category: Medical

POLICY:

The use of a device with U.S. Food and Drug Administration (FDA) approval for percutaneous left atrial appendage closure may be considered medically necessary for the prevention of stroke in individuals with atrial fibrillation when the following criteria are met:

  • There is an increased risk of stroke and systemic embolism based on CHADS2 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 for stroke prevention in individuals 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 device, for stroke prevention in individuals with atrial fibrillation is considered investigational.

For Surgical Left Atrial Appendange Occlusion Devices for Stroke Prevention in Atrial Fibrillation, refer to Medical Policy 751.

DESCRIPTION OF PROCEDURE OR SERVICE:

Stroke prevention in individuals 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. Two left atrial appendage devices (the Watchman and Amulet devices) have approval from the U.S. Food and Drug Administration for stroke prevention in patients with AF.

Atrial Fibrillation and Stroke

Atrial fibrillation (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; despite a lower risk of AF, Black and Hispanic patients have an increased risk of stroke compared with White patients. 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.

Treatment

Pharmacologic

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, apixaban, and edoxaban have 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. Newer agents do not require the frequent monitoring seen with warfarin therapy; however, specific reversal agents do not exist for all of these agents. 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. CHADS2 and CHA2DS2-VASc Scores to Predict Ischemic Stroke Risk in Patients With Atrial Fibrillation

Letter

Clinical Characteristics

Points Awarded

C

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

1

H

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

1

A

Age ≥75 y

1 (CHADS2)

2 (CHA2DS2-VASc)

D

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

1

S

Stroke or transient ischemic attack (includes any history of cerebral ischemia)

2

V

Vascular disease (prior myocardial infarction, peripheral arterial disease, or aortic plaque)

1

A

Age 65-74 y

1

Sc

Sex category of female (female sex confers higher risk)

1

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.

Surgery

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 Watchman FLX device is a next-generation Watchman device that is also FDA-approved for LAAC. This device is based on the design of the Watchman device, is fully recapturable and repositionable, and was made to occlude a wider size range of LAA than the original Watchman device. 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 also received FDA approval and has been developed for the specific indication of LAAC. 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.

Outcome Measures

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.

Ideally, percutaneous LAAC devices would represent an alternative to oral anticoagulation for the prevention of stroke in patients with AF. However, during the postimplantation period, the device may be associated with increased thrombogenicity and, therefore, anticoagulation is used during the periprocedural period. Most studies evaluating percutaneous devices have included patients who are eligible for anticoagulation.

KEY POINTS:

The most recent update with literature review covers the period of through March 21, 2024.

Summary of Evidence:

For individuals who have atrial fibrillation (AF) who are at increased risk for embolic stroke who receive an FDA approved percutaneous left atrial appendage closure (LAAC) device (e.g. Watchman or Amulet), the evidence includes RCTs and observational studies. 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. Evidence for the Amplatzer Amulet device comes from 2 RCTs comparing the Amulet and Watchman devices, one of which was a shorter trial that assessed periprocedural outcomes at 45 days and again at 13 months. The second trial comparing the Amulet and Watchman devices found the Amulet device to be noninferior to the Watchman device after 18 months of follow-up for a composite efficacy outcome that included ischemic stroke or systemic embolism and for a composite safety outcome that included all-cause mortality, major bleeding or procedure-related complications. At the 3-year follow-up, clinical outcomes remained similar between patients in the Amulet group and the Watchman group, with a higher percentage of Amulet users not using oral anticoagulation. One additional RCT evaluated the use of either the Amplatzer Amulet or Watchman device versus anticoagulants; subgroup analyses according to device were not performed. After up to 4 years of follow-up, the study found LAA closure with either the Watchman or Amulet was noninferior to anticoagulants for a composite outcome that included stroke, TIA, systemic embolism, clinically significant bleeding, significant periprocedural or device-related complications, or cardiovascular mortality. 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 an 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 or Amplatzer Amulet device (e.g., Lariat or Amplatzer Cardiac Plug), the evidence includes several nonrandomized comparator studies and uncontrolled observational studies. Relevant outcomes are overall survival, morbid events, and treatment-related morbidity. One nonrandomized study that 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. Evidence from other observational studies of these devices which report high procedural success but also numerous complications. In addition, these devices do not have FDA approval for LAAC. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Chest Physicians

In 2018, the American College of Chest Physicians (CHEST) guideline made the following recommendation regarding left atrial appendage (LAA) occlusion and oral anticoagulation: "In patients with AF [atrial fibrillation] at high risk of ischemic stroke who have absolute contraindications for OAC [oral anticoagulation], we suggest using LAA occlusion (Weak recommendation, low-quality evidence)."

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. The 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 (weak) and the level of evidence is B-NR (moderate quality of evidence, non-randomized). No other LAA closure devices are mentioned in the guideline. Another guideline update was published in 2023. Based on additional data on safety and efficacy of LAA occlusion devices, the class of recommendation was updated to IIa (moderate) compared to the 2019 recommendation of IIb.

The AHA also released a scientific statement in 2021 about managing AF in patients with heart failure and reduced ejection fraction. They state that, "It is reasonable to consider LAA closure in patients with AF and heart failure with reduced ejection fraction (HFrEF) with moderate to high stroke risk and contraindications to long-term oral anticoagulation", however, they also note that the role of LAA therapies in patients with AF with HFrEF needs to be better understood, and this is an opportunity for future research.

Heart Rhythm Society

In collaboration with the Society for Cardiovascular Angiography and Interventions Foundation, the HRS published an expert consensus statement on transcatheter LAAC in 2023. They state that “LAAC is appropriate for patients with nonvalvular atrial fibrillation with high thromboembolic risk who are not suited for long-term oral anticoagulation and who have adequate life expectancy (minimum >1 year) and quality of life to benefit from LAAC.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Left Atrial Appendage Closure Device, WATCHMAN®, LARIAT®, AMPLATZER®, PLATTO, LAA, Amplatzer Cardiac Plug device, WaveCrest

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. In 2020, the Watchman FLX device (Boston Scientific) was approved by the FDA based on the single-arm, nonrandomized PINNACLE FLX study. The Amplatzer™ Amulet™ Left Atrial Appendage Occluder (Abbott) received FDA approval in 2021 through the premarket approval process based on results from the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE Trial). The Watchman and Amplatzer Amulet devices are 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 anticoagulation therapy; and
  • Have an appropriate rationale to seek a nonpharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared with anticoagulation therapy.

Several other devices are being evaluated for LAA occlusion but are not approved in the U.S. for percutaneous LAAC. In 2006, the Lariat ™ Loop Applicator device (SentreHEART), a suture delivery system, was cleared for marketing by the FDA through the510(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 Cardiac Plug device (St. Jude Medical) and WaveCrest™ (Johnson & Johnson Biosense Webster) have CE approval in Europe for LAAC but are not currently approved in the U.S. for this indication.

BENEFIT APPLICATION:

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. 

CURRENT CODING:

CPT Codes:  

For percutaneous LAA closure:

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.

REFERENCES:

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  59. Nietlispach F, Gloekler S, Krause R et al. Amplatzer left atrial appendage occlusion: Single center 10-year experience. Catheter Cardiovasc Interv 2013 Aug 1; 82(2):283-9.
  60. Noelck N, Papak J, Freeman M, et al. Effectiveness of left atrial appendage exclusion procedures to reduce the risk of stroke: a systematic review of the evidence. Circ Cardiovasc Qual Outcomes. Jul 2016; 9(4):395- 405.
  61. Osmancik P, Herman D, Neuzil P, et al. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk PatientsWith Atrial Fibrillation. J Am Coll Cardiol. Jun 30 2020; 75(25): 3122-3135.
  62. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 04 2022; 79(1): 1-14.
  63. 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):700-6.
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POLICY HISTORY:

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.

Medical Policy Panel, May 2021

Medical Policy Group, June 2021: Updates to Description, Key Points, Approved by Governing Bodies, and References.  Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, November 2021: 2022 Annual Coding Update.  Added CPT code 33999 and new CPT code 33269 to current coding section.  Removed Previous coding section and code 0281T.  Clarified policy section by adding LAA clipping policy statement and removed specific devices from coverage statement.  Added updated information regarding the Amulet device FDA approval.  Removed the Amulet from the IV statement.  Additional updates to Key Points, Approved by Governing Bodies and References.

Medical Policy Group, March 2022 (4): Clarification to policy statement by adding “Percutaneous and other stand alone procedures” for epicardial clipping are IV.  No change to policy intent.

Medical Policy Panel, May 2022

Medical Policy Group, May 2022 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References.  Old references removed.  No change to policy statements.

Medical Policy Group, August 2022 (4): Removed information related to epicardial clipping.  CPT codes 33269 and 33999 removed.  See new medical policy 751.

Medical Policy Panel, May 2023

Medical Policy Group, May 2023 (4): Updates to Description, Key Points, Governing Bodies, Practice Guidelines, Key Words (Amplatzer Cardiac Plug device, WaveCrest) Benefit Application and References.

Medical Policy Panel, May 2024

Medical Policy Group, May 2024 (4): Updates to Description, Key Points, Approved by Governing Bodies, 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.