Latest Review Date: August 2024

Category: Surgery                                         

POLICY:

The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention as a stand-alone procedure in individuals with atrial fibrillation is considered investigational.

The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention in individuals with atrial fibrillation may be considered medically necessary for those undergoing concomitant open or thoracoscopic cardiac procedures.

DESCRIPTION OF PROCEDURE OR SERVICE:

Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. 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 one of the main goals of AF treatment. Treatment with anticoagulant medications is a first-line approach to stroke prevention in individuals with AF, although occlusion of the left atrial appendage (LAA) may offer a non-pharmacological alternative to anticoagulant medications for those with a contraindication or intolerance to long-term anticoagulant use or with poor anticoagulant adherence. Multiple surgical techniques may be used to excise or occlude the LAA. One device, the AtriClip Left Atrial Appendage Exclusion System, has approval from the U.S. Food and Drug Administration for surgical LAA occlusion for stroke prevention in patients with AF.

Stroke Prevention

The risk for stroke among patients with AF is evaluated using several factors. Two commonly used scores, the CHADS2 score and theCHA2DS2-VASc score are described below:

CHADS2 and CHA2DS2-VASc Scores to Predict Ischemic Stroke Risk in Patients With Atrial Fibrillation

Stroke in AF occurs primarily as a result of thromboemboli from the left atrium. The erratic atrial contractions in AF lead to blood stasis in the left atrium, and this low flow state increases the risk for thrombosis. The first-line treatment for stroke prevention in AF is long-term anticoagulation, which has proven efficacy. Warfarin, a vitamin K antagonist, is the predominant agent in clinical use. Several newer direct oral anticoagulant (DOAC) agents, 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 noninferiority to warfarin in clinical trials. Warfarin requires frequent monitoring and adjustments as well as lifestyle changes; DOACs do not require the frequent monitoring seen with warfarin therapy. While anticoagulation is effective for stroke prevention, it carries an increased risk of bleeding. Reversal agents can be used to counter the effects life-threatening bleeding in individuals using warfarin or DOAC therapy. Such agents carry their own risk of inducing life-threatening thrombosis. For individuals with AF who have a contraindication to warfarin and DOACs, dual antiplatelet therapy with aspirin and clopidogrel is an option for stroke prevention, though it is less protective than either warfarin or DOACs.

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 LAA is a small extension of the left atrium that can vary widely in both size and shape (morphology). LAA morphologies are described according to their appearance and include: the chicken wing, which is the most common morphology and features a prominent bend in the dominant lobe; the cactus, characterized by a dominant central lobe with superior and inferior secondary lobes; the windsock, which features one dominant lobe; and the cauliflower, which is the least common morphology and features numerous lobes with none being dominant. It has been estimated that over 90% of left atrial thrombi occur in the LAA. Surgical removal or exclusion of the LAA is often performed in patients with AF who are undergoing open heart surgery. Surgical techniques to exclude the LAA include resection or occlusion through stapling or clipping.

For percutaneous endovascular LAA occlusion, refer to medical policy 490.

KEY POINTS:

The most recent literature update was performed through June 14, 2024.

Summary of Evidence

For individuals with AF at increased risk for embolic stroke undergoing LAA occlusion with an AtriClip device as a stand-alone procedure, the evidence includes a controlled observational study and case series. Relevant outcomes are ischemic stroke, cardiac events, and mortality. One small (N=40) industry sponsored retrospective observational study reported that use of the AtriClip device as a stand-alone procedure resulted in similar outcomes compared to percutaneous LAA occlusion. This evidence is too limited to draw definitive conclusions. Well-designed RCTs with follow-up of 1 year or more comparing stand-alone AtriClip device placement with percutaneous LAA occlusion are needed to provide adequate evidence for assessment of net health benefit. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with AF at increased risk for embolic stroke undergoing LAA occlusion with an AtriClip device concomitant with open or thoracoscopic cardiac surgical procedures, the evidence includes a RCT, a controlled observational study, and case series. Relevant outcomes are ischemic stroke, cardiac events, and mortality. Evidence from several systematic reviews and a large (N>10,000) observational study found surgical LAA occlusion was associated with a reduction in the risk of stroke without an increase in the risk of adverse events. LAA occlusion was associated with a reduced risk of stroke versus no occlusion in the LAAOS III trial. A retrospective database study that compared the AtriClip device with no occlusion found that AtriClip placement was associated with a lower risk of ischemic stroke, and a reduced risk of thromboembolism. Large (N>100) case series of AtriClip device use with 2- to 3- year follow-up reported stroke rates ≤1% in the postoperative period and ≤2% in the long-term follow-up. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Heart Association et al

In 2023, the American Heart Association, in conjunction with the American College of Cardiology, the American College of Clinical Pharmacy, and the Heart Rhythm Society, issued a joint guideline on the management of individuals with atrial fibrillation (AF). The following are the recommendations provided on performing LAAC for patients undergoing cardiac surgery:

• In patients with AF undergoing cardiac surgery with a CHA₂DS₂-VASc score ≥2 or equivalent stroke risk, surgical LAA exclusion, in addition to continued anti-coagulation, is indicated to reduce the risk of stroke and systemic embolism. (Class of recommendation I: Level of evidence: A)

• In patients with AF undergoing cardiac surgery and LAA exclusion, a surgical technique resulting in the absence of flow across the suture line and a stump of <1 cm as determined by intraoperative trans-esophageal echocardiography should be used. (Class of recommendation I: Level of evidence: A)

• In patients with AF undergoing cardiac surgery with CHA₂DS₂-VASc score ≥2 or equivalent stroke risk, the benefit of surgical LAA exclusion in the absence of continued anticoagulation to reduce the risk of stroke and systemic embolism is uncertain. (Class of recommendation IIb: Level of evidence: A)

No recommendation was made regarding the method of surgical LAA occlusion.

Society for Cardiovascular Angiography & Interventions et al

In 2023, the Society for Cardiovascular Angiography & Interventions (SCAI) and Heart Rhythm Society (HRS) issued a consensus statement on transcatheter endovascular left atrial appendage closure (LAAC). The following are the recommendations on patient selection and physician experience prior to receiving or performing LAAC:

• Transcatheter 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. There should be patient-provider discussion for shared decision making.

• Physicians performing LAAC should have a prior experience, including 50 or more prior left-sided ablations or structural procedures and 25 or more transseptal punctures (TSPs). Interventional imaging physicians should have experience in guiding 25 or more TSPs before supporting any LAAC procedures independently.

Society for Thoracic Surgeons

In 2023, the Society for Thoracic Surgeons (STS) published guidelines for the surgical treatment of atrial fibrillation. The following are the recommendations on patient selection and physician experience prior to receiving or performing LAAC:

• Left atrial appendage obliteration for atrial fibrillation is recommended for all first-time nonemergent cardiac surgery procedures, with or without concomitant surgical ablation, to reduce morbidity from thromboembolic complications.

• Isolated surgical left atrial appendage obliteration may be considered in patients with longstanding persistent atrial fibrillation, a high stroke risk, and contraindications for or failure of long-term oral anticoagulation. (Class of recommendation IIb: Level of evidence: B)

No recommendation was made regarding the method of surgical LAA occlusion.

American College of Chest Physicians

Guidance from the American College of Chest Physicians in 2018, recommends:

• In patients with AF at high risk of ischemic stroke who have absolute contraindications for oral anticoagulants (OAC), we suggest using LAA occlusion (weak recommendation, low quality evidence).
• In AF patients at risk of ischemic stroke undergoing cardiac surgery, we suggest considering surgical exclusion of the LAA for stroke prevention, but the need for long-term OAC is unchanged (weak recommendation, low quality evidence).

No guideline statement recommends a specific occlusion method or approach.

U.S. Preventive Services Task Force Recommendations

No U.S. Preventive Services Task Force (USPSTF) recommendations for surgical LAA occlusion have been identified.

KEY WORDS:

AtriClip, Left atrial appendage, LAA

APPROVED BY GOVERNING BODIES:

In June 2010, the AtriClip LAA Exclusion System (Atricure) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K093679). The FDA determined that this device was substantially equivalent to existing devices for occlusion of the LAA. The AtriClip has gone through numerous iterations since 2010, primarily relating to changes in the clip material composition and refinements of the clip applicator. The current FDA cleared indication is unchanged from the original 2010 indication, which states that the AtriClip is indicated for "exclusion of the LAA, performed under direct visualization, in conjunction with other cardiac surgical procedures." The FDA clearance documentation notes that direct visualization “requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc. or other appropriate viewing technologies." As of 2022, AtriCure markets 7 different versions of the AtriClip device, whose use varies according to LAA size and type of concomitant surgical procedure.

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 contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT codes:   

REFERENCES:

1. Abrich VA, Narichania AD, Love WT, et al. Left atrial appendage exclusion during mitral valve surgery and stroke in atrial fibrillation. J Interv Card Electrophysiol. Dec 2018; 53(3): 285-292.
2. Ando M, Funamoto M, Cameron DE, et al. Concomitant surgical closure of left atrial appendage: A systematic review and meta-analysis. J Thorac Cardiovasc Surg. Sep 2018; 156(3): 1071-1080.e2.
3. Andreotti, F, Geisler T, Collet JP, et al. Acute , periprocedureal and long-term antithrombotic therapy in older adults: 2022 Update by the ESC working group on thrombosis. Eur Heart J. Jan 21, 2023; 44(4): 262-279.
4. Aryana A, Singh SK, Singh SM, et al. Association between incomplete surgical ligation of left atrial appendage and stroke and systemic embolization. Heart Rhythm. Jul 2015; 12(7): 1431-7.
5. AtriClip Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS). https://clinicaltrials.gov/ct2/show/NCT02701062. Accessed June 16, 2023.
6. AtriCure. AtriClip LAA Exclusion System. Accessed June 27, 2022.
7. Atti V, Anantha-Narayanan M, Turagam MK, et al. Surgical left atrial appendage occlusion during cardiac surgery: A systematic review and meta-analysis. World J Cardiol. Nov 26 2018; 10(11): 242-249.
8. Blackshear JL, Johnson WD, Odell JA, et al. Thoracoscopic extracardiac obliteration of the left atrial appendage for stroke risk reduction in atrial fibrillation. J Am Coll Cardiol. Oct 01 2003; 42(7): 1249-52.
9. Branzoli S, Guarracini F, Marini M, et al. Heart Team for Left Atrial Appendage Occlusion: A Patient-Tailored Approach. J ClinMed. Dec 29 2021; 11(1).
10. Caliskan E, Sahin A, Yilmaz M, et al. Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery. Europace. Jul 01 2018; 20(7): e105-e114.
11. Cartledge R, Suwalski G, Witkowska A, et al. Standalone epicardial left atrial appendage exclusion for thromboembolism prevention in atrial fibrillation. Interact Cardiovasc Thorac Surg. Mar 31 2022; 34(4): 548-555.
12. Collado FMS, Lama von Buchwald CM, Anderson CK, et al. Left Atrial Appendage Occlusion for Stroke Prevention in Nonvalvular Atrial Fibrillation. J Am Heart Assoc. Nov 02 2021; 10(21): e022274.
13. Dewland TA, Olgin JE, Vittinghoff E, et al. Incident atrial fibrillation among Asians, Hispanics, blacks, and whites. Circulation.Dec 03 2013; 128(23): 2470-7.
14. Franciulli M, De Martino G, Librera M, et al. Stand-Alone Thoracoscopic Left Atrial Appendage Closure in Nonvalvular Atrial Fibrillation Patients at High Bleeding Risk. Innovations (Phila). Nov/Dec 2020; 15(6): 541-546.
15. Friedman DJ, Piccini JP, Wang T, et al. Association Between Left Atrial Appendage Occlusion and Readmission for Thromboembolism Among Patients With Atrial Fibrillation Undergoing Concomitant Cardiac Surgery. JAMA. Jan 23 2018;319(4): 365-374.
16. Fu M, Qin Z, Zheng S, et al. Thoracoscopic Left Atrial Appendage Occlusion for Stroke Prevention Compared with Long-Term Warfarin Therapy in Patients With Nonvalvular Atrial Fibrillation. Am J Cardiol. Jan 01 2019; 123(1): 50-56.
17. Ibrahim AM, Tandan N, Koester C, et al. Meta-Analysis Evaluating Outcomes of Surgical Left Atrial Appendage Occlusion During Cardiac Surgery. Am J Cardiol. Oct 15 2019; 124(8): 1218-1225.
18. Inoue T, Suematsu Y. Left atrial appendage resection can be performed minimally invasively with good clinical and echocardiographic outcomes without any severe risk. Eur J Cardiothorac Surg. Jul 01 2018; 54(1): 78-83.
19. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
20. 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. J Am Coll Cardiol. Dec 02 2014; 64(21): e1-76.
21. January CT, Wann LS, Calkins H, et al. 2019 AHA/ACC/HRS focused update of the 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 Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. Aug 2019; 16(8): e66-e93.
22. Jiang S, Zhang H, Wei S, et al. Left atrial appendage exclusion is effective in reducing postoperative stroke after mitral valve replacement. J Card Surg. Dec 2020; 35(12): 3395-3402.
23. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. Jan 02 2024; 149(1): e1-e156.
24. Kiankhooy A, Liem B, Dunnington GH, et al. Left atrial appendage ligation using the atriclip device: Single-center study of device safety and efficacy. Innovations (Phila). 2022; 17(3): 209-216.
25. Kurfirst V, Mokracek A, Canadyova J, et al. Effectivity of Left Atrial Appendage Occlusion with AtriClip in 155 Consecutive Patients - Single Center Study. Cor et Vasa. August 2017; 59(4): e376-e380.
26. Kurfirst V, Mokracek A, Canadyova J, et al. Epicardial clip occlusion of the left atrial appendage during cardiac surgery provides optimal surgical results and long-term stability. Interact Cardiovasc Thorac Surg. Jul 01 2017; 25(1): 37-40.
27. Lip GYH, Banerjee A, Boriani G, et al. Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report.Chest. Nov 2018; 154(5): 1121-1201.
28. Kewcharoen J, Shah K, Bhardwaj R, et al. Surgical left atrial appendage occlusion in patients with left ventricular assist device. Pacing Clin Electrophysiol. Apr 2022; 45(4): 567-570.
29. Mandell DR, Boisen ML. Surgical left atrial appendage occlusion with concomitant cardiac surgical procedures: exacerbating heart failure or preventing stroke. Curr opin Anaesthesiol. 2023 Feb 1;36(1):20-24.
30. Mou L, Norby FL, Chen LY, et al. Lifetime Risk of Atrial Fibrillation by Race and Socioeconomic Status: ARIC Study (Atherosclerosis Risk in Communities). Circ Arrhythm Electrophysiol. Jul 2018; 11(7): e006350.
31. Narayan P. Concomitant left atrial appendage occlusion in patients undergoing cardiac surgery. Indian J Thorac Cardiovasc Surg. 2021 Sep;37(5):605-607.
32. Nesheiwat Z, Goyal A, Jagtap M. Atrial Fibrillation. In: Stat Pearls. Treasure Island (FL): StatPearls Publishing; November 28,2021.
33. Ohtsuka T, Nonaka T, Hisagi M, et al. Thoracoscopic stapler-and-loop technique for left atrial appendage closure in nonvalvular atrial fibrillation: Mid-term outcomes in 201 patients. Heart Rhythm. Sep 2018; 15(9): 1314-1320.
34. Park-Hansen J, Holme SJV, Irmukhamedov A, et al. Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study. J Cardiothorac Surg. May 23 2018; 13(1): 53.
35. Rhee Y, Park SJ, Lee JW. Epicardial left atrial appendage clip occlusion in patients with atrial fibrillation during minimally invasive cardiac surgery. J Thorac Cardiovasc Surg. Aug 2023; 166(2): 468-474.
36. Rosati F, de Maat GE, Valente MAE, et al. Surgical clip closure of the left atrial appendage. J Cardiovasc Electrophysiol. Oct2021; 32(10): 2865-2872.
37. Saw J, Holmes DR, Cavalcante JL, et al. SCAI/HRS expert consensus statement on transcatheter left atrial appendage closure. Heart Rhythm. May 2023; 20(5): e1-e16.
38. Soltesz EG, Dewan KC, Anderson LH, et al. Improved outcomes in CABG patients with atrial fibrillation associated with surgical left atrial appendage exclusion. J Card Surg. Apr 2021; 36(4): 1201-1208.
39. Toale C, Fitzmaurice GJ, Eaton D, et al. Outcomes of left atrial appendage occlusion using the AtriClip device: a systematic review. Interact Cardiovasc Thorac Surg. Nov 01 2019; 29(5): 655-662.
40. U.S. Food and Drug Administration. AtriClip LAA Exclusion System. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172742. 
41. van der Heijden CAJ, Weberndörfer V, Luermans JGLM, et al. Hybrid ablation of atrial fibrillation: A unilateral left-sided thoracoscopic approach. J Card Surg. Dec 2022; 37(12): 4630-4638.
42. Whitlock RP, Belley-Cote EP, Paparella D, et al. Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke. N Engl J Med. Jun 03 2021; 384(22): 2081-2091.
43. Wyler von Ballmoos MC, Hui DS, Mehaffey JH, et al. The Society of Thoracic Surgeons 2023 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation. Ann Thorac Surg. Jan 27 2024.
44. Yao X, Gersh BJ, Holmes DR, et al. Association of Surgical Left Atrial Appendage Occlusion With Subsequent Stroke and Mortality Among Patients Undergoing Cardiac Surgery. JAMA. May 22 2018; 319(20): 2116-2126.

POLICY HISTORY:

Medical Policy Panel, August 2022

Medical Policy Group, August 2022 (4): Adopted new policy.  

Medical Policy Administration Committee: August 2022

Available for Comment: September 1 - October 15, 2022

Medical Policy Panel, August 2023

Medical Policy Group, August 2023 (4): Updates to Description, Key Points, and References.  No change to policy statements.

Medical Policy Panel, August 2024

Medical Policy Group, August 2024 (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.