Humana Left Atrial Appendage and Cardiac Structural Defect Closure for Stroke Prevention Form

Description Left Atrial Appendage

Left Atrial Appendage

The left atrial appendage (LAA) is a finger-like extension originating from the left atrium (upper chamber) in the heart. Atrial fibrillation (AF), one of the most common clinically significant cardiac arrhythmias, is associated with substantial stroke risk due to thrombus (clot) formation. The weak contractions during atrial fibrillation and blood pooling in the LAA often result in thrombus formation that may interrupt blood flow to the brain leading to a stroke.

Description

Closure by exclusion or occlusion of the LAA may reduce the risk for ischemic stroke and is either performed surgically at the same time as another open cardiac procedure, or via a less invasive, percutaneous approach.

Left Atrial Appendage Closure

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Left Atrial Appendage and Cardiac Structural Defect Closure for Stroke Prevention

• Effective Date: 09/28/2023
• Revision Date: 09/28/2023
• Review Date: 09/28/2023
• Policy Number: HUM-0539-013
• Page: 2 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Imaging using either transesophageal echocardiogram (TEE) or cardiac computed tomographic angiography (CCTA) is used for preprocedural planning. An individual with nonvalvular AF may be a candidate for LAA closure when long-term anticoagulation medication (eg, warfarin or other oral anticoagulants) is contraindicated due to a history of bleeding or increased bleeding risk, noncompliance with medication regimen or comorbidity treatment, lifestyle or occupation that is incompatible with oral anticoagulants.

Surgical or open closure generally involves clipping or suturing the LAA during open cardiac procedures such as mitral valve surgery. Examples of US Food & Drug Administration (FDA) approved devices used for this approach include, but are not limited to, the AtriClip, AtriClip Flex-V and AtriClip Pro-V. These are approved for use under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope or other appropriate viewing technologies.

The Lariat suture delivery device is intended to facilitate suture placement and knot tying in surgical applications where soft tissue is being approximated or tied off with a pre-tied polyester suture. It has been used percutaneously to tie off or exclude the LAA. It has not been FDA-approved specifically for this indication. (Refer to Coverage Limitations section)

Percutaneous (transcatheter) closure is performed with a specialized catheter used to insert the device through a vein in the individual’s leg and advanced through the atrial septum to the LAA where it opens and creates an occlusion of the appendage. Over time, the area develops a thin layer of tissue which inhibits future clot formation.

The WATCHMAN FLX and WATCHMAN FLX Pro are examples of FDA-approved percutaneous LAA closure devices that use a single seal closure mechanism. The use of the WATCHMAN devices requires the ability to tolerate individualized oral antithrombotic therapy following LAA closure. Expanded FDA labelling for the WATCHMAN FLX and WATCHMAN FLX Pro now allows for oral antithrombotic therapy for the initial 45-day post-procedure period using either oral anticoagulation (eg, warfarin, direct oral anticoagulant [DOAC]) or dual antiplatelet therapy ([DAPT] and may or may not be limited to aspirin, clopidogrel or other oral anticoagulants).

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When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.antiplatelet). This is followed by DAPT for approximately 6 months. Shared decision-making between the healthcare provider and the individual may determine that DAPT for 6 months or less (without the initial period of oral anticoagulation) following LAA closure is indicated due to elevated bleeding risk.^36,48

The Amplatzer Amulet is another FDA-approved percutaneously implanted LAA closure device that differs from the WATCHMAN devices in that it uses a dual seal mechanism to form a complete seal in the LAA opening and eliminates the need for postimplantation anticoagulation.⁶² Dual antiplatelet therapy (may or may not be limited to aspirin, clopidogrel or other oral antiplatelets) is recommended for up to 6 months following the procedure.³²

Patent Foramen Ovale

A patent foramen ovale (PFO) is a hole in the heart that remains open after birth. The small, flap-like foramen ovale is found between the right and left atria of the fetal heart and allows blood to bypass the lungs prior to birth. The foramen ovale usually closes when a newborn takes the first breath; however, for some individuals it remains patent (open). This condition generally does not cause symptoms, although there is a risk of thrombus formation and subsequent stroke from the blood that could leak from this opening.

PFO occlusion devices were developed to reduce the risk of recurrent stroke in individuals between 18 and 60 years of age who have had a cryptogenic (unknown cause) stroke due to a presumed paradoxical embolism that crosses an intracardiac defect into systemic circulation. This is determined by a neurologist and a cardiologist following an evaluation to exclude known causes of ischemic stroke. The PFO is occluded (closed) during a transcatheter procedure, which stops leakage of blood from the foramen ovale. The Amplatzer Talisman PFO occluder and the GORE CARDIOFORM Septal Occluder are examples of FDA-approved devices for PFO closure.

Atrial Septal Defect

An atrial septal defect (ASD) is a failure of the septal tissue to form between the atria before birth. This congenital heart defect increases the amount of blood that flows through the lungs which can elevate stroke risk. An individual may have no symptoms; however, the risk for clot formation exists and repair may be recommended to prevent stroke. An ASD may be repaired via transcatheter approach using a device specifically designed to occlude the opening.

Left Atrial Appendage and Cardiac Structural Defect Closure for Stroke Prevention Effective Date: 09/28/2023
Revision Date: 09/28/2023
Review Date: 09/28/2023
Policy Number: HUM-0539-013
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Examples of FDA-approved devices for ASD closure include the Amplatzer Septal Occluder and the GORE CARDIOFORM Septal Occluder. NobleStitch EL is an endovascular suture tool intended for use during cardiovascular procedures, including PFO closure and potentially LAA and ASD closures.³⁵ (Refer to Coverage Limitations section)

Coverage Determination

Percutaneous LAA Closure for the Prevention of Stroke

Humana members may be eligible under the Plan for percutaneous LAA closure for the prevention of stroke when the following criteria are met:

• Absence of contraindications; AND
• Device (eg, Amplatzer Amulet, WATCHMAN FLX, WATCHMAN FLX Pro) is FDA approved for percutaneous LAA closure; AND
• Increased risk for stroke and systemic embolism based on BOTH of the following:
  • CHA2DS2-VASc (Congestive heart failure, Hypertension, Age greater than or equal to 65, Diabetes, Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex category) score: Greater than or equal to 2 for males; OR Greater than or equal to 3 for females; AND
  • Recommended for anticoagulation therapy per an evidence-based decision tool (eg, HAS-BLED); AND
• Individual is suitable for short-term (immediate preoperative and/or postoperative period) anticoagulant or antiplatelet therapy as indicated; AND
• Medical contraindication to long-term anticoagulation is documented by the healthcare provider for one or more of the following:
  • Comorbidities require treatment incompatible with anticoagulation; OR
  • Evidence-based decision tool (eg, HAS-BLED) indicates contraindication; OR
  • Lifestyle or occupation is incompatible with oral anticoagulation; OR
  • Noncompliance with anticoagulation medications; AND
• Nonvalvular atrial fibrillation^14,54

Surgical (Open) LAA Closure for the Prevention of Stroke

Humana members may be eligible under the Plan for surgical (open) LAA closure for the prevention of stroke in conjunction with other cardiac surgical procedures when the following criteria are met:

• Absence of contraindications; AND
• Device (eg, AtriClip, AtriClip Flex-V and Pro-V) is FDA approved for surgical LAA closure; AND
• Increased risk for stroke and systemic embolism based on BOTH of the following:
  • CHA2DS2-VASc score: Greater than or equal to 2 for males; OR Greater than or equal to 3 for females; AND
  • Recommended for anticoagulation therapy per an evidence-based decision tool (eg, HAS-BLED); AND
• Individual is suitable for short-term (immediate preoperative and/or postoperative period) anticoagulation; AND
• Medical contraindication to long-term anticoagulation is documented by the healthcare provider for one or more of the following:
  • Comorbidities require treatment incompatible with anticoagulation; OR
  • Evidence-based decision tool (eg, HAS-BLED) indicates contraindication; OR
  • Lifestyle or occupation is incompatible with oral anticoagulation; OR
  • Noncompliance with anticoagulation medications; AND

Left Atrial Appendage and Cardiac Structural Defect Closure for Stroke Prevention Effective Date: 09/28/2023
Revision Date: 09/28/2023
Review Date: 09/28/2023
Policy Number: HUM-0539-013
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• Paroxysmal or persistent (permanent) atrial fibrillation

Note: The criteria for LAA closure are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for percutaneous (transcatheter) LAA closure for the prevention of stroke for any indications other than those listed above including, but not limited to:

• Contraindications to the use of short-term anticoagulants (eg, warfarin) or long- term antiplatelet agents when indicated (eg, aspirin or clopidogrel; not an all- inclusive list); OR
• History of repair or use of closure device for PFO or atrial septal defect; OR
• Intracardiac thrombus visualized by echocardiography^61,62; OR
• Known sensitivity to any portion of the device material; OR
• LAA anatomy will not accommodate a closure device; OR
• Unsuitable for percutaneous catheterization due to any of the following, which may or may not be limited to:
  • Active infection or bleeding disorder^61,62; OR
  • Body size unable to accommodate intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) probe^61,62; OR
  • Femoral venous access unsuitable due to size or condition

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Left Atrial Appendage and Cardiac Structural Defect Closure for Stroke Prevention Effective Date: 09/28/2023
Revision Date: 09/28/2023
Review Date: 09/28/2023
Policy Number: HUM-0539-013
Page: 7 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for surgical (open) LAA closure for the prevention of stroke, in conjunction with other cardiac surgical procedures for any indications other than those listed above including, but not limited to:

• Contraindication to the use of short-term anticoagulants (eg, warfarin) or long- term antiplatelet agents (eg, aspirin or clopidogrel, not an all-inclusive list); OR
• Intracardiac thrombus visualized by echocardiography^21,60; OR
• Known sensitivity to any portion of the device material^21,60; OR
• LAA anatomy will not accommodate a closure device

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for surgical (open/ thoracoscopic) LAA closure for the prevention of stroke without a concurrent cardiac surgical procedure. This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for LAA closure with the Lariat suture delivery device or NobleStitch EL.

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Coverage Determination

PFO Closure for the Prevention of Recurrent Stroke

Humana members may be eligible under the Plan for PFO closure for the prevention of recurrent stroke when the following criteria are met:

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• 18 through 60 years of age; AND
• Absence of contraindications; AND
• Device (eg, Amplatzer Talisman PFO, GORE CARDIOFORM Septal Occluder) is FDA approved for PFO closure; AND
• Cryptogenic stroke due to presumed paradoxical embolism, as determined by a neurologist and a cardiologist following an evaluation to exclude known causes of ischemic stroke

Coverage Limitations

Humana members may NOT be eligible under the Plan for PFO closure for the prevention of recurrent stroke for any indications other than those listed above including, but not limited to:

• Active endocarditis or other untreated infections^63,65; OR
• Anatomy in which the required size of the FDA-approved device would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins⁶³; OR
• Intracardiac mass, vegetation, tumor or thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which the PFO is accessed; OR
• Other source of right-to-left shunts, including an atrial septal defect and/or a fenestrated atrial septum; OR
• Vasculature through which the PFO is accessed is inadequate to accommodate the appropriate sheath size⁶³

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for PFO closure with the NobleStitch EL.

This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

ASD Closure for the Prevention of Stroke

Coverage Determination

• Absence of contraindications; AND
• Device (eg, Amplatzer Septal Occluder, GORE CARDIOFORM Septal Occluder) is FDA approved for ASD closure; AND any of the following:
  • Individual who has undergone a fenestrated Fontan procedure and now requires closure of the fenestration; OR
  • Individual with a shunt fraction greater than 1.5; OR
  • Ostium secundum position ASD

Coverage Limitations

• Humana members may NOT be eligible under the Plan for ASD closure for the prevention of stroke for any indications other than those listed above including, but not limited to, the following:
• A congenital cardiac anomaly which requires open surgical intervention; OR
• Bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months⁶⁴; OR
• Demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi); OR
• Evidence of irreversible pulmonary hypertension (eg, Eisenmenger physiology [net right-to-left shunt], pulmonary artery pressure or pulmonary vascular resistance greater than two-thirds systemic)^46,56; OR
• Known sepsis within one month prior to implantation, active endocarditis or any systemic infection that cannot be successfully treated prior to device placement; OR
• Margins of the defect are less than 5 mm to the coronary sinus, atrioventricular valves or right upper lobe pulmonary vein; OR
• Unsuitable for percutaneous catheterization due to any of the following, which may or may not be limited to:
  • Body size unable to accommodate intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) probe⁶⁴; OR
  • Peripheral access limited by size or condition (eg, peripheral vascular disease)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for ASD closure with the NobleStitch EL.

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about atrial fibrillation or stroke may be found from the following websites:

Left Atrial Appendage and Cardiac Structural Defect Closure for Stroke Prevention Effective Date: 09/28/2023
Revision Date: 09/28/2023
Review Date: 09/28/2023
Policy Number: HUM-0539-013
Page: 11 of 20

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American Heart Association
American Stroke Association
National Library of Medicine

Medical Alternatives

• Alternatives to LAA, PFO or ASD closure for the prevention of stroke include, but may not be limited to, the following:
• Prescription drug therapy
• Physician consultation is advised to make an informed decision based on an individual's health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

CPT® Code(s)

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HCPCS Code(s)

References

• Agency for Healthcare Research and Quality (AHRQ). Stroke prevention in patients with atrial fibrillation: a systematic review update. Published October 2018. Accessed August 15, 2023.
• Alkhouli M, Ellis CR, Daniels M, Coylewright M, Nielsen-Kudsk JE, Holmes DR. Left atrial appendage occlusion: current advances and remaining challenges. JACC: Adv. 2022;1(5):100136. Accessed August 18, 2023.
• American Academy of Neurology (AAN). Practice advisory update summary: patent foramen ovale and secondary stroke prevention. Updated July 14, 2023. Accessed August 18, 2023.
• American Association for Thoracic Surgery (AATS).

References

• American Association for Thoracic Surgery (AATS). 2014 AATS guidelines for the prevention and management of perioperative atrial fibrillation and flutter for thoracic surgical procedures. https://www.aats.org. Published June 10, 2014. Accessed August 18, 2023.
• American College of Cardiology (ACC). 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. https://www.acc.org. Published March 28, 2014. Accessed August 18, 2023.
• American College of Cardiology (ACC). 2015 ACC/HRS/SCAI left atrial appendage occlusion device societal overview. https://www.acc.org. Published 2015. Accessed August 18, 2023.
• American College of Cardiology (ACC). 2017 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants. https://www.acc.org. Published December 19, 2017. Accessed August 18, 2023.
• American College of Cardiology (ACC). 2018 AHA/ACC guideline for the management of adults with congenital heart disease. https://www.acc.org. Published April 2, 2019. Accessed August 18, 2023.
• American College of Cardiology (ACC). 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. https://www.acc.org. Published July 9, 2019. Accessed August 18, 2023.
• American College of Cardiology (ACC). 2020 ACC/AHA guideline for the management of patients with valvular heart disease. https://www.acc.org. Published February 2, 2021. Accessed August 18, 2023.
• American College of Cardiology (ACC). 2020 AHA/ACC guideline for the diagnosis and treatment of patients with hypertrophic cardiomyopathy. https://www.acc.org. Published December 22, 2020. Accessed August 18, 2023.
• American College of Cardiology (ACC). 2020 update to the 2016 ACC/AHA clinical performance and quality measures for adults with atrial fibrillation or atrial flutter. https://www.acc.org. Published January 26, 2021. Accessed August 18, 2023.
• American College of Cardiology (ACC). 2022 AHA/ACC/HFSA guideline for the management of heart failure. https://www.acc.org. Published May 3, 2022. Accessed August 18, 2023.
• American Heart Association (AHA). 2021 guideline for the prevention of stroke in patients with stroke and transient ischemic attack. https://www.heart.org. Published July 2021. Accessed August 18, 2023.
• American Heart Association (AHA). Perioperative neurological evaluation and management to lower the risk of acute stroke in patients undergoing noncardiac, nonneurological surgery. https://www.heart.org. Published May 11, 2021. Accessed August 18, 2023.
• American Heart Association (AHA). Prevention of stroke in patients with silent cerebrovascular disease. https://www.heart.org. Published December 15, 2016. Accessed August 18, 2023.
• American Heart Association (AHA). Considerations for reduction of risk of perioperative stroke in adult patients undergoing cardiac and thoracic aortic operations. https://www.heart.org. Published August 26, 2020.

Left Atrial Appendage and Cardiac Structural Defect Closure for Stroke Prevention Effective Date: 09/28/2023
Revision Date: 09/28/2023
Review Date: 09/28/2023
Policy Number: HUM-0539-013
Page: 13 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

• American Heart Association (AHA). AHA Scientific Statement. Managing atrial fibrillation in patients with heart failure and reduced ejection fraction. https://www.heart.org. Published July 2021. Accessed August 18, 2023.
• American Heart Association (AHA). AHA Scientific Statement. Recognition, prevention and management of arrhythmias and autonomic disorders in cardio-oncology. https://www.heart.org. Published July 20, 2021. Accessed August 18, 2023.
• American Heart Association (AHA). Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association. https://www.heart.org. Published 2014. Accessed August 18, 2023.
• AtriCure. AtriClip PRO-V LAA Exclusion System instructions for use. https://www.atricure.com. Published May 2022. Accessed September 7, 2023.
• Berti S, Pastormerlo LE, Santoro G, et al. Intracardiac versus transesophageal echocardiographic guidance for left atrial appendage occlusion. JACC Cardiovasc. Interv. 2018;11(11):1086-1092. https://www.jacc.org. Accessed August 16, 2023.
• Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Percutaneous left atrial appendage closure (LAAC) (20.34). https://www.cms.gov. Published February 8, 2016. Accessed August 17, 2023.
• ClinicalKey. Alberts M. Prevention and management of ischemic stroke. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1587-1592. https://www.clinicalkey.com. Accessed August 15, 2023.
• ClinicalKey. Calkins H, Tomaselli GF, Morady F. Atrial fibrillation: clinical features, mechanisms and management. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1587-1592. https://www.clinicalkey.com. Accessed August 15, 2023.
• ClinicalKey. Ferri FF. Patent foramen ovale. In: Ferri FF. Ferri’s Clinical Advisor 2024. Elsevier; 2023:1151.e12-1151.e13. https://www.clinicalkey.com. Accessed August 15, 2023.
• ClinicalKey. Price MJ, Valderrabano M. Left atrial appendage closure and stroke: local device therapy for cardioembolic stroke protection. In: Topol EJ, Tierstein PS. Textbook of Interventional Cardiology. 8th ed. Elsevier; 2020:793- 812.e3. https://www.clinicalkey.com. Accessed August 15, 2023.
• ClinicalKey. Sarraf M, Packer DL, Holmes DR. Left atrial appendage management: anatomy, physiology, and role in atrial fibrillation-related stroke. In: Jalife J, Stevenson WG. Zipes and Jalife’s Cardiac Electrophysiology: From Cell to Bedside. 8th ed. Elsevier; 2022:902-910. https://www.clinicalkey.com. Accessed August 15, 2023.
• ClinicalKey. Shahanavaz S, Lasala J, Balzer D. Catheter-based treatment of congenital heart disease in adults. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD.
  • ClinicalKey. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1587-1592. https://www.clinicalkey.com. Accessed August 15, 2023.
  • ClinicalKey. Sodhi N, Zajarias A, Balzer DT, Lasala JM. Percutaneous closure of patent foramen ovale and atrial septal defect. In: Topol EJ, Teirstein PS. Textbook of Interventional Cardiology. Elsevier; 2020:772-792.e4. https://www.clinicalkey.com. Accessed August 15, 2023.
  • ECRI Institute. Clinical Evidence Assessment. Amplatzer Amulet left atrial appendage occluder (Abbot Vascular) for treating atrial fibrillation. https://www.ecri.org. Published April 6, 2022. Accessed August 14, 2023.
  • ECRI Institute. Clinical Evidence Assessment. Amplatzer Amulet left atrial appendage occluder (Abbot Vascular) versus Watchman (Boston Scientific Corp) for reducing mortality risk in patients with atrial fibrillation. https://www.ecri.org. Published January 24, 2022. Accessed August 14, 2023.
  • ECRI Institute. Clinical Evidence Assessment. AtriClip Flex-V and Pro-V (AtriCure, Inc.) for left atrial appendage occlusion. https://www.ecri.org. Published February 19, 2021. Accessed August 14, 2023.
  • ECRI Institute. Clinical Evidence Assessment. Gore Cardioform ASD occluder (W.L. Gore and Associates, Inc.) for closing atrial septal defects in children. https://www.ecri.org. Published October 20, 2019. Updated September 16, 2021. Accessed August 14, 2023.
  • ECRI Institute. Clinical Evidence Assessment. NobleStitch EL (HeartStitch, Inc.) for patent foramen ovale closure. https://www.ecri.org. Published November 4, 2020. Accessed August 14, 2023.
  • ECRI Institute. Clinical Evidence Assessment. Watchman and Watchman FLX left atrial appendage closure device (Boston Scientific Corp.) for treating atrial fibrillation. https://www.ecri.org. Published April 26, 2015. Updated March 15, 2021. Accessed August 14, 2023.
  • ECRI Institute. Health Technology Forecast. Transcatheter left atrial appendage occlusion for preventing stroke in patients with atrial fibrillation. https://www.ecri.org. Published May 6, 2008. Updated May 22, 2017. Accessed August 14, 2023.
  • ECRI Institute. Product Brief (ARCHIVED). Lariat suture delivery device (SentreHeart, Inc.) for performing left atrial appendage occlusion to prevent atrial fibrillation-related stroke. https://www.ecri.org. Published August 11, 2015. Accessed August 14, 2023.
  • Hayes, Inc. Health Technology Assessment. Left atrial appendage exclusion with the AtriClip system in patients with atrial fibrillation. https://evidence.hayesinc.com. Published March 11, 2021. Updated April 24, 2023. Accessed August 14, 2023.
  • Hayes, Inc. Health Technology Brief (ARCHIVED). Gore Cardioform septal occluder (W. L. Gore & Associates Inc.) for closure of atrial septal defects. https://evidence.hayesinc.com. Published November 30, 2017. Updated December 12, 2019. Accessed August 14, 2023.
  • Hayes, Inc. Medical Technology Directory. Percutaneous left atrial appendage closure to reduce stroke risk in patients with atrial fibrillation. https://evidence.hayesinc.com. Published February 13, 2018. Updated February 8, 2022. Accessed August 14, 2023.

  Transcatheter Closure of Patent Foramen Ovale for Prevention of Recurrent Cryptogenic Stroke

  Left Atrial Appendage and Cardiac Structural Defect Closure for Stroke Prevention Effective Date: 09/28/2023
  Revision Date: 09/28/2023
  Review Date: 09/28/2023
  Policy Number: HUM-0539-013
  Page: 18 of 20

  Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  https://evidence.hayesinc.com. Published May 31, 2018. Updated June 7, 2022. Accessed August 14, 2023.

  • Lane D, Lip G. Use of the CHA2DS2-VASc and HAS-BLED scores to aid decision-making for thromboprophylaxis in nonvalvular atrial fibrillation. Circulation. 2012;126(7):860-865. https://www.ahajournals.org. Accessed August 18, 2023.
  • Luca F, Pino PG, Parrini I, et al. Patent foramen ovale and cryptogenic stroke: integrated management. J. Clin. Med. 2023;12(5):1952. https://www.mdpi.com. Accessed September 8, 2023.
  • MCG Health. Cardiac septal defect: atrial, repair. 27th edition. https://www.mcg.com. Accessed August 2, 2023.
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