Open and Thoracoscopic Approaches to Treat Atrial Fibrillation and Atrial Flutter (Maze and Related Procedures)

POLICY NUMBER

A.7.01.14

DESCRIPTION

There are various surgical approaches to treat atrial fibrillation (AF) that work by interrupting abnormal electrical activity in the atria. Open surgical procedures, such as the Cox maze procedure were first developed for this purpose and are now generally performed in conjunction with valvular or coronary artery bypass graft surgery.Surgical techniques have evolved to include minimally invasive approaches that use epicardial radiofrequency ablation, a thoracoscopic or mediastinal approach,and hybrid catheter ablations/open procedures.

Atrial Fibrillation

Atrial fibrillation (AF) is a supraventricular tachyarrhythmia characterized by disorganized atrial activation with ineffective atrial ejection. The underlying mechanism of AF involves interplay between electrical triggering events that initiate AF and the myocardial substrate that permits propagation and maintenance of the aberrant electrical circuit. The most common focal trigger of AF appears to be located within the cardiac muscle that extends into the pulmonary veins. The atria are frequently abnormal in patients with AF and demonstrate enlargement or increased conduction time. Atrial flutter is a variant of atrial fibrillation.

Epidemiology

In the US, more than 3 to 6 million people have AF and it has been estimated that more than 12 million people will have AF by 2030. Age, body mass index, height, hypertension, diabetes mellitus, obstructive sleep apnea, myocardial infarction, heart failure, hyperthyroidism, chronic kidney disease, smoking, moderate to heavy alcohol consumption, and genetic predisposition are all risk factors for AF. Age-adjusted AF incidence and prevalence is higher among men than women, although the lifetime risk is similar at 24% for men and 22% for women. AF incidence and prevalence appear lower in individuals who are Black compared to White, despite a higher burden of comorbidities. However, this difference is likely largely explained by differential detection of AF by race/ethnicity.

Treatment

The first-line treatment for AF usually includes medications to maintain sinus rhythm and/or control the ventricular rate. Antiarrhythmic medications are only partially effective; therefore, medical treatment is not sufficient for many patients. Percutaneous catheter ablation, using endocardial ablation, is an accepted second-line treatment for patients who are not adequately controlled on medications and may also be used as first-line treatment. Catheter ablation is successful in maintaining sinus rhythm for most patients, but long-term recurrences are common and increase over time. Performed either by open surgical techniques or thoracoscopy, surgical ablation is an alternative approach to percutaneous catheter ablation.

Several ablation systems have been approved or cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process for cardiac tissue ablation (product code OCL) or PMA process (product code OCM). Table 1 provides a select list.

Table 1. Radiofrequency Ablation Approved by the U.S. Food and Drug Administration

 A number of cryoablation systems, which may be used during cardiac ablation procedures, have also been cleared for marketing, including those in Table 2.

Table 2. Cryoablation Systems Approved by the U.S. Food and Drug Administration

See Catheter Ablation as Treatment for Atrial Fibrillation medical policy.

POLICY

The maze or modified maze procedure, performed on a non-beating heart during cardiopulmonary bypass with concomitant cardiac surgery, is considered medically necessary for the treatment of symptomatic atrial fibrillation or flutter.

Stand-alone minimally invasive, off-pump maze procedures (ie, modified maze procedures), including those done via mini-thoracotomy, are considered investigational for treatment of atrial fibrillation or flutter.

Hybrid ablation (defined as a combined percutaneous and thoracoscopic approach) is considered investigational for the treatment of atrial fibrillation or flutter.

The use of an open maze or modified maze procedure performed on a non-beating heart during cardiopulmonary bypass without concomitant cardiac surgery is considered investigational for the treatment of atrial fibrillation or flutter.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Given the availability of less-invasive alternative approaches to treat atrial fibrillation (see Catheter Ablation as Treatment for Atrial Fibrillation medical policy), performing the maze procedure without concomitant cardiac surgery should rarely be needed.

Per the 2017 Expert Consensus Statement by the Heart Rhythm Society, European Heart Rhythm Association, and European Cardiac Arrhythmia Society, the indication for concomitant open or closed surgical ablation, stand-alone, and hybrid surgical ablation of atrial fibrillation is symptomatic disease refractory or intolerant to at least 1 Class I or III antiarrhythmic medication.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

12/13/2006: Policy added.

1/2/2007: Code reference section updated per the 2007 CPT/HCPCS revisions

3/22/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)

12/18/07: Coding updated per 2008 CPT/HCPCS revisions

5/9/2008: Policy reviewed, no changes

9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied

10/14/2010: Annual ICD-9 code update: Revised the description of ICD-9 procedure code 37.34.

02/23/2011: Policy title changed from "Maze Procedure" to "Open and Thoracoscopic Approaches to Treat Atrial Fibrillation (Maze and Related Procedures)." Policy description updated; policy statement unchanged.

07/12/2012: Policy reviewed; no changes.

10/24/2013: Added the following policy statement: Hybrid ablation (defined as a combined percutaneous and thoracoscopic approach) is considered investigational for the treatment of atrial fibrillation or flutter. Added ICD-9 procedure code 37.37 to the Code Reference section.

09/11/2014: Policy reviewed; description updated regarding hybrid techniques. Medically necessary policy statement updated to state that the maze or modified maze procedure, performed on a non-beating heart during cardiopulmonary bypass with or without concomitant cardiac surgery is considered medically necessary for treatment of symptomatic, drug-resistant atrial fibrillation or flutter. First investigational policy statement revised to add "(ie, modified maze procedures)" and remove "pulmonary vein isolation" and "drug-resistant" from the statement. It previously stated: Minimally invasive, off-pump maze procedures, including pulmonary vein isolation via mini-thoracotomy, is considered investigational for treatment of drug-resistant atrial fibrillation or flutter. Removed deleted CPT code 33253 from the Code Reference section.

04/20/2015: CPT code 33257 moved from investigational to covered in the Code Reference section.

08/27/2015: Code Reference section updated for ICD-10.

04/20/2016: Policy title updated to add "Atrial Flutter." Policy description updated regarding radiofrequency ablation and cryoablation systems. Policy statement updated to remove the phrase "without concomitant cardiac surgery" from the medically necessary statement for maze or modified maze during cardiopulmonary bypass. Added not medically necessary policy statement for open maze or modified maze done without concomitant cardiac surgery. Policy guidelines updated regarding the maze procedure without concomitant cardiac surgery and to add medically necessary and investigative definitions.

05/31/2016: Policy number A.7.01.14 added.

08/17/2016: Policy description updated regarding open surgical techniques. Policy statements unchanged.

06/22/2017: Policy description updated. Medically necessary policy statement updated to remove "drug-resistant." It previously stated: The maze or modified maze procedure, performed on a non-beating heart during cardiopulmonary bypass with concomitant cardiac surgery, is considered medically necessary for treatment of symptomatic drug-resistant atrial fibrillation or flutter.

07/18/2017: Policy section revised to remove "symptomatic, drug-resistant" from the not medically necessary policy statement. It previously stated: The use of an open maze or modified maze procedure performed on a non-beating heart during cardiopulmonary bypass without concomitant cardiac surgery is considered not medically necessary for treatment of symptomatic, drug-resistant atrial fibrillation or flutter.

06/14/2018: Policy reviewed; no changes.

06/07/2019: Policy reviewed; no changes.

09/23/2019: Code Reference section updated to add new ICD-10 diagnosis codes I48.11, I48.19, I48.20, and I48.21, effective 10/01/2019.

06/19/2020: Policy description updated regarding radiofrequency ablation systems. Investigational statement regarding off-pump maze procedures updated to add "stand-alone."

08/03/2021: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated regarding the indication for concomitant open or closed surgical ablation, stand-alone, and hybrid surgical ablation of atrial fibrillation. "Nervous/Mental Conditions" changed to "Mental Health Disorders" and "Medically Necessary" changed to "medical necessity." Code Reference section updated to remove deleted ICD-10 diagnosis codes I48.1 and I48.2.

06/21/2022: Policy reviewed; no changes.

07/14/2023: Policy description revised to remove information regarding open surgical techniques, minimally invasive (thoracoscopic) techniques, and hybrid techniques. Added information regarding epidemiology and updated list of devices. Policy section updated to change "not medically necessary" to "investigational." Policy Guidelines updated with minor changes.

03/27/2024: Code Reference section updated to add new ICD-10 procedure code 02583ZF, effective 04/01/2024.

04/22/2025: Policy description updated. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.14

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

  Investigational Codes 

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