Description:
Atrial Fibrillation 
Atrial Fibrillation (AF) is a supraventricular tachyarrhythmia characterized by disorganized atrial activation with ineffective atrial ejection. The underlying mechanism of AF involves the 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 AF. 

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. 

Open Surgical Techniques 
The classic Cox maze III procedure is a complex surgical procedure for patients with AF. It involves sequential atriotomy incisions that interrupt the aberrant atrial conduction pathways in the heart. The procedure is also intended to preserve atrial pumping function. It is indicated for patients who do not respond to medical or other surgical antiarrhythmic therapies and is often performed in conjunction with correction of structural cardiac conditions such as valve repair or replacement. This procedure is considered the criterion standard for the surgical treatment of drug-resistant AF, with a success rate of approximately 90%. 

The maze procedure entails making incisions in the heart that: 

• direct an impulse from the sinoatrial node to the atrioventricular node; 
• preserve activation of the entire atrium; and 
• block re-entrant impulses responsible for AF or atrial flutter. 

The classic Cox maze procedure is performed on a nonbeating heart during cardiopulmonary bypass. Simplification of the maze procedure has evolved with the use of different ablation tools such as microwave, cryotherapy, ultrasound, and radiofrequency energy sources to create the atrial lesions instead of employing the incisional technique used in the classic maze procedure. The Cox maze IV procedure involves the use of radiofrequency energy or cryoablation to create transmural lesions analogous to the lesions created by the “cut-and-sew” maze. 

Minimally Invasive (Thoracoscopic) Techniques 
Less invasive, transthoracic, endoscopic, off-pump procedures to treat drug-resistant AF have been developed. The evolution of these procedures involves both different surgical approaches and different lesion sets. Alternative surgical approaches include mini-thoracotomy and total thoracoscopy with video assistance. Open thoracotomy and mini-thoracotomy employ cardiopulmonary bypass and open-heart surgery, while thoracoscopic approaches are performed on the beating heart. Thoracoscopic approaches do not enter the heart and use epicardial ablation lesion sets, whereas the open approaches use either the classic “cut-and-sew” approach or endocardial ablation. 

Lesion sets may vary independent of the surgical approach, with a tendency toward less extensive lesion sets targeted to areas most likely to be triggers of AF. The most limited lesion sets involve pulmonary vein isolation and exclusion of the left atrial appendage. More extensive lesion sets include linear ablations of the left and/or right atrium and ablation of ganglionic plexi. Some surgeons perform left atrial reduction in cases of left atrial enlargement. 

The type of energy used for ablation also varies; radiofrequency energy is most commonly applied. Other energy sources such as cryoablation and high-intensity ultrasound have been used. For our purposes, the variations on surgical procedures for AF will be combined under the heading of “modified maze” procedures. 

Hybrid Techniques 
“Hybrid” ablation refers to the use of both thoracoscopic and percutaneous approaches in the same patient. Ablation is performed on the outer surface of the heart (epicardial) via the thoracoscopic approach, and on the inner surface of the heart (endocardial) via the percutaneous approach. The rationale for a hybrid procedure is that a combination of both techniques may result in a complete ablation. Thoracoscopic epicardial ablation is limited by the inability to perform all possible ablation lines because the posterior portions of the heart are not accessible via thoracoscopy. Percutaneous, endoscopic ablation is limited by incomplete ablation lines that often require repeat procedures. By combining both procedures, a full set of ablation lines can be performed, and incomplete ablation lines can be minimized. 

The hybrid approach first involves thoracoscopy with epicardial ablation. Following this procedure, an electrophysiologic study is performed percutaneously followed by endocardial ablation as directed by the results of electrophysiology. Most commonly, the electrophysiology study and endocardial ablation are done immediately after the thoracoscopy as part of a single procedure. However, some hybrid approaches perform the electrophysiology study and endocardial ablation on separate days, as directed by the electrophysiology study. 

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

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

Society Guidelines 
The Society of Thoracic Surgeons 2017 clinical practice guideline for the surgical treatment of atrial fibrillation (AF): 

Mitral Valve Operations and Concomitant Surgical Ablation: 

• Surgical ablation for AF can be performed without additional risk of operative mortality or major morbidity, and is recommended at the time of concomitant mitral operations to restore sinus rhythm. (Class I, Level A) 

Aortic Valve and CABG Operations with Concomitant Ablation: 

• Surgical ablation for AF can be performed without additional risk of operative mortality or major morbidity, and is recommended at the time of concomitant isolated AVR, isolated CABG, and AVR plus CABG operations to restore sinus rhythm. (Class I, Level B nonrandomized) 

Stand-Alone Surgical Ablation for AF: 

• Surgical ablation for symptomatic AF in the absence of structural heart disease that is refractory to class I/III antiarrhythmic drugs or catheter-based therapy is reasonable as a primary stand-alone procedure to restore sinus rhythm (Class IIA, Level B) 
• Surgical ablation for symptomatic persistent or longstanding persistent AF in the absence of structural heart disease is reasonable as a stand-alone procedure using the Cox-Maze III/IV lesion set compared with PVI alone. (Class IIA, Level B nonrandomized) 
• Surgical ablation for symptomatic AF in the setting of left atrial enlargement (≥4.5 cm) or more than moderate mitral regurgitation by PVI alone is not recommended. (Class III no benefit, Level C expert opinion)

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.

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 MEDICALLY NECESSARY for treatment of symptomatic, atrial fibrillation or flutter EITHER of the following are met: 

• Atrial fibrillation is refractor to at least one class I/III antiarrhythmic drugs, OR;
• Atrial fibrillation is refractory to catheter-based therapy having had at least one unsuccessful catheter-based ablation

Hybrid ablation (defined as a combined percutaneous and thoracoscopic approach) and minimally invasive, off=pump maze procedures (i.e., modified maze procedures), including those done via mini-thoracotomy, may be considered MEDICALLY NECESSARY for the treatment of symptomatic persistent atrial fibrillation or flutter when All below are met:

• Atrial fibrillation is refractory to at least one class I/III antiarrhythmic drugs and/or catheter based therapy, AND;
• Both the surgeon and electrophysiologist agree that the procedure is an appropriate treatment.

All other indications are investigational/unproven therefore considered NOT MEDICALLY NECESSARY, as there is insufficient evidence to support a general conclusion concerning the health outcome of benefits associated with this procedure.

Policy Guidelines
Given the availability of less-invasive alternative approaches to treat atrial fibrillation, 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 (Calkins et al., 2017, referenced in the Supplemental Information section), 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.

Coding
See the Codes table for details.

Benefit Application

BlueCard^®/National Account Issues
State or federal mandates (e.g., Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity. 

Rationale
Summary of Evidence 
For individuals who have symptomatic AF or flutter who are undergoing cardiac surgery with bypass who received a Cox maze or a modified maze procedure, the evidence includes several randomized controlled trials (RCTs) and nonrandomized comparative studies, along with systematic reviews of these studies. Relevant outcomes are overall survival, medication use, and treatment-related morbidity. Several small RCTs have provided most of the direct evidence confirming the benefit of a modified maze procedure for patients with AF who are undergoing mitral valve surgery. These trials have established that the addition of a modified maze procedure results in a lower incidence of atrial arrhythmias following surgery, with minimal additional risks. Observational studies have supported these RCT findings. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. 

For individuals who have symptomatic, drug-resistant AF or flutter who are not undergoing cardiac surgery with bypass who receive minimally invasive, off-pump thoracoscopic maze procedures, and the evidence includes RCTs and observational studies, some of which identify control groups. Relevant outcomes are overall survival, medication use, and treatment-related morbidity. Most of the direct evidence comparing surgical AF ablation with percutaneous catheter ablation comes from one RCT (FAST) that used video-assisted thoracoscopy in patients with antiarrhythmic drug-refractory atrial fibrillation with left atrial dilatation and hypertension, 67% of which had previously failed CA. In FAST, at one year, thoracoscopic ablation had higher success at maintaining sinus rhythm (36.5% for CA and 65.6% for surgical ablation), but also reported higher adverse event rates compared with CA. At 7 years, outcomes were consistently improved with thoracoscopic ablation, but interpretation of those findings is limited by important flaws in study conduct. In contrast, findings from a small single-center RCT in patients with no previous CA suggested no significant benefit with minimally invasive thoracoscopic ablation and more major complications. The case series have generally reported high success rates, and a few with matched comparison groups have reported higher success 
rates with surgical treatment than with catheter ablation. However, most series lacked a control group, generally only reported short-term outcomes, and did not consistently report adverse events. Therefore, this evidence does not permit definitive conclusions whether a specific approach is superior to the other. Factors, such as previous treatment, the probability of maintaining sinus rhythm, the risk of complications, contraindications to anticoagulation, and patient preference, may all affect the risk-benefit ratio for each procedure.

For individuals who have symptomatic, drug-resistant AF or flutter who are not undergoing cardiac surgery with bypass who receive hybrid thoracoscopic and endocardial ablation procedures, the evidence includes a nonrandomized comparative study and single-arm case series. Relevant outcomes are overall survival, medication use, and treatment-related morbidity. The studies have suggested that hybrid ablation procedures are associated with high rates of freedom from AF. 

Definitions

ATRIAL FLUTTER is a cardiac arrhythmia marked by rapid (about three hundred beats per minute) regular atrial beating, and, usually, a regular ventricular response. 

ATRIOVENTRICULAR (AV) NODE is an area of specialized cardiac muscle that receives the cardiac impulse from the sinoatrial (SA) node and conducts it to the AV bundle and then to the Purkinje fibers and the walls of the ventricles. The AV node is located in the septal wall between the left and right atria. 

ATRIUM is the upper chamber of each half of the heart. Atria is the plural of atrium. 

MYOCARDIUM is the middle layer of the walls of the heart, composed of cardiac muscle. 

SINOATRIAL (SA) NODE is a specialized group of cardiac muscle cells in the wall of the right atrium at the entrance to the superior vena cava. These cells depolarize spontaneously and rhythmically to initiate normal heartbeats. 

SUPRAVENTRICULAR TACHYCARDIA (SVT) is any cardiac rhythm with a rate exceeding one hundred (100) beats per minute that originates above the branching part of the atrioventricular bundle, that is, in the sinus node, atria, or AV junction. 

TACHYCARDIA is an abnormally rapid heart rate, greater than one hundred (100) beats per minute.

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74. Badhwar V, Rankin JS, Damiano RJ, et al. The Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation. Ann Thorac Surg. Jan 2017; 103(1): 329-341. PMID 28007240
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76. Ad N, Damiano RJ, Badhwar V, et al. Expert consensus guidelines: Examining surgical ablation for atrial fibrillation. J Thorac Cardiovasc Surg. Jun 2017; 153(6): 1330-1354.e1. PMID 28390766

Coding Section  

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.  

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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