Catheter Ablation as Treatment for Atrial Fibrillation

POLICY NUMBER

A.2.02.19

DESCRIPTION

Atrial fibrillation (AF) frequently arises from an abnormal focus at or near the junction of the pulmonary veins and the left atrium, thus leading to the feasibility of more focused ablation techniques directed at these structures. Catheter-based ablation, using radiofrequency ablation (RFA) or cryoablation, is a treatment option for various types of AF. Pulsed field ablation is a novel ablation technique for atrial fibrillation.

Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an estimated prevalence of 0.4% of the population, increasing with age. The underlying mechanism of AF involves the interplay between electrical triggering events 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.

Atrial fibrillation can be subdivided into three types: paroxysmal, persistent, and permanent. Atrial fibrillation accounts for approximately one-third of hospitalizations for cardiac rhythm disturbances. Symptoms of AF (eg, palpitations, decreased exercise tolerance, dyspnea) are primarily related to poorly controlled or irregular heart rate. The loss of atrioventricular synchrony results in a decreased cardiac output, which can be significant in patients with compromised cardiac function. Also, patients with AF are at higher risk for stroke, with anticoagulation typically recommended. Atrial fibrillation is also associated with other cardiac conditions, such as valvular heart disease, heart failure, hypertension, and diabetes. Although episodes of AF can be converted to normal sinus rhythm using either pharmacologic or electroshock conversion, the natural history of AF is that of recurrence, thought to be related to fibrillation-induced anatomic and electrical remodeling of the atria.

Treatment strategies can be broadly subdivided into rate control, in which only the ventricular rate is controlled, and the atria are allowed to fibrillate, or rhythm control, in which there is an attempt to re-establish and maintain normal sinus rhythm. Rhythm control has long been considered an important treatment goal for management of AF, although its primacy has recently been challenged by the results of several randomized trials reporting that pharmacologically maintained rhythm control offered no improvement in mortality or cardiovascular morbidity compared with rate control.

However, rhythm control is not curative. A variety of ablative procedures have been investigated as potentially curative approaches, or as modifiers of the arrhythmia so that drug therapy becomes more effective. Ablative approaches focus on the interruption of the electrical pathways that contribute to AF through modifying the arrhythmia triggers and/or the myocardial substrate that maintains the aberrant rhythm. The maze procedure, an open surgical procedure often combined with other cardiac surgeries (eg, valve repair), is an ablative treatment that involves sequential atriotomy incisions designed to create electrical barriers that prevent the maintenance of AF. Because of the highly invasive nature of this procedure, it is currently, mainly reserved for patients undergoing open-heart surgery for other reasons (eg, valve repair, coronary artery bypass grafting). 

Catheter Ablation for Atrial Fibrillation

Radiofrequency ablation (RFA) using a percutaneous catheter-based approach is widely used to treat a variety of supraventricular arrhythmias, in which intracardiac mapping identifies a discrete arrhythmogenic focus that is the target of ablation. The situation is more complex for AF because there may be no single arrhythmogenic focus.Atrial fibrillation most frequently arises from an abnormal focus at or near the junction of the pulmonary veins and the left atrium, thus leading to the feasibility of more focused, percutaneous ablation techniques. Strategies that have emerged for focal ablation within the pulmonary veins originally involved segmental ostial ablation guided by pulmonary vein potential (electrical approach) but currently more typically involve circumferential pulmonary vein ablation (anatomic approach).Circumferential pulmonary vein ablation using radiofrequency energy is the most common approach at present.

Research into specific ablation and pulmonary vein isolation techniques is ongoing.

The use of current radiofrequency catheters for AF has a steep learning curve because they require extensive guiding to multiple ablation points. The procedure can also be done using cryoablation technology. One of the potential advantages of cryoablation is that cryoablation catheters have a circular or shaped endpoint, permitting a “one-shot” ablation.

Pulsed field ablation (PFA) employs a series of brief electrical pulses to desiccate tissue without significantly heating the tissue and is believed to be more selective for myocardial tissue than other ablative techniques. Two PFA devices were recently approved in the US.

Repeat ProceduresRepeat procedures following initial RFA are commonly performed if AF recurs or if atrial flutter develops post-procedure. The need for repeat procedures may, in part, depend on the clinical characteristics of the patient (eg, age, persistent vs paroxysmal AF, atrial dilatation), and the type of ablation initially performed. Repeat procedures are generally more limited in scope than the initial procedure. Additional clinical factors associated with the need for a second procedure include the length of AF, permanent AF, left atrial size, and left ventricular ejection fraction.

In February 2009, the NaviStar® ThermoCool® Irrigated Deflectable Diagnostic/Ablation Catheter and EZ Steer® ThermoCool NAV Catheter (Biosense Webster) received expanded approval by the U.S. Food and Drug Administration (FDA) through the premarket approval process for radiofrequency ablation to treat drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.

Devices using laser or cryoablation techniques for substrate ablation have been approved by the FDA through the premarket approval process for atrial fibrillation. They include:

• Arctic Front™ Cardiac CryoAblation Catheter and CryoConsole (Medtronic) in 2010.

• TactiCath™ Quartz Catheter and TactiSysQuartz® Equipment (St. Jude Medical) in 2014.

• HeartLight® Endoscopic Ablation System (Cardiofocus) in 2016.

• The Freezor™ Xtra Catheter (Medtronic) in 2016.

Pulsed field ablation (non-thermal energy) devices have also been approved by the FDA for catheter ablation of atrial fibrillation (FDA product code: QZI). FARAPULSE™ (Boston Scientific) is approved for paroxysmal AF in drug-resistant patients. PulseSelect™ (Medtronic) is approved for both paroxysmal and persistent AF. Sphere-9™ Catheter and Affera™ Ablation System (Medtronic) is capable of delivering either radiofrequency energy or pulsed field energy is approved for drug refractory, recurrent, symptomatic persistent atrial fibrillation (episode duration less than 1 year).

Also, numerous catheter ablation systems have been approved by the FDA for other ablation therapy for arrhythmias such as supraventricular tachycardia, atrial flutter, and ventricular tachycardia.

The  Maze procedure is addressed in a separate policy.

POLICY

Transcatheter radiofrequency ablation, cryoablation, or pulsed field ablation to treat atrial fibrillation may be considered medically necessary as a treatment for either of the following indications, which have failed to respond to adequate trials of antiarrhythmic medications:

• Symptomatic paroxysmal or symptomatic persistent atrial fibrillation; or

• As an alternative to atrioventricular nodal ablation and pacemaker insertion in individuals with class II or III congestive heart failure and symptomatic atrial fibrillation.

Transcatheter radiofrequency ablation, cryoablation, or pulsed field ablation to treat atrial fibrillation may be considered medically necessary as an initial treatment for individuals with recurrent symptomatic paroxysmal atrial fibrillation (>1 episode, with 4 or fewer episodes in the previous 6 months) in whom a rhythm-control strategy is desired.

Repeat radiofrequency ablation, cryoablation, or pulsed field ablation may be considered medically necessary in individuals with recurrence of atrial fibrillation and/or development of atrial flutter following the initial procedure (see Policy Guidelines).

Transcatheter radiofrequency ablation, cryoablation, and pulsed field ablation to treat atrial fibrillation is considered investigational as a treatment for cases of atrial fibrillation that do not meet the criteria outlined above.

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.

Transcatheter treatment of atrial fibrillation may include pulmonary vein isolation and/or focal ablation.

There is no single procedure for catheter ablation. Electrical isolation of the pulmonary vein musculature (pulmonary vein isolation) is the cornerstone of most AF ablation procedures, but additional ablation sites may be included during the initial ablation. Potential additional ablation procedures include: creation of linear lesions within the left atrium; ablation of focal triggers outside the pulmonary veins; ablation of areas with complex fractionated atrial electrograms; and ablation of left atrial ganglionated plexi. The specific ablation sites may be determined by electroanatomic mapping to identify additional sites of excitation. As a result, sites may vary from individual to individual, even if they are treated by the same physician. Individuals with long-standing persistent AF may need more extensive ablation. Similarly, repeat ablation procedures for recurrent AF generally involve more extensive ablation than do initial procedures.

As many as 30% of individuals will require a follow-up (repeat) procedure, due to recurrence of AF or to development of atrial flutter. In most published studies, success rates have been based on having as many as three separate procedures, although these repeat procedures may be more limited in scope than the initial procedure.

It is currently unknown whether there is a feature of the pulsed field ablation approach that alters the conventional 3-month blanking period. Pulsed field ablation is purported to have a desirable safety profile through the avoidance of thermal injury compared to other catheter ablation methods.

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

7/27/2006: Approved by Medical Policy Advisory Committee (MPAC).

8/3/2007: Policy reviewed, no changes.

9/24/2009: Policy statement section updated to include indications which may be considered medically necessary. Code reference section updated to add diagnosis codes 427.31 and 428.0.

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

12/30/2010: New policy statement added to indicate that transcatheter cryoablation of the pulmonary veins as a treatment for atrial fibrillation is considered investigational.

06/08/2011: Policy statements revised for clarity; intent unchanged. Added policy statement regarding repeat procedures.

04/19/2012: Policy title changed from "Pulmonary Vein Isolation and Ablation as a Treatment of Atrial Fibrillation" to "Catheter Ablation of the Pulmonary Veins as Treatment for Atrial Fibrillation." Policy statement unchanged.

03/08/2013: Added the following new 2013 CPT codes to the Code Reference section: 93656 and 93657. Since new specific CPT codes are available, added note to CPT code 93651 to indicate that this code should only be used for procedures performed prior to 01/01/2013. Added ICD-9 code 427.32 to the Code Reference section.

08/07/2013: Policy reviewed; no changes to policy statement. Added ICD-9 code 427.0 to Code Reference section.

04/24/2014: Policy title changed from "Catheter Ablation of the Pulmonary Veins as Treatment for Atrial Fibrillation" to "Catheter Ablation as Treatment for Atrial Fibrillation." Deleted "in the pulmonary veins" from the first medically necessary policy statement and both investigational statements.

08/21/2015: Code Reference section updated to add ICD-10 codes and to remove CPT code 93651.

02/23/2016: Policy statements updated to add cryoablation as medically necessary. Added policy statement that transcatheter RFA or cryoablation may be considered medically necessary as an initial treatment for patients with symptomatic paroxysmal atrial fibrillation in whom a rhythm-control strategy is desired. Revised investigational statement on transcatheter ablation of arrhythmogenic foci to state that transcatheter RFA or cryoablation to treat atrial fibrillation is considered investigational as a treatment for cases of atrial fibrillation that do not meet certain criteria. Removed the following policy statement:Transcatheter cryoablation of arrhythmogenic foci as a treatment for atrial fibrillation is considered investigational. Policy guidelines updated regarding transcatheter treatment of atrial fibrillation and to add medically necessary and investigative definitions.

06/06/2016: Policy number A.2.02.19 added.

08/24/2016: Policy description updated regarding ablation/pulmonary vein isolation techniques and devices. Medically necessary statement for RFA or cryoablation as an initial treatment for paroxysmal atrial fibrillation clarified to state that the atrial fibrillation should be recurrent.

06/06/2017: Policy description updated. Policy statements unchanged.

09/29/2017: Code Reference section updated to add new ICD-10 diagnosis codes I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, and I50.89. Effective 10/01/17.

06/01/2018: Policy description updated regarding outcome assessments in the treatment of atrial fibrillation. Policy statements unchanged.

08/12/2019: Policy description revised. Policy statements unchanged.

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.

08/14/2020: Policy reviewed; no changes.

07/27/2021: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted ICD-10 diagnosis codes I48.1 and I48.2.

12/15/2021: Code Reference section updated to revise code description for CPT code 93656, effective 01/01/2022.

06/08/2022: Policy reviewed. Policy statements and Policy Guidelines updated to change "patients" to "individuals." Policy intent unchanged.

06/06/2023: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "patient" to "individual."

09/29/2023: Code Reference section updated to add new ICD-10 diagnosis codes I47.10, I47.11, and I47.19, effective 10/01/2023.

12/31/2024: Code Reference section updated to revise description for CPT code 93656 effective 01/01/2025.

05/05/2025: Policy description updated regarding pulsed field ablation and devices. Policy statements updated to add pulsed field ablation as medically necessary for the indications listed. Policy Guidelines updated regarding pulsed field ablation. Code Reference section updated to remove deleted ICD-10 diagnosis code I47.1.

08/29/2025: Code Reference section updated to add ICD-10 procedure code 02583ZF.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 2.02.19

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

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