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Radiofrequency ablation (RFA) using a percutaneous catheter is a common approach to treat supraventricular arrhythmias. 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 RFA or cryoablation, is being studied in the treatment of various types of AF.
Atrial fibrillation (AF) is the most common cardiac arrhythmia, with a prevalence estimated at 0.4% of the population, increasing with age. The underlying mechanism of AF involves an 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.
AF accounts for approximately one-third of hospitalizations for cardiac rhythm disturbances. Symptoms of AF (i.e., palpitations, decreased exercise tolerance, dyspnea) are primarily related to poorly controlled or irregular heart rate. The loss of atrioventricular (AV) synchrony results in a decreased cardiac output, which can be significant in patients with compromised cardiac function. In addition, patients with AF are at higher risk for stroke, and anticoagulation is typically recommended. AF 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 one of recurrence, thought to be related to fibrillation-induced anatomic and electrical remodeling of the atria.
AF can be subdivided into 3 types:
Atrial Fibrillation Treatment Strategies
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.
Currently, the main indications for a rhythm control are for patients with paroxysmal or persistent AF who have hemodynamic compromise associated with episodes of AF or who have bothersome symptoms, despite adequate rate control. A rhythm-control strategy involves initial pharmacologic or electronic cardioversion, followed by pharmacologic treatment to maintain normal sinus rhythm. However, antiarrhythmic medications are often not effective in maintaining sinus rhythm. As a result, episodes of recurrent AF are typical, and patients with persistent AF may require multiple episodes of cardioversion. Implantable atrial defibrillators, which are designed to detect and terminate an episode of AF, are an alternative in patients otherwise requiring serial cardioversions, but these have not yet achieved widespread use. Patients with paroxysmal AF, by definition, do not require cardioversion, but may be treated pharmacologically to prevent further arrhythmic episodes.
Treatment of permanent AF focuses on rate control, using either pharmacologic therapy or ablation of the AV node, followed by ventricular pacing. Although AV nodal ablation produces symptomatic improvement, it does entail lifelong anticoagulation (due to the ongoing fibrillation of the atria), loss of AV synchrony, and lifelong pacemaker dependency. Implantable defibrillators are contraindicated in patients with permanent AF.
The above treatment options are not considered curative. A variety of ablative procedures have been investigated as potentially curative approaches, or perhaps modifying the arrhythmia such that drug therapy becomes more effective. Ablative approaches focus on 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 (i.e., valve repair), is an ablative procedure 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 who are undergoing open heart surgery for other reasons, such as valve repair or coronary artery bypass grafting.
Catheter Ablation for Atrial Fibrillation
Radiofrequency ablation using a percutaneous catheter-based approach is a widely used technique for 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 is no single arrhythmogenic focus. Since the inception of ablation techniques in the early 1990s, there has been a progressive understanding of the underlying electrical pathways in the heart that are associated with AF. In the late 1990s, it was recognized that AF most frequently arose 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. The 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).
The individual lesion set (in addition to the pulmonary vein isolation) and the degree to which the pulmonary vein antrum is electrically isolated vary. Research into specific ablation/pulmonary vein isolation techniques is ongoing. Evidence from a randomized controlled trial (RCT) comparing pulmonary vein isolation alone to pulmonary vein isolation plus ablation to treat patients with electrograms showing complex fractionated activity, and to pulmonary vein isolation plus additional linear ablation across the left atrial roof and mitral valve isthmus, suggests that the more extensive lesion sets do not reduce the AF recurrence rate. Meta-analyses have found that the addition of complex fractionated atrial electrogram ablation to pulmonary vein isolation alone did not improve rates of freedom from recurrent AF, although at least one RCT has reported that patients with ablation of dormant conduction sources outside the pulmonary veins had fewer arrhythmia recurrences than those treated with pulmonary vein isolation alone.
Circumferential pulmonary vein ablation using radiofrequency energy is the most common approach at the present time. The procedure also can be done using cryoablation technology. Use of currently available catheters for AF has a steep learning curve because they require extensive guiding to multiple ablation points. One of the potential advantages to cryoablation techniques is that cryoablation catheters have a circular or shaped end point, allowing a “one-shot” ablation. Other types of radiofrequency catheters, such as Medtronic’s radiofrequency-based Pulmonary Vein Ablation Catheter®, which incorporate circular or otherwise shaped end points, may also be used.
Repeat procedures following initial RFA are commonly performed if AF recurs or if atrial flutter develops postprocedure. The need for repeat procedures may, in part, depend on clinical characteristics of the patient (eg, age, persistent vs paroxysmal AF, atrial dilatation), and the type of initial ablation performed. Repeat procedures are generally more limited than the initial procedure. For example, in cases where electrical reconnections occur as a result of incomplete ablation lines, a ”touch up” procedure is done to correct gaps in the original ablation. In other cases where atrial flutter develops following ablation, a "flutter ablation” is performed, which is more limited than the original AF procedure. A number of clinical and demographic factors have been associated with the need for a second procedure, including age, length of AF, permanent AF, left atrial size, and left ventricular ejection fraction (LVEF).
In February 2009, the NaviStar® ThermoCool® Irrigated Deflectable Diagnostic/Ablation Catheter and EZ Steer ThermoCool NAV Catheter (Biosense Webster, South Diamond Bar, CA) received expanded approval by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process for radiofrequency ablation for treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.
Devices using laser or cryoablation techniques for substrate ablation have been approved by FDA through the PMA process for atrial fibrillation. These devices include:
In addition, numerous catheter ablation systems have been approved by FDA for other ablation therapy for arrhythmias such as supraventricular tachycardia, atrial flutter, and ventricular tachycardia.
Transcatheter radiofrequency ablation or cryoablation 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:
Transcatheter radiofrequency ablation or cryoablation to treat atrial fibrillation may be considered medically necessary as an initial treatment for patients 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 or cryoablation may be considered medically necessary in patients with recurrence of atrial fibrillation and/or development of atrial flutter following the initial procedure (see Policy Guidelines).
Transcatheter radiofrequency ablation or cryoablation to treat atrial fibrillation is considered investigational as a treatment for cases of atrial fibrillation that do not meet the criteria outlined above.
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, but several variations. Electrical isolation of the pulmonary vein musculature (pulmonary vein isolation) is the cornerstone of most AF ablation procedures, but additional ablation sites may also 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 patient to patient, even if they are treated by the same physician. Patients 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 patients will require a follow-up (repeat) procedure due to recurrence of AF or to developing atrial flutter. In most of the published studies, success rates were based on having as many as three separate procedures, although these repeat procedures may be more limited than the initial procedure.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
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 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.
Blue Cross Blue Shield Association Policy # 2.02.19
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.