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Transcatheter Ablation as a Treatment of Atrial Fibrillation

Policy Number: MP-283

 

Latest Review Date: May 2021

Category:  Medical                                                                

Policy Grade:  A

 

POLICY:

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:

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

 

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.

 

Transcatheter radiofrequency ablation or cryoablation to treat atrial fibrillation is considered investigational as a treatment for all other indications including, but not limited to cases of atrial fibrillation that do not meet the criteria outlined above.

  

DESCRIPTION OF PROCEDURE OR SERVICE:

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 being studied as a treatment option for various types of AF.

 

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 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 (e.g., 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, with 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 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.

 

AF can be subdivided into three types:

  • paroxysmal (episodes that last fewer than 7 days and are self-terminating),
  • persistent (episodes that last for more than 7 days and can be terminated pharmacologically or by electrical cardioversion), or
  • Permanent.

 

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 reestablish 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 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 (e.g., valve repair), is an ablative treatment that involves sequential atriotomy incisions designed to create electrical barriers that prevent the maintenance of AF.

 

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. AF 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.

 

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

 

Repeat Procedures

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 the clinical characteristics of the patient (e.g., 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 are associated with the need for a second procedure, including age, length of AF, permanent AF, left atrial size, and left ventricular ejection fraction.

  

KEY POINTS:

The most recent literature search was performed through March 24, 2021.

 

Summary of Evidence

For individuals who have symptomatic paroxysmal or persistent AF who have failed antiarrhythmic drugs who receive RFA or cryoablation, the evidence includes multiple RCTs and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and quality of life. RCTs comparing RFA with antiarrhythmic medications have reported that freedom from AF is more likely after ablation than after medications. Results of long-term follow-up (5-6 years) after ablation have demonstrated that late recurrences continue in patients who are free of AF at 1 year. However, most patients who are AF-free at 1 year remain AF-free at 4 to 6 years. RFA and cryoablation differ in their adverse event profiles. For example, cryoablation is associated with higher rates of phrenic nerve paralysis but may permit a shorter procedure time. Given current data, it would be reasonable to consider both RFA and cryoablation effective for catheter ablation of AF foci or pulmonary vein isolation, provided there is a discussion about the risks and benefits of each. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

 

For individuals who have symptomatic AF and congestive heart failure who have failed rate control and antiarrhythmic drugs who receive RFA or cryoablation, the evidence includes RCTs and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and quality of life. Findings from RCTs have been supported by other comparative studies, which have reported improvements in AF. It is reasonable to consider both RFA and cryoablation effective for catheter ablation of AF foci or pulmonary vein isolation, provided that there is a discussion about the risks and benefits of each. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

 

For individuals who have recurrent symptomatic paroxysmal AF who receive RFA or cryoablation as an initial rhythm-control strategy, the evidence includes RCTs, nonrandomized studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and quality of life. One RCT with adequate follow-up compared pulmonary vein isolation by catheter ablation (using either cryoablation or RFA to medical therapy. Catheter ablation was not superior to medical therapy for major cardiovascular outcomes but secondary outcomes including AF recurrence favored catheter ablation. QOL measures reported in this RCT favored catheter ablation. Two other RCTs with low risk of bias compared RFA for pulmonary vein isolation with antiarrhythmic medications. One RCT demonstrated reduced rates of AF recurrence, while the other reported reduced cumulative overall AF burden. Additionally, 2 RCTs comparing cryoablation to antiarrhythmic drug therapy as first-line therapy demonstrated improved outcomes for atrial arrhythmia recurrence up to 1 year. Together, these results suggest that, when a rhythm-control strategy is desired, catheter ablation is a reasonable alternative to antiarrhythmic drug therapy. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

 

Practice Guidelines and Position Statements

Heart Rhythm Society et al

An expert consensus document on catheter and surgical catheter ablation for atrial fibrillation (AF) was developed jointly by 7 cardiac specialty societies (Heart Rhythm Society [HRS], European Heart Rhythm Association, European Cardiac Arrhythmia Society, American College of Cardiology, American Heart Association, Asia Pacific Heart Rhythm Society, Society of Thoracic Surgeons) in 2012. A related group of cardiac specialty societies (HRS, European Heart Rhythm Association, European Cardiac Arrhythmia Society, Asia Pacific Heart Rhythm Society, Latin American Society of Cardiac Stimulation and Electrophysiology) updated these guidelines in 2017, suggesting the following recommendations for catheter ablation (see Table 1).

 

Table 1. Guidelines for Management of Catheter Ablation for AF

Recommendation

COR

LOE

Symptomatic AF refractory or intolerant to at least 1 class 1 or 3 antiarrhythmic medication

 

 

Paroxysmal: Catheter ablation is recommended

I

A

Persistent: Catheter ablation is reasonable

IIa

B-NR

Long-standing persistent: Catheter ablation may be considered

IIb

C-LD

Symptomatic AF prior to initiation of antiarrhythmic drug therapy with a class 1 or 3 antiarrhythmic agent

Paroxysmal: Catheter ablation is reasonable

IIa

B-R

Persistent: Catheter ablation may be considered

IIa

C-EO

Longstanding Persistent: Catheter ablation may be considered

IIb

C-EO

AF: atrial fibrillation; COR: class of recommendation: LOE: level of evidence.

 

American College of Cardiology et al

In 2014, American College of Cardiology, American Heart Association, and HRS issued guidelines for management of patients with AF. In 2019, the AHA/ACC/HRS conducted a focused update of areas for which new evidence had emerged since the 2014 publication.  Together, the guidelines included the following recommendations for rate control and rhythm control (see Table 2).

 

Table 2. Guidelines for Rate and Rhythm in Management of AF

Recommendation

COR

LOE

Rate control

 

 

“AV nodal ablation with permanent ventricular pacing is reasonable to control heart rate when pharmacological therapy is inadequate and rhythm control is not achievable.”

I

B

“AV nodal ablation with permanent ventricular pacing should not be performed to improve rate control without prior attempts to achieve rate control with medications.”

IIIa

C

Rhythm control

 

 

“AF catheter ablation is useful for symptomatic paroxysmal AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication when a rhythm-control strategy is desired.”

I

A

“Before consideration of AF catheter ablation, assessment of the procedural risks and outcomes relevant to the individual patient is recommended.”

I

C

“AF catheter ablation is reasonable for some patients with symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication.”

IIa

A

“In patients with recurrent symptomatic paroxysmal AF, catheter ablation is a reasonable initial rhythm-control strategy before therapeutic trials of antiarrhythmic drug therapy, after weighing the risks and outcomes of drug and ablation therapy.”

IIa

B

“AF catheter ablation may be considered for symptomatic long-standing (>12 months) persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication when a rhythm-control strategy is desired).”

IIb

B

“AF catheter ablation may be considered before initiation of antiarrhythmic drug therapy with a class I or III antiarrhythmic medication for symptomatic persistent AF when a rhythm-control strategy is desired.”

IIb

C

“AF catheter ablation should not be performed in patients who cannot be treated with anticoagulant therapy during and after the procedure.”

IIIa

C

“AF catheter ablation to restore sinus rhythm should not be performed with the sole intent of obviating the need for anticoagulation.”

IIIa

C

“AF catheter ablation may be reasonable in selected patients with symptomatic AF and HF with reduced left ventricular (LV) ejection fraction (HFrEF) to potentially lower mortality rate and reduce hospitalization for HF”

IIb

B-R

AF: atrial fibrillation; AV: arteriovenous; COR: class of recommendation: LOE: level of evidence.
a Not recommended

 

Although the guidelines did not make a specific recommendation on the use of cryoablation, they did state that “Cryoballoon ablation is an alternative to point-by-point radiofrequency ablation to achieve pulmonary vein isolation.”

 

U.S. Preventive Services Task Force Recommendations

Not applicable

 

KEY WORDS:

Atrial fibrillation, circumferential pulmonary vein ablation (PVA), pulmonary vein isolation, arrhythmogenic, cryoablation, cryoballoon therapy, cryoballoon intervention, cryoballoon technique, cryoballoon isolation, cryoballoon ablation

  

APPROVED BY GOVERNING BODIES:

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 RFA to treat drug-refractory recurrent symptomatic paroxysmal AF. FDA product code: OAD.

Devices using laser or cryoablation techniques for substrate ablation have been approved by FDA through the premarket approval process for AF (FDA product code: OAE). 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.

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

 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

  

CURRENT CODING:

CPT Codes:

93655

Intracardiac catheter ablation of a discrete mechanism of arrhythmia which is distinct from the primary ablated mechanism,including repeat diagnostic maneuvers, to treat a spontaneous or induced arrhythmia

93656

Comprehensive electrophysiologic evaluation including transseptal catheterizations, insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia including left or right atrial pacing/recording when necessary, right ventricle pacing/recording when necessary, and HIS bundle recording when necessary with intracardiac catheter ablation of atrial fibrillation by pulmonary vein isolation

93657

; additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation

93799

Unlisted cardiovascular service or procedure

 

 

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  65. Khan MN, Jais P, Cummings J et al. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med 2008; 359(17):1778-85.
  66. Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. Nov 2016; 18(11):1609-1678.
  67. Koch L, Haeusler KG, Herm J et al. Mesh ablator vs. cryoballoon pulmonary vein ablation of symptomatic paroxysmal atrial fibrillation: results of the MACPAF study. Europace 2012; 14(10):1441-9.
  68. Kojodjojo P, O’Neill MD, Lim PB, Malcolm-Lawes L, et al.  Pulmonary venous isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation:  medium-term outcomes and non-randomized comparison with pulmonary venous isolation by radiofrequency ablation.  Heart 2010; 96:1379-84.
  69. Krittayaphong R, Raungrattanaamporn O, Bhuripanyo K et al. A randomized clinical trial of the efficacy of radiofrequency catheter ablation and amiodarone in the treatment of symptomatic atrial fibrillation. J Med Assoc Thai 2003; 86 Suppl 1:S8-16.
  70. Kuck KH, Brugada J, Furnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. Jun 09 2016; 374(23):2235-2245.
  71. Kuck KH, Furnkranz A, Chun KR, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. Oct 07 2016; 37(38):2858-2865.
  72. Kuck KH, Merkely B, Zahn R, et al. Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial. Circ Arrhythm Electrophysiol. Dec 2019; 12(12): e007731.
  73. Lakhani M, Saiful F, Parikh V, et al. Recordings of diaphragmatic electromyograms during cryoballoon ablation for atrial fibrillation accurately predict phrenic nerve injury. Heart Rhythm. Mar 2014; 11(3):369-374.
  74. Lee MA, et al.  The effect of atrial pacing therapies on atrial tachyarrhythmia burden and frequency.  JACC, June 2003, Vol. 41, No. 11, pp. 1926-1932.
  75. Lellouche N, Jais P, Nault I et al. Early recurrences after atrial fibrillation ablation: prognostic value and effect of early reablation. J Cardiovasc Electrophysiol 2008; 19(6):599-605.
  76. Linhart M, Bellmann B, Mittmann-Braun E et al. Comparison of cryoballoon and radiofrequency ablation of pulmonary veins in 40 patients with paroxysmal atrial fibrillation: a case-control study. J. Cardiovasc. Electrophysiol. 2009; 20(12):1343-8.
  77. Linhart M, Nielson A, Andrie RP, et al. Fluoroscopy of spontaneous breathing is more sensitive than phrenic nerve stimulation for detection of right phrenic nerve injury during cryoballoon ablation of atrial fibrillation. J Cardiovasc Electrophysiol. Aug 2014; 25(8):859-865.
  78. Liu XH, Chen CF, Gao XF, et al. Safety and efficacy of different catheter ablations for atrial fibrillation: a systematic review and meta-analysis. Pacing Clin Electrophysiol. Aug 2016; 39(8):883-899.
  79. Luik A, Merkel M, Hoeren D et al. Rationale and design of the FreezeAF trial: a randomized controlled noninferiority trial comparing isolation of the pulmonary veins with the cryoballoon catheter versus open irrigated radiofrequency ablation in patients with paroxysmal atrial fibrillation. Am. Heart J. 2010; 159(4):555-60 e1.
  80. Luik A, Radzewitz A, Kieser M, et al. Cryoballoon versus open irrigated radiofrequency ablation in patients with paroxysmal atrial fibrillation: the prospective, randomized, controlled, noninferiority FreezeAF study. Circulation. Oct 6 2015; 132(14):1311-1319.
  81. Malmborg H, Lonnerholm S, Blomstrom P et al. Ablation of atrial fibrillation with cryoballoon or duty-cycled radiofrequency pulmonary vein ablation catheter: a randomized controlled study comparing the clinical outcome and safety; the AF-COR study. Europace 2013; 15(11):1567-73.
  82. Mansour M, et al.  Efficacy and safety of segmental ostial versus circumferential extra—Ostial pulmonary vein isolation for atrial fibrillation.  Journal of Cardiovascular Electrophysiology, May 2004, Vol. 15, No. 5, pp. 532-537.
  83. Mark DB, Anstrom KJ, Sheng S, et al. Effect of catheter ablation vs medical therapy on quality of life among patients with atrial fibrillation: the CABANA randomized clinical trial. JAMA. 2019;Epub ahead of print.
  84. Marrouche NF, Brachmann J, Andresen D, et al. Catheter ablation for atrial fibrillation with heart failure. N Engl J Med. Feb 1 2018;378(5):417-427
  85. Mont L, Bisbal F, Hernandez-Madrid A et al. Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur. Heart J. 2013.
  86. Mont L, Bisbal F, Hernandez-Madrid A, et al. Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur Heart J. Feb 2014; 35(8):501-507.
  87. Morillo CA, Verma A, Connolly SJ, et al. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2): a randomized trial. JAMA. Feb 19 2014; 311(7):692-700.
  88. Nair GM, Nery PB, Diwakaramenon S et al. A Systematic Review of Randomized Trials Comparing Radiofrequency Ablation with Antiarrhythmic Medications in Patients with Atrial Fibrillation. J. Cardiovasc. Electrophysiol. 2009; 20(2):138-44.
  89. Nakamura K, Naito S, Sasaki T, et al. Randomized comparison of contact force-guided versus conventional circumferential pulmonary vein isolation of atrial fibrillation: prevalence, characteristics, and predictors of electrical reconnections and clinical outcomes. J Interv Card Electrophysiol. Dec 2015; 44(3):235-245.
  90. Neumann T, Vogt J, Schumacher B, et al. Circumferential pulmonary vein isolation with the cryoballoon technique results from a prospective 3-center study. J Am Coll Cardiol. Jul 22 2008; 52(4):273-278.
  91. Neumann T, Wojcik M, Berkowitsch A et al. Cryoballoon ablation of paroxysmal atrial fibrillation: 5-year outcome after single procedure and predictors of success. Europace 2013; 15(8):1143-9.
  92. Nielsen JC, Johannessen A, Raatikainen P, et al. Long-term efficacy of catheter ablation as first-line therapy for paroxysmal atrial fibrillation: 5-year outcome in a randomised clinical trial. Heart. Mar 2017; 103(5):368-376.
  93. Noheria A, Kumar A, Wylie JV, Jr. et al. Catheter ablation vs antiarrhythmic drug therapy for atrial fibrillation: a systematic review. Arch Intern Med 2008; 168(6):581-6.
  94. Nyong J, Amit G, Adler AJ, et al. Efficacy and safety of ablation for people with non-paroxysmal atrial fibrillation. Cochrane Database Syst Rev. Nov 22 2016; 11:CD012088.
  95. Oral H, et al.  Catheter ablation for paroxysmal atrial fibrillation:  Segmental pulmonary vein ostial ablation versus left atrial ablation.  Circulation 2003; 108: 2355-2360.
  96. Oral H, et al.  Pulmonary vein isolation for paroxysmal and persistent atrial fibrillation. Circulation, March 2002; 105: 1077-1081.
  97. Oral H, et al. A tailored approach to catheter ablation of paroxysmal atrial fibrillation.  Circulation 2006; 113: 1824-1831.
  98. Oral H, Pappone C, Chugh A et al. Circumferential pulmonary-vein ablation for chronic atrial fibrillation. N Engl J Med 2006; 354(9):934-41.
  99. Packer DL, Kowal RC, Wheelan KR et al. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J. Am. Coll. Cardiol. 2013; 61(16):1713-23.
  100. Packer DL, Mark DB, Robb RA, et al. Effect of catheter ablation vs antiarrhythmic drug therapy on mortality, stroke, bleeding, and cardiac arrest among patients with atrial fibrillation: the CABANA randomized clinical trial. JAMA. 2019;Epub ahead of print.
  101. Packer DL, Piccini JP, Monahan KH, et al. Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From theCABANA Trial. Circulation. Apr 06 2021; 143(14): 1377-1390.
  102. Pappone C, Augello G, Sala S et al. A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study. J Am Coll Cardiol 2006; 48(11):2340-7.
  103. Pappone C, et al.  Pulmonary vein denervation enhances long-term benefit after circumferential ablation for paroxysmal atrial fibrillation.  Circulation, January 2004; 109: 327-334.
  104. Pappone G, et al.  Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation.  JACC, July 2003, Vol. 42, No. 2, pp. 185-197.
  105. Paylos JM, Hoyt RH, Ferrero C et al. Complete pulmonary vein isolation using balloon cryoablation in patients with paroxysmal atrial fibrillation. Rev. Esp. Cardiol. 2009; 62(11):1326-31.
  106. Paylos JM, Hoyt RH, Ferrero C, et al. Complete pulmonary vein isolation using balloon cryoablation in patients with paroxysmal atrial fibrillation. Rev Esp Cardiol. Nov 2009; 62(11):1326-1331.
  107. Pokushalov E, Romanov A, De Melis M et al. Progression of atrial fibrillation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation: a randomized comparison of drug therapy versus reablation. Circ Arrhythm Electrophysiol 2013; 6(4):754-60.
  108. Providencia R, Lambiase PD, Srinivasan N, et al. Is there still a role for complex fractionated atrial electrogram ablation in addition to pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation? Meta-analysis of 1415 patients. Circ Arrhythm Electrophysiol. Oct 2015; 8(5):1017-1029.
  109. Reddy VY, Dukkipati SR, Neuzil P, et al. Randomized, controlled trial of the safety and effectiveness of a contact force-sensing irrigated catheter for ablation of paroxysmal atrial fibrillation: results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) study. Circulation. Sep 8 2015; 132(10):907-915.
  110. Saad E, et al.  Pulmonary vein stenosis after radiofrequency ablation of atrial fibrillation:  Functional characterization, evolution, and influence of the ablation strategy.  Circulation, December 2003; 108: 3102-3107.
  111. Sawhney N, Anousheh R, Chen WC et al. Five-year outcomes after segmental pulmonary vein isolation for paroxysmal atrial fibrillation. Am J Cardiol 2009; 104(3):366-72.
  112. Schmidt B, Neuzil P, Luik A, et al. Laser balloon or wide-area circumferential irrigated radiofrequency ablation for persistent atrial fibrillation: a multicenter prospective randomized study. Circ Arrhythm Electrophysiol. Dec 2017;10(12).
  113. Schmidt M, Dorwarth U, Andresen D et al. Cryoballoon versus RF Ablation in Paroxysmal Atrial Fibrillation: Results from the German Ablation Registry. J. Cardiovasc. Electrophysiol. 2014; 25(1):1-7.
  114. Schmidt M, Dorwarth U, Andresen D, et al. German ablation registry: Cryoballoon vs radiofrequency ablation in paroxysmal atrial fibrillation-One-year outcome data. Heart Rhythm. Apr 2016; 13(4):836-844.  
  115. Scott PA, Silberbauer J, Murgatroyd FD. The impact of adjunctive complex fractionated atrial electrogram ablation and linear lesions on outcomes in persistent atrial fibrillation: a meta-analysis. Europace. Mar 2016; 18(3):359-367.
  116. Shah RU, Freeman JV, Shilane D et al. Procedural complications, rehospitalizations, and repeat procedures after catheter ablation for atrial fibrillation. J Am Coll Cardiol 2012; 59(2):143-9.
  117. Shemin RJ, Cox JL, Gillinov AM et al. Guidelines for reporting data and outcomes for the surgical treatment of atrial fibrillation. Ann Thorac Surg 2007; 83(3):1225-30.
  118. Shi LZ, Heng R, Liu SM, et al. Effect of catheter ablation versus antiarrhythmic drugs on atrial fibrillation: A meta-analysis of randomized controlled trials. Exp Ther Med. Aug 2015; 10(2):816-822.
  119. Snow V, Weiss KB, LeFevre M et al. Management of newly detected atrial fibrillation: a clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians. Ann Intern Med 2003; 139(12):1009-17.
  120. Squara F, Zhao A, Marijon E, et al. Comparison between radiofrequency with contact force-sensing and second-generation cryoballoon for paroxysmal atrial fibrillation catheter ablation: a multicentre European evaluation. Europace. May 2015; 17(5):718-724. 
  121. Stabile G, Bertaglia E, Senatore G et al. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). Eur Heart J 2006; 27(2):216-21.
  122. Su W, Orme GJ, Hoyt R, et al. Retrospective review of Arctic Front Advance Cryoballoon Ablation: a multicenter examination of second-generation cryoballoon (RADICOOL trial). J Interv Card Electrophysiol. Apr 2018;51(3):199-204.
  123. Takigawa M, Takahashi A, Kuwahara T, et al. Long-term follow-up after catheter ablation of paroxysmal atrial fibrillation: the incidence of recurrence and progression of atrial fibrillation. Circ Arrhythm Electrophysiol. Apr 2014; 7(2):267-273.
  124. Teunissen C, Kassenberg W, van der Heijden JF, et al. Five-year efficacy of pulmonary vein antrum isolation as a primary ablation strategy for atrial fibrillation: a single-centre cohort study. Europace. Feb 2 2016.
  125. Theis C, Konrad T, Mollnau H, et al. Arrhythmia termination versus elimination of dormant pulmonary vein conduction as a procedural end point of catheter ablation for paroxysmal atrial fibrillation: a prospective randomized trial. Circ Arrhythm Electrophysiol. Oct 2015; 8(5):1080-1087.
  126. Tzou WS, Marchlinski FE, Zado ES et al. Long-term outcome after successful catheter ablation of atrial fibrillation. Circ Arrhythm Electrophysiol 2010; 3(3):237-42.
  127. Vaidya K, Arnott C, Russell A, et al. Pulmonary Vein Isolation Compared to Rate Control in Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis. Heart Lung Circ. Aug 2015; 24(8):744-752. 
  128. Van Belle Y, Janse P, theuns D, et al.  One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation.  Europase 2008; 10:1270-6.
  129. Verma A, Jiang CY, Betts TR, et al. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. May 7 2015; 372(19):1812-1822.
  130. Vogt J, Heintze J, Gutleben KJ et al. Long-term outcomes after cryoballoon pulmonary vein isolation: results from a prospective study in 605 patients. J. Am. Coll. Cardiol. 2013; 61(16):1707-12.
  131. Waldo AL, Wilber DJ, Marchlinski FE et al. Safety of the open-irrigated ablation catheter for radiofrequency ablation: safety analysis from six clinical studies. Pacing Clin. Electrophysiol. 2012; 35(9):1081-9.
  132. Wasserlauf J, Pelchovitz DJ, Rhyner J, et al. Cryoballoon versus radiofrequency catheter ablation for paroxysmal atrial fibrillation. Pacing Clin Electrophysiol. Apr 2015; 38(4):483-489.
  133. Wazni OM, et al.  Circumferential pulmonary-vein ablation for atrial fibrillation.  NEJM, May 2006, Vol. 354, No. 21, pp. 2289-2291.
  134. Wazni OM, et al.  Radiofrequency ablation vs. antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: A randomized trial. JAMA, June 2005; 293(21): 2634-2640.
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POLICY HISTORY:

Medical Policy Group, May 2006 (2)

Medical Policy Group, August 2006 (2)

Medical Policy Group, January 2007 (2)

Medical Policy Administration Committee, February 2007

Available for comment February 9-March 26, 2007

Medical Policy Group, September 2009 (3)

Medical Policy Administration Committee, September 2009

Available for comment September 18-November 2, 2009

Medical Policy Group, October 2012 (2): Cryoablation of pulmonary veins as a treatment for atrial fibrillation added as a non covered indication. Updates to Description, Policy, Key Points, Approved by Governing Bodies, and References

Medical Policy Administration Committee, November 2012

Medical Policy Group, May 2013 (2):  Added policy statement for coverage of cryoablation of pulmonary veins.  Key Points, Key Words, and References updated to support coverage statement.

Medical Policy Administration Committee, June 2013

Available for comment May 30 through July 13, 2013

Medical Policy Panel March 2014

Medical Policy Group March 2014 (4):  Changed title by removing “in the Pulmonary Veins”;  Removed “in the Pulmonary Veins” from the policy; Updated Description, Key Points, and References.

Medical Policy Administration Committee, May 2014

Available for comment May 5 through June 18, 2014

Medical Policy Group June 2014(4): Updated 2013 CPT Codes. Removed section of the policy related to structural heart disease.

Medical Policy Administration Committee, July 2014

Available for comment June 30 through August 13, 2014

Medical Policy Panel, June 2015

Medical Policy Group, June 2015 (4): Updates to Key Points, Approved Governing Bodies and References.  Removed “of Arrhythmogenic Foci” from the title.  Reworded 1st policy statement for clarification and specified paroxysmal and persistent afib.  New policy statements added; removed arrhythmogenic foci from last policy statement and changed to a fib.

Medical Policy Administration Committee July 2015

Available for comment July 7 through August 20, 2015

Medical Policy Panel, May 2016

Medical Policy Group, May 2016 (4): Updates to Description, Key Points, References. Removed policy statements from June 2013; Added “recurrent” and “>1 episode, with 4 or fewer episodes in the previous 6 months”. Also added “radiofrequency” and “or cryoablation” to investigational statement for clarification.

Medical Policy Panel, May 2017

Medical Policy Group, May 2017 (4): Updates to Key Points and References. No change to Policy Statement.

Medical Policy Panel, May 2018

Medical Policy Group, June 2018 (4):  Removed policy statements that were effective for dates of service on or after June 1, 2013 and prior to May 1, 2014.  Updates to Key Points and References.  No change to Policy Statement

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (4): Updates to Description, Key Points, and References.  Removed previous coding section. No change to policy statements.

Medical Policy Panel, July 2020

Medical Policy Group, July 2020 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, May 2021

Medical Policy Group, May 2021 (4):  Updates to Key Points, Coding, and References. Added CPT code 93655 to coding section. Policy statement updated to remove “not medically necessary,” no change to policy intent. The following references were removed: AFFIRM Investigators.  A comparison of rate control and rhythm control in patients with atrial fibrillation; Wyse DG, Waldo AL, DiMarco JP et al. A comparison of rate control and rhythm control in patients with atrial fibrillation; Van Gelder I, et al. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation; Stabile G, et al.  Is pulmonary vein isolation necessary for curing atrial fibrillation?

 

 

 

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.