Catheter Ablation as Treatment for Atrial Fibrillation Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 01|01|2026 POLICY LAST REVIEWED: 09|17|2025 OVERVIEW Atrial fibrillation 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 or cryoablation, is a treatment option for various types of AF. Pulsed field ablation is a novel ablation technique for atrial fibrillation.
MEDICAL CRITERIA Medicare Advantage Plans and Commercial Products Transcatheter radiofrequency ablation (RFA), cryoablation or pulsed field ablation to treat atrial fibrillation maybe considered medically necessary as a treatment for either of the following indications, which have failed to respond to adequate trials of antiarrhythmic medications (see definition below for antiarrhythmic drug (AAD) failure): • 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. Antiarrhythmic drug failure can be defined as the inability of an AAD to adequately control arrhythmia symptoms or prevent recurrence, despite appropriate dosing and adherence. It can also include intolerable side effects or proarrhythmic complications that necessitate discontinuation. Transcatheter RFA, 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 (2 or more episodes within the previous 6 months) in whom a rhythm-control strategy is desired. Repeat RFA, 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. PRIOR AUTHORIZATION
Medicare Advantage Plans and Commercial Products Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products for catheter ablation via the online tool for participating providers. See the Related Policies section. POLICY STATEMENT Medicare Advantage Plans and Commercial Products Catheter ablation as a treatment for atrial fibrillation may be considered medically necessary when the medical criteria above are met.
Medicare Advantage Plans Catheter ablation is not covered in all other scenarios, as there is insufficient evidence to determine that the effects of the technology results in an improvement in the net health outcome.
Commercial Products Catheter ablation is not medically necessary in all other scenarios, as there is insufficient evidence to determine that the effects of the technology results in an improvement in the net health outcome.
Medical Coverage Policy | Catheter Ablation as Treatment for Atrial Fibrillation

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COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable surgery and not medically necessary/not covered benefits/coverage.

BACKGROUND 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 3 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 heartrate. The loss of atrioventricular synchrony results in a decreased cardiac output, which can be significant inpatients 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 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 the 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 (see evidence review 2.02.01). 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.

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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 Procedures Repeat 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.

Regulatory Status In February 2009, the NaviStar® ThermoCool® Irrigated Deflectable Diagnostic/Ablation Catheter and EZSteer® 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.

Devices using laser or cryoablation techniques for substrate ablation have been approved by the 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.

Pulsed field ablation (non-thermal energy) devices have also been approved by the FDA for catheter ablation of atrial fibrillation. 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.

CODING The following code may be considered medically necessary for Medicare Advantage Plans and Commercial Products when the medical criteria above are met:
93656 Comprehensive electrophysiologic evaluation with transseptal catheterizations, insertion and repositioning of multiple electrode catheters, induction or attempted induction of an arrhythmia including left or right atrial pacing/recording, and intracardiac catheter ablation of atrial fibrillation by pulmonary vein isolation, including intracardiac electrophysiologic 3-dimensional mapping, intracardiac echocardiography with imaging supervision and interpretation, right ventricular pacing/recording, and His bundle recording, when performed

RELATED POLICIES Prior Authorization via Web-Based Tool for Procedures

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PUBLISHED Provider Update, November 2025

REFERENCES

1. Lee MA, Weachter R, Pollak S, et al. The effect of atrial pacing therapies on atrial tachyarrhythmia burden and frequency: results of a randomized trial in patients with bradycardia and atrial tachyarrhythmias. J Am Coll Cardiol. Jun 04 2003; 41(11): 1926-32. PMID 12798559
2. Kay GN, Ellenbogen KA, Giudici M, et al. The Ablate and Pace Trial: a prospective study of catheter ablation of the AV conduction system and permanent pacemaker implantation for treatment of atrial fibrillation. APT Investigators. J Interv Card Electrophysiol. Jun 1998; 2(2): 121-35. PMID 9870004
3. Falk RH. Management of atrial fibrillation--radical reform or modest modification?. N Engl J Med. Dec 05 2002; 347(23): 1883-4. PMID 12466514
4. Van Gelder IC, Hagens VE, Bosker HA, et al. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med. Dec 05 2002; 347(23): 1834-40. PMID 12466507
5. Wyse DG, Waldo AL, DiMarco JP, et al. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. Dec 05 2002; 347(23): 1825-33. PMID 12466506
6. Gupta A, Perera T, Ganesan A, et al. Complications of catheter ablation of atrial fibrillation: a systematic review. Circ Arrhythm Electrophysiol. Dec 2013; 6(6): 1082-8. PMID 24243785
7. Shemin RJ, Cox JL, Gillinov AM, et al. Guidelines for reporting data and outcomes for the surgical treatment of atrial fibrillation. Ann Thorac Surg. Mar 2007; 83(3): 1225-30. PMID 17307507
8. Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol. Aug 15 2006; 48(4): 854-906. PMID 16904574
9. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Catheter ablation of the pulmonary veins as a treatment for atrial fibrillation. TEC Assessments. 2008;Volume 23:Tab 11.
10. Jaïs P, Cauchemez B, Macle L, et al. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. Dec 09 2008; 118(24): 2498-505. PMID 19029470
11. Khan MN, Jaïs P, Cummings J, et al. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med. Oct 23 2008; 359(17): 1778-85. PMID 18946063
12. Oral H, Pappone C, Chugh A, et al. Circumferential pulmonary-vein ablation for chronic atrial fibrillation. N Engl J Med. Mar 02 2006; 354(9): 934-41. PMID 16510747
13. 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. Dec 05 2006; 48(11): 2340-7. PMID 17161267
14. 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. Jan 2006; 27(2): 216-21. PMID 16214831
15. Wazni OM, Marrouche NF, Martin DO, et al. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA. Jun 01 2005; 293(21): 2634-40. PMID 15928285
16. Asad ZUA, Yousif A, Khan MS, et al. Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. Sep 2019; 12(9): e007414. PMID 31431051
17. Marrouche NF, Brachmann J, Andresen D, et al. Catheter Ablation for Atrial Fibrillation with Heart Failure. N Engl J Med. Feb 01 2018; 378(5): 417-427. PMID 29385358
18. 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(11): CD012088. PMID 27871122
19. Forleo GB, Mantica M, De Luca L, et al. Catheter ablation of atrial fibrillation in patients with diabetes mellitus type 2: results from a randomized study comparing pulmonary vein isolation versus antiarrhythmic drug therapy. J Cardiovasc Electrophysiol. Jan 2009; 20(1): 22-8. PMID 18775050

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20. Mont L, Bisbal F, Hernández-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): 501-7. PMID 24135832
21. 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. PMID 26622399
22. Chen HS, Wen JM, Wu SN, et al. Catheter ablation for paroxysmal and persistent atrial fibrillation. Cochrane Database Syst Rev. Apr 18 2012; (4): CD007101. PMID 22513945
23. Ganesan AN, Shipp NJ, Brooks AG, et al. Long-term outcomes of catheter ablation of atrial fibrillation: a systematic review and meta-analysis. J Am Heart Assoc. Mar 18 2013; 2(2): e004549. PMID 23537812
24. Zhuang Y, Yong YH, Chen ML. Updating the evidence for the effect of radiofrequency catheter ablation on left atrial volume and function in patients with atrial fibrillation: a meta-analysis. JRSM Open. Mar 2014; 5(3): 2054270414521185. PMID 25057380
25. Wilber DJ, Pappone C, Neuzil P, et al. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. Jan 27 2010; 303(4): 333-40. PMID 20103757
26. Kuck KH, Lebedev DS, Mikhaylov EN, et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace. Mar 08 2021; 23(3): 362-369. PMID 33330909
27. Wu G, Huang H, Cai L, et al. Long-term observation of catheter ablation vs. pharmacotherapy in the management of persistent and long-standing persistent atrial fibrillation (CAPA study). Europace. May 21 2021; 23(5): 731-739. PMID 33367669
28. Hussein AA, Saliba WI, Martin DO, et al. Natural history and long-term outcomes of ablated atrial fibrillation. Circ Arrhythm Electrophysiol. Jun 2011; 4(3): 271-8. PMID 21493959
29. 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. Sep 2016; 18(9): 1335-42. PMID 26838694
30. Bunch TJ, May HT, Bair TL, et al. Atrial fibrillation ablation patients have long-term stroke rates similar to patients without atrial fibrillation regardless of CHADS2 score. Heart Rhythm. Sep 2013; 10(9): 1272-7. PMID 23835257
31. Weerasooriya R, Khairy P, Litalien J, et al. Catheter ablation for atrial fibrillation: are results maintained at 5 years of follow-up?. J Am Coll Cardiol. Jan 11 2011; 57(2): 160-6. PMID 21211687
32. Tzou WS, Marchlinski FE, Zado ES, et al. Long-term outcome after successful catheter ablation of atrial fibrillation. Circ Arrhythm Electrophysiol. Jun 2010; 3(3): 237-42. PMID 20335557
33. Bertaglia E, Tondo C, De Simone A, et al. Does catheter ablation cure atrial fibrillation? Single-procedure outcome of drug-refractory atrial fibrillation ablation: a 6-year multicentre experience. Europace. Feb 2010; 12(2): 181-7. PMID 19887458
34. Sawhney N, Anousheh R, Chen WC, et al. Five-year outcomes after segmental pulmonary vein isolation for paroxysmal atrial fibrillation. Am J Cardiol. Aug 01 2009; 104(3): 366-72. PMID 19616669
35. Anselmino M, Grossi S, Scaglione M, et al. Long-term results of transcatheter atrial fibrillation ablation in patients with impaired left ventricular systolic function. J Cardiovasc Electrophysiol. Jan 2013; 24(1): 24-
36. PMID 23140485
37. 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): 267-73. PMID 24610740
38. Hunter RJ, Berriman TJ, Diab I, et al. A randomized controlled trial of catheter ablation versus medical treatment of atrial fibrillation in heart failure (the CAMTAF trial). Circ Arrhythm Electrophysiol. Feb 2014; 7(1): 31-8. PMID 24382410
39. Lellouche N, Jaïs P, Nault I, et al. Early recurrences after atrial fibrillation ablation: prognostic value and effect of early reablation. J Cardiovasc Electrophysiol. Jun 2008; 19(6): 599-605. PMID 18462321
40. 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. Aug 2013; 6(4): 754-60. PMID 23748210

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40. 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. Apr 23 2013; 61(16): 1713-23. PMID 23500312
41. 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. PMID 29478173
42. 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. Apr 23 2013; 61(16): 1707-12. PMID 23199518
43. Neumann T, Wójcik M, Berkowitsch A, et al. Cryoballoon ablation of paroxysmal atrial fibrillation: 5-year outcome after single procedure and predictors of success. Europace. Aug 2013; 15(8): 1143-9. PMID 23419659
44. Bohó A, Mišíková S, Spurný P, et al. A long-term evaluation of cryoballoon ablation in 205 atrial fibrillation patients: a single center experience. Wien Klin Wochenschr. Oct 2015; 127(19-20): 779-85. PMID 26142169
45. Davies AJ, Jackson N, Barlow M, et al. Long Term Follow-up of Pulmonary Vein Isolation Using Cryoballoon Ablation. Heart Lung Circ. Mar 2016; 25(3): 290-5. PMID 26621109
46. Andrade JG, Khairy P, Macle L, et al. Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial. Circ Arrhythm Electrophysiol. Feb 2014; 7(1): 69-75. PMID 24446022
47. Dagres N, Hindricks G, Kottkamp H, et al. Complications of atrial fibrillation ablation in a high-volume center in 1,000 procedures: still cause for concern?. J Cardiovasc Electrophysiol. Sep 2009; 20(9): 1014-9. PMID 19490383
48. Cappato R, Calkins H, Chen SA, et al. Prevalence and causes of fatal outcome in catheter ablation of atrial fibrillation. J Am Coll Cardiol. May 12 2009; 53(19): 1798-803. PMID 19422987
49. Haeusler KG, Koch L, Herm J, et al. 3 Tesla MRI-detected brain lesions after pulmonary vein isolation for atrial fibrillation: results of the MACPAF study. J Cardiovasc Electrophysiol. Jan 2013; 24(1): 14-21. PMID 22913568
50. Herm J, Fiebach JB, Koch L, et al. Neuropsychological effects of MRI-detected brain lesions after left atrial catheter ablation for atrial fibrillation: long-term results of the MACPAF study. Circ Arrhythm Electrophysiol. Oct 2013; 6(5): 843-50. PMID 23989301
51. 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. Sep 2012; 35(9): 1081-9. PMID 22817524
52. Shah RU, Freeman JV, Shilane D, et al. Procedural complications, rehospitalizations, and repeat procedures after catheter ablation for atrial fibrillation. J Am Coll Cardiol. Jan 10 2012; 59(2): 143-9. PMID 22222078
53. Ellis ER, Culler SD, Simon AW, et al. Trends in utilization and complications of catheter ablation for atrial fibrillation in Medicare beneficiaries. Heart Rhythm. Sep 2009; 6(9): 1267-73. PMID 19716081
54. 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 08 2015; 132(10): 907-15. PMID 26260733
55. 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): 235-45. PMID 26387117
56. Afzal MR, Chatta J, Samanta A, et al. Use of contact force sensing technology during radiofrequency ablation reduces recurrence of atrial fibrillation: A systematic review and meta-analysis. Heart Rhythm. Sep 2015; 12(9): 1990-6. PMID 26091856
57. Zhu M, Zhou X, Cai H, et al. Catheter ablation versus medical rate control for persistent atrial fibrillation in patients with heart failure: A PRISMA-compliant systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). Jul 2016; 95(30): e4377. PMID 27472728
58. Anselmino M, Matta M, Castagno D, et al. Catheter ablation of atrial fibrillation in chronic heart failure: state-of-the-art and future perspectives. Europace. May 2016; 18(5): 638-47. PMID 26857188

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59. 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): 744-52. PMID 25890871
60. Jones DG, Haldar SK, Hussain W, et al. A randomized trial to assess catheter ablation versus rate control in the management of persistent atrial fibrillation in heart failure. J Am Coll Cardiol. May 07 2013; 61(18): 1894-903. PMID 23500267
61. 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. PMID 31760819
62. Packer DL, Piccini JP, Monahan KH, et al. Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial. Circulation. Apr 06 2021; 143(14): 1377-1390. PMID 33554614
63. Parkash R, Wells GA, Rouleau J, et al. Randomized Ablation-Based Rhythm-Control Versus Rate-Control Trial in Patients With Heart Failure and Atrial Fibrillation: Results from the RAFT-AF trial. Circulation. Jun 07 2022; 145(23): 1693-1704. PMID 35313733
64. Turagam MK, Musikantow D, Whang W, et al. Assessment of Catheter Ablation or Antiarrhythmic Drugs for First-line Therapy of Atrial Fibrillation: A Meta-analysis of Randomized Clinical Trials. JAMA Cardiol. Jun 01 2021; 6(6): 697-705. PMID 33909022
65. Elsayed M, Abdelfattah OM, Sayed A, et al. Bayesian network meta-analysis comparing cryoablation, radiofrequency ablation, and antiarrhythmic drugs as initial therapies for atrial fibrillation. J Cardiovasc Electrophysiol. Feb 2022; 33(2): 197-208. PMID 34855270
66. 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.
67. 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.
68. Blomstrm-Lundqvist C, Gizurarson S, Schwieler J, et al. Effect of catheter ablation vs antiarrhythmic medication on quality of life in patients with atrial fibrillation: the CAPTAF randomized clinical trial. JAMA. 2019;Epub ahead of print.
69. Hakalahti A, Biancari F, Nielsen JC, et al. Radiofrequency ablation vs. antiarrhythmic drug therapy as first line treatment of symptomatic atrial fibrillation: systematic review and meta-analysis. Europace. Mar 2015; 17(3): 370-8. PMID 25643988
70. 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-
71. PMID 24549549
72. Cosedis Nielsen J, Johannessen A, Raatikainen P, et al. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. Oct 25 2012; 367(17): 1587-95. PMID 23094720
73. 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. PMID 27566295
74. Andrade JG, Wells GA, Deyell MW, et al. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. Jan 28 2021; 384(4): 305-315. PMID 33197159
75. Andrade JG, Deyell MW, Macle L, et al. Progression of Atrial Fibrillation after Cryoablation or Drug Therapy. N Engl J Med. 2023;388(2):105-116. doi:10.1056/NEJMoa2212540
76. Kuniss M, Pavlovic N, Velagic V, et al. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. Jul 18 2021; 23(7): 1033-1041. PMID 33728429
77. Pavlovic N, Chierchia GB, Velagic V, et al. Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms. Am Heart J. Dec 2021; 242: 103-114. PMID 34508694
78. Wazni OM, Dandamudi G, Sood N, et al. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. Jan 28 2021; 384(4): 316-324. PMID 33197158
79. Wazni O, Dandamudi G, Sood N, et al. Quality of life after the initial treatment of atrial fibrillation with cryoablation versus drug therapy. Heart Rhythm. Feb 2022; 19(2): 197-205. PMID 34666139
80. Reddy VY, Gerstenfeld EP, Natale A, et al. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. Nov 02 2023; 389(18): 1660-1671. PMID 37634148

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80. Mansour M, Gerstenfeld EP, Patel C, et al. Pulmonary vein narrowing after pulsed field versus thermal ablation. Europace. Feb 01 2024; 26(2). PMID 38305503
81. Anter E, Mansour M, Nair DG, et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med. Aug 2024; 30(8): 2303-2310. PMID 38760584
82. Food and Drug Administration. Summary of Safety and Effectiveness Data: Sphere-9 Catheter and Affera Ablation System. https://www.accessdata.fda.gov/cdrh_docs/pdf24/P240013B.pdf. Accessed Dec 9,
84. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. Jan 02 2024; 83(1): 109-
85. PMID 38043043

86. Gopinathannair R, Chen LY, Chung MK, et al. Managing Atrial Fibrillation in Patients With Heart Failure and Reduced Ejection Fraction: A Scientific Statement From the American Heart Association. Circ Arrhythm Electrophysiol. Jun 2021; 14(6): HAE0000000000000078. PMID 34129347

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS