Clinical UM Guideline


Subject:  Maze Procedure
Guideline #:  CG-SURG-05Current Effective Date:  10/14/2014
Status:ReviewedLast Review Date:  08/14/2014

Description

This document addresses the use of the Maze procedure as a curative surgical treatment of atrial fibrillation or flutter for individuals who do not respond to medical therapies. The Maze procedure involves sequential atriotomy incisions, which interrupt potential re-entrant circuits and thereby reestablishes activation of the entire atrial myocardium, restoring its transport function.

Note: Please see the following related document for additional information:

Clinical Indications

Medically Necessary:

The Maze procedure is considered medically necessary for drug resistant atrial fibrillation or flutter.

The Maze procedure is considered medically necessary for individuals with highly symptomatic atrial fibrillation who require open heart surgery for valvular, ischemic, or congenital heart disease.

Not Medically Necessary:

The Maze procedure is considered not medically necessary for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT 
33254Operative tissue ablation and reconstruction of atria, limited (eg, modified maze procedure)
33255Operative tissue ablation and reconstruction of atria, extensive (eg, maze procedure); without cardiopulmonary bypass
33256Operative tissue ablation and reconstruction of atria, extensive (eg, maze procedure); with cardiopulmonary bypass
33257Operative tissue ablation and reconstruction of atria, performed at the time of other cardiac procedure(s), limited (eg, modified maze procedure)
33258Operative tissue ablation and reconstruction of atria, performed at the time of other cardiac procedure(s), extensive (eg, maze procedure), without cardiopulmonary bypass
33259Operative tissue ablation and reconstruction of atria, performed at the time of other cardiac procedure(s), extensive (eg, maze procedure), with cardiopulmonary bypass
33265Endoscopy, surgical; operative tissue ablation and reconstruction of atria, limited (eg, modified maze procedure), without cardiopulmonary bypass
33266Endoscopy, surgical; operative tissue ablation and reconstruction of atria, limited (eg, maze procedure), without cardiopulmonary bypass
  
ICD-9 Procedure[For dates of service prior to 10/01/2015]
37.33Excision or destruction of other lesion or tissue of heart, open approach (transthoracic approach)
37.34Excision or destruction of other lesion or tissue of heart, other approach (endovascular approach)
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2015]
427.31Atrial fibrillation
427.32Atrial flutter
  
ICD-10 Procedure[For dates of service on or after10/01/2015]
02560ZZ-02564ZZDestruction of right atrium [by approach; includes codes 02560ZZ, 02563ZZ, 02564ZZ]
02570ZZ-02574ZZDestruction of left atrium [by approach; includes codes 02570ZZ, 02573ZZ, 02574ZZ]
02580ZZDestruction of conduction mechanism [by approach; includes codes 02580ZZ, 02583ZZ, 02584ZZ]
  
ICD-10 Diagnosis[For dates of service on or after10/01/2015]
I48.0-I48.92Atrial fibrillation and flutter
  
Discussion/General Information

Atrial fibrillation (AF) is the most common persistent arrhythmia with an increasing prevalence with age. Long-term risks include increased incidence of stroke, heart failure and premature mortality (Fuster, 2006; Saltman, 2009).

The Maze procedure is the "gold standard for surgical treatment of atrial fibrillation" (Calkins, 2012; Saltman, 2009; Weimar, 2011) and is the most effective curative surgical treatment of AF for individuals who do not respond to medical therapies. This open surgical procedure is frequently combined with other cardiac surgeries on a non-beating heart during cardiopulmonary bypass and involves complex, sequential atriotomy incisions. The "maze-like" incision pattern and resulting scar tissue do not conduct electrical activity, thus impeding propagation of the misfired impulses that result in abnormal atrial contraction characteristic of AF. Since its development, modifications have been made to the original Maze procedure to improve efficacy and decrease operative time, creating the now standard Cox Maze III procedure. Long-term follow-up from various studies have reported the efficacy of the Maze procedure, indicated by establishment of normal sinus rhythm, may range from 70% to 96% (Fuster, 2006; Saltman, 2009). Outcomes of the procedure have been found to be similar across genders (Henry, 2013). Although operative risk is also similar for aged individuals (Ad, 2013) long-term benefit has been found to decrease with increasing age (Bakker, 2013).

A comparative effectiveness review of treatment for AF was published in 2013 by the Agency for Healthcare Research and Quality (AHRQ). The report notes, "Surgical Maze at the time of other cardiac surgery (specifically mitral valve surgery) is superior to mitral valve surgery alone for maintenance of sinus rhythm over at least 12 months of follow-up in patients with persistent AF."

In a prospective trial, 99 individuals with chronic persistent AF and rheumatic heart disease (RHD) undergoing valvular operation were randomized to either Group A, treated with catheter ablation with circumferential pulmonary vein isolation (CPVI), or to Group B, treated with concomitant Maze procedure (Liu, 2010). The primary endpoint was freedom from recurrence of atrial arrhythmias lasting more than 30 seconds, 12 months post-procedure. With a mean follow-up of 15 ± 5 months (range 12-20 months) in Group A and 20 ± 8 months (range 12-27 months) in Group B, there was no significant difference in complications between both groups (P > 0.05). Freedom from atrial arrhythmias was higher, at 82%, for the Maze treatment group compared to 55% in the CPVI group (P < 0.001). The authors concluded the concomitant Cox-Maze procedure was more effective in treating individuals with chronic, persistent AF and RHD.

Kong and colleagues (2010) performed a meta-analysis of randomized trials comparing the efficacy of surgical Maze procedures performed concomitantly with cardiac surgery compared to cardiac surgery alone for the treatment of AF. Nine randomized studies using Cox-Maze III or modified Maze ablation procedures enrolled a total of 472 individuals. Three studies did not report freedom from AF within 12 months and one study enrolled participants with paroxysmal AF. The five remaining studies suggest that the "surgical Maze procedure greatly increases the odds of freedom from AF within 12 months post-procedure. The estimated odds ratio is 5.22 (95% confidence interval [CI], 1.71 to 15.88)" (Kong, 2010). There was no significant difference in operative mortality rate of 4.0% in the treatment group versus 3.3 % in the control group. There was also no significant difference in the overall rate of major complications with the treatment group experiencing 24.4% and the control group with a complication rate of 24.9%. There was no significant difference in freedom from AF and anti-arrhythmic drugs (AADs) in participants treated with cardiac surgery alone (51.9%) compared to those treated with the Maze procedure and a concomitant cardiac surgery (53.3%). The authors cautioned that the studies were heterogenous and the ablative techniques and modifications to the Maze procedures were not standardized. Therefore, large randomized trials with long-term follow-up are recommended to determine the efficacy of the Maze procedure for maintenance of sinus rhythm (Kong, 2010).

In a controlled study by Cui (2008), 45 individuals with long-standing, persistent AF and mitral valve disease were enrolled for concomitant open-heart surgery and a mini-Maze procedure using radiofrequency ablation. The control group included 40 individuals who were treated with radiofrequency Cox Maze III. All participants in both groups completed the procedures. There were no ablation related complications. The mean follow-up time was 16.6 ± 5.2 months (range 6 to 26). Overall survival was 100% and the actuarial freedom from stroke was 100%. There was 1 death that occurred 3 months after surgery in the control group.

Recently, some surgeons have used radiofrequency energy, microwaves and cryoprobes to create atrial lesions instead of the scalpel incisional technique used in the traditional Maze procedure. The resulting return of sustained sinus rhythm has been between 44% and 92% in various studies (Beukema, 2008). Khargi and colleagues (2007) performed a systematic review of 48 eligible studies to compare the surgical treatment utilizing alternative energy sources (Group 1) with the classical cut-and-sew Cox-Maze III procedure (Group 2). The authors noted an unexpected and significant difference in mean age of 6.2 years between the cohorts (61.2 years versus 55.0 years, respectively). In addition, AF alone (19.3%) was the primary indication for Group 2, compared to 1.6% of the participants in Group 1. After adjustment for the type of arrhythmia and type of surgery, there was no significant difference in the post-operative sinus rhythm conversion rate between the two groups (p = 0.260) suggesting that alternative energy sources are a feasible option for performing surgical incisions in the Cox-Maze procedure.

Weimar and colleagues (2011) reported results from a case series of 100 participants treated with the Cox-Maze procedure IV (CMP-IV), which is the modified Cox-Maze III procedure utilizing bipolar radiofrequency and cryoenergy, to create the linear ablation lines. The CMP-IV procedure included isolation of the pulmonary vein with either the box lesion or the non-box lesion set. The mean follow-up was 17 ± 10 months and freedom from AF at 6-, 12- and 24-months was 93%, 90% and 90% respectively. In addition, freedom from AF while off of antiarrhythmic medication was 82%, 82% and 84% at 6-, 12- and 24-months. The overall 30-day mortality rate was 1%. Subset analysis at 1-year for the complete box lesion set (n=78), resulted in 96% freedom from AF and 86% were off of antiarrhythmic drugs. Participants treated with the non-box lesion set (n = 22) had 79% freedom from AF and 47% were off of antiarrhythmic drugs at 1-year. Authors conclude that the less invasive CMP-IV has a high success rate.

Based on the literature presented here, there is evidence from a number of prospective and retrospective studies that the Maze procedure is effective in restoring sinus rhythm in the majority of participants with medically refractory, chronic, symptomatic AF, in whom rhythm control is considered essential. In addition, there is some evidence that, when performed in conjunction with valve repair or replacement, the Maze procedure may reduce the risk of stroke compared with valve replacement alone. While some mortality is associated with this procedure, study results suggest that it adds little or no additional risk when performed simultaneously with other open heart surgeries such as valvular repair or replacement.

In case series of individuals with medically refractory AF, the Maze procedure has restored the normal function of the atrium by eliminating the arrhythmia, eliminating the underlying pathophysiology of thrombus formation and restoring the atrial kick to the cardiac output.

The American College of Cardiology (ACC; Fuster, 2006) endorsed and published guidelines for the management of AF in 2006, which state that consideration should be given to concomitant Maze surgery for individuals with highly symptomatic AF, who require open heart operations for valvular, ischemic, or congenital heart disease.

On January 25, 2002, the FDA approved the Medtronic® Cardioblate System (Medtronic Inc., Minneapolis, MN) which uses radiofrequency energy to ablate cardiac tissue. On January 29, 2003 the Cardima® Ablation System (Cardima, Inc. Fremont, CA) received FDA approval, as substantially equivalent to the Medtronic device, amongst others which are also FDA-approved for performing ablation of cardiac tissue.

Definitions

Atrial fibrillation (AF): A condition where there is disorganized electrical conduction in the atria, resulting in ineffective pumping of blood into the ventricle.

References

Peer Reviewed Publications:

  1. Ad N, Henry L, Holmes SD, Halpin L. Results of the Cox Maze III/IV procedure in patients over 75 years old who present for cardiac surgery with a history of atrial fibrillation. J Cardiovasc Surg. 2013, 54(2): 281-288.
  2. Bakker RC, Akin S, Rizopoulos D, et al. Results of clinical application of the modified maze procedure as concomitant surgery. Interact Cardiovasc Thorac Surg. 2013; (16)2: 151-156.
  3. Ballaux PK, Geuzebroek GS, van Hemel NM, et al. Freedom from atrial arrhythmias after classic maze III surgery: a 10-year experience. J Thorac Cardiovasc Surg. 2006; 132(6):1433-1440.
  4. Bando K, Kobayashi J, Kosakai Y, et al. Impact of Cox maze procedure on outcome in patients with atrial fibrillation and mitral valve disease. J Thorac Cardiovasc Surg. 2002; 124(3):575-583.
  5. Beukema WP, Sie HT, Misier AR, et al. Intermediate to long-term results of radiofrequency modified maze procedure as an adjunct to open-heart surgery. Ann Thorac Surg. 2008; 86(5):1409-1414.
  6. Cox JL. Intraoperative options for treating atrial fibrillation associated with mitral valve disease. J Thorac Cardiovasc Surg. 2001; 122(2):212-215.
  7. Cui YQ, Sun LB, Li Y, et al. Intraoperative modified Cox mini-Maze procedure for long-standing persistent atrial fibrillation. Ann Torac Surg. 2008; 85(4):1283- 1289.
  8. Damiano RJ Jr., Schuessler RB, Voeller RK. Surgical treatment of atrial fibrillation: a look into the future. Semin Thorac Cardiovasc Surg. 2007; 19(1):39-45.
  9. Falk RH. Management of atrial fibrillation—radical reform or modest modification? N Engl J Med. 2002; 347(23):1883-1884.
  10. Henry L, Hunt S, Holmes SD, et al. Are there gender differences in outcomes after the Cox Maze procedure for atrial fibrillation? Innovations. 2013; 8(3); 190-198.
  11. Khargi K, Keyhan-Falsafi A, Hutten BA. Surgical treatment of atrial fibrillation: a systematic review. Herzschrittmacherther Elektrophysiol. 2007; 18(2):68-76.
  12. Kim JS, Lee JH, Chang HW, Kim KH. Surgical Outcomes of Cox-maze IV Procedure Using Bipolar Irrigated Radiofrequency Ablation and Cryothermy in Valvular Heart Disease. Korean J Thorac Cardiovasc Surg. 2011; 44(1):18-24.
  13. Kong MH, Lopes RD, Piccini JP, et al. Surgical Maze procedure as a treatment for atrial fibrillation: a meta-analysis of randomized controlled trials. Cardiovasc Ther. 2010; 28(5):311-326.
  14. Liu X, Tan HW, Wang XH, et al. Efficacy of catheter ablation and surgical CryoMaze procedure in patients with long-lasting persistent atrial fibrillation and rheumatic heart disease: a randomized trial. Eur Heart J. 2010; 31: 2633-2641.
  15. Lonnerholm S, Blomstrom P, Nilsson L, et al. Effects of the maze operation on health-related quality of life in patients with atrial fibrillation. Circulation. 2000; 101(22):2607-2611.
  16. Reston JT, Shuhaiber JH. Meta-analysis of clinical outcomes of maze-related surgical procedures for medically refractory atrial fibrillation. Eur J Cardiothorac Surg. 2005; 28(5):724-730.
  17. Saltman AE, Gillinov AM. Surgical approaches for atrial fibrillation. Cardiol Clin. 2009; 27(1):179-188.
  18. Stulak JM, Dearani JA, Sundt TM 3rd, et al. Ablation of Atrial Fibrillation: Comparison of Catheter-Based Techniques and the Cox-Maze III Operation. Ann Thorac Surg. 2011; 91(6):1882-1889.
  19. Weimar T, Bailey MS, Watanabe Y, et al. The Cox-maze IV procedure for lone atrial fibrillation: a single center experience in 100 consecutive patients. J Interv Card Electrophysiol. 2011; 31(1):47-54.
  20. Wyse DG, Waldo AL, DiMarco JP, et al. The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002; 347(23):1825-1833.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Agency for Healthcare Research and Quality. Atrial Fibrillation. Comparative Effectiveness Review Number 119. 2013 June. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/358/1559/atrial-fibrillation-report-130628.pdf. Accessed on July 03, 2014.
  2. Calkins H, Brugada J, Cappato R, et al. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow- up, definitions, endpoints, and research trial design. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm. 2012; 9(4):632-696.
  3. Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: 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): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006; 114(7):e257-e354.
  4. January C, Wann S, Alpert J, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force. J Am Coll Cardiol. 2014. Available at: http://www.hrsonline.org/Practice-Guidance/Clinical-Guidelines-Documents/Focused-Update-on-the-Management-of-Patients-With-Atrial-Fibrillation/2014-Guideline-for-the-Management-of-Patients-With-AFib#axzz36L78bExS. Accessed on July 03, 2014
  5. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Cardimal, Inc. Cardima Ablation System. No. K022008. Rockville, MD: FDA. January 23, 2003. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K022008.pdf. Accessed on July 03, 2014.
  6. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Medtronic, Inc. Medtronic Cardioblate Radiofrequency Ablation System. No. K013392. Rockville, MD: FDA. January 25, 2002. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/K013392.pdf. Accessed on July 03, 2014.
  7. Wann LS, Curtis AB, Craig T, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (Updating the 2006 guideline. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011; 57(2):223-242.
Index

Cox Maze III
Maze Procedure

History
StatusDateAction
Reviewed08/14/2014Medical Policy & Technology Assessment Committee (MPTAC) review.
Updated Description, Discussion and References sections. Definition section added.
Reviewed08/08/2013MPTAC review. Discussion section and references updated.
Reviewed08/09/2012MPTAC review. Discussion section and references updated.
Reviewed08/18/2011MPTAC review. Discussion/Background section and references updated.
Reviewed08/19/2010MPTAC review. Discussion/Background section and references updated.
Reviewed08/27/2009MPTAC review. Discussion section and references updated.
Revised08/28/2008MPTAC review. Added medically necessary statement for individuals with highly symptomatic atrial fibrillation who require open heart operations for valvular, ischemic, or congenital heart disease. Added not medically necessary statement. Discussion section and references updated.
Reviewed01/01/2008Updated coding section with 01/01/2008 CPT changes.
Reviewed08/23/2007MPTAC review. References updated. Coding updated; removed CPT 33253 deleted 12/31/2006. 
Reviewed09/14/2006MPTAC review. References and coding updated.
Revised09/22/2005MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.  
Pre-Merger OrganizationsLast Review
Date
Document
Number
Title
Anthem, Inc.

 

 No document
WellPoint Health Networks, Inc.09/23/20043.04.02Maze Procedure