Clinical UM Guideline
|Guideline #:||CG-SURG-05||Current Effective Date:||10/08/2013|
|Status:||Reviewed||Last Review Date:||08/08/2013|
The Maze procedure involves sequential atriotomy incisions, which interrupt potential re-entrant circuits, and are used to restore the normal atrial pacemaker complex and allow activation of the entire atrial myocardium to preserve atrial transport function. 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.
Note: For additional information, please see MED.00064 Transcatheter Ablation of Arrhythmogenic Foci in the Pulmonary Veins as a Treatment of Atrial Fibrillation (Radiofrequency and Cryoablation).
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.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference. 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.
|33254||Operative tissue ablation and reconstruction of atria, limited (eg, modified maze procedure)|
|33255||Operative tissue ablation and reconstruction of atria, extensive (eg, maze procedure); without cardiopulmonary bypass|
|33256||Operative tissue ablation and reconstruction of atria, extensive (eg, maze procedure); with cardiopulmonary bypass|
|33257||Operative tissue ablation and reconstruction of atria, performed at the time of other cardiac procedure(s), limited (eg, modified maze procedure)|
|33258||Operative tissue ablation and reconstruction of atria, performed at the time of other cardiac procedure(s), extensive (eg, maze procedure), without cardiopulmonary bypass|
|33259||Operative tissue ablation and reconstruction of atria, performed at the time of other cardiac procedure(s), extensive (eg, maze procedure), with cardiopulmonary bypass|
|33265||Endoscopy, surgical; operative tissue ablation and reconstruction of atria, limited (eg, modified maze procedure), without cardiopulmonary bypass|
|33266||Endoscopy, surgical; operative tissue ablation and reconstruction of atria, limited (eg, maze procedure), without cardiopulmonary bypass|
|37.33||Excision or destruction of other lesion or tissue of heart, open approach (transthoracic approach)|
|37.34||Excision or destruction of other lesion or tissue of heart, other approach (endovascular approach)|
|ICD-10 Procedure||ICD-10-PCS draft codes; effective 10/01/2014:|
|02560ZZ-02564ZZ||Destruction of right atrium [by approach; includes codes 02560ZZ, 02563ZZ, 02564ZZ]|
|02570ZZ-02574ZZ||Destruction of left atrium [by approach; includes codes 02570ZZ, 02573ZZ, 02574ZZ]|
|02580ZZ||Destruction of conduction mechanism [by approach; includes codes 02580ZZ, 02583ZZ, 02584ZZ]|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014:|
|I48.0-I48.92||Atrial fibrillation and flutter|
Atrial fibrillation (AF) is the most common persistent arrhythmia with an increasing prevalence with age. Long-term morbidity includes increased risk for stroke, heart failure and increased morbidity and 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 atrial fibrillation or flutter for individuals who do not respond to medical therapies. This open surgical procedure is frequently combined with other cardiac surgeries and involves complex, sequential atriotomy incisions and is performed on a non-beating heart during cardiopulmonary bypass. The incision pattern and the resulting scar tissue do not conduct electrical activity, thus decreasing the signals leading to aberrant atrial fibrillation. 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 may range from 70% to 96% of individuals who establish sinus rhythm after undergoing the Maze procedure (Fuster, 2006; Saltman, 2009).
A comparative effectiveness review of treatment of atrial fibrillation was published in 2013 by the Agency for Healthcare Research and Quality. 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, ninety-nine 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) group or to Group B treated with concomitant Maze procedure group (Liu, 2010). The primary endpoint was freedom from recurrence of atrial arrhythmias lasting more than 30 seconds 12 months post-ablation after one 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 persisting 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 atrial fibrillation. 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 5 remaining studies suggest that the "surgical Maze procedure greatly increases the odds of freedom from AF within 12 months postprocedure. 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 rates 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 Maze procedure and a concurrent 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 followup 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 with 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, atrial fibrillation 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 groups (p = 0.260).
Weimar and colleagues (2011) reported results from a case series of 100 participants treated with 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.
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 atrial fibrillation, 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 atrial fibrillation or flutter, 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 atrial fibrillation in 2006 which state that consideration should be given to concomitant Maze surgery for individuals with highly symptomatic atrial fibrillation and 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.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Atrial Fibrillation, Maze Procedure for
Cox Maze III
|Reviewed||08/08/2013||Medical Policy & Technology Assessment Committee (MPTAC) review. Discussion section and references updated|
|Reviewed||08/09/2012||MPTAC review. Discussion section and references updated.|
|Reviewed||08/18/2011||MPTAC review. Discussion/Background section and references updated.|
|Reviewed||08/19/2010||MPTAC review. Discussion/Background section and references updated.|
|Reviewed||08/27/2009||MPTAC review. Discussion section and references updated.|
|Revised||08/28/2008||MPTAC 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.|
|Reviewed||01/01/2008||Updated coding section with 01/01/2008 CPT changes.|
|Reviewed||08/23/2007||MPTAC review. References updated. Coding updated; removed CPT 33253 deleted 12/31/2006.|
|Reviewed||09/14/2006||MPTAC review. References and coding updated.|
|Revised||09/22/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
Last Review Date
|WellPoint Health Networks, Inc.|