Clinical UM Guideline
|Guideline #:||CG-SURG-05||Current Effective Date:||10/06/2015|
|Status:||Reviewed||Last Review Date:||08/06/2015|
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:
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. 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|
|ICD-10 Procedure||[For dates of service on or after 10/01/2015]|
|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||[For dates of service on or after 10/01/2015]|
|I48.0-I48.92||Atrial fibrillation and flutter|
|ICD-9 Procedure||[For dates of service prior to 10/01/2015]|
|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-9 Diagnosis||[For dates of service prior to 10/01/2015]|
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.
In the 2014 Guideline from the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) for the management of individuals with atrial fibrillation, the following recommendations for surgical maze procedures were issued:
An AF surgical ablation procedure is reasonable for selected patients with AF undergoing cardiac surgery for other indications. [Class IIa recommendation; Level of Evidence: C]
A stand-alone AF surgical ablation procedure may be reasonable for selected patients with highly symptomatic AF not well managed with other approaches. [Class IIb recommendation; Level of Evidence: B]
The 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.
Atrial fibrillation (AF): A condition where there is disorganized electrical conduction in the atria, resulting in ineffective pumping of blood into the ventricle.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Cox Maze III
|Reviewed||08/06/2015||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion and References sections.|
|Reviewed||08/14/2014||MPTAC review. Updated Description, Discussion and References sections. Definition section added.|
|Reviewed||08/08/2013||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.|
|Pre-Merger Organizations||Last Review |
|WellPoint Health Networks, Inc.||09/23/2004||3.04.02||Maze Procedure|