The maze procedure is covered for drug resistant atrial fibrillation or flutter. This procedure is subject to review.

Transcription

1 Medical Policy Title: Maze Procedure for ARBenefits Approval: 10/19/2011 Atrial Fibrillation/Flutter Effective Date: 01/01/2012 Document: ARB0241 Revision Date: Code(s): Operative tissue ablation and reconstruction of atria, limited (eg, modified maze procedure) Operative tissue ablation and reconstruction of atria, extensive (eg, maze procedure); without cardiopulmonary bypass Operative tissue ablation and reconstruction of atria, extensive (eg, maze procedure); with cardiopulmonary bypass Operative tissue ablation and reconstruction of atria, performed at the time of other cardiac procedure(s), limited (eg, modified maze procedure) (List separately in addition to code for primary procedure) Operative tissue ablation and reconstruction of atria, performed at the time of other cardiac procedure(s), extensive (eg, maze procedure), without cardiopulmonary bypass (List separately in addition to code for primary procedure) Operative tissue ablation and reconstruction of atria, performed at the time of other cardiac procedure(s), extensive (eg, maze procedure), with cardiopulmonary bypass (List separately in addition to code for primary procedure) Endoscopy, surgical; operative tissue ablation and reconstruction of atria, limited (eg, modified maze procedure), without cardiopulmonary bypass Endoscopy, surgical; operative tissue ablation and reconstruction of atria, extensive (eg, maze procedure), without cardiopulmonary bypass Public Statement: Administered by: The maze procedure is covered for drug resistant atrial fibrillation or flutter. This procedure is subject to review. Percutaneous catheter ablation procedures are discussed under policy ARB008. Page 1 of 6

2 Medical Policy Statement: The maze procedure is considered medically necessary and is covered for patients with atrial fibrillation or flutter who: 1) Fail or are unable to tolerate medical therapy; AND 2) Are not candidates for percutaneous catheter ablation. Background: The maze procedure is the surgical treatment of atrial fibrillation for patients who do not respond to medical or other surgical antiarrhythmic therapies. This procedure involves sequential atriotomy incisions that interrupt potential re-entrant circuits to restore the normal atrial pacemaker complex and allow activation of the entire atrial myocardium to preserve atrial transport function. The maze procedure entails making incisions in the heart that: o o o Direct an impulse from the sinoatrial (SA) node to the atrioventricular (AV) node; Preserve activation of the entire atrial myocardium; and Block re-entrant impulses that are responsible for atrial fibrillation (AF) or atrial flutter (AFl). Atrial fibrillation is a supraventricular tachyarrhythmia, characterized by disorganized atrial activation with ineffective atrial ejection. 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. The atria are frequently abnormal in patients with AF and demonstrate enlargement or increased conduction time. Atrial flutter is a variant of atrial fibrillation The classic Cox maze procedure is performed on a non-beating heart during cardiopulmonary bypass. Simplification of the maze procedure has evolved with the use of different ablation tools such as microwave, cryotherapy, ultrasound, and radiofrequency energy sources to create the atrial lesions instead of employing the incisional technique used in the classic maze procedure. In addition, less invasive, trans-thoracic, endoscopic, off-pump procedures to treat drugresistant AF are being developed and evaluated. Page 2 of 6

3 Khargi and colleagues analyzed 48 studies comprising 3,832 patients who received surgical treatment of atrial fibrillation using the classic cut and sew Cox-maze III technique or an alternative source of energy. They concluded that they could not identify any significant differences in the postoperative sinus rhythm conversion rates between the classical approach and alternative sources of energy. While prospective randomized studies are lacking, the data involve a wide range of ablative patterns and their effects on atrial tissue. Topkara and colleagues reported comparable postoperative rhythm success in use of either radiofrequency (121 patients) or microwave (85 patients) energy in surgical ablation of atrial fibrillation. Reston and colleagues reviewed 4 randomized controlled trials and 6 comparative studies to determine whether a simultaneous maze procedure reduces the risk of stroke or death in patients with chronic or paroxysmal atrial fibrillation who receive mitral valve surgery. They concluded that the studies support a reduction in stroke rates and a small increased risk in need for pacemakers among patients receiving simultaneous maze procedures. Alternative energy sources, such as radiofrequency, may reduce the risk of postoperative bleeding associated with classic maze incisions. Several observational studies compared the Cox-Maze III procedure with other procedures (radiofrequency ablation, pulmonary vein isolation) performed at single institutions, with procedure selection guided by the surgeon. Two studies attempted to address the selection bias inherent in these studies by matching. In the first from the Washington University School of Medicine, where the maze procedure was developed, the 242 patients who underwent the Cox-maze procedure (154 with the classic cut and sew (CMIII) procedure, and 88 where radiofrequency ablation replaced the incisions of the classic procedure (CMIV)) were matched on their propensity for treatment assignment (a logistic regression where the outcome is treatment assignment and the predictors are covariates that might influence which procedure is chosen by the surgeon). (Lall et al, 2007) Fifty-eight matched pairs were studied. At one year, survival was 94% and 89% (p=0.19) and freedom from AF recurrence was 96% and 93% (p=0.52) for the CMIII and CMIV groups, respectively. The authors note that the CMIV procedure was offered to higher risk patients than the CMIII procedure, which is partly why only 58 of 88 CMIV patients were able to be matched in their analysis. The matched propensity analysis is able to remove measurable selection biases, but if unmeasured factors lead surgeons to choose one surgery over the other, these factors are not accounted for in the analysis. In a second matched analysis, 56 patients who underwent a CMIV radiofrequency ablation procedure at the Mayo Clinic were matched (historical controls) to 56 patients who underwent the CMIII procedure. (Stulak et al, 2007) Matching factors were age, gender, NYHA class, AF type, and concomitant mitral valve surgery. Here the CMIV group had greater postoperative AF (43% vs. 24%), more pacemaker requirements (25% vs 5%), more antiarrhythmic drug use (75% vs. 25%), and fewer patients with freedom from AF at late follow-up (mean 8.4 months) (62% vs. 92%). Again the CMIV patients had greater underlying disease (more concomitant procedures were performed). Page 3 of 6

4 References: Blitz A, McLoughlin D, Gross J, et al.(1992) Combined maze procedure and septal myectomy in a septuagenarian. Ann Thor Surg 1992; 54: Bonchek LI, Burlingame MW, Worely SJ, et al.(1993) Cox/Maze procedure for atrial septal defect with atrial fibrillation: management strategies. Ann Thor Surg 1993; 55: Cox JL, Ad N, Palazzo T, et al.(2000) Current status of the Maze procedure for the treatment of atrial fibrillation. Semin Thor CV Surg 2000; 12:15-9. Cox JL, Ad N.(2000) New surgical and catheter-based modifications of the Maze procedure. Semin Thor CV Surg 2000; 12: Cox JL, Boineau JP, Schuessler RB, et al.(1993) Five-year experience with the maze procedure for atrial fibrillation. Ann Thor Surg 1993; 56: Cox JL.(1993) Evolving applications of the maze procedure for atrial fibrillation. Ann Thor Surg 1993; 55: DeSanctis RW, Ruskin JN.(1993) Disturbances of cardiac rhythm and conduction. Scientific Am Med 1993; Sept; 1:1-47. Gosselink AT, Crijns HJ, Van Gelder IC, et al.(1992) Low-dose amiodarone for maintenance of sinus rhythm after cardioversion of atrial fibrillation or flutter. JAMA 1992; 267: Guiraudon GM, Klein GJ, Yee R.(1993) Supraventricular tachycardias: the role of surgery. PACE 1993; 16: Heinz G, Siostrzonek P, Kreiner G, et al.(1992) Improvement in left ventricular systolic function after successful radiofrequency His bundle ablation for drug refractory, chronic atrial fibrillation and recurrent atrial flutter. Am J Card 1992; 69: Khargi K, Hutten BA, et al.(2005) Surgical treatment of atrial fibrillation: a systematic review. Eur J Cardiothorac Surg, 2005; 27: Kim KC, Cho KR, et al.(2007) Long-term results of the Cox-Maze III procedure for persistent atrial fibrillation associated with rheumatic mitral valve disease: 10-year experience. Eur J Cardiothorac Surg 2007; 31(2): Kobayashi J, Yamamoto F, Nakano K, et al.(1998) Maze procedure for atrial fibrillation associated with atrial septal defect. Circ 1998; 98: Kubac G, Malowany L.(1992) Functional capacity of patients with atrial fibrillation and Page 4 of 6

5 controlled heart rate before and after cardioversion. Can J Card 1992; 8: Lall SC, Melby SJ, et al.(2007) The effect of ablation technology on surgical outcomes after the Cox-maze procedure: a propensity analysis. J Thorac Cardiovasc Surg, 2007; 133(2): Marchant BG, Timmis AD.(1993) Benefits and risks of thrombolytic, anticoagulant, and antiplatelet therapies in atrial fibrillation. Br J Hosp Med 1993; 49: Mavroudis C, Backer CL, Deal BJ, et al.(2001) Total cavopulmonary conversion and maze procedure for patients with failure of the Fontan operation. J Thor CV Surg 2001; 122: McCarthy PM, Castle LW, Maloney JD, et al.(1993) Initial experience with the maze procedure for atrial fibrillation. J Thor CV Surg 1993; 105: McCarthy PM, Castle LW, Trohman RG, et al.(1993) The maze procedure: surgical therapy for refractory atrial fibrillation. Clev Clin J Med 1993; 60: McCarthy PM, Cosgrove DM, Castle LW, et al.(1993) Combined treatment of mitral regurgitation and atrial fibrillation with valvuloplasty and the maze procedure. Am J Card 1993; 71: McElderry HT; McGiffin DC; Plumb VJ, et al.(2008) Proarrhythmic aspects of atrial fibrillation surgery: mechanisms of postoperative macroreentrant tachycardias. Circulation. 2008;117: Millar RC, Arcidi JM Jr, Alison PJ.(2000) The Maze III procedure for atrial fibrillation: should the indications be expanded. Ann Thor Surg 2000; 10: Ninet J, Roques X, et al.(2005) Surgical ablation of atrial fibrillation with off-pump, epricardial, high-intensity focused ultrasound: results of a mutlicenter trial. J Thorac Cardiovasc Surg, 2005; 130: Pai SM, Torres V.(1993) Atrial fibrillation: new management strategies. Curr Prob Card 1993; 18: Pruitt JC, Lazzara RR, Ebra G.(2007) Minimally invasive surgical ablation of atrial fibrillation: The thoracoscopic box lesion approach. J Interv Card Electrophysiol 2007; 20(3):83-7. Pruitt JC, lazzara RR, et al.(2006) Totally endoscopic ablation of lone atrial fibrillation: initial clinical experience. Ann Thorac Surd, 2006; 81: Raanani E, Albage A, David TE, et al.(2001) The efficacy of the Cox/maze procedure combined with a mitral valve surgery: a matched control study. Eur J Cardiothorac Surg Page 5 of 6

6 2001;19: Reston JT, Shuhaiber JH.(2005) Meta-analysis of clinical outcomes of maze-related surgical procedures for medically refractory atrial fibrillation. Eur J Cardiothorac Surg, 2005; 28: Souza O, Gursoy S, Simonis F, et al.(1992) Right-sided versus left-sided radiofrequency ablation of the His bundle. PACE 1992; 15: Stulak JM, Dearani JA, et al.(2007) Superiority of cut-and-sew technique for the Cox maze procedure: comparison with radiofrequency ablation. J Thorac Cardiovasc Surg 2007; 133(4): Suttorp MJ, Kingma JH, Koomen EM, et al.(1993) Recurrence of paroxysmal atrial fibrillation or flutter after successful cardioversion in patients with normal left ventricular function. Am J Card 1993; 71: Topkara VK, Williams MR, et al.(2006) Radiofrequency and microwave energy sources in surgical ablation of atrial fibrillation: a comparative analysis. Heart Surg Forum, 2006; 9:E Trohman RG, Simmons TW, Moore SL, et al.(1992) Catheter ablation of the atrioventricular junction using radiofrequency energy and a bilateral approach. Am J Card 1992; 70: Williams MR, Garrido M, et al.(2004) Alternative energy sources for surgical atrial ablation. J Card Surg, 2004; 19: Yuda S, Nakatani S, Kosakai S, et al.(2001) Long-term follow-up of atrial contraction after the maze procedure in patients with mitral valve disease. JACC 2001; 37: Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. Last modified by: Date: Page 6 of 6