Three-Dimensional Magnetic Navigation Mapping System for Radiofrequency Ablation for the Treatment of Arrhythmias
DESCRIPTION
Three-dimensional magnetic navigation mapping system (e.g., CARTO™ EP Navigation System; ENSITE 3000 system, Model EE3000) is used to guide radiofrequency catheter ablation for the treatment of cardiac arrhythmias. This is a non-fluoroscopic, catheter-based, electro-anatomic mapping system. It allows locating the arrhythmia focus or foci. Radiofrequency (RF) energy is delivered via intracardiac catheter and destroys the targeted myocardial tissue.
POLICY
Three-dimensional magnetic navigation mapping system when performed in conjunction with radiofrequency catheter ablation for the treatment of cardiac arrhythmias is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Three-dimensional magnetic navigation mapping system when performed in conjunction with radiofrequency catheter ablation for the treatment of cardiac arrhythmias is considered medically appropriate if ANY ONE of the following criteria are met if:
The individual has supraventricular tachyarrhythmias
The individual has chronic recurrent drug-resistant ventricular tachycardias with an identifiable arrhythmogenic focus originating in the right ventricle or outside the right ventricular outflow tract
SOURCES
Betts, T. R., Roberts, P. R., Allen, S. A., Salmon, A. P., Keeton, B. R., Haw, M. P., et al. (2000). Electrophysiological mapping and ablation of intra-atrial reentry tachycardia after Fontan surgery with the use of a noncontact mapping system. Circulation, 102 (4), 419-425.
Complete Guide To Medicare Coverage Issues [Computer software]. (2008, November). Intraoperative ventricular mapping (NCD 20.11, 2-17). The Ingenix Complete Guide to Medicare Coverage Issues.
Eckart, R.E., & Epstein, L.M., (2008). Therapy for atrial and ventricular arrhythmias. Cohn, L.H. (Ed.), Cardiac Surgery in the Adult. (3rd ed., pp 1357-1374). New York: McGraw-Hill.
Ernst, S., Schluter, M., Ouyang, F., Khanedani, A., Cappato, R., Hebe, J., et al. (1999). Modification of the substrate for maintenance of idiopathic human atrial fibrillation: Efficacy of radiofrequency ablation using non-fluoroscopic catheter guidance. Circulation, 100 (20), 2085-2092.
Hoffman, E., Nimmerman, P., Reithmann, C., Elser, F., Remp, T., & Steinbeck, G. (2000). New mapping technology for atrial tachycardias. Journal of Interventional Cardiac Electrophysiology, 1 (Suppl. 4), 17-120. Abstract retrieved December 13, 2000 from MD Consult database.
Khongphatthanayothin, A., Kosar, E., & Nademanee, K. (2000). Non-fluoroscopic three-dimensional mapping for arrhythmia ablation: tool or toy? Journal of Cardiovascular Electrophysiology, 11 (3), 239-243.
Kottkamp, H., Hugl, R., Krauss, B., Wetzel, U., Fleck, A., et al. (2000). Electromagnetic versus fluoroscopic mapping of the inferior isthmus for ablation of typical atrial flutter. Circulation, 102 (17), 2082-2086.
Marrouche, N. F., Beheiry, S., Tomassoni, G., Cole, C., Bash, D., Dresing, T., et al. (2002). Three-dimensional nonfluoroscopic mapping and ablation of inappropriate sinus tachycardia. Procedural strategies and long-term outcome. Journal of the American College of Cardiology, 39 (6), 1046-054. Retrieved May 16, 2005 from PubMed database.
Schreieck, J., Ndreppa, G., Zrenner, B., Schneider, M. A., Weyerbrock, S., Dong, J., et al. (2002). Radiofrequency ablation of cardiac arrhythmias using a three-dimensional real-time position management and mapping system. Pacing Clinical Electrophysiology, 25 (12). 1699-1707. Abstract retrieved January 4, 2007 from PubMed database.
Smeets, J. L., Ben-Haim, S. A., Rodriguez, L. M., Timmermans, C., & Wellens, H. J. J. (1998). New methods for non-fluoroscopic endocardial mapping in humans. Circulation, 97 (24), 2426-2432.
U. S. Food and Drug Administration. (2000, July). Center for Devices and Radiological Health. New Device Approvals: Navi-star® diagnostic/ablation deflectable tip catheter. Retrieved January 21, 2003 from http://www.fda.gov/cdrh/mda/docs/p990025.pdf.
U. S. Food and Drug Administration. (2000, June). Center for Devices and Radiological Health. Pre-Market Notification, 510 (k) number K001437 for ENSITE 3000 system and 510 (k) number K992968 for CARTO EP navigation system. Retrieved December 15, 2000 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10486.
ORIGINAL EFFECTIVE DATE: 6/1/2001
MOST RECENT REVIEW DATE: 3/12/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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