Laser-induced thermal ablation is proposed as a minimally invasive surgical option for the treatment of neurological indications such as tumors or epilepsy. This technique uses light energy delivered through a fiberoptic catheter to targeted tissues. The light energy is converted to thermal energy in the tissues, which are damaged by the heat. The catheter used to deliver the energy to the target site has a built-in cooling system; thus, the thermal energy purportedly damages only the targeted tissues. The applicator is surgically installed under MRI guidance, and the lesion is treated using MRI guidance to ensure precise targeting of the thermal energy. Examples of FDA approved devices include NeuroBlate® and Visualase®.
MRI-guided laser-induced thermotherapy for any use is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Evidence is insufficient to determine whether this technology works as well or better than alternative therapies, because no comparative studies are available. This technology’s effect on patient survival and quality of life is unknown and can best be addressed through comparative studies. Clinical trials are in progress at this time. However, comparative studies are not included in these trials.
American College of Radiology/American Society of Neuroradiology (2014) ACR_ASNR practice parameter for the performance of non-breast magnetic resonance imaging (MRI) guided procedures. Retrieved October 23, 2018 from https://www.acr.org.
Du, V.X., Gandhi, S.V., Rekate, H.L., & Mehta, A.D. (2017). Laser interstitial thermal therapy: a first line treatment for seizures due to hypothalamic hamartoma? Epilepsia, 58 (Suppl 2), 77-84. Abstract retrieved December 8, 2017 from PubMed database.
ECRI Institute. Product Brief. (2014, August) Visualase® Thermal Therapy System (Visualase, Inc.) for MRI-guided laser ablation for neurologic tumors. Retrieved October 23, 2018 from ECRI Institute. (18 abstracts and/or guidelines reviewed)
Hoppe, C., Witt, J.A., Helmstaedter, C., Gasser, T., Vatter, H., & Elger, C.E. (2017). Laser interstitial thermotherapy (LiTT) in epilepsy surgery. Seizure, 48, 45-52. Abstract retrieved December 8, 2017 from PubMed database.
Kang, J., Wu, C., Tracy, J., Lorenzo, M., Evans, J., Nei, M., et al. (2015). Laser interstitial thermal therapy for medically intractable mesial temporal lobe epilepsy. Epilepsia, 57 (2), 325-334.Abstract retrieved December 29, 2016 from PubMed database.
LaRiviere, M., and Gross, R. (2016). Stereotactic laser ablation for medically intractable epilepsy: the next generation of minimally invasive surgery. Frontiers in Surgery. Vol. 3, Article 64. (Level 2 evidence)
Lewis, E. C., Weil, A. G., Duchowny, M., Bhatia, S., Ragheb, J., & Miller, I. (2015). MR-guided laser interstitial thermal therapy for pediatric drug-resistant lesional epilepsy. Epilepsia, 56 (10), 1590-1598. Abstract retrieved January 27, 2016 from PubMed database.
Mohammadi, A. M., Hawasli, A. H., Schroeder, J. L., Laxton, A. W., Elson, P., et al. (2014). The role of laser interstitial thermal therapy in enhancing progression-free survival of difficult-to access high-grade gliomas: a multicenter study. Cancer Medicine, 3 (4), 971-979. (Level 3 evidence)
National Comprehensive Cancer Network. (2018, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Central nervous system cancers (V1.2018). Retrieved October 23, 2018 from www.nccn.org.
Sun, X. R., Patel, N. V., & Danish, S. F. (2015). Tissue ablation dynamics during magnetic resonance-guided, laser-induced thermal therapy. Neurosurgery, 77 (1), 51-58. Abstract retrieved January 27, 2016 from PubMed database.
Tatsui, C., Stafford, R., Li, J., Sellin, J., Amini, B., Rao, G., et al. (2015). Utilization of laser interstitial thermotherapy guided by real-time thermal MRI as an alternative to separation surgery in the management of spinal metastasis. Journal of Neurosurgery Spine. (4), 400-411. Abstract retrieved December 29, 2016 from PubMed database.
Torres-Reveron, J., Tomasiewicz, H., Shetty, A., Amankulor, N. & Chiang, V. (2013). Stereotactic laser induced thermotherapy (LITT): a novel treatment for brain lesions regrowing after radiosurgery. Journal of Neurooncology. 113 (3), 495-503.Abstract retrieved December 29, 2016 from PubMed database.
U. S. Food and Drug Administration. (2007, August). Center for Devices and Radiological Health. 510k Premarket Notification Database. K071328. Retrieved December 29, 2016 from http://www/fda/.gov.
U. S. Food and Drug Administration. (2013, April). Center for Devices and Radiological Health. 510k Premarket Notification Database. K120561. Retrieved December 29, 2016 from http://www/fda/.gov.
ORIGINAL EFFECTIVE DATE: 6/11/2016
MOST RECENT REVIEW DATE: 1/10/2019
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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