BlueCross BlueShield of Tennessee Medical Policy Manual

Endometrial Ablation for Treatment of Menorrhagia

DESCRIPTION

Menorrhagia is defined as profuse menstrual bleeding lasting greater than eight days or with greater than eighty mL per cycle. Ablation or destruction of the endometrium is used to treat menorrhagia in women who fail to respond to first line therapy such as hormone therapy and/or dilatation and curettage (D&C). Ablation procedures, with general or epidural anesthesia, can be performed on an outpatient basis.

Multiple energy sources have been proposed to accomplish the ablation.

The following techniques require hysteroscopic guidance: Nd-YAG laser, resecting loop, rollerball using electric current or thermal ablation.

The following techniques do not require hysteroscopic guidance: Liquid-filled balloon, cryosurgical or radiofrequency devices.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

The following are brief descriptions of examples of second-generation endometrial ablation procedures:

Balloon Endometrial Ablation: (e.g., ThermaChoice) involves the use of a balloon at the tip of a catheter tube that is filled with fluid and inflated until it conforms to the walls of the uterus. A probe in the balloon heats the fluid to destroy the endometrial lining. After eight minutes the fluid is drained out and the balloon is removed. Hysteroscopic guidance is not required for this procedure.

Electric Wand Ablation:(e.g., NovaSure System) involves inserting a slender wand up through the cervix. A triangular mesh-like device is the passed through the wand and expands to fit the uterus. Electrical energy is passed through it for about 90 seconds and the mesh and wand are then withdrawn. Hysteroscopic guidance is not required for this procedure.

Cryoablation: (e.g., Her Option uterine cryoablation therapy system) involves placing a liquid nitrogen probe into the uterus to destroy tissue by freezing. Ultrasound is used to guide the procedure.

Hot Saline: (e.g., the Hydro-Therm-Ablator [HTA] system). This method involves the use of hot saline to destroy the uterine lining. This device is a closed loop system designed to ablate the endometrial lining of the uterus by recirculating heated saline within the uterus. This is not a "blind" procedure but uses hysteroscopy so that the surgeon can view the uterus.

Laser Ablation:Endometrial laser ablation (ELA) uses a distention media delivered into the uterus. After the uterus has been distended, a laser is used to destroy the lining of the uterus. This is not a blind procedure, but uses hysteroscopy so that the surgeon can view the uterus.

SOURCES 

American College of Obstetricians and Gynecologists (ACOG). ( May, 2007; reaffirmed 2012). Endometrial ablation. Obstetrics and Gynecology, 109 (5), 1233-1248. Retrieved May 15, 2015 from the National Guideline Clearinghouse (NGC: 10918).

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2015). Endometrial ablation (4.01.04). Retrieved December 14, 2015 from BlueWeb. (21 articles and/or guidelines reviewed)

BlueCross BlueShield of Tennessee network physicians. July 2008.

Fischer, F., Klapdor, R., Gruessner, S., Ziert, Y., Hillemanns, P., & Hertel, H. (2015). Radiofrequency endometrial ablation for the treatment of heavy menstrual bleeding among women at high surgical risk. International Journal of Gynaecology & Obstetrics, 131 (2), 123-128. Abstract retrieved December 14, 2015 from PubMed database.

Iglesias, D., Madani Sims, S., & Davis, J. (2010). The effectiveness of endometrial ablation with Hydro ThermAblator (HTA) for abnormal uterine bleeding. American Journal of Obstetrics and Gynecology, 202 (6), 622 - e 1-6. (Level 4 evidence)

Jacob, S., Abdullah, A., Hurwitz, J., Stedman, J., Samuelson, R., & Shahabi, S. (2015). Endometrial ablation for aplastic anemia-associated menorrhagia. Connecticut Medicine Journal, 79 (5), 289-290. Abstract retrieved December 14, 2015 from PubMed database.

Laberge, P., Garza-Leal, J., Fortin, C., Sabbah, R., Fulop, T., Pasztor, N., et al. (2015). One-year follow-up results of a multicenter, single-arm, objective performance criteria-controlled international clinical study of the safety and efficacy of the Minerva Endometrial Ablation System. Journal of Minimally Invasive Gynecology, 22 (7), 1169-1177. Abstract retrieved December 18, 2015 from PubMed database.

Longinotti, M., Jacobson, G., Hung, Y., & Learman, L. (2008). Probability of hysterectomy after endometrial ablation. Obstetrics and Gynecology, 112 (6), 1214 - 1220. (Level 4 evidence)

National Institute for Health and Clinical Excellence. NICE Pathways. (July, 2015). Treatment options for heavy menstrual bleeding. Retrieved December 17, 2015 from http://pathways.nice.org.uk/pathways/heavy-menstrual-bleeding.

U. S. Food and Drug Administration. (2001, April). Center for Devices and Radiological Health. New Device Approvals: HerOption™ Uterine Cryoablation Therapy™ System - P000032. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/p000032a.pdf.

U. S. Food and Drug Administration. (2001, April). Center for Devices and Radiological Health. New Device Approvals: Hydro ThermAblator® Endometrial Ablation System - P000040. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/p000040a.pdf.

U. S. Food and Drug Administration. (2001, September). Center for Devices and Radiological Health. New Device Approvals: Microsulis Microwave Endometrial Ablation (MEA) System - P020031. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020031a.pdf.

U. S. Food and Drug Administration. (2003, September). Center for Devices and Radiological Health. New Device Approvals: NovaSure™ Impedance Controlled Endometrial Ablation System - P010013. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P010013a.pdf.

ORIGINAL EFFECTIVE DATE:  3/1985

MOST RECENT REVIEW DATE:  4/14/2016

ID_BT

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