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
Endometrial ablation with or without hysteroscopic guidance for the treatment of menorrhagia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Endometrial ablation with or without hysteroscopic guidance for the treatment of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Endometrial ablation with or without hysteroscopic guidance for the treatment of menorrhagia is considered medically appropriate if the individual meets ALL of the following criteria:
They are Pre-menopausal
Failure of a three month trial of hormone therapy except when contraindicated or not tolerated
ABSENCE of ALL the following:
History or suspicion of endometrial cancer or endometrial hyperplasia
A hysterectomy is the procedure of choice
Enlargement of the uterus with endometrial cavities that exceed device limitations (NOTE: In general, greater than 12 weeks gestation size)
Uterine prolapse greater than 1st degree
Intention of continued childbearing
Intrauterine device (IUD) currently in place
Uterine polyps and/or submucosal fibroids greater than 3cm in diameter
Adnexal pathology
History of previous classical cesarean section or transmural myomectomy
Intrauterine adhesions or septi
Pelvic inflammatory disease
Undiagnosed genital bleeding
Untreated symptomatic urinary tract or uterine infection
ADDITIONAL INFORMATION
Well-designed randomized controlled trials regarding the use of endometrial ablation with or without hysteroscopic guidance for the treatment of other conditions/diseases are lacking.
Brief description 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.
Freezing (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). 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
Abbott, J., Hawe, J., Hunter, D., & Garry, R. (2003). A double-blind randomized trial comparing the Cavaterm and the NovaSure endometrial ablation systems for the treatment of dysfunctional uterine bleeding. Fertility and Sterility, 80 (1), 203-208. Abstract retrieved August 27, 2003 from PubMed database. (Level 1 Evidence)
ACOG Committee on Practice Bulletins. (2007). ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 81. Endometrial ablation. Obstetrics and Gynecology, 109 (5), 1233-1248.
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2005). Endometrial ablation (4.01.04). Retrieved September 11, 2007 from BlueWeb. (16 articles and/or guidelines reviewed)
BlueCross BlueShield of Tennessee network physicians. July 2008.
Duleba, A. J., Heppard, M. C., Soderstrom, R. M., & Townsend, D. E. (2003). A randomized study comparing endometrial cryoablation and rollerball electroablation for treatment of dysfunctional uterine bleeding. The Journal of the American Association of Gynecologic Laparoscopist, 10 (1), 17-26. (Level 1 Evidence - Industry sponsored)
ECRI Institute. Health Technology Information Service. TARGET database. (2004, April). Cryosurgical endometrial ablation for excessive uterine bleeding. Retrieved June 8, 2006 from ECRI Institute. (16 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Windows on Medical Technology. (2002, July). Thermal uterine balloon endometrial ablation therapy for treatment of benign menorrhagia. Retrieved July 3, 2002 from ECRI Institute. (19 articles and/or guidelines reviewed)
Furst, S. N., Phillipson, T., & Jorgensen, J. C. (2007). Ten year follow-up of endometrial ablation. Acte Obstetrician ET Gynecological Scandinavica, 86 (3), 334-338. Abstract retrieved September 11, 2007 from PubMed database. (Level 1 Evidence)
Gallinat, A. (2004). NovaSure impedance-controlled system for endometrial ablation: Three-year follow-up of 107 patients. American Journal of Obstetrics and Gynecology, 191 (5) 1585-1589. (Level 1 Evidence - Independent study)
Gallinat, A. (2007). An impedance-controlled system for endometrial ablation: Five-year follow-up of 107 patients. Journal of Reproductive Medicine, 52 (6), 467-472. Abstract retrieved September 14, 2007 from PubMed database. (Level 1 Evidence)
Hayes. Medical Technology Directory. (2003, July). Endometrial ablation. Retrieved September 11, 2007 from www.Hayesinc.com/subscribers. (57 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2003, May). Thermal balloon and hydrothermal endometrial ablation. Retrieved September 11, 2007 from www.Hayesinc.com/subscribers. (59 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2003, November). Endometrial cryoablation. Retrieved September 11, 2007 from www.Hayesinc.com/subscribers. (22 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2004, May). Radiofrequency endometrial ablation for menorrhagia secondary to dysfunctional uterine bleeding. Retrieved September 11, 2007 from www.Hayesinc.com/subscribers. (65 articles and/or guidelines reviewed)
Lethaby A, Hickey M, Garry R. Endometrial destruction techniques for heavy menstrual bleeding. The Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD001501. DOI: 10.1002/14651858.CD001501.pub2.
U. S. Food and Drug Administration. (2001, April). Center for Devices and Radiological Health. New Device Approvals: HerOption™ Uterine Cryoablation Therapy™ System - P000032. Retrieved September 11, 2007 from http://www.fda.gov/cdrh/pdf/p000032.html.
U. S. Food and Drug Administration. (2001, April). Center for Devices and Radiological Health. New Device Approvals: Hydro ThermAblator® Endometrial Ablation System - P000040. Retrieved September 11, 2007 from http://www.fda.gov/cdrh/pdf/p000040.html.
U. S. Food and Drug Administration. (2001, September). Center for Devices and Radiological Health. New Device Approvals: NovaSure™ Impedance Controlled Endometrial Ablation System - P010013. Retrieved September 11, 2007 from http://www.fda.gov/cdrh/pdf/p010013.html.
ORIGINAL EFFECTIVE DATE: 3/1985
MOST RECENT REVIEW DATE: 12/19/2008
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