Clinical UM Guideline

 

Subject: Endometrial Ablation
Guideline #:  CG-SURG-15 Publish Date:    10/17/2018
Status: Reviewed Last Review Date:    09/13/2018

Description

This document addresses endometrial ablation. Ablation or destruction of the endometrium is used to treat abnormal uterine bleeding. The U.S Food and Drug Administration (FDA) has approved devices for endometrial ablation which include, but may not be limited to: laser therapy, electrical wire loop, rollerball using electric current, and thermal ablation using a liquid-filled balloon, microwave, electrode array, or a cryosurgical device.

Clinical Indications

Medically Necessary:

Endometrial ablation, using an FDA approved device, is considered medically necessary for premenopausal individuals with abnormal uterine bleeding when both of the criteria (A and B) below are met:

  1. Has one of the following:
    1. Failed prior hormone therapy; or
    2. Declined hormone therapy; or
    3. Contraindications to hormone therapy; and
  2. Has no evidence of polyps or other surgically correctable cause of bleeding on sonogram or hysteroscopy.

Endometrial ablation, using an FDA approved device, is considered medically necessary for residual menstrual bleeding after androgen treatment in a female to male transgender person.

Not Medically Necessary:

Endometrial ablation is considered not medically necessary for individuals:

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT

 

58353

Endometrial ablation, thermal, without hysteroscopic guidance

58356

Endometrial cryoablation with ultrasonic guidance, including endometrial curettage, when performed

58563

Hysteroscopy, surgical; with endometrial ablation (e.g., endometrial resection, electrosurgical ablation, thermoablation)

 

 

ICD-10 Procedure

 

0U5B0ZZ

Destruction of endometrium, open approach

0U5B3ZZ

Destruction of endometrium, percutaneous approach

0U5B4ZZ

Destruction of endometrium, percutaneous endoscopic approach

0U5B7ZZ

Destruction of endometrium, via natural or artificial opening

0U5B8ZZ

Destruction of endometrium, via natural or artificial opening endoscopic

0UDB7ZZ

Extraction of endometrium, via natural or artificial opening

0UDB8ZZ

Extraction of endometrium, via natural or artificial opening endoscopic

 

 

ICD-10 Diagnosis

 

 

All diagnoses

Discussion/General Information

Endometrial ablation was originally performed using rollerball ablation. FDA approval of subsequent devices designed explicitly for the purposes of endometrial ablation has been based in part on the results of randomized trials comparing the results of newer devices with rollerball ablation. In general, these studies have suggested equivalent outcomes in terms of reduction of abnormal uterine bleeding.

Examples of devices approved by the FDA for endometrial ablation are:

There are two groups of techniques typically available for performing endometrial ablation: hysteroscopic procedures and non hysteroscopic procedures. The following have been used for hysteroscopic endometrial ablation: Nd:YAG laser, resecting loop using electric current, and electrosurgical rollerball instruments. The following have been used for non hysteroscopic endometrial ablation: thermal balloon devices, cryosurgical devices, radiofrequency devices, and microwave endometrial ablation systems.

Guidance on endometrial ablation has been issued from several U.S. organizations including the American College of Obstetricians and Gynecologists (ACOG) and the Practice Committee of the American Society for Reproductive Medicine (ASRM).

In 2018, ACOG reaffirmed their 2007 endometrial ablation recommendations which were based on good and consistent evidence and included the following:

A 2013 (reaffirmed 2017) ACOG committee opinion for the management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women stated:

Endometrial ablation, although readily available in most centers, should be considered only if other treatments have been ineffective or are contraindicated, and it should be performed only when a woman does not have plans for future childbearing and when the possibility of endometrial or uterine cancer has been reliably ruled out as the cause of the acute abnormal uterine bleeding.

In 2008, the Practice Committee of the ASRM reviewed their 2006 Practice Committee report and reissued their statement on indications and options for endometrial ablation. Conclusions were:

The Society for Gynecologic Surgeons (SGS) systematic review group (Wheeler, 2012) published a clinical practice guideline on treatment of abnormal uterine bleeding. The guideline recommends that for individuals with bleeding caused mainly by ovulatory disorders or endometrial hemostatic disorders, any of the following treatments may be chosen: hysterectomy, endometrial ablation, systemic medical therapies or levonorgestrel-releasing intrauterine systems. In choosing between endometrial ablation and hysterectomy, the authors note that if the preference is for amenorrhea, less pain or avoiding additional therapy, hysterectomy is suggested. If the preference is for lower operative and post-operative procedural risk, and a shorter hospital stay, endometrial ablation is recommended.

An Endocrine Society Clinical Practice Guideline (Hembree, 2017) addressed endometrial ablation as treatment for female to male sex reassignment.

Cessation of menses may occur within a few months with testosterone treatment alone, although high doses of testosterone may be required. If uterine bleeding continues, clinicians may consider the addition of a progestational agent or endometrial ablation.

Comparison of Treatments

Different methods of endometrial ablation have been compared in published randomized controlled trials (RCTs) and systematic reviews of RCTs. In 2012, Matteson and colleagues performed a systematic review of RCTs that compared the efficacy of hysterectomy with less invasive techniques for controlling abnormal uterine bleeding. A total of nine trials were identified directly comparing hysterectomy with another intervention and reporting health outcomes; seven of these studies compared hysterectomy to endometrial ablation. The seven studies included a total of 1167 participants, and follow-up ranged from 4 to 48 months. Following treatment, amenorrhea rates in the endometrial ablation groups ranged from 13-64% versus an implied 100% rate after hysterectomy. Five trials reported pain beyond the immediate post-operative period. The authors judged the quality of evidence on pain to be low but that results favored hysterectomy over ablation. Three studies reported that pelvic pain was less prevalent in the hysterectomy group than the ablation group; however, only one study compared rates statistically, and this study found a significantly lower rate of pain at 2 to 3 years’ follow-up in the group receiving hysterectomy. All seven trials reported additional treatments obtained by participants after the initial intervention. At 1 to 4 years’ follow-up, the proportion of participants in the ablation group who had an additional surgical procedure for bleeding was 16-42%; of these, 10-29% were treated with hysterectomy. The evidence suggests better outcomes (for example, bleeding control, pelvic pain) and fewer additional surgeries in those who have hysterectomy compared to endometrial ablation. However, endometrial ablation is less invasive and involves retention of the uterus.

A Cochrane review by Lethaby and colleagues (2013) compared the efficacy, safety and acceptability of endometrial destruction techniques to reduce heavy menstrual bleeding (HMB) in premenopausal individuals. A total of 25 randomized trials (4040 individuals) with sample sizes ranging from 20 to 372 were included in the analysis. The authors concluded:

Endometrial ablation techniques offer a less invasive surgical alternative to hysterectomy. The rapid development of a number of new methods of endometrial destruction has made systematic comparisons between individual methods and with the “gold standard” first generation techniques difficult. Most of the newer techniques are technically easier to perform than traditional hysteroscopy-based methods but technical difficulties with the new equipment need to be addressed. Overall, the existing evidence suggests that success, satisfaction rates and complication profiles of newer techniques of ablation compare favourably with hysteroscopic techniques.

Sambrook and colleagues (2014) reported 5-year outcomes of a prospective, double-blind randomized controlled trial in the United Kingdom comparing microwave endometrial ablation and thermal balloon endometrial ablation (Thermachoice). The study consisted of participants with heavy menstrual bleeding who were premenstrual and had completed their families. A total of 217 of 314 participants originally randomized (69.1%) responded to a written questionnaire at 5 years. The analysis was intention-to-treat, with non-responders classified as treatment failures. Menstrual outcomes did not differ significantly between groups at 5 years. The rate of amenorrhea was 51% in the microwave ablation group and 45% in the thermal ablation group. The proportion of those with light menstrual bleeding was 27% in the microwave ablation group and 33% in the thermal ablation group. There was no statistically significant difference in the number undergoing hysterectomy. A total of 10 participants (8.8%) in the microwave ablation group and 7 participants (6.8%) in the thermal ablation group subsequently had a hysterectomy. The authors concluded that the long-term results achieved in both groups were comparable.

A small double-blind, RCT by Athanotos and colleagues (2015) compared the safety and efficacy of two second-generation endometrial ablation devices: the MEA and the Novasure impedance control system. A total of 66 participants with abnormal uterine bleeding, unresponsive to prior therapy, were allocated at a 1:1 ratio to either bipolar radio-frequency ablation or MEA. The participants were assessed at 3 and 12 months post ablative procedure, and the primary outcome measure was the rate of amenorrhea at 12 months post treatment. The authors reported that the rate of amenorrhea at 12-months post-ablation was significantly higher in participants treated by Novasure (25/33; 75.8%) as compared to those treated by MEA (8/33; 24.2%).

In a 2015 study, Laberge and colleagues evaluated the safety and efficacy of the Minerva endometrial ablation system against objective performance criteria (OPC), an FDA-provided analysis of the success rates of five previously approved endometrial devices (Her Option, HydroThermablator, MEA, NovaSure, and ThermaChoice). Using 7 clinical locations, the researchers studied 105 menorrhagia subjects with a pictorial blood loss assessment score (PBLAC) >150, who underwent the Minerva endometrial ablation procedure. After 1 year, researchers found a ≤ 75 PBLAC score in 96.2% of subjects and amenorrhea in 69.5% of subjects. No serious adverse events from the device were reported. The Minerva device was found to be superior to the OPC (lower confidence bound 66%, p<0.0001; upper confidence bound 83.5%, p<0.0001).

In an industry-supported, randomized, double-arm, controlled, multicenter study, Laberge and colleagues (2016) evaluated the safety and effectiveness of the Minerva endometrial ablation system compared to rollerball endometrial ablation. Prior to inclusion in the study, participants had to demonstrate a minimum menstrual blood loss of 160 mL by AH laboratory analysis. Using 13 clinical locations, researchers randomly assigned 153 subjects to receive the Minerva procedure (n=102) or the rollerball procedure (n=51). Blood loss was measured at 6 months and 12 months and success was considered ≤80 mL. After 1 year, the Minerva group had a 93.1% success rate compared to 80.4% for the rollerball group (p=0.02). Additionally, amenorrhea was achieved for 71.6% of the Minerva group and 49% for the rollerball group (p=0.01). Researchers used a validated questionnaire to determine that satisfaction was 91.9% for the Minerva group and 79.5% for the rollerball group (p<0.05). The Minerva group had 5 serious adverse events (4.9%) compared to 3 for the rollerball group (6.0%). The most common adverse event for the Minerva group was abdominal pain and/or bloating (2.9%). Limitations of the study included a lack of subject diversity and short follow-up duration.

Safety

Brown and Blank (2012) analyzed adverse events associated with endometrial ablation procedures that were reported in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. A total of 829 adverse events were reported between 2005 and 2011. Nearly two-thirds of the adverse events (540 of 829, 65%) were genital tract or skin burns and 529 of these events (98%) were associated with hydrothermal endometrial ablation. The next 2 most frequent types of adverse events were thermal bowel injury (93 of 820, 11%) and transmural uterine thermal injury (89 of 820, 11%). Of the 182 thermal injuries, 140 (77%) were associated with radiofrequency endometrial ablation. Additionally, 47 cases of sepsis or bacteremia were reported, and 43 of the 47 cases (91%) were associated with radiofrequency endometrial ablation. Four deaths were reported, two associated with radiofrequency ablation and one each associated with thermal balloon ablation and cryoablation. A total of 66 of the 829 events (8%) occurred when endometrial ablation was performed outside of the labeled instructions for use of the procedure. The total number of endometrial ablations performed during this time period was not reported by the authors; therefore, the proportion of procedures with adverse events could not be determined from these data.

In 2014, Dood and colleagues investigated whether endometrial ablation carried an increased risk of endometrial cancer or delay in diagnosis as compared to medically managed abnormal uterine bleeding. Data were collected from a population-based cohort that included a total of 234,721 individuals with abnormal bleeding, 4776 of whom underwent endometrial ablation. The remaining 229,945 underwent medical management. During a median follow-up time of 4.07 years, 3 participants with a history of endometrial ablation and 601 participants who were treated medically developed endometrial cancer. There was not a statistically significant difference in endometrial cancer rates between groups (age-adjusted HR=0.61; 95% CI, 0.20 to 1.89; p=0.17). Additionally, the median time to endometrial cancer diagnosis, 237 days after ablation and 299 days with medical management, did not differ significantly between groups. The authors conclude their study finds that the comparative effectiveness of medical management and endometrial ablation for abnormal uterine bleeding is similar in regards to endometrial cancer outcomes.

Kalampokas and colleagues (2017) reported on a retrospective study that evaluated the long-term incidence of hysterectomy after endometrial resection/endometrial ablation (ERA) for heavy menstrual bleeding. A total of 901 individuals underwent ERA with first or second-generation methods between 1990 and 1997. The researchers found that 22.9% (206/901) of individuals had a post-ERA hysterectomy; 75.2% of individuals had the hysterectomy within 5 years of ERA. Only 4.4% (9 individuals) had a hysterectomy within 16-25 years of having ERA. The most common reasons for hysterectomy were fibroids, ovarian cysts, and prolapse. The researchers concluded that ERA is a successful long-term treatment for heavy menstrual bleeding as most individuals do not require a hysterectomy within 25 years of ERA.

Soini and colleagues (2017) conducted a retrospective cohort study to determine the risk of cancer and the hysterectomy rate after endometrial ablation for abnormal uterine bleeding. The researchers collected data on 5484 female individuals between 1997 and 2014 who had an endometrial ablation and who had never been diagnosed with cancer. They compared the cohort to a control group of 26,938 females. A total of 154 individuals in the endometrial ablation cohort were diagnosed with cancer during 39,892 women-years at risk. The standard incidence ratio for all cancers was 0.96 (95% CI, 0.82 to 1.13). The standard incidence ratio for endometrial cancer was 0.56 (95% CI, 0.12 to 1.64) and for breast cancer was 0.86 (95% CI, 0.67 to 1.09). A total of 1086 (19.8%) of individuals had hysterectomies post-endometrial ablation compared to 2521 (9.4%) in the control group. The adjusted hazard risk for hysterectomy in the endometrial ablation cohort was 3.63 (95% CI, 3.32 to 3.96; p<0.001). The authors found that endometrial ablation was not associated with an increased risk for endometrial or breast cancer, and endometrial ablation is an effective alternative to hysterectomy in selected women with heavy menstrual bleeding.

References

Peer Reviewed Publications:

  1. Amso NN, Stabinsky SA, McFaul P, et al. Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-centre study. International Collaborative Uterine Thermal Balloon Working Group. Br J Obstet Gynaecol. 1998; 105(5):517-523.
  2. Athanatos D, Pados G, Venetis CA, et al. Novasure impedance control system versus microwave endometrial ablation for the treatment of dysfunctional uterine bleeding: a double-blind, randomized controlled trial. Clin Exp Obstet Gynecol. 2015; 42(3):347-351.
  3. Brown J, Blank K. Minimally invasive endometrial ablation device complications and use outside of the manufacturers' instructions. Obstet Gynecol. 2012; 120(4):865-870.
  4. Cooley S, Yuddandi V, Walsh T, et al. The medium- and long-term outcome of endometrial ablative techniques. Eur J Obstet Gynecol Reprod Biol. 2005; 121(2):233-235.
  5. Corson, SL. A multicenter evaluation of endometrial ablation by Hydro ThermAblator and rollerball for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 2001; 8(3):359-367.
  6. Dood RL, Gracia CR, Sammel MD, et al. Endometrial cancer after endometrial ablation vs medical management of abnormal uterine bleeding. J Minim Invasive Gynecol. 2014; 21(5):744-752.
  7. Laberge P, Garza-Leal J, Fortin C, et al. A randomized controlled multicenter US Food and Drug Administration trial of the safety and efficacy of the Minerva endometrial ablation system: one-year follow-up results. J Minim Invasive Gynecol. 2017; 24(1):124-132.
  8. Laberge P, Garza-Leal J, Fortin C, et al. 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. J Minim Invasive Gynecol. 2015; 22(7):1169-1177.
  9. Meyer WR, Walsh BW, Grainger DA, et al. Thermal balloon and roller ball ablation to treat menorrhagia: a multicenter comparison. Obstet Gynecol. 1998; 92(1):98-103.
  10. Sambrook AM, Elders A, Cooper KG. Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomized controlled trial. BJOG. 2014; 121(6):747-753.
  11. Soini T, Rantanen M, Paavonen J, et al. Long-term follow-up after endometrial ablation in Finland: cancer risks and later hysterectomies. Obstet Gynecol. 2017; 130(3):554-560.
  12. Vilos GA, Fortin CA, Sanders B, et al. Clinical trial of the uterine thermal balloon for treatment of menorrhagia. J Am Assoc Gynecol Laparosc. 1997; 4(5):559-565.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American College of Obstetricians and Gynecologists. Endometrial Ablation. 2007. Reaffirmed 2018. ACOG Practice Bulletin No. 81. Available at: http://www.acog.org/Search?Keyword=ENDOMETRIAL+ABLATION. Accessed on July 24, 2018.
  2. American College of Obstetricians and Gynecologists. ACOG committee opinion no. 557: Management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women. Obstet Gynecol. 2013 (reaffirmed 2017); 121(4):891-896. Available at: https://www.acog.org/-/media/Committee-Opinions/Committee-on-Gynecologic-Practice/co557.pdf?dmc=1&ts=20180723T2123532532. Accessed on July 24, 2018.
  3. American Society for Reproductive Medicine. Indications and options for endometrial ablation. The Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2008; 90:S236-240.
  4. Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine treatment of gender-dysphoric/gender-incongruent persons: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2017; 102(11):3869-3903.
  5. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. AEGEA Vapor System. 2017. Available at: https://www.accessdata.fda.gov/‌scripts/cdrh/devicesatfda/‌index.cfm?db=pma&id=394194. Accessed on July 24, 2018.
  6. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Her Option Uterine Cryoablation Therapy System. 2000. Available at: https://‌‌www.accessdata.fda.gov/scripts/‌‌cdrh/devicesatfda/‌index.cfm?db=pma&id=319995. Accessed on July 24, 2018.
  7. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Hydro ThermAblator Endometrial Ablation System. 2001. Available at: https://‌www.accessdata.fda.gov/‌scripts/cdrh/devicesatfda/‌index.cfm?db=pma&id=320002. Accessed on July 24, 2018.
  8. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Microsulis Microwave Endometrial Ablation (MEA) System. 2003. Avail https://‌www.accessdata.fda.gov/‌scripts/cdrh/‌devicesatfda/‌index.cfm?db=pma&id=320111. Accessed on July 24, 2018.
  9. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. Minerva Endometrial Ablation System. 2015. Available at: https://‌www.accessdata.fda.gov/‌scripts/‌cdrh/‌devicesatfda/‌index.cfm?db=pma&id=320585. Accessed on July 24, 2018.
  10. Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data. NovaSure Impedance Controlled Endometrial Ablation System. 2001. Available at: https://‌www.accessdata.fda.gov/‌scripts/‌cdrh/‌devicesatfda/‌index.cfm?db=pma&id=320033. Accessed on July 24, 2018.
  11. Kalampokas E, McRobbie S, Payne F, Parkin DE. Long-term incidence of hysterectomy following endometrial resection or endometrial ablation for heavy menstrual bleeding. Int J Gynaecol Obstet. 2017; 139(1):61-64.
  12. Laberge P, Leyland N, Murji A, et al. Endometrial ablation in the management of abnormal uterine bleeding. Society of Obstetricians and Gynaecologists of Canada (SOGC). J Obstet Gynaecol Can. 2015; 37(4):362-379. Available at: http://sogc.org/wp-content/uploads/2015/04/GUI322CPG1504E2.pdf. Accessed on July 24, 2018.
  13. Lethaby A, Penninx J, Hickey M, et al. Endometrial resection and ablation techniques for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013;(8):CD001501.
  14. Matteson KA, Abed H, Wheeler TL 2nd, et al.; Society of Gynecologic Surgeons Systematic Review Group. A systematic review comparing hysterectomy with less-invasive treatments for abnormal uterine bleeding. J Minim Invasive Gynecol. 2012; 19(1):13-28.
  15. Practice Committee of American Society for Reproductive Medicine. Indications and options for endometrial ablation. Fertil Steril. 2008; 90(5 Suppl):S236-240.
  16. Wheeler TL 2nd, Murphy M, Rogers RG, et al.; Society of Gynecologic Surgeons Systematic Review Group. Clinical practice guideline for abnormal uterine bleeding: hysterectomy versus alternative therapy. J Minim Invasive Gynecol. 2012; 19(1):81-88.
Index

AEGEA Vapor System
Endometrial Ablation
Genesys HTA System
Her Option Uterine Cryoablation Therapy System
Hydro ThermaAblator System
Intrauterine Ablation
Laser Ablation of the Endometrium
Microwave Endometrial Ablation (MEA) System
Minerva Endometrial Ablation System
NovaSure
Rollerball Ablation of the Endometrium
ThermaChoice

The use of specific product names is illustrative 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. 

History

Status

Date

Action

Revised

09/13/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. MN criteria clarified in Clinical Indications section. Discussion, References, and Index sections updated.

Reviewed

11/02/2017

MPTAC review. Discussion, Reference and Index sections updated. The document header wording updated from “Current Effective Date” to “Publish Date.”

Revised

11/03/2016

MPTAC review. Medically Necessary criteria added for residual menstrual bleeding after androgen treatment in a female to male transgender person. Description, Discussion and Reference sections updated.

Reviewed

11/05/2015

MPTAC review. Discussion and Reference sections updated. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Discussion and Reference sections updated.

Reviewed

11/14/2013

MPTAC review. Discussion and Reference sections updated.

Reviewed

11/08/2012

MPTAC review. Discussion and Reference sections updated.

Reviewed

11/17/2011

MPTAC review. Coding, Discussion and Reference sections updated.

Reviewed

11/18/2010

MPTAC review. Description, Discussion, References, and Index updated.

Reviewed

11/19/2009

MPTAC review. Removed place of service. References updated.

Reviewed

11/20/2008

MPTAC review. References updated.

Reviewed

11/29/2007

MPTAC review. References updated.

Reviewed

12/07/2006

MPTAC review. References and discussion updated.

Revised

12/01/2005

MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

 

None

Anthem BCBS

 

 

None

WellPoint Health Networks, Inc.

06/24/2004

3.09.06

Endometrial Ablation

 

06/24/2004

Clinical Guideline

Endometrial Ablation