Medical Policy

 

Subject: Uterine Fibroid Ablation: Laparoscopic or Percutaneous Image Guided Techniques
Document #: SURG.00077 Publish Date:    08/29/2018
Status: Reviewed Last Review Date:    07/26/2018

Description/Scope

This document addresses laparoscopic and percutaneous ablative techniques for the treatment of symptomatic uterine fibroids. Uterine fibroids, also referred to as leiomyomas, are a common condition affecting women in their reproductive years; symptoms include excessive menstrual bleeding and pelvic pain.

Note: Please see the following related document(s) for additional information:

Position Statement

Investigational and Not Medically Necessary:

The use of laparoscopic or percutaneous ablation techniques in combination with imaging guidance as a treatment of uterine fibroids is considered investigational and not medically necessary, including but not limited to lasers, bipolar electrodes, interstitial thermotherapy, cryotherapy, and radiofrequency ablation.

Rationale

Radiofrequency volumetric thermal ablation (RFVTA)

One published RCT, which was blinded, has evaluated RFVTA for the treatment of uterine fibroids. The study by Brucker and colleagues (2014) compared RFVTA and laparoscopic myomectomy in 51 women with symptomatic fibroids and reported on length of hospitalization and perioperative outcomes. Participants in the treatment group experienced significantly faster discharge from the hospital and less mean operative blood loss. In 2016, Kramer and colleagues published 2-year results of this study. At 2 years, there were no significant differences between the RFVTA and myomectomy groups in the frequency of symptoms including heavy menstrual bleeding, pelvic pain and frequency of urination. Three individuals in the RFVTA group sought additional surgical interventions; the authors noted this was not due to fibroid symptoms. No one in the myomectomy group had surgical re-intervention. Three individuals in the RFVTA group and 6 in the myomectomy group conceived and there were no miscarriages. Limitations include manufacturer sponsorship of the trial, homogenous sample population (lack of ethnic diversity), and interim reporting of study results (2-year findings out of 5 years total that participants will be followed).

In addition to the RCT, there are several case series. Some had sample sizes of fewer than 50 participants (Garza 2011; Robles 2013).  One of the larger case series evaluating RFVTA, reported by Galen and colleagues (2014), was retrospective and included 206 individuals. From baseline to 12 months, participants experienced significant reductions in symptom severity (p<0.001); health-related quality of life (HR-QOL) scores (p<0.001); and mean uterine volume (p=0.008). The rate of adverse events associated with the RFVTA procedure was relatively low at 1.4% (1 of 69).

Chudnoff and colleagues (2013) reported on a case series involving 135 subjects with symptomatic uterine myomas who underwent laparoscopic ultrasound-guided RFVTA. Subjects were premenopausal women with uterine size of 14 weeks gestation or less and six or fewer treatable myomas. No myoma was larger than 7 cm in diameter and total myoma volume was 300 cm3 or less. At 12 months, 127 subjects were included in the analysis. The authors reported that, compared with baseline, monthly menstrual blood loss, myoma volume and total uterine volume were significantly lower at 12 months. Results on the Uterine Fibroid Symptom and Quality of Life Questionnaire indicated significant improvements in both symptom severity and HR-QOL (p<0.001 for both measures). Similar results were also reported for the responses on the EQ-5DTM Health Status score (p<0.001).

Guido and colleagues (2013) conducted a case series to evaluate RFVTA of symptomatic uterine fibroids in 121 premenopausal women (HALT Trial). At the 24-month follow-up, subjects showed a significant improvement in symptom severity compared with baseline values (p<0.001), as well as significant improvements in HR-QOL scores in all categories (p<0.001). A total of 6 individuals (4.8%) required repeat surgical intervention for bleeding related to fibroids between 12 and 24 months. At 36 months of follow-up, Berman (2014) reported similar results in 104 subjects from the same trial. RFVTA resulted in continued and significant relief from symptoms of uterine fibroids, including significant improvements in HR-QOL scores. At 36 months, the total rate of re-intervention was 11% (14 of 135 subjects).

The ability to draw conclusions from case series results is limited due to lack of a control group with which to compare change in symptoms and adverse effects, and only one RCT has been published.

In 2012, the Food and Drug Administration (FDA) cleared the Acessa System (Halt Medical, Inc., now Acessa Health) through the 510(k) process for use in percutaneous coagulation and ablation of soft tissue under laparoscopic ultrasound guidance, including treatment of symptomatic uterine fibroids. No controlled data were presented in the 510(k) summary.

Microwave ablation

In 2018, Ierardi and colleagues published a systematic review of the published literature on percutaneous high-frequency microwave ablation for the treatment of uterine fibroids. The authors identified six studies with a total of 541 participants. All of the studies were case series; there were no RCTs or non-randomized controlled studies. The rate of clinical success, defined as reduction in uterine fibroid volume, in the individual studies ranged from 15.9% to 93.1%. The authors stated that this wide range in findings was due, at least in part, to different lengths of follow-up in the studies. No major complications were reported in any of the studies and there were minor complications were primarily those that would be expected after this type of intervention. The authors did not pool study findings.

The largest series was published by Liu and colleagues in 2017. The study prospectively enrolled 311 Chinese women who underwent ultrasound-guided percutaneous microwave ablation therapy for symptomatic uterine fibroids. Women were evaluated at baseline, 3, 6 and 12 months for fibroid size, hemoglobin level, uterine fibroid symptoms and HR-QOL scores. The mean reduction rate in fibroid volume was 63.5%, 78.5% and 86.7% at 3, 6 and 12 months, respectively (p<0.001). The mean hemoglobin level increased significantly from 88.84 ± 9.31 g/L at baseline to 107.14 ± 13.32, 116.05 ± 7.66 and 117.79 ± 6.51 g/L at 3, 6 and 12 months posttreatment, respectively (p<0.000). The symptom severity score (SSS) and HR-QOL scores were also significantly improved at each follow-up compared with baseline (p<0.000). While these results are promising, a randomized trial comparing microwave ablation of uterine fibroids to standard of care in a diverse population with long-term outcomes is warranted.

Nd:YAG laser myolysis

Hindley (2002) and colleagues reported on a case series of 66 women with symptomatic fibroids who were treated with MRI-guided percutaneous Nd:YAG laser myolysis. Outcome measures included assessment of fibroid size and a menorrhagia questionnaire. The mean reduction in size of fibroids was 31%. Compared to a control group of those undergoing hysterectomy, the total outcome score was less in those undergoing percutaneous myolysis but the quality of life score was similar. Although not entirely clear, it appears that treatment was targeted to only the largest fibroid in each woman. The study does not provide details on the number and location of fibroids. It should also be noted that MRI guidance was provided with a high field (0.5T) open machine.

Cryomyolysis

Zreik and colleagues (2008) presented their experience with cryomyolysis in 14 women, while Zupi and colleagues (2004; 2005) presented initial experience with 20 women. In both of these small case series, the authors reported post-intervention symptom resolution. In the Zreik study, the participants were given GnRH agonist before the procedure; cryomyolysis maintained or slightly reduced the post-GnRH uterine size. In contrast, GnRH was not used in the Zupi study, and cryomyolysis was associated with a 25% reduction in fibroid size, and a resolution of bleeding at 12 months.

Clinical guidelines

The American College of Obstetricians and Gynecologists (ACOG) guideline (2008, reaffirmed in 2016) entitled, Alternatives to Hysterectomy in the Management of Leiomyomas, stated that they do not recommend percutaneous techniques for myolysis as a treatment of uterine fibroids.

In 2015 an evidence-based guideline was published by the Journal of Obstetrics and Gynaecology Canada (JOGC) with the following recommendation, “Of the conservative interventional treatments currently available, uterine artery embolization has the longest track record and has been shown to be effective in properly selected patients...Newer focused energy delivery methods are promising but lack long-term data.”

In 2008, the American Society of Reproductive Medicine (ASRM) in collaboration with the Society of Reproductive Surgeons (SRS) published a joint statement regarding myomas and reproductive function. In this document they stated:

Another laparoscopic technique, myolysis, involves thermal destruction of myomas via insertion of cryoprobes, electrocautery needles, or fiberoptic lasers.  A nonsurgical method for myolysis involving MRI-guided focused ultrasound has also been described.  Data relating to the short- and long-term outcomes achieved with such treatments are still lacking and, until they become available, myolysis cannot be recommended for women hoping to maintain or improve their fertility.

Conclusion

The published literature regarding the techniques for myolysis is limited and of poor quality, even though some techniques, such as Nd:YAG laser myolysis, have been available since the early 1990s. There are no controlled clinical trials comparing myolysis with hysterectomy, and one RCT comparing myolysis with myomectomy, which only reported interim results. The available studies largely lack pertinent information such as uterine size, number and size of fibroids, location of fibroids (i.e., either subserosal, intramural or submucosal), and recurrence rates. Clinical outcomes have been inconsistent or not reported.

Background/Overview

Uterine fibroids are one of the most common conditions affecting women during their reproductive years. Symptoms include menorrhagia, pelvic pressure, or pain. Hysterectomy and various myomectomy procedures are considered the gold standard of treatment. However, there has been continual research interest in developing minimally invasive alternatives that may preserve fertility, including endometrial ablation (for submucosal fibroids), uterine artery embolization, and various techniques to induce myolysis. Several types of energy sources have been used for myolysis, including Nd:YAG lasers, bipolar electrodes, cryotherapy, or radiofrequency ablation. In general, the procedures involve the insertion of probes multiple times into the fibroid. When activated, the various energy sources induce devascularization and ultimately ablation of the target tissue. When radiofrequency ablation is used, the procedure may be referred as the HALT (Hysterectomy Alternative) procedure.

Myolysis, a surgical procedure that involves the destruction of uterine fibroids (also referred to as leiomyomas), has typically been performed during a laparoscopic procedure focusing on subserosal and intramural fibroids; more recently, percutaneous approaches with MRI guidance have been reported. Typically, women are pretreated with depot gonadotropin-releasing hormone (GnRH) agonists, over a period of 2 to 6 months, to shrink fibroids prior to the procedure.

Cryomyolysis is a technique in which a cryoprobe is inserted into the center of a fibroid. Freezing temperatures of minus 180 degrees centigrade create an “iceball” within the fibroid. Several freeze/thaw cycles are typically used.

Definitions

Cryomyolysis:  Use of a freezing agent for the dissolution of tissue.

Fibroids: Fibrous tissue collected in the uterine wall; also referred to as leiomyomas.

Laparoscopic: A surgical procedure performed using a laparoscope, a thin fiberoptic scope introduced into a body cavity for diagnostic and surgical purposes.

Magnetic resonance imaging (MRI): The use of a nuclear magnetic resonance spectrometer to produce electronic images of specific atoms and molecular structures in solids, especially human cells, tissues and organs.

Myolysis: The dissolution of muscular tissue.

Percutaneous: A medical procedure in which access to inner organs or other tissue is achieved via puncture of the skin.

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.

When services are Investigational and Not Medically Necessary:

CPT

 

58578

Unlisted laparoscopy procedure, uterus [when specified as laparoscopic ablation by laser, bipolar electrodes, interstitial thermotherapy, cryotherapy]

58674

Laparoscopy, surgical, ablation of uterine fibroid(s) including intraoperative ultrasound guidance and monitoring, radiofrequency

58999

Unlisted procedure, female genital system (nonobstetrical) [when specified as image-guided percutaneous ablation by laser, bipolar electrodes, interstitial thermotherapy, cryotherapy, radiofrequency]

 

 

ICD-10 Procedure

 

0U593ZZ

Destruction of uterus, percutaneous approach

0U594ZZ

Destruction of uterus, percutaneous endoscopic approach

 

 

ICD-10 Diagnosis

 

D25.0-D25.9

Leiomyoma of uterus

References

Peer Reviewed Publications:

  1. Berman JM, Guido RS, Garza Leal JG, et al. Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas. J Minim Invasive Gynecol. 2014; 21(5):767-774.
  2. Brucker SY, Hahn M, Kraemer D, et al. Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. Int J Gynaecol Obstet. 2014; 125(3):261-265.
  3. Chudnoff SG, Berman JM, Levine DJ, et al. Outpatient procedure for the treatment and relief of symptomatic uterine myomas.  Obstet Gynecol. 2013; 121(5):1075-1082.
  4. Galen DI, Pemeuller RR, Leal JG, et al. Laparoscopic radiofrequency fibroid ablation: phase II and phase III results. JSLS. 2014; 18(2):182-190.
  5. Garza Leal JG, Hernandez LI, Castillo SL, Lee BB. Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System. J Minim Invasive Gynecol. 2011; 18(3):364-371.
  6. Guido RS, Macer JA, Abbott K, et al. Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years’ outcome from the Halt trial. Health Qual Outcomes. 2013; 11(1):139.
  7. Hindley JT, Law PA, Hickey M, et al. Clinical outcomes following perctuaneous magnetic resonance image guided laser ablation of symptomatic uterine fibroids. Hum Reprod. 2002; (1)7:2737-2741.
  8. Ierardi AM, Savasi V, Angileri A et al. Percutaneous high-frequency microwave ablation of uterine fibroids: Systematic review. Biomed Res Int. 2018 Jan 8; [eCollection]. Available at: https://www.hindawi.com/journals/bmri/2018/2360107/. Accessed April 27, 2018.
  9. Krämer B, Hahn M, Taran FA, et al. Interim analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy. Int J Gynaecol Obstet. 2016; 133(2):206-211.
  10. Law P, Gedroyc WM, Regan L. Magnetic resonance-guided percutaneous laser ablation of uterine fibroids. J Magn Reson Imaging. 2000; 12(4):565-570.
  11. Liu H, Zhang J, Han ZY, et al. Effectiveness of ultrasound-guided percutaneous microwave ablation for symptomatic uterine fibroids: a multicentre study in China. Int J Hyperthermia. 2016; 32(8):876-880.
  12. Robles R, Aguirre VA, Argueta AI, Guerrero MR. Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up. Int J Gynaecol Obstet. 2013; 120(1):65-69.
  13. Zreik TG, Rutherford TJ, Palter SF, et al. Cryomyolysis, a new procedure for the conservative treatment of uterine fibroids. J Am Assoc Gynecol Laparosc. 1998; 5(1):33-38.
  14. Zupi E, Piredda A, Marconi D, et al. Directed laparoscopic cryomyolysis: a possible alternative to myomectomy and/or hysterectomy for symptomatic leiomyomas. Am J Obstet Gynecol. 2004; 190(3):639-643.
  15. Zupi E, Marconi D, Sbracia M, et al. Directed laparoscopic cryomyolysis for symptomatic leiomyomata: one-year follow up. J Minim Invasive Gynecol. 2005; 12(4):343-346.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American College of Obstetricians and Gynecologists (ACOG). Alternatives to hysterectomy in the management of leiomyomas. ACOG practice bulletin No. 96. 2016. Available at: http://www.acog.org/-/media/List-of-Titles/PBListOfTitles.pdf.  Accessed on April 27, 2018.
  2. American College of Obstetricians and Gynecologists (ACOG) practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. 2008; 112(2 Pt 1):387-400.
  3. American Society of Reproductive Medicine. Myomas and reproductive function. The Practice Committee of the American Society of Reproductive Medicine in collaboration with the Society of Reproductive Surgeons. Fertili Steril. 2008; 910(5 Suppl):S125-S130.
  4. Food and Drug Administration. 510(k) Summary (K121858). Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf12/k121858.pdf. Accessed on May 8, 2018.
Websites for Additional Information
  1. National Institute of Child Health and Human Development. Surgical treatments for fibroids. Available at: http://www.nichd.nih.gov/health/topics/uterine/conditioninfo/treatments/Pages/surgical-treatments.aspx. Accessed on April 27, 2018.
  2. National Library of Medicine. Medline Plus Health Topics: Uterine fibroids. Updated on March 21, 2018. Available at: http://www.nlm.nih.gov/medlineplus/uterinefibroids.html. Accessed on April 27, 2018.
Index

Laparoscopic
Myolysis
Percutaneous
Radiofrequency volumetric thermal ablation (RFVTA)
Uterine Fibroids

Document History

Status

Date

Action

Reviewed

07/26/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date”. Rationale, Background/Overview, Definitions and References sections updated.

Reviewed

08/03/2017

MPTAC review. Rationale, Background/Overview and References sections updated.

 

01/01/2017

Updated Coding section with 01/01/2017 CPT changes; removed code 0336T deleted 12/31/2016.

Reviewed

08/04/2016

MPTAC review. References section updated. Removed ICD-9 codes from Coding section.

Reviewed

08/06/2015

MPTAC review. Rationale and References sections updated.

Reviewed

08/14/2014

MPTAC review. Rationale and Reference sections updated.

 

01/01/2014

Updated Coding section with 01/01/2014 CPT and HCPCS changes; removed C9736 deleted 12/31/2013.

Reviewed

08/08/2013

MPTAC review. Clarified title and position statement.  Rationale, References and Index sections updated.

 

07/01/2013

Updated Coding section with 07/01/2013 HCPCS changes.

Reviewed

08/09/2012

MPTAC review. Rationale and References updated.

Reviewed

08/18/2011

MPTAC review. Rationale and References updated.

Reviewed

08/19/2010

MPTAC review. References updated.

Reviewed

08/27/2009

MPTAC review. Rationale and references updated.

Reviewed

08/28/2008

MPTAC review. References updated.

 

02/21/2008

The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.

Reviewed

08/23/2007

MPTAC review. References updated.

Reviewed

09/14/2006

MPTAC review. References updated. Removed CMS NCD, added November 2005 in error.

 

11/21/2005

Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

Revised

09/22/2005

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

Pre-Merger Organizations Last Review Date Document Number

Title

Anthem, Inc.  

No prior document

 

WellPoint Health Networks, Inc.

6/24/2004

3.09.10

Laparoscopic and Percutaneous MRI-Image Guided Techniques for Myolysis as a Treatment of Uterine Fibroids