CAM 40119

Laparoscopic, Percutaneous and Transcervical Techniques for the Myolysis of Uterine Fibroids

Category:Ob/Gyn/Reproduction   Last Reviewed:September 2019
Department(s):Medical Affairs   Next Review:September 2020
Original Date:July 2004    

A variety of minimally invasive treatments have been proposed for treatment of uterine fibroids as alternatives to surgery. Among these approaches are laparoscopic and percutaneous techniques to induce myolysis, which includes radiofrequency volumetric thermal ablation (RFVTA), laser and bipolar needles, cryomyolysis and magnetic resonance imaging (MRI)-guided laser ablation.

For individuals who have uterine fibroids who receive RFVTA, the evidence includes 1 randomized controlled trial (RCT). Relevant outcomes are symptoms, quality of life and treatment-related morbidity. The RCT found that RFVTA was noninferior to laparoscopic myomectomy on the study’s primary outcome, length of hospitalization. A number of secondary outcomes were reported at 12 and 24 months and there were no significant between-group differences on any of these. There were methodological limitations to this study, e.g., lack of intention-to-treat analysis, and the statistical hypotheses and analyses were not well-described. As a result, the validity of the reported results is decreased and no definitive conclusions can be made. Additional high-quality RCTs are needed to determine the effect of RFVTA on long-term health outcomes. Moreover, future studies should have a greater focus on fertility outcomes following RFVTA. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have uterine fibroids who receive laser or bipolar needles, the evidence includes case series. Relevant outcomes are symptoms, quality of life and treatment-related morbidity. The case series were published in the 1990s, and the procedures used may not reflect current practice. RCTs comparing laser or bipolar needles to alternative treatments for uterine fibroids are needed to adequately evaluate the safety and efficacy of this technology. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have uterine fibroids who receive cryomyolysis, the evidence includes case series. Relevant outcomes are symptoms, quality of life and treatment-related morbidity. There were a small number of case series and sample sizes were small (≤ 20 patients). RCTs comparing cryomyolysis to alternative treatments for uterine fibroids are needed to adequately evaluate the safety and efficacy of this technology. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have uterine fibroids who receive MRI-guided laser ablation, the evidence includes 1 case series. Relevant outcomes are symptoms, quality of life and treatment-related morbidity. A single case series (N=66) is insufficient for evaluating the technology. RCTs comparing MRI-guided laser ablation to alternative treatments for uterine fibroids are needed to adequately evaluate the safety and efficacy of this technology. The evidence is insufficient to determine the effects of the technology on health outcomes.

Uterine Fibroids
Uterine fibroids, also known as leiomyomas, are among the most common conditions affecting women in their reproductive years; symptoms include menorrhagia, pelvic pressure, or pain.

Surgery, including hysterectomy and various myomectomy procedures, is considered the criterion standard for symptom resolution. However, there is the potential for surgical complications and, in the case of a hysterectomy, the uterus is not preserved. In addition, multiple myomectomy may be associated with longer operating time, postoperative febrile morbidity, and development of pelvic adhesions. There has been long-standing research interest in developing minimally invasive alternatives for treating uterine fibroids, including procedures that retain the uterus and permit future childbearing. Treatment options include uterine artery embolization (see evidence review 4.01.11) and the transcutaneous magnetic resonance imaging-guided focused ultrasound therapy (see evidence review 7.01.109). Various techniques to induce myolysis have also been studied including Nd:YAG lasers, bipolar electrodes, cryomyolysis, and radiofrequency ablation. With these techniques, an energy source is used to create areas of necrosis within uterine fibroids, reducing their volume and thus relieving symptoms. Early methods involved multiple insertions of probes into the fibroid, performed without imaging guidance. There were concerns about serosal injury and abdominopelvic adhesions with these techniques, possibly due to the multiple passes through the serosa needed to treat a single fibroid.1, Newer systems using radiofrequency energy do not require repetitive insertions of needle electrodes. Ultrasonography is used laparoscopically to determine the size and location of fibroids, to guide the probe, and to ensure the probe is in the correct location so that optimal energy is applied to the fibroid. Percutaneous approaches using magnetic resonance imaging guidance have also been reported

Regulatory Status
In 2012, the Acessa™ System (Acessa Health, formerly Halt Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for percutaneous laparoscopic coagulation and ablation of soft tissue and treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance (K121858). The technology was previously approved in 2010, at which time it was called the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System. In 2014, the ultrasound guidance system received marketing clearance from FDA (K132744). FDA product code: GEI.

Cryoablation is a surgical procedure that uses previously approved and available cryoablation systems; and as a surgical procedure, it is not subject to regulation by FDA. Other products addressed in this review (eg,Nd:YAG lasers, bipolar electrodes) have long-standing FDA approval, and there are no products specifically approved for treatment of uterine fibroids. 

Related Policies:
40111 Occlusion of Uterine Arteries Using Transcatheter Embolization
701109 MRI-Guided Focused Ultrasound (MRqFUS)

Laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa) for the treatment of uterine fibroids may be considered MEDICALLY NECESSARY for the following:

  • Excessive uterine bleeding as evidenced by either profuse bleeding lasting more than eight days, or anemia due to acute or chronic blood loss; or
  • Pelvic discomfort caused by leiomyomata, manifested as:
    • Acute severe pain, OR
    • Chronic lower abdominal pain; OR
    • Low back pressure; OR
    • Bladder pressure with urinary frequency not due to urinary tract infection.

Laparoscopic, percutaneous and transcervical techniques of myolysis as a treatment of uterine fibroids other than laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa) are considered INVESTIGATIONAL including Nd:Yag Lasers, bipolar electrodes and supercooled cryoprobes. 

Uterine power  or mechanical morcellation in LAPAROSCOPIC HYSTERECTOMY OR LAPAROSCOPIC MYOMECTOMY for the treatment of fibroids is considered INVESTIGATIONAL. Use of a morcellator should be filed if it was used.

MRI guidance performed in conjunction with percutaneous myolysis of uterine fibroids is considered INVESTIGATIONAL.  

Policy Guidelines
The following codes might be used for a laparoscopic procedure:

58674 Laparoscopy, surgical, ablation of uterine fibroid(s) including intraoperative ultrasound guidance and monitoring, radiofrequency 

58578 Unlisted laparoscopy procedure, uterus

58999 Unlisted procedure, female genital system (nonobstetrical).

For percutaneous procedures, the following code would likely be used to describe the magnetic resonance imaging component of the procedure:

77022 Magnetic resonance guidance for, and monitoring of, parenchymal tissue ablation.

For ultrasound guidance, one of the following codes might be used:

76940 Ultrasound guidance for and monitoring of, parenchymal tissue ablation

76998 Ultrasonic guidance, intraoperative.

In November 2014, the U.S. Food and Drug Administration published a safety communication on laparoscopic power morcellators used for myomectomy and hysterectomy in most women. (Morcellators are not otherwise addressed herein). The Administration recommended that manufacturers of these devices include in their product labels a boxed safety warning and wording on contraindications (see 

Benefit Application
BlueCard®/National Account Issues
Some of the lysis procedures are specialized and are not widely disseminated; therefore, requests for out-of-network referral may occur. 

Randomized controlled trials (RCTs), which minimize selection bias and confounding, are the optimal study design for evaluating the safety and efficacy of a new medical intervention. Only 1 RCT comparing a laparoscopic and percutaneous myolysis technique with another uterine fibroid treatment (i.e., surgical methods or noninvasive procedures such as uterine artery embolization) was identified in literature searches. The RCT evaluated laparoscopic radiofrequency ablation and is described next.

The remainder of the literature consists of uncontrolled case series.

Laparoscopic Procedures
Ultrasound-guided Radiofrequency Ablation
In 2014, Brucker et al. in Germany published an industry-sponsored RCT comparing radiofrequency ablation with the Acessa system (Halt Medical) to laparoscopic myomectomy.(2) The study included 51 premenopausal women at least 18 years old with symptomatic uterine fibroids less than 10 cm in any diameter and a uterine size of less than 17 weeks of gestation. Pregnancy and lactation were exclusion criteria. Prior to randomization, all participants underwent laparoscopic ultrasound mapping. Data on 50 of the 51 women were analyzed. The primary study outcome, mean time to hospital discharge (SD), was 10.0 (5.5) hours in the radiofrequency ablation group and 29.9 (14.2) hours in the myomectomy group. The criteria for noninferiority was met at a significance level of p less than 0.001. All patients in the myomectomy group were hospitalized overnight; although not explicitly stated, this appeared to be the standard procedure at the study hospital. In the Acessa group, there was 1 unplanned hospitalization due to unexplained vertigo and 4 hospitalizations as standard procedure because the patients underwent adhesiolysis in addition to radiofrequency ablation. The study did not report outcomes beyond the perioperative period.

In addition to the RCT, several uncontrolled case series were identified. Data on the largest series was initially published in 2013 by Chudnoff et al. (3) This industry-funded study was prospective and multicenter (9 sites in the U.S., 2 sites in Latin America). It included 135 premenopausal women at least 25 years old with symptomatic uterine fibroids, a uterine size of 14 weeks of gestation or less and 6 or fewer treatable fibroids, with no single fibroid larger than 7 cm. In addition, women desired to preserve their uteri but not to have children in the future. Radiofrequency thermal ablation was conducted using the Acessa system. According to the study protocol, most fibroids less than 1 cm in diameter were not treated. The primary efficacy outcomes were change in the volume of menstrual bleeding and the surgical reintervention rate after 12 months. A total of 127 of 135 women (94%) completed the study. From baseline to 12 months, 53 of 127 women (42%; 95% confidence interval, 32% to 49%) experienced at least a 50% reduction in the volume of menstrual bleeding. Most women (104 of 127, 82%) experienced a decrease in menstrual bleeding at 12 months. Only 1 woman underwent a surgical reintervention through 12 months (this woman had been lost to follow-up and was not included in the other efficacy analyses). Three-year outcomes were reported by Berman et al. in 2014.(4) A total of 104 of the 135 women who participated in the study (77%) were evaluable at 3 years. Fourteen women underwent reintervention over the 3 years to treat uterine fibroid symptoms. Eleven women had hysterectomies, 2 had myomectomies and 1 had uterine artery embolization. Bleeding outcomes were not reported for the cohort at 3 years, but the authors stated that quality-of-life variables improved from baseline to 36 months and that most of the improvement in quality-of-life occurred in the 3 months following the procedure. The main limitation of the study was lack of a control or comparison group.

Other, smaller case series have also been published. For example, in 2011 Garza Leal et al. in Mexico reported on 31 women with symptomatic uterine fibroids who underwent ultrasound-guided radiofrequency ablation using the Halt 2000 system.(5) Women wanted to retain their uteri but did not desire future pregnancies. Primary outcome measures included the frequency of adverse events, symptom reduction, reintervention rate and scores on the Uterine Fibroid Symptom and Quality-of-Life (UFSQOL) questionnaire. Scores on the UFSQOL had a potential range of 0 to 100, with a lower symptom score indicating fewer symptoms and a higher quality-of-life score. None of the patients underwent another procedure related to uterine fibroid treatment during the follow-up period. Twenty-nine women (94%) completed 6 months of follow-up and 19 (61%) completed 12 months of follow-up. Seven of 31 women (23%) reported adverse events. These included 4 cases of abdominal pain after the procedure, 2 urinary tract infections and 1 case of an abdominal wall vascular injury. At 6 months, the mean symptom score decreased by 72% and the mean quality of life score increased by 91%. Exact numbers were not reported. At baseline, 25 of 31 women (81%) reported heavy or very heavy menstrual bleeding. At 6 months, this was reported by 2 of 29 women (7%).

Laser and Bipolar Needles
Several case series were identified, and most of these were published in the 1990s. For example, in 1995, Goldfarb et al. reported the outcomes of 300 women with symptomatic fibroids no larger than 10 cm who underwent myolysis using either Nd:YAG or bipolar needles.(6) The author reported that the coagulating effect of the bipolar needle devascularized the fibroids, and the resulting shrinkage was comparable with that produced by Nd:YAG laser. Another study by Goldfarb et al., published in 1992, included 75 patients who presented with symptomatic fibroids 5 to 10 cm in diameter.(7) Symptoms included pelvic pain, pressure, dyspareunia and recurrent menorrhagia. The Nd:YAG laser was inserted into the fibroid multiple times; for example, 75 to 100 punctures were used to coagulate a 5-cm fibroid. Based on assessment by endovaginal ultrasound, the fibroids regressed in size and, after 6 to 14 months of follow-up, the size remained stable. No patient experienced significant complications. In 1993, Nisolle et al. reported on a case series of 48 women who were apparently offered myolysis instead of myomectomy if they had completed childbearing. Although the report states that 28 of the 48 had more than 2 fibroids, it is not clear if all fibroids were treated in each patient, and if not, how the treated fibroids were selected.(8) The authors reported that maximal decrease in fibroid size had occurred by 6 months. However, there is no report of associated patient symptoms.

Several authors have reported pelvic adhesions as a complication, presumably due to thermal damage to the serosal surface. In addition, the Nd:YAG laser produces a significant amount of smoke, which can obscure visibility.(9,10)

Cryomyolysis is a technique in which a cryoprobe is inserted into the center of a fibroid. Freezing temperatures of -180° Centigrade create an “iceball” within the fibroid. Several freeze/thaw cycles are typically used. In 1998, Zreik et al. published a prospective pilot study with 14 patients, and in in 2004, Zupi et al. presented their experience with 20 patients.(11,12) In both of these small case series, the authors reported that patients had symptom resolution. In the Zreik study, patients were given a gonadotropin-releasing hormone (GnRH) agonist before the procedure to reduce the size of the fibroid. Cryomyolysis maintained or slightly reduced the post-GnRH uterine size. In contrast, in the Zupi study, GnRH was not used, and cryomyolysis was associated with a 25% reduction in fibroid size. In 2005, Zupi et al. reported the 1-year follow-up of these patients. (13) Mean shrinkage in fibroid size continued until 9 months after surgery, to a mean volume reduction of 60%. Patients reported absence of symptoms. Interpretation of these studies is limited due to their small size and lack of a comparison group.

Percutaneous Procedures
Magnetic resonance imaging-guided laser ablation
In 2002, Hindley et al. reported on a case series of 66 patients with symptomatic fibroids who were treated with magnetic resonance imaging (MRI)-guided percutaneous Nd:YAG laser myolysis.(14) Outcome measures included assessment of fibroid size and responses to a menorrhagia questionnaire. The mean reduction in fibroid size was 31%. Compared with a historical control group of women 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 patient. The study did not provide details on the number and location of fibroids.

Ongoing Clinical Trials
Randomized controlled trials:
Post Market TRUST (Treatment Results of Uterine Sparing Technologies) Study (NCT01563783) (15): This industry-sponsored RCT is comparing global fibroid ablation, abdominal or laparoscopic myomectomy and uterine artery embolization. The study is enrolling women who are at least 18 years old and menstruating, have symptomatic uterine fibroids, have a uterine size of no more than 16 weeks’ gestation, have fibroids less than 10 cm in any diameter and who desire uterine conservation. The primary outcomes are the relative costs of the procedures and adverse event rates in the 3 months following the procedures. Estimated enrollment is 260 women, and the expected completion date is December 2019.

Case Series:
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) (NCT01840124) (16): This single-arm uncontrolled study plans to include 100 women with symptomatic uterine fibroids who will be recruited from 5 sites in the University of California Fibroid Network. Patients will be treated with the Acessa system and will be followed for 3 years. The primary outcome is change in fibroid-related symptoms and a secondary outcome is the pregnancy rate after fibroid treatment. The estimated study completion date is June 2017.

Fibroid Ablation Study - Large Fibroids (FAST-L) (NCT01539187) (17): The single-arm uncontrolled study is being conducted at a number of sites outside of the U.S. (i.e., Mexico, the Netherlands, U.K.). It aims to enroll 48 women age 28 and older with a history of excessive bleeding for at least 3 months and at least 1 fibroid with a maximum diameter between 5 cm and 10 cm. Patients will be treated with the VizAblate® ultrasound-guided radiofrequency ablation system and followed for 3 months. (VizAblate has not been cleared by FDA). The primary outcome is the change in fibroid perfused volume. The estimated completion date is June 2015.

Various laparoscopic and percutaneous techniques for the myolysis of uterine fibroids have been proposed. Only 1 RCT has been published, comparing radiofrequency ablation to laparoscopic myomectomy. Outcome reporting in this trial was limited to the perioperative period; longer term outcomes were not reported. The remainder of the evidence base consists of uncontrolled case series, mainly with small sample sizes.

The published articles on myolysis techniques lack well-designed randomized controlled trials comparing the new technologies with surgery and/or other minimally invasive procedures. Because of these deficiencies in the published evidence, laparoscopic and percutaneous techniques of myolysis, other than laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa) for the treatment of symptomatic uterine fibroids are considered experimental, investigational and/or unproven.

Practice Guidelines and Position Statements
In 2012, the American College of Obstetricians and Gynecologists reaffirmed a 2008 Practice Bulletin titled “Alternatives to Hysterectomy in the Management of Leiomyomas.”(18) Recommendations based on good and consistent scientific evidence are that abdominal myomectomy is a safe and effective treatment of women with symptomatic leiomyomas and that uterine artery embolization is a safe and effective option for appropriately selected women who wish to retain their uteri. The bulletin contains no recommendations regarding myolysis utilizing laparoscopic or percutaneous techniques. 


  1. Jones S, O'Donovan P, Toub D. Radiofrequency ablation for treatment of symptomatic uterine fibroids. Obstet Gynecol Int. Oct 2012;2012:194839. PMID 21961009
  2. Sandberg EM, Tummers F, Cohen SL, et al. Reintervention risk and quality of life outcomes after uterine-sparing interventions for fibroids: a systematic review and meta-analysis. Fertil Steril. Apr 2018;109(4):698-707 e691. PMID 29653718
  3. Brucker SY, Hahn M, Kraemer D, et al. Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. Int J Gynaecol Obstet. Jun 2014;125(3):261-265. PMID 24698202
  4. Kramer 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. May 2016;133(2):206-211. PMID 26892690
  5. Hahn M, Brucker S, Kraemer D, et al. Radiofrequency volumetric thermal ablation of fibroids and laparoscopic myomectomy: long-term follow-up from a randomized trial. Geburtshilfe Frauenheilkd. May 2015;75(5):442-449. PMID 26097247
  6. Keltz J, Levie M, Chudnoff S. Pregnancy outcomes after direct uterine myoma thermal ablation: review of the literature. J Minim Invasive Gynecol. May - Jun 2017;24(4):538-545. PMID 28109894
  7. Goldfarb HA. Bipolar laparoscopic needles for myoma coagulation. J Am Assoc Gynecol Laparosc. Feb 1995;2(2):175-179. PMID 9050553
  8. Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. Jul 1992;37(7):636-638. PMID 1387912
  9. Nisolle M, Smets M, Malvaux V, et al. Laparoscopic myolysis with the Nd:YAG laser. J Gynecol Surg. Summer 1993;9(2):95-99. PMID 10171973
  10. Donnez J, Squifflet J, Polet R, et al. Laparoscopic myolysis. Hum Reprod Update. Nov-Dec 2000;6(6):609-613. PMID 11129695
  11. Phillips DR, Nathanson HG, Milim SJ, et al. Laparoscopic leiomyoma coagulation. J Am Assoc Gynecol Laparosc. Aug 1996;3(4 Suppl):S39. PMID 9074213
  12. Zreik TG, Rutherford TJ, Palter SF, et al. Cryomyolysis, a new procedure for the conservative treatment of uterine fibroids. J Am Assoc Gynecol Laparosc. Feb 1998;5(1):33-38. PMID 9454874
  13. 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. Mar 2004;190(3):639-643. PMID 15041993
  14. Zupi E, Marconi D, Sbracia M, et al. Directed laparoscopic cryomyolysis for symptomatic leiomyomata: one-year follow up. J Minim Invasive Gynecol. Jul-Aug 2005;12(4):343-346. PMID 16036195
  15. Hindley JT, Law PA, Hickey M, et al. Clinical outcomes following percutaneous magnetic resonance image guided laser ablation of symptomatic uterine fibroids. Hum Reprod. Oct 2002;17(10):2737-2741. PMID 12351555
  16. American College of Obstetricians Gynecologists. ACOG practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. Aug 2008;112(2 Pt 1):387-400. PMID 18669742
  17. American College of Obstetricians and Gynecologists (ACOG). Alternatives to hysterectomy in the management of leiomyomas. ACOG practice bulletin No. 96. 2016; Accessed July 23, 2018.

Coding Section 






 See Policy Guidelines.


58674 (effective 1/1/2017) 

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



Investigational for all relevant diagnoses 



Leiomyoma of uterus, code range



ICD-10-PCS codes are only used for inpatient services.


0U593ZZ, 0U594ZZ, 0U598ZZ 

Surgical, female productive system, destruction, uterus, code range

Type of Service 



Place of Service 



Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2013 Forward     


Annual review, no change to policy intent. Updating background, regulatory status, guidelines and references. 


Annual review, no change to policy intent. 


Interim review to add clarifying language surrounding morcellation to indicate that morcellation in relation to a laparoscopic hysterectomy or laparoscopic myomectomy is investigational. 


Interim review updating morcellation language to include power and mechanical morcellation as investigational. 


Updating coding section with 2017 codes. 


Annual review. Updating Title, policy verbage, background, description, rationale, coding section and references. 


Annual review, no change to policy intent. Updating background, description, rationale and references. 


Annual reivew, no change to policy intent. Updated background, description, rationale and references. Added guidelines and regulatory status. 


Annual review. Updated title, rationale, description, references. Added language regarding morcellation being investigational. Added coding section.


Annual review, updated rationale, references and description. Added related policies and benefit application. No change to policy intent.

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