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MP 4.01.19 Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids

Medical Policy    
Section
OB/Gyn/Reproduction 
Original Policy Date
7/15/04
Last Review Status/Date
Reviewed with literature search/7:2013
Issue
7:2013
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


Description

A variety of minimally invasive treatments have been proposed for treatment of uterine fibroids as alternatives to surgery. Among the minimally invasive approaches are laparoscopic and percutaneous techniques to induce myolysis such as use of Nd:YAG lasers, bipolar electrodes, supercooled cryoprobes and ultrasonographically-guided radiofrequency ablation.

Background

Uterine fibroids are one of the most common conditions affecting women in the reproductive years; symptoms include menorrhagia, pelvic pressure, or pain. Surgery, including hysterectomy and various myomectomy procedures, is considered the gold standard treatment for symptom resolution. However, there is the potential for surgical complications and, in the case of hysterectomy, the uterus is not preserved. In addition, in the case of multiple uterine fibroids, myomectomy can be a time-consuming procedure.

There has been longstanding research interest in developing minimally invasive alternatives for treating uterine fibroids, including procedures that retain the uterus and allow for future childbearing. Treatment options include uterine artery embolization (UAE), addressed in policy 4.01.11 and the transcutaneous procedure magnetic resonance imaging (MRI)-guided focused ultrasound therapy (MRgFUS), addressed in 7.01.109. Various techniques to induce myolysis have also been studied including Nd:YAG lasers, bipolar electrodes, cryomyolysis and radiofrequency ablation. An energy source is used to create areas of necrosis within uterine fibroids, reducing their volume and thus relieving symptoms. Early methods involved the insertion of probes multiple times into the fibroid and were 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 multiple 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 MRI guidance have also been reported.

Regulatory Status

In November 2012, the Acessa™ System (Halt Medical; Brentwood, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA). The device is indicated for percutaneous laparoscopic coagulation and ablation of soft tissue and treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance is one of the listed indications. The technology was previously approved in 2010 at which time it was called the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System (Halt Medical; Brentwood, CA). The intended use of the Halt 2000GI™ system was for percutaneous laparoscopic coagulation and ablation of soft tissue. Unlike FDA clearance of the Acessa™ System, the intended use statement for the Halt 2000GI™ system does not specifically mention treatment of uterine fibroids.


Policy

Laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids are considered investigational.

 


Policy Guidelines

There is no specific CPT code for laparoscopic or percutaneous lysis of uterine fibroids. The following codes might be used for a laparoscopic procedure:

58578: Unlisted laparoscopy procedure, uterus

58999: Unlisted procedure, female genital system

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

77022: Magnetic resonance guidance for, and monitoring of, visceral tissue ablation

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

76940: UItrasound guidance for and monitoring of, parenchymal tissue ablation

76998: Ultrasonic guidance, intraoperative.

There is a category III CPT code effective 1/1/14:

0336T: Laparoscopy, surgical, ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency

This code is not to be reported with codes 76998 and 0071T.


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. 


Rationale

This policy was originally created in 2004 and was updated regularly with searches of the MEDLINE database until it was archived in December 2009. In July 2013, the policy returned to active status and was updated with a search of the MEDLINE database through June 12, 2013.

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. No RCTs comparing laparoscopic and percutaneous myolysis techniques to other uterine fibroid treatments (surgical methods or non-invasive procedures such as uterine artery embolization) were identified in the literature searches. Only uncontrolled case series were identified, and these are summarized below for each of the proposed laparoscopic and percutaneous myolysis technologies.

Laparoscopic Procedures

Ultrasound-guided Radiofrequency Ablation

The evidence base consists of uncontrolled case series. The largest series was published in 2013 by Chudnoff and colleagues. (2) This industry-funded study was prospective and multicenter (9 sites in the U.S. and 2 sites in Latin America). It included 135 pre-menopausal 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. 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. Fifty-three of 127 women (42%, 95% confidence interval [CI]: 32-49%) experienced at least a 50% reduction in the volume of menstrual bleeding from baseline to 12 months post-treatment. 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). Secondary outcomes included change in uterine and fibroid volume. Compared to baseline, the total mean fibroid volume decreased by 45% (95% CI: 39-52%) at 12 months and the mean uterine volume decreased by 25% (95% CI: 19-34%) at 12 months. 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 and colleagues in Mexico reported on 31 women with symptomatic uterine fibroids who underwent ultrasound-guided radiofrequency ablation using the Halt 2000 system. (3) Women wanted to retain their uteri but did not desire future pregnancies. Primary outcome measures included the frequency of adverse events, symptom reduction, the 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 (QOL) score indicating better QOL. 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 QOL 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%).

Earlier series include a 2007 study by Ghezzi and colleagues that reported 1- to 3-year follow-up on 25 consecutive patients. (4) The median diameter of the dominant (assessed) myoma was 5.3 cm (range, 3.0 to 8.6). One of the women (4%) required a hysterectomy before 1 year and was censored from subsequent follow-up. For the remaining patients (n=24), there was a 78% reduction in myoma volume at the 1-year follow-up, with significant improvement in symptoms (from 44 to 7) and QOL (from 63 to 100) scores. Follow-up at 2 (n=18) and 3 (n=9) years showed continued reduction (84%) in myoma volume, and maintenance of improvements in symptoms (0) and QOL (100).

Laser and Bipolar Needles

Several case series were identified and most of these were published in the 1990s. For example, in 1995 Goldfarb and colleagues reported the outcomes of 300 women with symptomatic fibroids no larger than 10 cm who underwent myolysis using either Nd:YAG or bipolar needles. (5) 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 and colleagues, published in 1992, included 75 patients who presented with symptomatic fibroids 5–10 cm in diameter. (6) 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 and colleagues 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. (7) 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. (8, 9)

Cryomyolysis

Cryomyolysis is a technique in which a cryoprobe is inserted into the center of a fibroid. Freezing temperatures of -180 degrees Centigrade create an “iceball” within the fibroid. Several freeze/thaw cycles are typically used. In 1998, Zreik and colleagues published a prospective pilot study with 14 patients, and in in 2004, Zupi and colleagues presented their experience with 20 patients. (10, 11) 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 reported the 1-year follow-up of these patients. (12) 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 (MRI)-guided laser ablation

In 2002, Hindley and colleagues reported on a case series of 66 patients with symptomatic fibroids who were treated with MRI-guided percutaneous Nd:YAG laser myolysis. (13) Outcome measures included assessment of fibroid size and responses to a menorrhagia questionnaire. The mean reduction in fibroid size was 31%. Compared to 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

A search of the online clinicaltrials.gov database in June 2013 did not identify any ongoing randomized trials evaluating laparoscopic or percutaneous techniques for the myolysis of uterine fibroids.

Several additional case series are ongoing:

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) (NCT01840124) (14): This single-arm 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.

Fibroid Ablation Study - Large Fibroids (FAST-L) (NCT01539187) (15): The single-arm study is being conducted at a number of sites outside of the U.S. (i.e., in Mexico, the Netherlands and the 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 one 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 the U.S. Food and Drug Administration [FDA]). The primary outcome is the change in fibroid perfused volume.

Summary

Various laparoscopic and percutaneous techniques for the myolysis of uterine fibroids have been proposed. Data on these procedures are inadequate to permit conclusions regarding their impact on health outcomes. Only case series are available, mainly with small sample sizes. Data are needed from well-designed randomized controlled trials comparing the new technologies to surgery and/or other minimally invasive procedures. Moreover, the impact of these techniques on fertility need to be better understood, as it is hoped that laparoscopic and/or percutaneous myolysis procedures will preserve fertility. However, the published articles on myolysis techniques primarily include women who do not desire future childbearing, and there is a lack of studies reporting successful pregnancies after treatment with these techniques. Because of these deficiencies in the published evidence, laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids are considered investigational.

Practice Guidelines and Position Statements

In August 2008, the American College of Obstetricians and Gynecologists issued a Practice Bulletin titled “Alternatives to Hysterectomy in the Management of Leiomyomas”. (16) 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.

References:

 

  1. Jones S, O'Donovan P, Toub D. Radiofrequency ablation for treatment of symptomatic uterine fibroids. Obstet Gynecol Int 2012; 2012:194839.
  2. Chudnoff SG, Berman JM, Levine DJ et al. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol 2013; 121(5):1075-82.
  3. Garza Leal JG, Hernandez Leon I, Castillo Saenz L et al. 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):364-71.
  4. Ghezzi F, Cromi A, Bergamini V et al. Midterm outcome of radiofrequency thermal ablation for symptomatic uterine myomas. Surg Endosc 2007; 21(11):2081-5.
  5. Goldfarb HA. Bipolar laparoscopic needles for myoma coagulation. J Am Assoc Gynecol Laparosc 1995; 2(2):175-9.
  6. Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med 1992; 37(7):636-8.
  7. Nisolle M, Smets M, Malvaux V et al. Laparoscopic myolysis with the Nd:YAG laser. J Gynecol Surg 1993; 9(2):95-9.
  8. Donnez J, Squifflet J, Polet R et al. Laparoscopic myolysis. Hum Reprod Update 2000; 6(6):609-13.
  9. Phillips DR, Nathanson HG, Milim SJ et al. Laparoscopic Leiomyoma Coagulation. J Am Assoc Gynecol Laparosc 1996; 3(4, Supplement):S39.
  10. 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):33-8.
  11. 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):639-43.
  12. 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):343-6.
  13. Hindley JT, Law PA, Hickey M et al. Clinical outcomes following percutaneous magnetic resonance image guided laser ablation of symptomatic uterine fibroids. Hum Reprod 2002; 17(10):2737-41.
  14. Sponsored by University of California (San Francisco). Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) (NCT01840124). Available online at: www.clinicaltrials.gov. Last accessed June, 2013.
  15. Sponsored by Gynesonics. Fibroid Ablation Study - Large Fibroids (FAST-L) (NCT01539187). Available online at: www.clinicaltrials.gov. Last accessed June, 2013.
  16. American College of Obstetricians and Gynecologists (ACOG). Alternatives to hysterectomy in the management of leiomyomas. ACOG practice bulletin; no. 96. Available online at: www.guideline.gov. Last accessed June, 2013. 
  17.  

Codes

Number

Description

CPT 

 

See Policy Guidelines

 

0336T

Laparoscopy, surgical, ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency (new code effective 1/1/14)

ICD-9 Diagnosis 

 

investigational for all relevant diagnoses

 

218.0 – 218.9

Uterine leiomyomata code range

ICD-10-CM (effective 10/1/14)  

investigational for all relevant diagnoses

  D25.0-D25.9 Leiomyoma of uterus, code range
ICD-10-PCS (effective 10/1/14)   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.
  0U593ZZ, 0U594ZZ, 0U598ZZ Surgical, female reproductive system, destruction, uterus, code range

Index

Bipolar Electrodes, Treatment of Uterine Fibroids
Fibroids, Uterus, Laparoscopic and Percutaneous Treatment
Laser, Laparoscopic Treatment of Uterine Fibroids
MRI Guided Percutaneous Treatment of Uterine Fibroids
Uterine Fibroids, Laparoscopic Techniques of Myolysis
 


Policy History
Date Action Reason
07/15/04 Add policy to Obstetrics and Gynecology section New policy
05/23/05 Replace policy Policy updated with literature search; no change in policy statement.
7/20/06 Replace policy Policy updated with literature search; no change in policy statement; reference numbers 11–13 added
12/13/07 Replace policy Policy updated with literature search; references 17 and 18 added; no change in policy statement. MRI guidance code number updated.
1/08/09 Replace policy  Policy updated with literature search; reference numbers 19-21 added; no change in policy statement
7/11/13 Replace policy Policy updated with literature search through June 12, 2013. Rationale substantially rewritten. References 1-3 and 14-15 added; other references renumbered or removed. No change in policy statement.