BlueCross BlueShield of Tennessee Medical Policy Manual

Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids

DESCRIPTION

A variety of minimally invasive treatments have been proposed for treatment of uterine fibroids. Among these approaches are laparoscopic and percutaneous techniques to induce myolysis (shrink or degenerate the tissue) using:

The earlier procedures involved inserting probes multiple times into the fibroid and were performed without imaging guidance. Concerns about serosal injury and abdominopelvic adhesions with these techniques were raised. A newer technology has been developed to perform myolysis laparoscopically using ultrasound guided radiofrequency ablation. However, the impact of these techniques on fertility need to be better understood.

Uterine fibroids (i.e., uterine leiomyomas or uterine myomas) are one of the most common conditions affecting women in their reproductive years. Symptoms associated with uterine fibroids include heavy or prolonged menstrual bleeding, pelvic pressure or pain, urinary frequency, and reproductive dysfunction. Surgery, including hysterectomy and various myomectomy procedures, is considered standard treatment for symptom resolution.

POLICY

See also:  MRI-Guided Focused Ultrasound (MRgFUS)

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Data on these procedures are inadequate to permit conclusions regarding their impact on health outcomes. Because of these deficiencies in the published evidence, laparoscopic and percutaneous techniques of myolysis as a treatment of uterine fibroids are considered investigational.

SOURCES 

American College of Obstetricians and Gynecologists. (2008, August; reaffirmed 2016). Alternatives to hysterectomy in the management of leiomyomas. ACOG Practice Bulletin Number 96. Retrieved November 6, 2017 from www.acog.org.

Berman, J., Guido, R., Garza Leal, J., Pemueller, R., Whaley, F., Chudnoff, S., et al. (2014). Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas. Journal of Minimally Invasive Gynecology, 21 (5), 767-774. Abstract retrieved November 6, 2017 from PubMed database.

BlueCross BlueShield Association. Medical Policy Reference Manual. (2017, August). Laparoscopic and percutaneous techniques for the myolysis of uterine fibroids (4.01.19). Retrieved November 6, 2017 from BlueWeb. (19 articles and/or guidelines reviewed)

Brucker, S., Hahn, M., Kraemer, D., Taran, F., Isaacson, K. & Krämer, B. (2014). Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. International Journal of Gynecology and Obstetrics, 125 (2014), 261–265. (Level 2 evidence)

Chudnoff, S. G., Berman, J. M., Levine, D. J., Harris, M., Guido, R. S., & Banks, E. (2013). Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstetrics and Gynecology, 121 (5), 1075-1082. (Level 2 evidence)

Guido, R., Macer, J., Abbott, K., Falls, J., Tilley, I., Chudnoff, S. (2013) Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years’ outcome from the Halt trial. Health and Quality of Life Outcomes 2013, 11, 139. (Level 3 evidence)

Hahn, M., Brucker, S., Kraemer, D., Wallwiener, M., Taran, F., Wallwiener, C., et al. (2015). Radiofrequency volumetric thermal ablation of fibroids and laparoscopic myomectomy: long-term follow-up from a randomized trial. Geburtshilfe Frauenheilkd, 75 (5), 442-449. Abstract retrieved November 6, 2017 from PubMed database.

Havryliuk, Y., Setton, R., Carlow, J., & Shaktman, B. (2017). Symptomatic fibroid management: systematic review of the literature. Journal of the Society of Laparoendoscopic Surgeons, 21 (3), DOI: 10.4293/JSLS.2017.00041. (Level 2 evidence)

Krämer, B., Hahn, M., Taran, F., Kraemer, D., Issacson, K., & Brucker, S. (2016). Interim analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy. International Journal of Gynaecology and Obstetrics, 133 (2), 206-211. Abstract retrieved November 6, 2017 from PubMed database.

U. S. Food and Drug Administration. (2012, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K121858 (Acessa Guidance). Retrieved July 29, 2013 from http://www.accessdata.fda.gov. 

U. S. Food and Drug Administration. (2012, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K040302 (VersaPoint™). Retrieved May 21, 2015 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2012, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K113810 (Alma Lasers). Retrieved May 21, 2015 from http://www.accessdata.fda.gov.   

Winifred S. Hayes, Inc. Health Technology Brief. (2016, October). Laparoscopic radiofrequency volumetric thermal ablation (Acessa system; Halt Medical inc.) for treatment of uterine fibroids. Retrieved November 6, 2017 from www.Hayesinc.com/subscribers. (24 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  1/11/2014

MOST RECENT REVIEW DATE:  12/14/2017

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