Surgery Section - Endometrial Ablation

IMPORTANT REMINDER

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PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION

Ablation or destruction of the endometrium is used to treat menorrhagia in women who fail standard therapy. The procedure is typically preceded by hormonal treatment to thin the endometrium. It is considered a less invasive alternative to hysterectomy; however, as with hysterectomy, the procedure is not recommended for women who wish to preserve their fertility.

Techniques for endometrial ablation are generally divided into two categories:

Hysteroscopic techniques
Hysteroscopic techniques require skilled surgeons and, due to the requirement for cervical dilation, use of general or regional anesthesia. In addition, the need for the instillation of hypotonic distension media creates a risk of pulmonary edema and hyponatremia such that very accurate monitoring of fluids is required.

The initial hysteroscopic technique involved photovaporization of the endometrium using an Nd-YAG laser.  This was followed by electrosurgical ablation using an electrical rollerball or electrical wire loop. (The latter technique is also known as transcervical resection of the endometrium or TCRE). Hydrothermal ablation is another technique involving hysteroscopy.

Non-hysteroscopic techniques
Non-hysteroscopic techniques can be performed without general anesthesia and do not involve use of a fluid distention medium. Techniques include thermal fluid-filled balloon, cryosurgical endometrial ablation, instillation of heated saline, and RF ablation.

Regulatory Status

The U.S. Food and Drug Administration (FDA) indicates that endometrial devices are for use in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. FDA-approved devices for endometrial ablation 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. Examples of devices for endometrial ablation are:

• The Hydro ThermAblator® system (Boston Scientific, Natick, MA): This involves the instillation and circulation of heated saline into the uterus using hysteroscopic guidance.
• The Genesys HTA™ system (also Boston Scientific), a newer version of this technology that includes features such as a smaller console and simplified set-up requirements, was approved by the FDA in May 2010.
• The Microwave Endometrial Ablation (MEA) system (Microsulis Medical, U.K.): This delivers fixed-frequency microwave energy and may be performed in a physician’s office but does require use of the hysteroscope.
• The ThermaChoice® device (J&J Ethicon Gynecare, Somerville, NJ): This device ablates endometrial tissue by thermal energy heating of sterile injectable fluid within a silicone balloon. Endometrial ablation will only work when there is direct contact between the endometrial wall and the fluid-filled balloon. Therefore, patients with uteri of abnormal shape, resulting from tumors such as myomas or polyps, or large size, due to fibroids, are generally not considered candidates for this procedure.
• The NovaSure™ impedance-controlled endometrial ablation system (Cytyc Corp, Marlborough, MA): The system delivers RF energy to the endometrial surface. The device consists of an electrode array on a stretchable porous fabric that conforms to the endometrial surface.
• Her Option™ Uterine Cryoablation Therapy™ system (American Medical Systems, Minnetonka, MN): The system consists of, in part, a cryoprobe that is inserted through the cervix into the endometrial cavity. When cooled, an ice ball forms around the probe, which permanently destroys the endometrial tissue. Cryoablation is typically monitored by abdominal ultrasound.

POLICY/CRITERIA

SCIENTIFIC BACKGROUND

Three published systematic reviews evaluated the accumulated evidence for endometrial ablation.  The three reviews address both first- generation techniques (laser ablation, electrical wire loop, rollerball, or vaporizing electrode procedure) and second-generation techniques (newer techniques that generally do not require hysteroscopy such as balloon ablation, microwave ablation, and electrode ablation).

• A 1991 BlueCross BlueShield Technology Assessment Center (TEC) Assessment concluded that endometrial ablation using either an Nd-YAG laser or a resecting loop was an effective treatment of menorrhagia unresponsive to hormone treatment or dilation and curettage.^[1]
• A Cochrane systematic review of studies comparing the efficacy and safety of different endometrial ablation techniques was published in 2005 and updated in 2009.^[2] The review included RCTs that compared 2 ablation techniques and assessed amenorrhea and patient satisfaction.
  
  A total of 21 studies with 3,395 premenopausal women were eligible for the review. Five of the trials compared two “first generation” ablation methods (laser ablation, electrical wire loop, rollerball, or vaporizing electrode procedure). Two trials compared “second generation” techniques to one another.  The remaining 14 trials compared first- to second-generation procedures. There were only 1 or 2 studies on any given comparison of techniques; the exception was balloon ablation versus rollerball for which there were 3 studies.
  
  The investigators also conducted a meta-analysis that combined studies comparing first- and second-generation techniques. A pooled analysis of 12 studies (total n=2,085) did not find a significant difference in the rate of amenorrhea at 1 year (OR: 0.92; 95% CI: 0.62–1.37). Eleven studies (total n=1,690) reported satisfaction rates at 1 year, and there was not a significant difference between first-and second-generation techniques. The absolute rates of satisfaction were high in both groups; 88% among those who received first-generation techniques and 91% among those who received second-generation techniques.
  
  In a pooled analysis of 7 studies (total n=1,058), there was no significant difference in the rate of additional surgeries within 1 year (OR: 0.74; 95% CI: 0.42–1.31). Data on fluid overload were available from 4 trials that compared first- and second-generation procedures. There was a total of 10/327 (3%) cases of fluid overload using first-generation techniques and 0/354 using second-generation techniques (OR=0.17; 95% CI: 0.04 to 0.77). Compared to first-generation techniques, second-generation techniques were also associated with a significantly lower risk of perforation (OR: 0.32; 95% CI: 0.10 to 1.0), cervical lacerations (OR: 0.22; 95% CI: 0.08-0.6), and hematometra (OR: 0.31; 95% CI: 0.11 to 0.85). In contrast, second-generation techniques were associated with a significantly increased risk of nausea and vomiting (OR: 2.4; 95% CI: 1.6 to 3.9) and uterine cramping (OR: 1.8; 95% CI: 1.1 to 2.8). The meta-analysis did not find evidence of significant differences in other complications rates or in secondary outcomes such as inability to work or need for additional surgery or hysterectomy.
  
  The authors of the Cochrane review concluded that, overall, the existing evidence suggests that success rates and complications profiles of second-generation techniques compare favorably with the first generation hysteroscopic techniques.
  
  
• In 2011, the Health Technology Assessment (HTA) program in the U.K. conducted a meta-analysis of individual patient data from RCTs evaluating second-line treatments for menorrhagia.^[3] They identified data on 2,448 women from 14 trials comparing first- and second-generation endometrial ablation devices and data on 1,127 women from 7 trials comparing first-generation devices to hysterectomy. A limitation of the review is that individual patient data were not available for approximately 35% of women randomized in the trials. The most frequently measured outcome in the studies was patient satisfaction/dissatisfaction and this was used as the primary outcome of the meta-analysis. After 12 months of follow-up, 7.3% (57/454) of women treated with first-generation endometrial ablation devices and 5.3% (23/432) of women who had a hysterectomy were dissatisfied with their treatment outcome. This difference was statistically significant, favoring hysterectomy (OR: 2.46, 95% CI: 1.54 to 3.93, p=0.0002). Rates of dissatisfaction were similar among women treated with first-generation endometrial ablation devices (123/1,006 [12.2%]) and second-generation devices (110/1,034 [10.6%], p=0.20). The authors noted that rates of dissatisfaction were low for all treatments.
  
  The HTA also conducted meta-analyses on several clinical outcomes. For example, when first- and second-generation endometrial ablation devices were compared, there was not a significant difference between groups in the rate of amenorrhea after 12 months. When findings from 13 studies were pooled, rates of amenorrhea were 326/899 (36%) with first-generation devices and 464/1,261 (37%) with second-generation devices (OR: 1.12; 95% CI: 0.93 to 1.35). There were insufficient data to conduct meta-analyses of longer-term amenorrhea rates. Similarly, the rates of menorrhagia after 12 months did not differ between groups. In a pooled analysis of 12 studies, rates were 111/899 (12.3%) with first-generation devices and 151/1,281 (11.8%) after second-generation devices (pooled OR: 0.97, 95% CI: 0.74 to 1.28). In addition, a pooled analysis of 6 studies did not find a significant difference in repeat endometrial ablations over 12 months after initial treatment with first-generation devices (4/589, 0.7%) or second-generation devices (4/880, 0.5%) (OR: 0.71, 95% CI: 0.17 to 2.94). The proportion of women requiring hysterectomy within 12 months after endometrial ablation did not differ significantly when first-generation devices (39/933 [4.2%]) or second-generation devices (35/1,343 [2.6%]) were used (OR: 0.77; 95% CI: 0.47 to 1.24 [11 studies]).
  
  In addition to the meta-analyses of data from published studies, the HTA included an analysis of individual patient data from national databases in Scotland to evaluate long-term outcomes after hysterectomy or endometrial ablation. The investigators identified a total of 37,120 women who underwent hysterectomy and 11,299 women who underwent endometrial ablation for dysfunctional uterine bleeding between 1989 and 2006. Women who received endometrial ablation were significantly older (mean of 42.5 years) compared to those receiving hysterectomy (mean of 41.0 years). The type of endometrial ablation device could not be determined. The median duration of follow-up was 6.2 years in the endometrial ablation group and 11.6 years in the hysterectomy group. During follow-up, 962 (8.5%) women who received endometrial ablation had additional gynecologic surgery compared to 1,446 (3.9%) women who had hysterectomy; this difference was statistically significant (adjusted hazard ratio [HR]: 3.56, 95% CI: 3.26-3.89). The most common types of additional surgery after endometrial ablation were intrauterine procedures (n=577, 5.1%) and repeat endometrial ablation (n=278, 2.5%). However, women who had initial endometrial ablation procedures were significantly less likely than those with initial hysterectomies to have surgery for pelvic floor repair (0.9% vs. 2.2%, respectively, adjusted HR: 0.50 to 0.77). Women were also less likely to have tension-free vaginal tape surgery for stress urinary incontinence after endometrial ablation than after hysterectomy (0.5% vs. 1.1%, respectively, adjusted HR: 0.55, 95% CI: 0.41 to 0.74).

Practice Guidelines and Position Statements

• Practice Committee of the American Society for Reproductive Medicine (ASRM)
  
  In 2008, ASRM reviewed their 2006 Practice Committee report and reissued their statement on indications and options for endometrial ablation.^[4] Conclusions were:
  
  
  • “Endometrial ablation is an effective therapeutic option for the management of menorrhagia.
  • Hysteroscopic and nonhysteroscopic techniques for endometrial ablation offer similar rates of symptom relief and patient satisfaction.
  • Later definitive surgery may be required in 6% to 20% of women after endometrial ablation.
  • Women who undergo hysterectomy after a failed endometrial ablation report significantly more satisfaction after 2 years of follow-up.
  • Endometrial ablation generally is more effective when the endometrium is relatively thin.
  • Ideally, hysteroscopic methods for endometrial ablation should be performed using a fluid monitoring system to reduce the risks and complications relating to fluid overload and electrolyte imbalance.
  • Nonhysteroscopic methods for endometrial ablation require less skill and operating time.”
    
    
• American Congress of Obstetricians and Gynecologists (ACOG)
  
  ACOG published a guideline on endometrial ablation in 2007.^[5] Recommendations they assessed as being based on good and consistent evidence include:
  
  
  • “For women with normal endometrial cavities, resectoscopic endometrial ablation and nonresectoscopic endometrial ablation systems appear to be equivalent with respect to successful reduction in menstrual flow and patient satisfaction at 1 year following index surgery.
  • Resectoscopic endometrial ablation is associated with a high degree of patient satisfaction but not as high as hysterectomy. “

Summary

There is evidence from multiple randomized controlled trials that endometrial ablation improves the net health outcome in women who have failed prior treatment for menorrhagia and are otherwise eligible for hysterectomy. Moreover, meta-analyses of randomized controlled trials suggest similar benefits with first-generation (hysteroscopic) techniques and second-generation (mainly nonhysteroscopic) techniques. There is a lack of consistent evidence that any one ablation technique is superior to another.

REFERENCES

1. TEC Assessment 1991. "Intrauterine ablation or resection of the endometrium for menorrhagia." BlueCross BlueShield Association Technology Evaluation Center, Vol. 6 p. 296.
2. Lethaby A, Hickey M, Garry R, Penninx J. Endometrial resection / ablation techniques for heavy menstrual bleeding. Cochrane Database Syst Rev. 2009(4):CD001501.  PMID: 19821278
3. Bhattachara S, Middleton LJ, Tsourapas A et al. Hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis. Health Technology Assessment 2011; Vol. 15. No. 19. [cited 06/2011]; Available from: http://www.hta.ac.uk/fullmono/mon1519.pdf
4. Indications and options for endometrial ablation. Fertil Steril. 2008 Nov;90(5 Suppl):S236-40.  PMID: 19007637
5. American College of Obstetricians and Gynecologists. Endometrial Ablation. 2007 ACOG Practice Bulletin No. 81.   [cited 06/2011]; Available from: http://www.guideline.gov

CROSS REFERENCES

None

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