Global Endometrial Ablation for Menorrhagia: The Office Option

Introduction

In the United States, an estimated 10 million new cases of menorrhagia—also known as abnormal uterine bleeding (AUB) or, more recently, as heavy menstrual bleeding (HMB)—are reported annually, resulting in an overall prevalence of approximately 20% among American women.^1,2

Over the past decade, management of the more severe cases of HMB has been accomplished by ablating the endometrium in the hospital setting. However, as practitioners became more proficient in endometrial ablation, and the instruments used became safer, more efficient, and easier to use, practitioners began to introduce the procedure into the office setting. Transitioning endometrial ablation from a hospital to an office-based procedure can benefit both patient and practitioner as well as substantially reduce the costs of treatment.³

On December 3, 2011, a panel of experts was convened in Boston, Massachusetts, with the goal of identifying and addressing key challenges and opportunities to improve the care of women in the area of endometrial ablation. The panel discussed the latest options for treating HMB that were safe, efficacious, and cost-effective for patient and physician, and had minimal disruption on the patient’s life. This CME activity is based largely on the review and discussion of evidence-based data, and the expert opinions put forth by the panelists.⁴

Treatment of Heavy Menstrual Bleeding:
The Beginnings

Over the past century, treatment of HMB has made tremendous strides forward from drug therapy to major surgery to minimally invasive procedures that can be performed on an outpatient basis or in the office setting. In today’s cost-conscious medical environment, safe and efficacious treatments that reduce the costs associated with inpatient hospital care are highly desirable.

Prior to the introduction of surgical intervention, the primary treatment of HMB was pharmacotherapy. Indeed, pharmacotherapy is still considered as first-line therapy by clinicians as well as major insurers who require that the patient must have failed hormonal treatment or pharmacotherapy or have a contraindication to either of these, before insurers will reimburse for endometrial ablation.^3,5 Common pharmacologic approaches include nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives, and tranexamic acid.⁶

Until the early 1980s, the primary alternative to pharmacotherapy was hysterectomy. Hysterectomy remains an option for some women with menorrhagia, and approximately 15% of women who undergo global endometrial ablation (GEA) will eventually undergo a hysterectomy.⁷ However, panel members broadly agreed that hysterectomy—not GEA—is being offered too frequently as the primary option, a belief substantiated in a patient survey performed by AAGL.^4,8 That survey found that while 98% of women expected their doctors to provide all options, only 40% were aware there were minimally invasive options that might enable them to avoid hysterectomy.

The first surgical attempts at endometrial ablation using radiofrequency were in the 1930s, but it was not until the introduction of the shallow-cutting Nd-YAG laser in 1981 that modern devices and techniques began to emerge.^6,9 These early procedures had many risks (including perforation), and required extensive training, experience, and surgical skills that put them beyond the capabilities of many office-based gynecologists.^10,11

Global Endometrial Ablation

The term “GEA” indicates the use of second-generation devices that began with the thermal balloon endometrial ablation system (Gynecare Thermachoice^®), which was approved by the US Food and Drug Administration (FDA) in 1997, and cryoablation (Her Option^®), which was approved by the FDA in 2001.^12,13 There are currently 5 devices approved for GEA in the United States:

Global Endometrial Ablation:
Is it Ready for the Office?

Whether performed in a hospital, ambulatory care center, or office, GEA results have been consistently good. Concerns associated with in-office use of the second-generation instruments have substantially waned.⁴

Outcomes: Successful ablation can be clinically defined as reduction of menorrhagia to normal menstrual bleeding or less; the overall success rate for all GEA devices is >85%, with rates of amenorrhea estimated between 15% and 60%.¹⁴ These results can now be achieved by far more practitioners than possible with first generation technology.¹⁵ Predictors of amenorrhea following GEA include age > 45 years, uterine length < 9 cm, and endometrial thickness < 4 mm.¹⁰

Patient satisfaction: Overall, patient satisfaction following GEA is high, whether the procedure results in complete amenorrhea or reduction of menstrual bleeding into a “normal” pattern of duration and flow. A review of the Cochrane Database shows overall patient satisfaction between 90% and 95%.¹⁴

Safety: Global endometrial ablation is generally regarded as a safe procedure; today’s devices have built-in safeguards to prevent further patient injury in the event of a perforation, leak, or other malfunction.¹⁶ Fewer than 3% of patients undergoing GEA will experience a procedure-related infection, cervical laceration, uterine perforation, or thermal injury to the bladder, bowel, cervix, or vagina.⁷

As many women with HMB have career and family obligations, the GEA procedure and recuperation period become much more attractive than hysterectomy with its long recovery period.

Two other concerns are pain and postprocedural scarring of the endometrium. Neither has been evaluated in class-wide clinical trials, leaving only a few head-to-head trials and anecdotal reports as bases for judgment.⁴ In one trial (balloon vs radiofrequency) 12 of 412 patients (2.9%) required hysterectomy because of persistent pelvic pain.¹⁰ Periprocedural pain will vary on anesthesia and analgesia used as well as patient perception.⁴

The potentials for both complications and pain may be minimized by the approach used for ablation: “thermal” (heat) or “cryo” (freezing). As cryoablation requires no liquid be introduced into the uterus, there is no leakage, especially at cytotoxic temperatures. In addition, as lower temperatures contribute to analgesia, analgesic/anesthetic requirements for patients undergoing cryoablation are markedly less than for thermal-based approaches, often limited to preoperative ibuprofen.⁴

Uterine scarring after endometrial ablation can obscure sources of bleeding, such as hematometra, postablation tubal sterilization syndrome, retrograde menstruation, and possibly interfere with diagnosing endometrial cancer.¹⁷ Again, there is limited data, although anecdotal data appear to favor cryoablation as the least-scarring option.⁴

Ensuring Success

Patient selection for global endometrial ablation: As excessive uterine bleeding may be the result of a variety of underlying problems, such as endometrial cancer, hormone imbalance, fibroids, coagulopathies, or other causes, these conditions must be ruled out before considering GEA.

In general, contraindications to GEA include pregnancy (or the desire for future pregnancy), cancer or indications of a premalignant condition in endometrial tissue, an infection of the genital or urinary tracts, pelvic inflammatory disease, or current intrauterine device (IUD).¹⁸

In addition, certain patient characteristics (eg, uterine anatomy) may preclude the use of a specific GEA device; patient inclusion and exclusion criteria vary slightly among devices.¹⁹

Patients with the following conditions/characteristics may not be appropriate candidates for office-based procedures:

• Uncontrolled anxiety

• Uncontrolled pain

• Moderate to severe systemic diseases (eg, hypertension, arrhythmias, arteriosclerotic vascular disease, severe chronic obstructive pulmonary disease [COPD])

• A difficult anatomy which impedes uterine visualization

• Patients in generally poor health who may need special attention or precautions

The panel stressed that practitioners who administer anesthetics or sedating (narcotic) analgesics must ascertain the patient will have assistance available following the procedure, but patients managed with NSAIDs alone are normally capable of driving or finding another way home themselves.⁴

Other factors include:

• Optimal location for use (eg, office, clinic, and hospital)

  • A patient with concurrent health problems requiring special monitoring and resuscitation capabilities is better suited to an institutional rather than an office setting.

• Personnel needed (eg, anesthesiologist, pulmonologist, etc)

• Analgesia/anesthetic requirements

• Options/facilities available

• Patient wishes

In-Office Global Endometrial Ablation

Performing GEA in the office setting has several advantages over the hospital or ambulatory setting for both patient and practitioner^4,20,21:

• Physician benefits

  • No travel

  • Complete control

  • Ease of scheduling

  • Cost-effective (ie, better reimbursement and fewer or no ancillary personnel)

• Patient benefits

  • Familiarity with staff and setting

    • Less intimidating

  • Privacy

  • Individualized attention

  • Less risk

  • Streamlined procedure (eg, no preadmissions, etc)

  • Possibly lower copay (or lower cost for uninsured)

  • Less interruption of routine

There are several regulatory agencies governing in-office surgeries with oversight including professional as well as federal, state, and possibly local regulations. Practitioners considering in-office surgery should become familiar with the regulation involved.^19,22

Physical Office Needs: Creating the physical operating area in an office requires minimal space and equipment. Provisions must be made for equipment needed for visualization, anesthesia, patient monitoring, and equipment sterilization. Resuscitation equipment must be available for emergencies.¹⁹

Although all GEA devices are basically similar, the Her Option^® cryoablation system is the only system specifically designed for use in the office setting.^19,23 All systems, however, can be used successfully in either the office, hospital, or clinic.

Many practitioners believe much of a system’s desirability lies in the actual time required to use the instrument to do the actual ablation. Working times for the various systems range from 90 seconds to almost 15 minutes, statistics that were considered irrelevant by the panel as the time saved during the procedure may be lost to prep time or time needed for analgesia to become effective.⁴

GEA Systems at a Glance*

Gynecare Thermachoice^®20

Gynecare Thermachoice^® consists of a hot liquid-filled balloon that ablates endometrial tissue with thermal energy. A sterile fluid is heated to ~83°C in a silicone balloon that requires direct contact with the endometrium for 7 to 9 minutes.

Advantage(s): It has a small-diameter, flexible catheter that requires minimal dilation; it is easily used and easily taught. Gynecare Thermachoice^® performed in the office setting had success rates equal to procedures performed in the hospital setting.

Drawback(s): The inflation pressure (160 to 180 mm Hg) is capable of causing pain to the patient for the duration of the procedure.

The procedure requires a 3-minute pretreatment suction curettage, and analgesia is usually provided with a paracervical block and keterolac, and possibly narcotics.

Exclusions include abnormally shaped uteri caused by myomas, polyps or submucous fibroids; anatomic or pathologic conditions in which weakness of the myometrium could exist, including classical cesarean sections or transmural myomectomy. Other exclusions are a uterine cavity >10 cm or previous ectopic abdominal pregnancy (EAP).

In US trials to 1 year, major safety issues included cramping (mild, 34.3%; moderate, 47.8%; severe, 9.7%), nausea/vomiting (23.9%), and vaginal discharge (74.6%).²⁴

Her Option^®20

Her Option^® is a cryoablation system consisting of a cryoprobe inserted through the cervix into the uterus. An ice ball forms around the probe as the temperature drops to –90°C, permanently destroying the endometrial tissue (–20°C is cytotoxic). The procedure is monitored by ultrasound to help prevent potential injury to adjacent organs should the cryo zone extend beyond the serosal surface of the uterus; it has the lowest pain score of all devices.

Advantage(s): Cryoablation is considered very safe; patients are able to leave unassisted following the procedure, the result of minimal, non-narcotic analgesia, and cold temperatures add to analgesic effect. Designed specifically for office use, Her Option^® is considered by many as the easiest system to learn.

Drawback(s): The required use of ultrasound guidance may be considered a drawback to those not proficient in using ultrasound.

It is recommended that patients should be pretreated with leuprolide acetate. Although in rare cases a paracervical block may be used, preoperative NSAIDs are generally adequate for analgesia.

Patients with anatomic or pathologic weakness of the myometrium may not be suitable candidates for cryoablation, including classical cesarean sections or transmural myomectomy, intramural myomas >2 cm, intrauterine polyps, pedunculated fibroids, and septate uterus; anatomy that impedes ultrasound visualization may also not be suitable for cryoablation.

In US trials to 1 year, the major adverse reactions were uterine cramping or other abdominal or pelvic pain/cramping (4% each); vaginal infection (4%); hot flashes (2%); urinary tract infection (UTI; 1%); and nausea/vomiting (1%).²⁵

NovaSure^{® 20}

NovaSure^® utilizes bipolar radiofrequency; energy from alternating current ablates endometrial tissue using an intrauterine probe consisting of an electrode array of stretchable gold-plated fabric. This fabric conforms to the endometrial surface and steam and moisture are suctioned as the endometrial tissue is desiccated.

Actual ablation is completed in 90 seconds, and this system is well suited for use in the hospital or ambulatory surgical center settings.

Advantage(s): Treatment is not cycle-dependent.

Drawback(s): The NovaSure^® system is more complex than other systems, requiring the keying of data into the controller.

No pretreatment is required, and analgesia requirements range from NSAIDs to oral narcotics and paracervical block.

NovaSure^® should not be used on a patient with an abnormal/obstructed uterine cavity, septate or bicornulate uterus, pedunculated submucosal leiomayomata, or polyps >2 cm. Previous uterine surgery and poor uterine wall integrity are also contraindications.

In a 12-month follow-up of clinical trials, pelvic pain/cramping and vaginal infections were each reported by 2.9% of patients; UTI, pelvic inflammatory disease (PID), and endometritis (1.1% each); and hematometra and hemorrhage (0.6% each).²⁶

Hydro ThermAblator^®20

Hydro ThermAblator^® is a circulating hot-water system; saline is introduced through a hysteroscope and circulated for ~10 minutes to destroy endometrial tissue. The Genesys HTA^™ system is a newer version with a smaller console and simplified set-up.

Advantage(s): These systems feature an automatic shut-off if there is unacceptable use or loss of fluid.

Drawback(s): This treatment approach requires extensive cervical dilation, often resulting in pain; the hot solution may result in vaginal burning.

The procedure can be monitored by visualization of the uterine cavity. Abnormally-shaped cavities can be successfully treated, as well as small fibroids.

Pretreatment with leuprolide acetate is recommended, analgesia is normally achieved with ketorolac, an anxiolytic (lorazapam), or oral narcotics.

This method of GEA should not be used for menorrhagia resulting from intramural fibroids >4 cm, or in cases of uterine anatomic abnormality, previous EAP, or patients who have undergone classic cesarean section.

In the 1-year follow-up to clinical trials, uterine cramping was the most common adverse event (14%); followed by vaginal infections (3%); nausea and vomiting (2% each); and hematometra, abdominal pain, and UTI (1% each).²⁷

*Data sources include manufacturer’s Web sites and www.accessdata.fda.gov.

GEA: Overall Contraindications

As noted above, each system has unique characteristics that may prove problematic. In addition, there are class-wide contraindications for global endometrial ablation:

• Pregnancy or desire to become pregnant

• A patient with a known or suspected endometrial carcinoma (uterine cancer) or premalignant change of the endometrium, such as unresolved adenomatous hyperplasia

• A patient with an active genital infection or UTI at the time of the procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis)

• A patient with active PID

• A patient with an IUD currently in place

Financial Aspects

Although office-based procedures such as GEA are extremely attractive to many patients, any practitioner who is considering offering office-based procedures must consider the move very carefully as it means a financial investment and, to a lesser extent, a change in practice patterns. It is important to consider possible increases in malpractice insurance and the physician’s payer mix.^16,23

Billing and Reimbursement

GEA has three primary current procedural terminology codes for billing. These are: 58353, GEA without hysteroscopy; 58356, cryoablation with ultrasound; and 58563, hysteroscopy and GEA. All codes can be used for office or institutional procedures.³

Summary

GEA offers women with HMB an important option that is effective, often permanent, and a minimal interruption into the patient’s life. Practitioners who bring GEA into the office setting add another important quality—privacy. However, in addition to the benefits in-office GEA brings to the patient, in-office GEA has many advantages for the practitioner as well.

Probably the most important decision to be made is the choice of system. As all units have data that show similar safety and efficacy, experts recommend a system that is easy to operate and causes the least pain for the patient.⁴ Careful review of the literature, FDA-approved product material, participation in available workshops sponsored through the American Congress of Obstetricians and Gynecologists (ACOG) and AAGL, and discussions with colleagues who use each of the systems will aid in the final decision.

OBG Management ©2012 Quadrant HealthCom Inc.