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Guest commentary: Endometrial ablation for treatment of heavy menstrual bleeding
In this guest commentary, Cindy Basinski, MD, a private practice physician in Indiana and volunteer clinical assistant professor of gynecology at Indiana University School of Medicine, discusses endometrial ablation as a proven safe, efficient and cost effective treatment option for abnormal uterine bleeding in affected women.
Abnormal uterine bleeding leading to heavy menstrual bleeding is a prevalent disease affecting 30% of women in their lifetimes and approximately 10 million women per year.
Women with abnormal uterine bleeding (AUB) have a lower quality of life due to a negative impact on sexual function, emotional well-being and overall health. In addition, the direct health care costs of AUB are estimated to be between $1 billion and $1.55 billion per year.
Approximately 500,000 hysterectomies are performed every year with approximately 100,000 due to AUB alone. For clinicians treating reproductive women, AUB is a major health care concern, and understanding available treatment options is important.
Appropriate treatment for AUB is dependent on the individual patient’s medical history and preferences. Women who desire future fertility are limited to medical management with various hormones or medications, including combination oral contraceptives, oral or intramuscular progesterone, progesterone intrauterine devices, tranexamic acid or NSAIDs.
However, not all women respond to or can tolerate medications. Many women do not desire to use medical therapy due to risks or medical conditions that contraindicate use. If this is the case and a woman no longer desires future fertility, endometrial ablation or hysterectomy may be appropriate options for her.
While hysterectomy is a definitive treatment option for AUB, it is associated with surgical risk that has been shown to be associated with higher risk and both short-term and long-term costs compared to endometrial ablation. Endometrial ablation has been shown to reduce the risk of hysterectomy by more than 83% at 10 years post-procedure. Endometrial ablation is a technique that utilizes heat or freezing to destroy the uterine endometrial lining down to the myometrial layer, resulting in either reduction or elimination of uterine bleeding permanently. Women should never attempt pregnancy after ablation as it can lead to significant maternal and fetal risk. In fact, women or their partners should be strongly encouraged to obtain either a tubal sterilization or vasectomy procedure prior to or concomitant with ablation. Genital tract infections must be absent by either clinical history and physical exam or specific laboratory evaluation. In addition, underlying uterine cancer needs to be ruled out by endometrial sampling. Endometrial ablation can be safely and successfully performed in the office setting, further reducing the cost of this option.
Endometrial ablation was initially performed utilizing hysteroscopic techniques to “hand resect” the lining of the uterus in strips under direct visualization. This technique required significant hysteroscopic skill and was associated with potential for fluid overload due to the use of hyperosmotic fluids to distend the uterine cavity during the procedure. In 1997, the first global endometrial ablation (GEA) device, Thermachoice, was approved for use in the United States. While no longer commercially available, Thermachoice utilized a small silicone balloon that was filled with circulated water to globally heat the internal cavity of the uterus and destroy the endometrial lining. GEA devices are easier and safer to use for endometrial ablation as they require little to no hysteroscopy to place the device. Over time, new techniques have been developed for global ablation that utilize energy sources such as radiofrequency, microwaves, heating water, freezing or plasma argon gas. Currently available devices are NovaSure Radiofrequency Ablation (Hologic Inc.), Hydrothermal Ablator (Boston Scientific), CryoAblation (Cooper Surgical Inc), and Mirena (Mirena Inc.). Currently, NovaSure is the most widely utilized technology for endometrial ablation with more than 2.5 million treated patients. GEA can also be safely performed in the physician’s office eliminating need for general anesthesia or an operating room suite.
The initial studies evaluating the success of endometrial ablation were limited to patients without significant uterine pathology. However, over the past 20 years, several studies have confirmed that endometrial ablation can be successfully utilized in patients with low transverse cesarean section scars, uterine fibroids, adenomyosis, severe dysmenorrhea, anovulatory bleeding, obesity or coagulopathy, with little to no difference in outcome when compared with patients with no underlying pathology. Success rates with endometrial ablation vary in the literature based on individual technologies but range from 80% to 98% patient satisfaction after 12 months. In addition, ablation will avoid hysterectomy in 80% to 90% of patients while markedly improving quality of life.
Some complications of endometrial ablation are infection, bleeding, perforation and injury to surrounding organs. The most concerning complication is related to energy transfer through a perforation or thin area of the uterus to surrounding organs such as the bowel or bladder. While this event is rare – occurring in approximately 1/10,000 patients – itcan be a major source of morbidity and mortality. However, endometrial ablation compares favorably to hysterectomy with a mortality rate of 1-1.6/1,000.
An additional, specific complication of endometrial ablation is hematometra, which can cause cyclical, severe crampy pain and is a sign of a failed ablation occurring in 1% to 5% of patients post-ablation. In a majority of cases, endometrial ablation causes intrauterine scarring. If significant amounts of endometrial lining escape destruction, bleeding from these areas will cause trapping of blood within adhesion pockets within the uterus. This will then create pressure that causes pain with or without vaginal bleeding. Clinicians treating patients post-ablation must have a high level of suspicion for this condition and assist patients to seek care, which may include hormonal treatment, hysterectomy or lysis of adhesions in the uterus to help blood escape the cavity. Of note, this condition is more likely to occur in women with a history of tubal ligation.20
A potential concern of patients and clinicians is the risk for endometrial cancer after ablation. Several recent studies have evaluated risk for and staging of endometrial cancer after endometrial ablation and concluded that no increased risk for cancer or advanced staging at time of diagnosis. In a large database evaluation in the United Kingdom, including 234,721 patients with AUB treated with medical treatment or endometrial ablation, no increase in incidence, survival or staging of endometrial cancer was observed between the two groups.
Success of endometrial ablation is very high and ranges from 80% to 95%. Reduction of bleeding has been reported in more than 90% of patients with amenorrhea rates between 11% and 69%. Patient satisfaction rates are 96% after 12 months with low short-term and long-term complication rates. In several recent studies, endometrial ablation was shown to reduce costs over use of hysterectomy for AUB by $6,200 to $9,200 per patient after a 5-year period of time.
For patients with AUB, endometrial ablation is a highly effective, safe and cost saving procedure. GEA reduces the risk for future hysterectomy in an AUB population with high levels of patient satisfaction.
Disclosure: Basinski reports being a paid consultant for Hologic, Inc. for the NovaSure and Myosure procedures, a paid consultant for Bayer, Inc. for the Essure procedure, a consultant for Channel Medical Systems for an FDA clinical trial, a consultant for AEGEA, Inc. for an FDA clinical trial and a primary investigator in FDA clinical trials for Minerva, Inc., AEGEA, Inc., Channel Medical Systems, Inc., Bayer, Inc. and Hologic, Inc.
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