Examining the Evidence
What is the 5-year cumulative failure rate of global endometrial ablation?
Abnormal uterine bleeding (AUB) among women of reproductive age has an enormous impact on quality of life and sexual function and consumes many health-care dollars in its evaluation and management.
If a woman has completed childbearing and has a uterus of normal size without intracavitary pathology, options include:
- the levonorgestrel-releasing intrauterine system (Mirena)
- hormonal contraception (both combination and progestin-only)
- nonsteroidal anti-inflammatory drugs
- cyclic progesterone therapy.
If the patient fails, refuses, or has contra-indications to nonsurgical therapy and seeks surgical intervention, endometrial ablation is a viable option. However, she should be informed that she may need additional treatment, resume menstruation, or develop a complication. She also should be apprised of the potential for pregnancy.
If she demands amenorrhea, total hysterectomy is the only option.
Age and other variables were predictors of outcome
The ability to predict outcomes of global endometrial ablation is clinically useful and may help the patient decide between ablation and hysterectomy. In the study by ElNashar and colleagues, women were more likely to achieve amenorrhea if they:
- were 45 years of age or older
- had a uterus shorter than 9 cm
- had endometrium thinner than 4 mm
- underwent radiofrequency ablation.
Women who were more likely to fail:
- were younger than 45 years
- had parity of 5 or higher
- had a history of tubal ligation
- had a history of dysmenorrhea.
The study included 816 women who underwent global endometrial ablation—455 in the model-development arm, and 361 in the validation arm. Three pregnancies occurred (all ended in spontaneous first-trimester abortion), 23 women (5%) complained of pelvic pain, and no patients died or developed endometrial cancer. Overall, 45 women in the model-development arm underwent hysterectomy—28 for persistent bleeding, 12 for persistent pain, and five for other indications.
Study size was a strength
Also valuable was long-term follow-up using an established registry. Among the weaknesses of the study was the fact that only two types of ablation were used.
This study confirms what many people have intuitively believed about endometrial ablation: It rarely causes permanent amenorrhea regardless of the system selected. In the original FDA clinical trials that included three other devices, the amenorrhea rate ranged from 22% to 55%, but patient satisfaction was greater than 90% in all devices studied.
Because most of the women in this study were white, further validation of this model among other races is needed.
WHAT THIS MEANS FOR PRACTICE
When a patient seeks surgical intervention for AUB, assess her expectations. Ask her, “If we can make your periods return to normal or reduce monthly blood flow below normal, would you be happy with the outcome?” If she answers, “Yes,” endometrial ablation is an option. The younger the patient, the greater is the likelihood that additional surgery will eventually be necessary. If, on the other hand, she demands amenorrhea, the only option is hysterectomy with removal of the cervix.
When endometrial ablation is planned, perform preoperative imaging with saline infusion sonography or hysteroscopy to exclude intracavitary pathology, and perform preoperative endometrial biopsy to exclude pre-malignant or malignant disease. In addition, assess preoperative dysmenorrhea closely to avoid ablation in a woman who may have adenomyosis.
Also evaluate women for bleeding diathesis, such as von Willebrand’s disease, prior to ablation.- LINDA D. BRADLEY, MD