The objective of this review was to evaluate the effectiveness and cost-effectiveness of thermal balloon endometrial ablation (TBEA) for dysfunctional uterine bleeding (DUB).
Background: Condition and Target Population
Abnormal uterine bleeding is defined as an increase in the frequency of menstruation, duration of flow or amount of blood loss. (1) DUB is a diagnosis of exclusion when there is no pelvic pathology or underlying medical cause for the increased bleeding. (1) It is characterized by heavy prolonged flow with or without breakthrough bleeding. It may occur as frequent, irregular, or unpredictable bleeding; lengthy menstrual periods; bleeding between periods; or a heavy flow during periods. Menorrhagia, cyclical HMB over several consecutive cycles during the reproductive years, is the most frequent form of DUB.
The incidence of DUB has not been reported in the literature. For Ontario, an expert estimated that about 15% to 20% of women over 30 years have DUB. The prevalence increases with age and peaks just before menopause. (1) Using 2001 Ontario census-based population estimates, there are about 2 million women between the ages of 30 and 49 years; therefore, of these, about 290,965 to 387,953 may have DUB.
The Technology Being Reviewed: Thermal Balloon Endometrial Ablation
Since the 1990s, second-generation endometrial ablation (EA) techniques developed, the aim to provide simpler, quicker, and more effective treatment options for menorrhagia compared with first-generation EA techniques and hysterectomy. (2) Compared with first-generation techniques these depend less on the people operating them and more on the actual devices to ensure safety and efficacy.
TBEA relies on the transfer of heat from heated liquid within a balloon that is inserted into the uterus. (2) It does not require a hysteroscope for direct visualization of the uterus and can be performed under local anesthesia. In order to use TBEA, patients with DUB cannot have a long (>10–12 cm) or irregularly shaped uterine cavity, because the balloon must be in direct contact with the uterine wall to cause ablation. For Ontario, an expert estimated that about 70% of patients with DUB considered for EA would have a uterus suitable for TBEA based on these criteria. If 70% of Ontario women between 30 and 49 years of age with DUB have a uterus suitable for TBEA, then about 203,675 to 271,567 women may be eligible. However, some of these women will be successfully treated by drugs or will want amenorrhea (the cessation of their periods) and therefore choose to have a hysterectomy.
The standard Medical Advisory Secretariat search strategy was used to locate international health technology assessments and English-language journal articles published from January 1996 to June 2004. A Cochrane systematic review from 2004 was identified that examined the effectiveness and cost-effectiveness of TBEA for heavy menstrual bleeding. (2) Another literature search was done to update information from the systematic review.
Summary of Findings
A 2004 systematic review of the literature by Garside et al. (2) in the United Kingdom, found that overall, there were few significant differences between outcomes for first-generation techniques and TBEA. The outcomes were bleeding, postoperative complications, patient satisfaction, quality of life, and repeat surgery rates. Significant differences were reported most often by one study by Pellicano et al., (3) but this was a level 2 study with methodological weaknesses. Furthermore, according to Garside et al., there was considerable clinical and methodological heterogeneity among the studies in the systematic review. Therefore, a quantitative synthesis using meta-analysis was not done. In Garfield and colleagues’ review:
TBEA had significantly shorter operating and theatre times (P < .05, < .01, and .0001).
TBEA had fewer intraoperative adverse effects (e.g., reported rates of uterine perforation with RB ablation: from 1% to 5%; TBEA: 0%; rates of cervical laceration with RB: 2% to 5%; TBEA 0%).
They found no studies have directly compared second-generation techniques and hysterectomy; therefore, the comparison can only be indirectly inferred from studies of first-generation techniques and hysterectomy.
Compared with hysterectomy, TCRE and RB are quicker to perform and result in shorter hospitalization stays and a faster return to work.
Hysterectomy results in more adverse effects.
Satisfaction with hysterectomy is initially higher, but there is no difference after 2 years.
Studies (level 2 evidence) published after Garside’s systematic review support these conclusions.
A study with level 2 evidence reported a significantly higher risk overall of intraoperative complications for RB compared with TBEA (P < .001). This included uterine perforation (RB, 5%; TBEA, 0%) and suspicion of perforation (RB, 2%; TBEA, 0%).
A multicentre long-term case series (level 4 evidence) that examined avoidance of hysterectomy after TBEA for menorrhagia reported that 86% of women who had TBEA did not require a hysterectomy, and 75% did not have any further surgery during a follow-up period of 4 to 6 years. (4)
Several TBEA studies did not provide justification for using general anesthesia over local anesthesia.
Patient preferences for different treatments will depend on a woman’s desire for amenorrhea as an outcome and/or avoidance of major surgery. Hysterectomy is the only procedure that can guarantee amenorrhea. TBEA will not totally replace hysterectomy in the treatment of DUB, because some women may want cessation of menstruation.
Ensuring that patient expectations are consistent with the outcomes achievable with TBEA is important to obtain high levels of satisfaction. Vilos et al. (5) noted that up to one-half of patients who underwent a second attempt at TBEA might have avoided the second procedure with proper preoperative counselling. Meyer et al. (6) noted that one consideration for patients with menorrhagia (and no structural lesions) is to return to normal or less blood loss rather than amenorrhea. Patients may have distinct concepts of menstrual bleeding depending on cultural background, and maintaining an acceptable menstrual flow instead of amenorrhea may represent a healthier status. (7)
A budget impact analysis suggests that the net annual budget outlay for TBEA would be between $1.4 million in savings and $2.8 million in additional outlays. (Note: Not all savings would be realized directly by the Ministry of Health and Long-Term Care, because much of the savings would accrue to the global budgets of hospitals).
TBEA is effective, safe, and cost-effective for patients with DUB.
For women who are not worried about amenorrhea, first-generation techniques offer advantages over hysterectomy.
TBEA is a better alternative to first-generation techniques for DUB, because it is associated with fewer intraoperative adverse effects.