Why Do Endometrial Ablations Fail?

Endometrial ablation has emerged as a highly effective solution to manage heavy menstrual bleeding (HMB), offering relief to countless women seeking a more conservative surgical treatment for excessive blood loss and dysmenorrhea. However, a subset of patients experience failed ablation treatments, necessitating further intervention, including a hysterectomy.

One retrospective cohort study analyzing a population of pre-menopausal women who underwent endometrial ablation with heat-based balloon therapy for abnormal bleeding patterns found that certain women experienced diminishing treatment satisfaction and efficacy.¹ At a minimum of two years post-treatment, the researchers reported the following results:¹

• 35.8% of ablations failed
• 32.7% of subjects had additional (medical and/or surgical) treatment
• 18.8% of subjects needed a hysterectomy

While each patient may define menorrhagia symptoms differently, the primary conclusion that can be drawn from these results is that endometrial ablation is not ubiquitously effective for every patient. Late-onset ablation failure is the most common complication of endometrial ablation, presenting as persistent or recurrent bleeding, cyclic pelvic pain (CPP), and the inability to sufficiently access and visualize the cavity for future diagnostic evaluation.²

Primary Causes of Ablation Failure

Several medical and demographic factors contribute to ablation failure. The top medical causes of suboptimal treatment outcomes, specifically those associated with recurrent bleeding, include:²

• Incomplete endometrial destruction
• Endometrial regrowth
• Endometrial polyps
• Underlying adenomyosis
• Persistent leiomyomas
• Necrosis associated with thermal ablation damage
• Uterine cancer

In addition to heavy bleeding, patients may also suffer from persistent dysmenorrhea or pelvic pain post- treatment. This is often seen with many heat-based ablation techniques, which rely on endometrial scarring and contracture to reduce or eliminate blood loss and cramping.² While the formation of intrauterine synechiae is a normal part of the healing process from thermal endometrial destruction, these adhesions are known to interact poorly with functional endometrial glands, resulting in obstructed uterine blood flow and CPP.²

Likewise, the definition of ablation failure is not limited to measurable outcomes. For some patients, the treatment simply does not provide enough improvement in quality of life (meaning they cannot fully perform daily tasks and regularly engage in social activities), in which case patients may ask their gynecologists for a secondary or more invasive procedure. However, many cases of failed ablation could be avoided and/or mitigated with proactive, evidence-based selection criteria.

The Essential Role of Patient Selection

The key to unlocking higher ablation success rates is improving patient selection. This evaluation extends beyond a patient’s treatment preferences and future plans for childbearing. OBGYNs should also consider how a patient’s treatment outcomes may change with certain conditions. The risk of failed ablation can increase if patients:²

• Are under the age of 35
• Have had a prior tubal ligation 
• Have a uterus with an irregular shape or size
• Have internal uterine abnormalities (leiomyomas, polyps, thickened endometrium)

However, selecting the right candidate is just the first step to driving successful treatment outcomes. Even with patients who have met the necessary criteria, there is still a risk of failed ablation. One reason could be the long-term effects of the ablation treatment itself, especially with thermal techniques.

Mitigating Failure Risks With Cryotherapy

Endometrial cryoablation utilizes freezing technology to foster a different treatment response than heat-based modalities. Cryotherapy activates healing mechanisms that result in minimal scarring and adhesion formation, helping patients experience long-term relief from excessive bleeding and cramping while helping address concerns about scarring complications.³ Despite the lower risk of heat-based damage, it should be noted that cryotherapy also carries a certain level of risk of treatment injury or need for a secondary procedure due to the nature of the ablation treatment. 

The Cerene Cryotherapy Device® is an FDA-approved device for safe, well-tolerated, and effective endometrial cryoablation. Cerene deploys nitrous oxide in an ultra-thin, cavity-conforming liner to gently freeze and ablate endometrial tissue, promoting high patient satisfaction while reducing the need for future hysterectomy. Cerene’s innovative cryotherapy technology achieves favorable outcomes for women suffering from HMB, including:

• 90% have normal, light, or no periods^†
• 86% report a reduction in dysmenorrhea^‡
• 99% had hysteroscopic cavity access 12 months post-ablation³
• 91% had full cavity visualization 12 months post-ablation³
• 3% hysterectomy rate for HMB over 3 years

Interested in exploring more clinical benefits of Cerene cryotherapy? Learn more at https://cerene.com/healthcare-professionals/. 

† Patient-reported data are 1 year after treatment with durable results at 3 years

‡  Improvement reported one year after treatment for patients reporting severe/very severe period pain

Key Takeaways:

• Endometrial ablation effectively treats heavy menstrual bleeding, but a number of procedures fail to deliver long-term improvement, leading to repeat ablation procedures or hysterectomy.
• Medical factors contributing to failed ablation include incomplete endometrial destruction, regrowth of endometrial tissue, polyps, adenomyosis, leiomyomas, tissue necrosis, and uterine cancer. Patients may be at higher risk if they are under 35, have had a prior tubal ligation, or have uterine abnormalities.
• In addition to selecting the right candidates, gynecologists can deliver positive ablation outcomes with cryotherapy. Cerene is a safe, well-tolerated, and effective cryotherapy device that is clinically proven to reduce bleeding, alleviate dysmenorrhea, provide for cavity access and visualization with a low risk of hysterectomy. 

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Sources

1. Stevens, K.Y.R., Meulenbroeks, D., Houterman, S., Gijsen, T., Weyers, S., Schoot, B.C. (2019). Prediction of unsuccessful endometrial ablation: a retrospective study. Gynecological Surgery 16(7).
2. Wortman M. (2017). Late-onset endometrial ablation failure. Case Reports in Women’s Health, 15, 11–28.
3. Curlin, H.L., Cintron, L.C., Anderson, T.L. (2021). A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding. Journal of Minimally Invasive Gynecology 28(4), 899-908.