Clinical Review

2019 Update on abnormal uterine bleeding

Howard T. Sharp, MD

Dr. Sharp is Professor and Vice Chair for Clinical Activities, Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City.

Marisa R. Adelman, MD

Dr. Adelman is Assistant Professor, Department of Obstetrics and Gynecology, University of Utah Health Sciences Center.

The authors report no financial relationships relevant to this article.


 

References

Can endometrial intraepithelial neoplasia be treated with the etonogestrel subdermal implant?

Wong S, Naresh A. Etonogestrel subdermal implant-associated regression of endometrial intraepithelial neoplasia. Obstet Gynecol. 2019;133:780-782.

Recently, Wong and Naresh gave us the first case report of successful treatment of EIN using the etonogestrel subdermal implant. With so many other options available to treat EIN, some of which have been studied extensively, why should we take note of this study? First, the authors point out the risk of endometrial cancer development among patients with EIN, and they acknowledge the standard recommendation of hysterectomy in women with EIN who have finished childbearing and are appropriate candidates for a surgical approach. There is also concern about lower serum etonogestrel levels in obese patients. In this case, the patient (aged 36 with obesity) had been nonadherent with oral progestin therapy and stated that she would not adhere to daily oral therapy. She also declined hysterectomy, levonorgestrel-releasing intrauterine device therapy, and injectable progestin therapy after being counseled about the risk of malignancy development. She consented to subdermal etonogestrel as an alternative to no therapy.

EIN regressed. Endometrial biopsies at 4 and 8 months showed regression of EIN, and at 16 months after implantation (as well as a dilation and curettage at 9 months) demonstrated an inactive endometrium with no sign of hyperplasia.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The authors remain cautious about recommending the etonogestrel subdermal implant as a first-line therapy for EIN, but the implant was reported to be effective in this case that involved a patient with obesity. In cases in which surgery or other medical options for EIN are not feasible, the etonogestrel subdermal implant is reasonable to consider. Its routine use for EIN management warrants future study.

New endometrial ablation technology shows promising benefits

Levie MD, Chudnoff SG. A prospective, multicenter, pivotal trial to evaluate the safety and effectiveness of the AEGEA vapor endometrial ablation system. J Minim Invasive Gynecol. 2019;26:679-687.

Do we need another endometrial ablation device? Are there improvements that can be made to our existing technology? There already are several endometrial ablation devices, using varying technology, that currently are approved by the US Food and Drug Administration (FDA) for treatment of AUB. The devices use bipolar radiofrequency, cryotherapy, circulating hot fluid, and combined thermal and radiofrequency modalities. Additional devices, employing heated balloon and microwaves, are no longer used. Data on a new device, approved by the FDA in 2017 (the AEGEA Vapor System, called Mara), were recently published.

Details of the study

Levie and colleagues conducted a prospective pivotal trial on Mara's safety and effectiveness. The benefits presented by the authors include that the device 1) does not require that an intrauterine array be deployed up to and abutting the fundus and cornu, 2) does not necessitate cervical dilatation, 3) is a free-flowing vapor system that can navigate differences in uterine contour and sizes (up to 12 cm in length), and 4) accomplishes ablation in 2 minutes. So there are indeed some novel features of this device.

This pivotal study was a multicenter trial using objective performance criterion (OPC), which is based on using the average success rates across the 5 FDA-approved ablation devices as historic controls. In the study an OPC of 66% correlated to the lower bound of the 95% confidence intervals. The primary outcome of the study was effectiveness in the reduction of blood loss using a pictorial blood loss assessment score (PBLAS) of less than 75. Of note, a PBLAS of 150 was a study entry criterion. FIGO types 2 through 6 fibroids were included in the trial. Secondary endpoints were quality of life and patient satisfaction as assessed by the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score, as well as the need to intervene medically or surgically to treat AUB in the first 12 months after ablation.

Efficacy, satisfaction, and quality of life results

At 12 months, the primary effectiveness end point was achieved in 78.7% of study participants. The satisfaction rate was 90.8% (satisfied or very satisfied), and 99% of participants showed improvement in quality of life scores. There were no reported serious adverse events.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

The takeaway is that the AEGEA device appears to be effective for endometrial ablation and offers the novel features of not relying on an intrauterine array to be deployed up to and abutting the fundus and cornu, not necessitating cervical dilatation in all cases, and offering a free-flowing vapor system that can navigate differences in uterine contour and sizes quickly (approximately 2 minutes).

The fact that new devices for endometrial ablation are still being developed is encouraging, and it suggests that endometrial ablation technology can be improved. Although AEGEA's Mara system is not yet commercially available, it is anticipated that it will be available at the start of 2020. The ability to treat large uteri (up to 12-cm cavities) with FIGO type 2 to 6 fibroids with less cervical dilatation makes the device attractive and perhaps well suited for office use.

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