Endometrial ablation continues to be performed in significant numbers in the United States, with an estimated 500,000 cases annually. Several nonresectoscopic endometrial ablation devices have been approved for use, and some are now discontinued. The newest endometrial ablation therapy to gain US Food and Drug Administration (FDA) approval and to have published outcomes is the Cerene cryotherapy ablation device (Channel Medsystems, Inc). The results of 36-month outcomes from the CLARITY study were published last year, and we have chosen to review these long-term data in addition to that of a second study in which investigators assessed the ability to access the endometrial cavity postcryoablation. We believe this is important because of concerns about the inability to access the endometrial cavity after ablation, as well as the potential for delay in the diagnosis of endometrial cancer. It is interesting that 2 publications simultaneously reviewed the incidence of endometrial cancer after endometrial ablation within the past 12 months, and we therefore present those findings as they provide valuable information.
Our second focus in this year’s Update is to provide additional information about the burgeoning data on gonadotropin-releasing hormone (GnRH) antagonists. We review evidence on linzagolix from the PRIMROSE 1 and PRIMROSE 2 trials and longer-term data on relugolix combination therapy for symptomatic uterine fibroids.
Three-year follow-up after endometrial cryoablation with the Cerene device found high patient satisfaction, low hysterectomy rates
Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28;899-908.
Curlin HL, Anderson TL. Endometrial cryoablation for the treatment of heavy menstrual bleeding: 36-month outcomes from the CLARITY study. Int J Womens Health. 2022;14:1083-1092.
The 12-month data on the clinical safety and effectiveness of the Cerene cryoablation device were published in 2021 in the CLARITY trial.1 The 36-month outcomes were published in 2022 and showed sustained clinical effects through month 36 with a low risk of adverse outcomes.2 The interesting aspect of this trial is that although the amenorrhea rate was relatively low at 12 months (6.5%), it continued to remain relatively low compared with rates found with other devices, but the amenorrhea rate increased at 36 months (14.4%). This was the percentage of patients who reported, “I no longer get my period.”
Patient satisfaction was high
Despite a relatively low amenorrhea rate, study participants had a high satisfaction rate and a low 3-year hysterectomy rate. Eighty-five percent of the participants were satisfied or very satisfied, and the cumulative hysterectomy rate was low at 5%.
The overall reintervention rate was 8.7%. Six patients were treated with medications, 2 patients underwent repeat endometrial ablation, 1 received a levonorgestrel-releasing intrauterine device, and 12 underwent hysterectomy.
At 36 months, 201 of the original 242 participants were available for assessment. Unfortunately, 5 pregnancies were reported through the 6-month posttreatment period, which emphasizes the importance of having reliable contraception. However, there were no reports of hematometra or postablation tubal sterilization syndrome (PATSS).
Effect on bleeding was long term
The main finding of the CLARITY study is that the Cerene cryoablation device appears to have a relatively stable effect on bleedingfor the first 3 years after therapy, with minimal risk of hematometra and PATSS. What we find interesting is that despite Cerene cryoablation having one of the lowest amenorrhea rates, it not only had a satisfaction rate in line with that of other devices but also had a low hysterectomy rate—only 5%—at 3 years.
The study authors pointed out that there is a lack of scarring within the endometrial cavity with the Cerene device. Some may find less endometrial scarring worth a low amenorrhea rate in the context of a favorable satisfaction rate. This begs the question, how well can the endometrial cavity be assessed? For answers, keep reading.
Can the endometrial cavity be reliably accessed after Cerene cryoablation?
Endometrial ablation has been associated with intracavitary scarring that results in hematometra, PATSS, and a concern for difficulty in performing an adequate endometrial assessment in patients who develop postablation abnormal uterine bleeding.
In a prospective study, 230 participants (of an initial 242) treated with Cerene cyroablation were studied with hysteroscopic evaluation of the endometrial cavity 12 months after surgery.3 The uterine cavity was accessible in 98.7% of participants. The cavity was not accessible in 3 participants due to pain or cervical stenosis.
Visualization of the uterine cavity was possible by hysteroscopy in 92.7% of study participants (204 of 220), with 1 or both tubal ostia identified in 89.2%. Both tubal ostia were visible in 78.4% and 1 ostium was visible in 10.8%. The cavity was not visualized in 16 of the 220 patients (7.2%) due to intrauterine adhesions, technical difficulties, or menstruation. Also of note, 97 of the 230 participants available at the 12-month follow-up had undergone tubal sterilization before cryoablation and none reported symptoms of PATSS or hematometra, which may be considered surrogate markers for adhesions.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
Results of the CLARITY study demonstrated the clinical safety and effectiveness of the Cerene cryoablation device at 12 months, with sustained clinical effects through 36 months and a low risk of adverse outcomes. Patient satisfaction rates were high, and the hysterectomy rate was low. In addition, in a prospective study of patients treated with Cerene cryoablation, hysteroscopic evaluation at 12 months found the uterine cavity accessible in more than 98% of participants, and uterine visualization also was high. Therefore, the Cerene cryoablation device may provide the advantage of an easier evaluation of patients who eventually develop abnormal bleeding after endometrial ablation.
Results of the CLARITY study demonstrated the clinical safety and effectiveness of the Cerene cryoablation device at 12 months, with sustained clinical effects through 36 months and a low risk of adverse outcomes. Patient satisfaction rates were high, and the hysterectomy rate was low. In addition, in a prospective study of patients treated with Cerene cryoablation, hysteroscopic evaluation at 12 months found the uterine cavity accessible in more than 98% of participants, and uterine visualization also was high. Therefore, the Cerene cryoablation device may provide the advantage of an easier evaluation of patients who eventually develop abnormal bleeding after endometrial ablation.
Continue to: Tissue effects differ with ablation technique...