VANCOUVER – A retrospective analysis of women who became pregnant after undergoing laparoscopic radiofrequency ablation (Lap-RFA) of symptomatic myomas found no evidence that the procedure negatively impacted pregnancy or birth outcomes, according to Jay Berman, MD.
The procedure is a minimally invasive alternative to myomectomy, hysterectomy, and other surgical techniques, with minimal scarring and quick recovery. But the pivotal trials excluded women who were planning to become pregnant, and the Food and Drug Administration recommends against its use in women planning a future pregnancy because of the lack of safety and efficacy data in that population.
The procedure, which gained FDA approval in 2016, combines laparoscopic ultrasound with targeted radiofrequency to heat fibroids, which then shrink over the next few months. “There have been a lot of questions from infertility specialists regarding whether Lap-RFA can be applied to their patients because there’s very little scarring and a quick return to work. It’s really a very nice outpatient procedure for dealing with fibroids,” Dr. Berman said in an interview.
There is natural concern, however, because clinicians are uncomfortable exposing women to a pregnancy risk. “I think there’s concern from many gynecologists and reproductive endocrinologists on the pregnancy outcomes following fibroid therapy, whatever that happens to be – traditional open laparoscopic myomectomy, robotic myomectomy, all of those kinds of therapies. We were interested in looking at pregnancy outcomes following [RFA for fibroids] and whether or not C-sections would need to be recommended, similar to what you see following myomectomy, where if you enter the cavity or go through more than half of the myometrium, you recommend a C-section for that patient in subsequent pregnancies,” said Dr. Berman, who is a professor of obstetrics and gynecology at Wayne State University, Detroit.
Early case studies, mostly done in Mexico and Guatemala, found the uteri of women to be normal following Lap-RFA, he said.
The results of this study are encouraging, but are far from the final word, as the data are retrospective and small. Acessa, which provided statistical analysis for the current work, is planning a prospective study. “I don’t think there’s enough to say that the labeling should be changed, but we’re moving in that direction. There needs to be a lot more information,” Dr. Berman said at the meeting sponsored by AAGL.
The study combined data from two randomized, controlled trials in the United States and Germany; six cohort studies in the United States, Germany, and Latin America; and commercial procedures performed in the United States. The researchers relied on standardized case reports that focused primarily on maternal and infant safety, and the mode of delivery. They collected data from 38 women (mean age, 36 years) who had fibroids types 1-6 that were of a maximum 0.2-13 cm in diameter. In 19 cases, it was 5.5 cm or smaller. The number of fibroids treated ranged from 1 to 31; 19 women had one or two fibroids treated.
There were a total of 43 pregnancies, 32 of which resulted in full-term live births (74%) and there was 1 preterm birth (2.3%). All infants were healthy, and there 19 vaginal births and 13 C-sections. The reasons for the C-sections were previous C-sections or obstetric indications, such as unusual bleeding, nonprogression of labor, or abnormal fetal heartbeat. There were eight spontaneous abortions (19%) and one therapeutic abortion (2.3%), and one pregnancy was ongoing (2.3%).
Dr. Berman has been a consultant for Acessa Health, Bayer, Boston Scientific, Medtronic, and Abbvie. He has been on the speakers bureau for Acessa, Merck, Boston Scientific, Medtronic, Abbvie, and Lupin. He has performed contracted research for Acessa, Bayer, Allergan, and Obseva.