SAN DIEGO — Thermal balloon endometrial ablation is a safe and effective option for the treatment of women with idiopathic menorrhagia, results from a 3-year study of 330 women have shown.
“The procedure is simple, does not require additional training in operative hysterectomy, and compares favorably with other ablative techniques,” Stefanos Chandakas, M.D., Ph.D., reported at an international congress of the Society of Laparoendoscopic Surgeons. “These good results, however, need to be confirmed in a randomized, controlled trial.”
For the study, he and his associates used a 6-mm diameter Cavaterm Plus thermoablation system in 330 women with a mean age of 42 years.
All of the participants had experienced heavy menstrual bleeding, failed medical treatment for the condition, and otherwise would have required hysterectomy, endometrial laser ablation, or endometrial resection.
The outpatient procedures were performed from January 2001 to June 2004 at Princess Royal University Hospital and Farnborough Hospital, Orpington, England.
Contraindications included undiagnosed uterine bleeding, pregnancy or the desire to become pregnant, atypical endometrial cells, cervical length greater than 6 mm, gross uterine abnormalities that would result in an inappropriate balloon contact with the endometrium, a uterine cavity less than 4 cm or greater than 10 cm, uterine wall weakness, or ongoing infection.
No endometrial preparation was used. Each ablation lasted 10 minutes at a temperature of 78° C.
Follow-up occurred at intervals of 3, 6, 12, 24, and 36 months, for a mean of 22 months.
Nearly half of the participants (48%) were amenorrheic after 1 year, while the rates of amenorrhea were 39% and 38% after 2 and 3 years, respectively. (See chart.)
The majority of women (83%) reported a reduction in dysmenorrhea and premenstrual symptoms at 1 year, “which is a recognized and consistent finding following endometrial destructive procedures,” said Dr. Chandakas of the minimal access unit in the department of obstetrics and gynecology at Princess Royal.
At 3 years, 73% of women reported a reduction in dysmenorrhea and premenstrual symptoms.
No balloons failed, and no major complications were noted.
Dr. Chandakas credited the success of the procedure in large measure to the Cavaterm Plus silicone balloon, which is formed to adapt to the uterine cavity. “The adjustable balloon length fits every uterus and protects the cervix from burns,” he said.
Dr. Chandakas disclosed that he has no financial interest in Wallsten Medical, the Swiss manufacturer of Cavaterm Plus.
