Radiofrequency volumetric thermal ablation (RFVTA) is a safe and effective treatment for menorrhagia in women with symptomatic fibroids, providing both clinically and statistically significant reduction in blood loss, according to new research.
A prospective, multi-center, single-arm clinical trial followed 135 women, aged 30 to 54, with moderate-to severe menorrhagia as verified by alkaline hematin (AH) testing.
At baseline, the mean AH was 271.5 +/- 80.67 mL. Patients then underwent laparoscopic ultrasound-guided RFVTA of their symptomatic myomas.
Researchers treated 674 fibroids between 1.0 cm and 9.7 centimeters in diameter, including 193 subserosals, 347 intramurals, 39 transmurals, and 164 submucosals. Three months after treatment, 124 patients had a mean AH of 1880.0 +/- 139.19, a reduction of 31%. Six months after treatment, 128 subjects had a mean AH of 160.7 +/- 101.67, a reduction of 41%. There was a reintervention rate of .7% (1 of 135).
Jay Berman, MD, presenting author at the 41st Global Congress of the American Association of Gynecologic Laparoscopists, noted that Lukes et al identified the minimum change in menstrual blood loss (MBL) that would be meaningful to patients at 6 months as assessed by the Menorrhagia Impact Questionnaire at 35 mL/cycle, or 22%, and that RFVTA provided MBL reduction of 113 mL per cycle, or a 41% mean decrease in bleeding.1
Additionally, authors confirmed that three patients had become pregnant after undergoing the procedure, including one successful vaginal delivery that was case-reported in the Journal of Minimally Invasive Gynecology, and two other pregnancies that are ongoing.
“This represents a new and exciting modality for symptomatic myoma management,” said Berman.