Radiofrequency Ablation: A Possible Game Changer for Uterine Fibroids

Although Dr. Chudnoff and his coauthors’ prospective, single-arm industry study of Acessa use of targeted radiofrequency ablation for uterine fibroids – which reports on only its first 12 months of follow-up – shows results that are promising, I would caution readers before adopting the technology wholeheartedly.

Dr.. Patrick J. Woodman

We have seen similar impressive results with targeted vascular embolization of uterine fibroids. The decision to enthusiastically adopt uterine artery embolization lined a good number of radiologists’ pockets, while leaving unhappy gynecologists to deal with the inevitable complications of pain and bleeding.

Equally concerning are the authors’ claims that "the risk is so low." Although I expect that the "intra-abdominal" ultrasound guidance to evolve so that it could be done transvaginally, the approach still resulted in a 1.5% chance of "superficial uterine serosal burns." This could represent the risk of bowel injury in a patient without laparoscopic-ultrasound guidance.

It is reassuring that the Food and Drug Administration has approved the technology, and we have the American registration study and those from Canada and Europe from which to extrapolate safety and efficacy. Dr. Chudnoff’s study also boasts high subjective "satisfaction" and "effectiveness" scores on patient questionnaires. However, with such a short follow-up, it is hard to predict how many subjects will develop recurrence or ultimately require hysterectomy.

Finally, I caution readers to pay attention to the difference between "statistically significant differences" and "clinically significant differences." Although the UFS-QOL and the EuroQoL are validated fibroid questionnaires, my perusal of published literature did not turn up what would be considered the "minimal clinically significant difference" for each measure. A 50% reduction in severity or improvement in QoL score means nothing if the symptoms are not severe, or if the "bother" is very low. Just because there was a numerical difference in the subjects between pre- and post-treatment does not mean that difference necessarily matters.

Patrick J. Woodman, D.O., is a urogynecologist, associate professor of obstetrics and gynecology, and is chief of specialty care at Marian University College of Osteopathic Medicine in Indianapolis. He said that he has no disclosures pertinent to the story.