A reasonable alternative
The lay press recently focused on our obligation, as ObGyns, to inform patients about alternative therapies for fibroids. These first reports from the Fibroid Registry are clear: UAE is a reproducible, low-risk procedure—certainly lower in risk than complex surgeries (though situations may arise when myomectomy is preferred, such as a desire for future fertility1).
The registry will continue to provide data we can share with our patients regarding risks, complications, and long-term outcomes. More importantly, our radiology colleagues have taken the lead in developing a voluntary patient registry to track the outcomes of new technology as it disseminates into the general medical community. Our patients would be well served if we developed similar registries to track our surgical outcomes.
Focused ultrasound shrinks fibroids, but has strict eligibility requirements
Hindley J, Gedroyc WM, Regan L, et al. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004;183:1713–1719.
Using MRI guidance, a completely noninvasive treatment is now possible: focused ultrasound ablation of uterine fibroids. This procedure, the newest high-tech treatment for symptomatic fibroids, was successfully tested in an earlier pilot study.2 Although it eased symptoms to a remarkable degree during this phase III trial, how many women will ultimately be suitable for the treatment remains unclear.
Selection criteria
This trial of the ExAblate 2000 (InSightec, Tirat Carmel, Israel) recruited symptomatic women who were otherwise suitable candidates for conventional surgeries. Excluded were postmenopausal patients, women weighing more than 250 lb, and women who had a uterus larger than 24 weeks’ size or any single myoma larger than 10 cm. Women with extensive abdominal scars were carefully examined and excluded if the scars lay in the path of the ultrasound beam. The reason: During the earlier study, these scars tended to absorb ultrasound energy, increasing the risk of thermal injury at the skin surface.
Before proceeding, patients underwent MRI or ultrasound to confirm a clear pathway from the anterior abdominal wall to the fibroids without traversing the bladder or bowel.
Hindley et al did not reveal how many women were initially screened, but 109 were finally enrolled at 7 international sites and completed a Uterine Fibroid Symptoms and Quality of Life Questionnaire before and 3 and 6 months after treatment. As for the location of the fibroids: 22% were submucosal, 57% were intramural, and 21% were subserosal.
Up to 4 fibroids were treated per patient—with MRI mapping and thermographic monitoring—with a margin of 1.5 cm from the edge of the ablated area to the edge of the uterus. Conscious sedation was provided as needed, and tolerance of the procedure was measured using a 4-point pain scale. Mean time in the MRI scanner was 202 minutes (range, 90–370 minutes).
Pain stopped when treatment ended
Most women reported mild to moderate pain during the procedure (66%), and 16% complained of severe pain. This discomfort ended immediately when treatment stopped in virtually all patients—only 1% reported severe pain afterwards.
Adverse events
Serious adverse events included: 5 women with heavy menses requiring blood transfusions, 1 patient with pain and bleeding consistent with preprocedure symptoms, 1 woman needing overnight hospitalization for nausea related to opioid analgesia during the procedure, and 1 patient with leg and buttock pain immediately after treatment (it was later discovered that the sciatic nerve was in the far field of the sonication pathway). These symptoms resolved by the follow-up visit.
Two other patients had adverse events unrelated to the procedure.
6-month outcomes
The mean fibroid volume reduction was 13.5%±32%. Although this improvement seems modest, women reported significant relief from fibroid-related symptoms, and the mean severity score on the quality-of-life questionnaire decreased.
Substantial improvement was seen for both mass effect and bleeding symptoms (32.8 points out of 100 for each).
Pros and cons for symptomatic women
Advantages over UAE include the absence of postprocedural pain in almost all patients, which eliminates the need for an overnight stay and likely speeds the return to normal activities.
Disadvantages are that women with major abdominal scarring, anterior myomas underneath the bladder flap, or adhesive disease that causes small or large bowel to lie in the path of the sound waves cannot take advantage of this new technology, nor can women who have myomas close to neurovascular bundles. Add to that the extremely long procedure time (over 3 hours) and the modest reduction in uterine volume.
Six-month outcomes are promising, but this approach is probably best reserved for an academic setting, so careful screening and long-term tracking can continue.