1. In patients with symptomatic uterine leiomyomas who received suprapubic ultrasound (US)- guided transvaginal (ST) radiofrequency ablation (RFA), uterine leiomyoma volumes were significantly reduced at multiple follow-up evaluations at 1-, 3-, 6-, and 12-months.
2. No severe perioperative complications or adverse effects were reported with US-guided ST RFA, and patient interviews following this minimally invasive procedure indicated overall favorable experiences and significantly improved measures of symptoms and health-related quality of life (QOL).
3. US- guided ST RFA is a cost effective intervention and may be repeated multiple times on one lesion for additional myolysis.
Evidence Rating Level: 3 (Fair)
Study Rundown: Uterine leiomyomas, or fibroids, are benign solid tumors that are common in women of childbearing age. While often asymptomatic, fibroids may cause abnormal uterine bleeding, fertility complications, dyspareunia, and other QOL-limiting symptoms. The mainstay of definitive management for symptomatic fibroids remains surgical, including hysterectomy and myomectomy, and may compromise fertility post-operatively. However, there remains an unmet need for more minimally invasive, fertility preserving treatments that can be performed without the risks of general anesthesia. RFA is one such option in which radiofrequency energy is used to focally heat the fibroids, resulting in targeted coagulative necrosis and volume reduction. While the emerging clinical literature base suggests RFA as a promising intervention for many tumor types, the feasibility of RFA in the management of patients with symptomatic fibroids has yet to be established. The present study sought to establish the safety and efficacy of suprapubic US-guided ST RFA in the treatment of symptomatic uterine leiomyomas by examining fibroid volume changes, complications and overall patient satisfaction at regular intervals over 1 year post-procedure.
The procedure was found to be efficacious in significantly reducing fibroid volume at all time points within the 1-year follow-up period, though it did not entirely eradicate fibroid burden. Additionally, most patients reported satisfaction with this intervention, with significantly improved measures of symptom control and quality of life and an absence of reported complications, either periprocedurally or during follow-up. The cost-effectiveness of the intervention as well as and the option for targeted repetition of the procedure were emphasized as significant strengths, over surgical management in management of uterine leiomymas. The study was limited by its small sample size of only 51 women, its lack of randomization and control group, in addition to the relatively short follow-up period of just 1 year. Although the findings represent a significant step in establishing RFA for the management of symptomatic leiomyomas, randomized controlled trials are needed to verify the efficacy of this treatment and its effect, if any, on fertility.
In-Depth [prospective cohort]: This trial included 51 women (mean age 42.2 years; range: 32–52 years) with symptomatic uterine leiomyomas who refused hysterectomy or myomectomy. Subjects were excluded for a history of a prior abnormal Pap test, coagulopathy, or gynecologic malignancy. Following transvaginal conventional and contrast material–enhanced US assessment of the number, size, volume, blood flow, and location of the leiomyomas included in the study, RFA was performed under continuous real-time suprapubic US monitoring. The intervention was performed in an outpatient setting and occurred 3 days following each subject’s last menstrual period, with all 62 leiomyomas included in the study ablated until 90% of the fibroid was echogenic. No postoperative complications such abdominal pain, trauma to surrounding tissue, vaginal discharge and bleeding, fever, dyspnea, or menorrhagia were reported during the periprocedural period or throughout follow-up. Each subject was assessed intermittently for 1 year, with follow-up visits at 1-, 3-, 6-, and 12-months during which leiomyoma volumes were reassessed and symptom and QOL scores were re-determined by questionnaire for comparison to pretreatment responses. Imaging studies confirmed efficacy of the treatment, showing significant reductions in leiomyoma volumes from a mean of 33.0±25.1 cm3 preoperatively to 6.8 ± 7.7 cm3 1 year post-procedure (p < .05). The mean percentage volume reduction at 1-, 3-, 6-, and 12-month follow-up was 28%, 57%, 63%, and 78%, respectively. Symptom improvement and QOL measures similarly showed significant improvement at follow-up (p < .05). Overall, 41 of 45 patients reported treatment satisfaction with RFA.
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