RFA is a promising option
RFA is another noninvasive fibroid ablation technique that has become more widely adopted in recent years. Here, we describe the basics of RFA and its impact on fibroid symptoms and reproductive outcomes.
The RFA technique
RFA uses hyperthermic energy from a handpiece and real-time ultrasound for targeted coagulative necrosis via a laparoscopic (L-RFA) or transcervical (TC-RFA) approach.22 A comparison between the 2 devices available on the market in the United States is shown in TABLE 2. Ultrasound guidance allows placement of radiofrequency needles directly into the fibroid to target local treatment to the fibroid tissue only. Once the fibroid undergoes coagulative necrosis, the process of fibroid resorption and volume reduction occurs over weeks to months, depending on the fibroid size.
Impact on fibroid symptoms
Both laparoscopic and transcervical RFA approaches have shown significant decreases in pelvic pain and heavy menstrual bleeding associated with fibroids and a low reintervention rate that emphasizes the durability of their impact.
A feasibility and safety study of a TC-RFA device prior to the primary clinical trials found only a 4.3% reintervention rate in the first 18 months postprocedure.23 The pivotal clinical trial of a TC-RFA device that followed also reported a low 5.5% reintervention rate in the first 24 months postprocedure, with significant improvement in health-related quality-of-life and high patient satisfaction24 (results shown in TABLE 2, along with trial results for an L-RFA device). A subsequent study of TC-RFA reported that symptomatic improvement persisted at 3-year follow-up, with a 9.2% reintervention rate comparable to existing fibroid treatments such as myomectomy and UAE.25 The original L-RFA trial also has shown similar positive results at 2-year follow-up, with a low reintervention rate of 4.8% after treatment, and similar patient satisfaction and quality-of-life improvements as TC-RFA.26 While long-term data are limited by only recent approval by the Food and Drug Administration (FDA) of a TC-RFA device in 2018, one study followed clinical trial patients for a mean duration of 64 months. This study found no surgical reinterventions in the first 3.5 years posttreatment and a persistent reduction in fibroid symptoms from baseline 64.9 points to 27.6 points, as assessed by a validated symptom severity scale (out of 100 points).27 Similar improvements in health-related quality-of life-were also found to persist for years posttreatment.4
In a large systematic review that compared L-RFA, MRgFUS, UAE, and myomectomy, L-RFA had similar improvement rates in quality-of-life and symptom severity scores compared with myomectomy, with no significant difference in reintervention rates.28 This review also noted minimal heterogeneity among RFA meta-analyses data in contrast to significant heterogeneity among UAE and myomectomy data.
Reproductive outcomes
Similar to MRgFUS, the initial studies of RFA devices largely excluded women with future fertility plans, as data on safety were lacking. However, many RFA devices are now on the market across the globe, and subsequent pregnancies have been tracked and reported.
A large case series that included clinical trials and commercial settings reported a miscarriage rate (13.3%) similar to that of the general obstetric population and no cases of uterine rupture, invasive placentation, preterm delivery, or placental abruption.29 Other case series have reported live birth rates similar those with myomectomy, and safe and favorable pregnancy outcomes with RFA have been supported by larger systematic reviews of all ablation techniques.12
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