Uterine leiomyomas are the most common gynecologic neoplasms, with one U.S. study using ultrasonography demonstrating their presence in more than 80% of women of self-identified African ancestry and almost 70% of self-identified White women.1,2 Within the universe of currently available therapies (Fig. 1), one newer option is radiofrequency ablation (RFA). Despite the availability of uterine-sparing medical and interventional treatments for leiomyomas, it has been demonstrated that up to 60% of patients do not trial conservative treatments before undergoing hysterectomy.3 A comparison of currently available uterine-sparing interventional options for leiomyomas is provided in Table 1.
The therapeutic use of heat to treat tumors in the human body is not a new concept. The Edwin Smith Surgical Papyrus reports that the Egyptians cauterized tumors around 3,000 BCE.4 In 1891, French physician and physicist Jacques-Arsene D'Arsonval demonstrated that oscillating current as low as 10 kHz could be passed though tissues without pain or muscle contraction but with a rise in tissue temperatures.5 William Bovie subsequently introduced a ground-breaking device for the operating room that transformed electrocautery into electrosurgery, wherein the tip of the probe did not build up heat but rather conducted current that caused cells within the body to generate heat through ionic agitation, allowing tissues to be cut or coagulated with minimal blood loss.6 Building from these principles and seeking a minimally invasive means of addressing liver tumors, in 1990, McGahan et al7 demonstrated that ultrasound-guided radiofrequency current could be delivered percutaneously using the insulated tip of an electrode to ablate defined areas of tissue with minimal surrounding damage.
The use of radiofrequency technology to address uterine leiomyomas is the result of pioneering work by Bruce Lee8 who, in 2002, reported 52 patients with leiomyomas treated with a deployable needle electrode. On the basis of those early successes, Lee refined his work to design a laparoscopic ultrasound-guided approach to treat leiomyomas using radiofrequency energy. That device, known as the Acessa ProVu system, received U.S. Food and Drug Administration (FDA) approval in 2012. In parallel, another technology focused on a transcervical approach to radiofrequency leiomyoma ablation began its development in 2005. That technology, Sonata, was cleared by the FDA in 2018.
The goal of this review is to help readers understand how RFA technology works, what the currently available clinical outcomes data demonstrate, and where this burgeoning field may lead in the future.
MECHANISM OF ACTION
Radiofrequency waves have the lowest frequency, longest wavelength, and lowest energy on the electromagnetic spectrum. Most medical applications use radiofrequency waves in the range of 450 kHz to 500 kHz, which is best for controlled and predictable ablation of human tissue. The circuit starts with a generator that creates an alternating current that is transmitted to target tissue through an exposed electrode and then travels back through return pads (dispersive electrodes) to complete the circuit. With monopolar electrical systems, return dispersive electrodes typically are used in the form of pads placed transversely on the patient's anterior thighs. It is important to ensure proper placement of dispersive electrodes because any break of the closed circuit can cause electrical shorts that result in patient burns.
In the case of radiofrequency, it is the alternating electromagnetic field that causes polarized cellular molecules (composed of mostly water) to vibrate, generate heat, and propagate the electromagnetic wave farther by tissue conductivity. Cellular temperature drops in a predictable and exponential fashion as the distance from the source electrode increases, allowing calculation of ablation zone size. Human tissue is very sensitive to temperature increases, and cell death typically occurs at temperatures greater than 60 °C, with tissue desiccation and protein coagulation observed at temperatures between 60 °C and 99 °C. Radiofrequency technology uses a slow, methodical deposition of energy through a variety of electrode configurations to effectively ablate target tissue rather than a rapid and high temperature rise.9,10 This results in coagulative necrosis of tissue in the treatment zone. One key aspect of a leiomyoma that affects ablative treatment outcome is the degree of associated vascularity; when target tissue is adjacent to a blood vessel that is 3 mm or larger, the flowing blood limits temperature rise, and a cooling “heat sink” effect is created.9 By incorporating consideration of heat sinks and the insulating effect of charred tissue, engineers are able to program software that maximize the target tissue ablation while minimizing surrounding tissue damage.
U.S. FOOD AND DRUG ADMINISTRATION–APPROVED RADIOFREQUENCY ABLATION TECHNOLOGIES FOR LEIOMYOMAS
At present, two RFA technologies are approved by the FDA to ablate uterine myomas. They are hereafter referred to as laparoscopic RFA9 and transcervical RFA.11 Both systems use radiofrequency currents at 460 kHz delivered through an electrode array with ultrasound-guided targeting of lesions and incorporated software that calculates ablation times according to the size of targeted tissue.
Current FDA-approved laparoscopic RFA technology (Fig. 2) uses a standard 5-mm laparoscope to visualize the manipulation of the 10-mm reusable laparoscopic ultrasound probe and a separate disposable handpiece with a trocar containing seven deployable radiofrequency electrodes. After leiomyomas are mapped with the ultrasound probe, the electromagnetic spatial tracking technology of the system is engaged to orient and target the handpiece with the radiofrequency electrodes. Under laparoscopic and ultrasound guidance, the trocar is advanced percutaneously and through the leiomyoma capsule; the electrode array is then deployed into the leiomyoma. Before initiation of the ablation, proper placement of the tines of the array is confirmed with both laparoscopic visualization of adjacent structures and ultrasound evaluation from various angles to ensure that unintended tissues are not included. Once the target tissue temperature reaches 95 °C, the ablation time begins. After the ablation is complete and the surgeon terminates the session, electrode arrays are retracted, and the handpiece tip is allowed to cool before removal from the target tissue. Hemostasis in the surrounding myometrium and serosa is obtained by cauterizing the penetrated tissue as the handpiece is removed from the uterus. The process is then repeated as needed to address the same or additional leiomyomas.
The FDA-approved transcervical RFA technology (Fig. 3) uses intrauterine ultrasound-guidance to introduce a trocar with a deployable array of seven needle electrodes intro target leiomyoma tissue. Unlike the laparoscopic RFA technology, the transcervical RFA system incorporates both the ultrasonographic and radiofrequency components into a single handpiece that is inserted through the cervix so that the device accesses the leiomyomas from within the uterus without the need for incisions. For the procedure, the cervix is dilated to 27F to accommodate the 8.4-mm-diameter handpiece. The device is advanced to the uterine fundus, and a global survey is performed to map leiomyomas. Once the desired ablation zone has been determined, the trocar is introduced from the shaft of the handpiece, penetrating the leiomyoma tissue. Before and after the needle electrodes are deployed, safety rotations are performed to confirm that the target ablation zone is within the uterine serosa and away from unintended organs. Once the ablation is complete, the radiofrequency generator automatically turns off, and the needle electrodes and introducer can then be retracted. Subsequent ablation can then be performed as needed.
Patients with enlarged uteri and suspected leiomyoma-related symptoms should undergo standard clinical evaluation, including pelvic imaging, before RFA treatment. Pelvic ultrasonography or magnetic resonance imaging (MRI) can provide useful preoperative information on the size and location of leiomyomas and to distinguish uterine leiomyomas from adenomyosis, although MRI may provide greater detail on soft tissue and vascular structures.
FIGO (International Federation of Gynecology and Obstetrics) types 2 through 6 and 2–6 leiomyomas can be treated with laparoscopic RFA. Type 7 pedunculated leiomyomas can also be treated, although care should be taken to avoid treating an exophytic leiomyoma with a thin stalk (eg, stalk size less than 50% the diameter of the leiomyoma) because of concerns about necrosis of the stalk and avulsion of the leiomyoma, which could result in pain or infectious complications. Broad ligament and cervical leiomyomas should also be approached with care to avoid damage from device insertion or deployment or from thermal spread to adjacent structures. Similarly, leiomyomas with a submucosal component should be treated with caution to avoid unintentional ablation of the endometrium. The transcervical RFA system is designed to treat FIGO types 1 through 6 and 2–5 leiomyomas. Cervical, broad ligament, and pedunculated submucosal or subserosal leiomyomas should not be treated with transcervical RFA. Endometrial cavities that are foreshortened to less than 4.5 cm from the fundus to the external os may also have limited access and ability to deploy the system.
Particularly in patients presenting with abnormal uterine bleeding or who are at risk for endometrial pathology, tissue sampling of the endometrium should be performed before RFA. Similarly, if patients describe pelvic pain or dysmenorrhea, further evaluation for other potential causes of these symptoms (endometriosis and adenomyosis) should be explored with appropriate preparation to address these causes if encountered intraoperatively. If intrauterine pathology such as endometrial polyps or submucosal myomas amenable to hysteroscopic resection are noted, these should be addressed either before or concurrent with RFA.
Anemia and coagulopathy should be corrected before the procedure. Patients with known metal implants in their hips and body jewelry that cannot be removed from the abdomen or vulva are not candidates for RFA because these implants will be in the path of radiofrequency return to the dispersive electrodes placed on the patient thighs.
From a preoperative counseling perspective, it is important to note that the pivotal trials for both current FDA-approved devices excluded leiomyomas greater than 7 cm and uteri larger than 14 weeks of gestational size. Although follow-up work has demonstrated successful outcomes with leiomyomas larger than those included in the clinical trials, surgeons should be aware of the limitations of existing data. An explicit discussion should also be held about reproductive goals, including that patients expressly desiring future fertility were excluded from early clinical trials.
Although laparoscopic RFA may be considered a clean procedure, and transcervical RFA is akin to hysteroscopy for which antibiotic prophylaxis is not generally recommended, it is notable that all pivotal trials included preoperative antibiotic administration. There are not enough data to support a strong recommendation for preoperative antibiotic prophylaxis, but it may be prudent to administer antibiotics given the potential for severe adverse outcomes if perioperative bacterial seeding of the uterus does occur.
Appreciation of surrounding anatomy and the ability to interpret laparoscopic or intrauterine ultrasonography are critical for RFA procedures. In particular, there is a learning curve with the use of ultrasonography in a different orientation from traditional transvaginal or transabdominal imaging. One investigation into the adoption of laparoscopic RFA suggested that surgeons naive to the procedure can gain competence after a minimum of two to five proctored cases.12 For laparoscopic RFA, placement of an optical port cephalad to the fundus is recommended to have a panoramic view of the pelvis. Generally, a 10- to 12-cm midline port for the ultrasonogram is placed at the level of the fundus to provide optimal image guidance and maximize options for alignment of the ultrasound probe, trocar, and needle electrodes. There should be a low threshold to place accessory laparoscopic ports if needed to assist with restoring normal anatomy or stabilizing the uterus. A nonconductive intrauterine manipulator may be helpful to provide countertraction and positioning away from surrounding structures during laparoscopic RFA.
Because of the dilation required for transcervical RFA device, preoperative preparation with misoprostol may prove beneficial. At the time of ultrasound mapping of target leiomyomas with the transcervical RFA system, a visceral slide test can be performed to reassure the surgeon that the bowel is not adherent to the uterus, particularly when treating posterior and fundal myomas. During the visceral slide test, the operator observes the interface between the uterine serosa and underlying bowel; if the bowel moves freely with natural respiratory motions, there is a lower suspicion for adhesive tethering at that site. In addition, fluid can be instilled into bladder or even injected through posterior fornix of vagina into posterior cul-de-sac to enhance visual demarcation of the serosal outline during transcervical RFA. With either approach, advancement of the trocar and needle arrays through the uterus should be done toward the midline and anteriorly when possible to mitigate risk to the bowel and pelvic sidewall.
For larger leiomyomas, some experts have recommended avoiding performing procedures during the luteal phase to minimize blood loss related to increased vascularity. Because the trocar must pass through myometrium, disruption of engorged vessels may contribute to bleeding and create a heat sink, which prevents optimal dispersion of thermal energy. For this reason, insertion of the trocar near large intrauterine vessels should be avoided when noted on the surface of the uterus or observed under ultrasound guidance.
Treatment of 70–80% of the volume of each leiomyoma is generally recommended to optimize outcomes, and this often requires overlapping treatments. The RFA handpieces allow the surgeon to check the temperature at the target areas by activating the electrodes briefly to determine whether areas have been affected by previous treatments (indicated by higher temperature readings). In general, it is recommended to perform overlapping deployments of 2–3 cm instead of fewer, larger deployments to optimize thermal effects. When leiomyomas are surrounded by a thin layer of myometrium, cooling of the tissue with irrigation fluid has also been suggested to mitigate myometrial damage. In all cases and before activation of the radiofrequency generator, surgeons should be aware that the thermal ablation and safety zones presented on the ultrasound images are based on mathematical models of thermal spread through bovine liver models. When superficial leiomyomas or leiomyomas in close proximity to other anatomic structures such as the bowel, bladder, pelvic sidewall, or endometrium are treated, more conservative treatments are encouraged to avoid thermal spread to these areas, even when these structures may appear to be distal to the proposed ablation zone.
Laparoscopic Radiofrequency Ablation
Laparoscopic RFA is an effective treatment for uterine leiomyomas with a short recovery time and rapid effect on adverse symptoms. In a systematic review and meta-analysis of prospective RFA treatment studies, mean time to discharge from laparoscopic RFA was 10.7 hours, with a mean of 6.5 days to return to work and 9.0 days to return to normal activity.13 Reports on side effects are limited; however, the pivotal trial of the Acessa ProVu system noted that no patients reported symptoms similar to post–uterine artery embolization syndrome such as fever, pain, nausea, vomiting, or leukocytosis.14 Serious adverse events, including postoperative pelvic abscess and a bowel serosal injury from the ultrasound probe repaired intraoperatively, were reported in 2 of 135 patients. The total adverse event rate of laparoscopic RFA from a recent meta-analysis was 1.78%.15 A case report describes postoperative necrosis and peritonitis requiring hysterectomy after treatment of a 10×12-cm leiomyoma with laparoscopic RFA, possibly related to a large amount of residual necrotic tissue.16 Several studies have demonstrated safe use of laparoscopic RFA for leiomyomas up to 10 cm despite the initial trial exclusion of leiomyomas larger than 7 cm. However, the described complication represents evidence for caution with RFA use in significantly large leiomyomas larger than 10 cm.17,18
The majority of women experience a reduction in menstrual blood loss and leiomyoma size by 3 months after treatment with laparoscopic RFA, resulting in improved quality of life. In the pivotal trial, women experienced a 31.8% (95% CI −40.3% to −23.3%) reduction in alkaline hematin from baseline after 3 months, with a total reduction of 38.3% (95% CI −45.2% to −31.4%) at 12 months (P<.001).14 The total mean myoma volume was reduced by 39.8% at 3 months (95% CI −44.1% to −35.6%), with a final reduction of 45.1% at 12 months (95% CI −51.6% to −38.6%; P=.001).14 Total uterine volume decreased by 15.7% (95% CI −20.4% to −11.0%; P<.001) and 24.3% (95% CI −30.0% to −18.7%; P<.001) at 3 and 12 months, respectively. This was reflected in improved quality of life measures using the Uterine Fibroid Symptom and Quality of Life Questionnaire and reduced Symptom Severity Scores, changes that were maximized at 12 months.15
Transcervical Radiofrequency Ablation
Transcervical RFA is a similarly well-tolerated method of leiomyoma treatment with even shorter recovery times. In a meta-analysis of five studies, mean time to discharge after transcervical RFA was 2.5 hours, with a mean of 3.3 days until resumption of normal daily activity and return to work after 3.6 days.13 The pivotal trial of the Sonata system in the United States reported postprocedural side effects in up to half of patients (50.4%), including leiomyoma sloughing (30.6%), cramping or pain (7.5%), leukorrhea (6.1%), uncomplicated genitourinary infections (4.8%), expelled leiomyomas (1.4%), and nausea or vomiting (0.7%). Similar side effects were reported in the FAST-EU (Fibroid Ablation Study-EU) trial of the transcervical RFA system in Europe and Mexico.19 It is difficult to directly compare this information with laparoscopic RFA because of limitations in reported information on laparoscopic RFA side effects.20 No serious device-related adverse events were noted; however, there was one event of lower-extremity deep venous thrombosis 15 days postoperatively and one event of pelvic pain and leukorrhea requiring readmission.
In the SONATA (Sonography Guided Transcervical Ablation of Uterine Fibroids) trial, pictorial assessments of blood loss demonstrated a reduction in blood loss by 38.9% at 3 months and a final reduction by 51.1% at 12 months (P<.001), with a total of 95.1% of patients experiencing some improvement in bleeding.20 Similarly, in the FAST-EU trial, 57.1% of patients reported greater than 50% reduction in pictorial assessment of blood loss after 3 months and up to 64.6% reduction at 12 months (P=.95), with a total of 79.2% of patients experiencing a meaningful reduction in blood loss, defined as greater than 22%.19,21 In a systematic review of 10 studies, a 54.7% reduction in total myoma volume was observed at 3 months, and a final reduction of 63.2% was seen at 12 months.22 Total uterine volume decreased by 12.9% at 12 months (P<.001).20 These improvements in blood loss and leiomyoma volume were reflected in improvements in Uterine Fibroid Symptom and Quality of Life Questionnaire and Symptom Severity Scores, peaking by 6 months.22
Laparoscopic Radiofrequency Ablation
Long-term outcome data related to laparoscopic RFA and transcervical RFA are limited because of their relatively recent FDA approval in 2012 and 2018, respectively; however, follow-up data up to 36 months are available. In a systematic review of eight studies of laparoscopic RFA, improvements in health-related quality of life scores and Symptom Severity Scores remained relatively stable after 36 months.15 The overall reintervention rate from seven studies over a weighted mean duration of 24.65 months of follow-up was 4.39% (95% CI 1.60%–8.45%; I2=65.0%). A 3-year follow-up of the pivotal laparoscopic RFA trial demonstrated a total reintervention rate of 11.0%, including one uterine artery embolization, two myomectomies, and 11 hysterectomies (seven in the final follow-up year).23 Half of patients who underwent reintervention had some evidence of adenomyosis. Mean alkaline hematin levels for patients who underwent repeat surgical intervention were significantly higher at baseline and after 12 months compared with those who did not require repeat surgical intervention after 12 months.23
There are two randomized trials comparing laparoscopic RFA with laparoscopic myomectomy. Brucker et al,24 in a trial of 51 patients, identified shorter length of stay among patients receiving laparoscopic RFA with less intraoperative blood loss and a greater number of overall leiomyomas treated. In a 1-year follow-up, there were no significant differences in patient-reported outcomes between groups.25 TRUST (Randomized Trial of Uterine-Sparing Techniques) (N=45) showed similar results of a shorter hospital stay and shorter return to work for laparoscopic RFA compared with laparoscopic myomectomy.26 There was a demonstrated improvement in symptoms and quality of life for both groups in a follow-up study at 12 months, although the improvement was greater in patients who underwent myomectomy.18
Transcervical Radiofrequency Ablation
After transcervical RFA, patient-reported outcomes show maintenance of improved quality of life at 36 months.27 In the 3-year follow-up to the original SONATA trial, the surgical reintervention rate after 36 months was 8.2%.27 Reinterventions included one endometrial ablation and 10 hysterectomies. A systematic review identified a reintervention rate of 5.2% after 24 months and up to 11.8% after 64 months (however, long-term follow-up data after 5 years were based on a small sample size of 17).22,28
Although preliminary data are promising, the safety of either laparoscopic RFA or transcervical RFA technology for use in women desiring future pregnancy is not yet established.11,29,30 In a case series of 28 women who underwent laparoscopic RFA, there were 30 pregnancies, with 26 full-term live births (86.7%) of healthy neonates (half by cesarean delivery [50%]) and four spontaneous abortions (13.3%), with one event each of placenta previa and postpartum hemorrhage.31 Similarly, in a case series of 28 women after transcervical RFA, there were 36 pregnancies resulting in 20 full-term deliveries (the majority [60%] were cesarean), three therapeutic abortions, and eight spontaneous abortions, with no significant morbidities.32 Observed rates of spontaneous abortion (12%) are similar to those in the general population, and approximately half of women were able to safely undergo vaginal delivery.30 No events of placenta accreta spectrum or uterine rupture have been reported; however, these are rare events, and further study is needed to assess these theoretical risks. The ULTRA (Uterine Leiomyoma Treatment with Radiofrequency Ablation) trial, currently enrolling patients receiving laparoscopic RFA treatment of leiomyomas, plans to report up to 3-year posttreatment outcomes, including pregnancy-related data.33
THE FUTURE OF RADIOFREQUENCY ABLATION AND UTERINE LEIOMYOMAS
Given the pace at which radiofrequency applications are proliferating across medical disciplines, it is likely that the radiofrequency technologies that are currently available to address uterine leiomyomas represent only the beginning of this likely growing field. Technologically, the addition of artificial intelligence–enhanced guidance is a particularly enticing prospect to improve the targeting and safety of RFA, and design changes to the shape and capabilities of electrodes will likely make future procedures even more efficient. On the clinical side, if data were to convincingly demonstrate safety with regard to fertility, one could foresee RFA technologies being used to prophylactically treat asymptomatic myomas to impede or reverse their growth before they become problematic.
Further research with larger cohorts with longer follow-up terms is needed to confirm the long-term efficacy of RFA treatment of leiomyomas and to offer more direct comparative evidence between laparoscopic RFA and transcervical RFA. In addition, further comparative studies are needed to determine the value of RFA technology compared with other minimally invasive uterine-sparing procedures such as hysteroscopic or laparoscopic myomectomy, uterine artery embolization, and MRI-guided focused ultrasound surgery.
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