Purpose of Review
This article provides the current evidence related to transcervical radiofrequency ablation of uterine fibroids under integrated intrauterine sonography guidance (the Sonata ...System).
Recent Findings
Published data on the treatment of fibroids with the Sonata System has demonstrated significant median reductions in total (73.3%) and perfused (73.3%) uterine fibroid volume, menstrual bleeding (72.3%), symptom severity (62.5%), and improvements in health-related quality of life (127%) at 12 months post-ablation. A clinical trial under an FDA Investigational Device Exemption is in progress.
Summary
The Sonata System is a promising treatment modality for uterine fibroids. As an incisionless, minimally invasive treatment that does not require general anesthesia or hospitalization, it has the potential for redefining the current paradigm for management of symptomatic fibroids.
Transcervical fibroid ablation (TFA) is an incisionless method to treat symptomatic uterine fibroids. While safety regarding future pregnancy remains to be established, TFA does not preclude the ...possibility of pregnancy, and a previous 36-patient case series of post-TFA pregnancies reported normal outcomes. That prior series did not include postmarket cases in the United States, as the Sonata
System was initially cleared and used in Europe. This is a substantive update of known pregnancies with the Sonata System since June 2011, and includes pregnancies in Europe, Mexico, and the US.
: TFA was carried out under both clinical trial and postmarket use to treat symptomatic uterine fibroids. All post-TFA pregnancies reported by physicians with their patient's consent were included.
: 89 pregnancies and 55 deliveries have occurred among 72 women treated with the Sonata System. This includes 8 women who conceived more than once after TFA. Completed pregnancies (
= 62 women) include 19 vaginal deliveries, 35 Cesarean sections, 5 therapeutic abortions, 1 ectopic pregnancy, and 1 delivery by an unknown route. Ten pregnancies are ongoing. Mean birthweight was 3276.7 ± 587.3 g. Ten women experienced 18 first-trimester spontaneous abortions (SAbs), with 10 of the 18 SAbs (55.6%) occurring between two patients with a history of recurrent abortion. The SAb rate was 22.8%, inclusive of these two patients, and 10.1% if they were excluded as outliers. There were no instances of uterine rupture, placenta accreta spectrum, or stillbirth.
: This case series, the largest to date for any hyperthermic ablation modality, suggests that TFA with the Sonata System could be a feasible, safe treatment option regarding eventual pregnancy in women with symptomatic uterine fibroids.
Transcervical radiofrequency ablation of uterine fibroids was performed on a patient in Germany, who subsequently conceived. This is the first report of a normal spontaneous vaginal delivery after ...fibroid ablation with the Sonata
System.
Adenomyosis is a common benign gynecologic condition characterized by ectopic endometrial glands and stroma in the myometrium causing pain (dysmenorrhea) and abnormal uterine bleeding. New ...interventional techniques have been introduced over recent years. This study evaluates the treatment success and side effects of radiofrequency ablation. An electronic literature search in the PubMed, Scopus, and ScienceDirect databases was carried out on the outcomes of pain reduction and, secondarily, on abnormal uterine bleeding, reintervention, reproductive outcome, imaging outcome, and complications. There was a mean decrease in dysmenorrhea pain scores by -63.4 ± 9.0% at 12 months. Data on other outcome parameters were sparse. No major complications were reported. Radiofrequency ablation represents a promising minimally invasive and organ-preserving treatment in patients with symptomatic adenomyosis. It is associated with clinically meaningful improvement of adenomyosis-related pain in the short term.
The use of thermal energy-based systems to treat uterine fibroids has resulted in a plethora of devices that are less invasive and potentially as effective in reducing symptoms as traditional options ...such as myomectomy. Most thermal ablation devices involve hyperthermia (heating of tissue), which entails the conversion of an external electromagnetic or ultrasound waves into intracellular mechanical energy, generating heat. What has emerged from two decades of peer-reviewed research is the concept that hyperthermic fibroid ablation, regardless of the thermal energy source, can create large areas of necrosis within fibroids resulting in reductions in fibroid volume, associated symptoms and the need for reintervention. When a greater percentage of a fibroid's volume is ablated, symptomatic relief is more pronounced, quality of life increases, and it is more likely that such improvements will be durable. We review radiofrequency ablation (RFA), one modality of hyperthermic fibroid ablation.
Objective
To develop a core outcome set for heavy menstrual bleeding (HMB).
Design
Core outcome set (COS) development methodology described by the COMET initiative.
Setting
University hospital ...gynaecology department, online international survey and web‐based international consensus meetings.
Population or sample
An international collaboration of stakeholders (clinicians, patients, academics, guideline developers) from 20 countries and 6 continents.
Methods
Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two‐round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS.
Main outcome measures
Outcome importance was assessed in the Delphi survey on a 9‐point scale.
Results
From the ‘long list’ of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level.
Conclusions
The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy.
Uterine fibroids are one of the most common diseases in female patients, lead mainly to bleeding disorders and lower abdominal pain, and reduce the chance of having children. In recent years we have ...seen a trend towards more and more pharmacotherapies and minimally invasive organ-preserving treatments. One novel and innovative procedure for an organ-preserving treatment of symptomatic uterine fibroids is the transcervical ultrasound-guided radiofrequency ablation (TRFA). TRFA has been used in Germany since 2013 and later found use in other German-speaking countries as well. There have now been more than 1200 TRFA treatments performed in Germany, Austria, and Switzerland. Experts from these three countries came together for a consensus meeting to analyze the significance of the procedure in the overall concept of the treatment of symptomatic uterine fibroids.
The FAST-EU Trial was designed to establish the effectiveness and confirm the safety of transcervical intrauterine sonography-guided radiofrequency ablation with the VizAblate™ System in the ...treatment of symptomatic uterine fibroids. This was a multicenter, prospective, single-arm trial involving academic and community hospitals in the United Kingdom, the Netherlands, and Mexico. Women with qualifying uterine fibroids and heavy menstrual bleeding underwent intrauterine sonography-guided transcervical radiofrequency ablation (RFA) with the VizAblate System; anesthesia was individualized. Patients were required to have up to five fibroids from 1 to 5 cm in diameter. The primary trial endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months by an independent core laboratory. Secondary endpoints, evaluated at 6 and 12 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score, and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) questionnaire, along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, nonsurgical reintervention for abnormal uterine bleeding, anesthesia regimen, patient satisfaction, and pain during the recovery period. An additional MRI study was performed at 12 months on a subgroup of patients. Fifty patients (89 fibroids) underwent transcervical radiofrequency ablation with the VizAblate System. At 3 and 12 months, perfused fibroid volumes were reduced from baseline by an average of 68.1 ± 28.6 and 67.4 ± 31.9 %, respectively, while total fibroid volumes were reduced from baseline by an average of 54.7 ± 37.4 and 66.6 ± 32.1 %, respectively (all
P
< .001 compared with baseline; Wilcoxon signed-rank test). At 12 months, mean MP score and SSS decreased by 53.8 ± 50.5 and 55.1 ± 41.0 %, respectively; the mean HRQOL score increased by 277 ± 483 %. There were four surgical reinterventions (8 %) within 12 months. This is the first report of the 12-month follow-up for patients in the FAST-EU Trial. In concert with previously reported 3- and 6-month endpoint data, the 12-month results of the FAST-EU Trial suggest that in addition to substantially reducing the perfused and total volume of targeted uterine fibroids, the VizAblate System is safe and effective through 12 months in providing relief of abnormal uterine bleeding associated with submucous, intramural, and transmural fibroids.
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