Transcervical fibroid ablation (TFA) to treat symptomatic uterine fibroids (UFs) is effective for a wide range of fibroid types and sizes, according to preliminary results of the first 160 women treated in the Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE registry).
The procedure also was found to have an excellent safety profile, with an adverse event rate of 0.6% for both device-related and serious procedure-related adverse events.
The study protocol and results were published in the journal Medical Devices: Evidence and Research.
TFA is minimally invasive therapy that uses intrauterine ultrasound for imaging and radiofrequency (RF) energy for ablation.
“Outcomes reported with TFA have been positive, with significant reductions in fibroid volume, improvements in symptom severity and health-related quality of life, and low complication and surgical reintervention rates,” wrote the Swiss and German authors.
The SAGE registry reports on outcomes of TFA for treating symptomatic UFs in a real-world setting. The ongoing
postmarket global registry comprises a maximum of 50 sites and up to 500 women who select TFA with the Sonata system (Gynesonics Inc., Redwood City, California).
The main outcomes are symptom severity score and health-related quality of life subscales of the Uterine Fibroid Symptom and Quality of Life(UFS-QoL); general health status on the EuroQol- 5 Dimension (EQ-5D); perceived treatment benefit; treatment satisfaction; work and activity patterns; overall patient treatment outcome; adverse events; pregnancy incidence and outcomes; and surgical reinterventions for heavy menstrual bleeding.
Patient recruitment began in June 2017. The total study duration is anticipated to be 7.5 years, with 2.5 years of patient recruitment and 5 years of follow-up.
“The SAGE registry represents the largest known study of TFA for uterine fibroids and will generate up to 2,500 patient-years of outcome data,” wrote the authors.
Between June 2017 and February 2020, 160 women received TFA treatment in the SAGE registry at 7 sites in Germany and Switzerland.
The mean patient age was 42 years, with a mean body mass index (BMI) of 24 kg/m2.In addition, 19% of patients previously underwent an intrauterine procedure, most commonly myomectomy.
The mean follow-up thus far is 5.3 months, with the maximum follow-up currently at 25 months.
Of the 241 fibroids treated, 10% were submucous, 52% transmural, 28% intramural and 10% subserous.
Ablated fibroid diameters ranged from <1 cm to >10 cm, with 27% of fibroids having a maximum diameter >5 cm.
No serious device-related adverse events have been reported among the 160 women, but non-serious procedure-related adverse events were reported in 5.0% of patients and were attributable to pain or vaginal bleeding.
One device-related adverse event was reported as a second-degree skin burn at the site of the dispersive electrodes, due to human error/misuse by the site staff.
One serious procedure-related AE was also reported: non-infectious endometritis that resolved with intravenous antibiotics and analgesia. However, because the event entailed an overnight hospital stay, it was classified as a serious adverse event.
The authors said that the SAGE register will strengthen existing evidence on the durability of TFA in providing meaningful relief from UF symptoms. The procedure also has valuable clinical and economic implications for patients, physicians and healthcare payers.
Christoffel L, Romer T, Schiermeier S. Transcervical radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): study protocol and preliminary results. Med Devices (Auckl). 2021 Mar 3;14:77-84; doi:10.2147/MDER.S301166