Radiofrequency Ablation Of Uterine Fibroids Research Articles

Ultrasound-guided transvaginal radiofrequency ablation of uterine fibroids assisted by virtual needle tracking system: a preliminary study

Purpose: The purpose of this study was to assess the feasibility and outcome of transvaginal ultrasound (US)-guided radiofrequency ablation of uterine fibroids assisted by a real-time virtual needle tracking (VT) system.Methods: Between January 2017 and February 2018, 19 patients (age 45 ± 8 y, range 36–53 y) with 25 symptomatic uterine fibroids underwent transvaginal radiofrequency ablation (RFA) at a single center. Mean number of fibroids for patient was 1.7 (min, max: 1–3). Patients with more than one fibroid were 10 (52.6%). Uterine fibroids (mean volume: 13.6 mL; range: 5.3–41.9 mL) were treated with a dedicated internally cooled 17 G 35 cm RF needle with 1 cm or variable active tip and the moving shot technique. An electromagnetic system was used for showing a virtual needle during the procedure. Contrast-enhanced ultrasound evaluation was performed before and immediately at the end of procedure. Feasibility of the procedure, technical success rate, volume percentage reduction at 1, 3 and 6 months, clinical outcome (QOL score) and complications were analyzed.Results: Procedure was feasible in 19/19 patients (100%). Technical success was achieved in 100% of 25 treated fibroids. Mean fibroids volume decreased from 13.6 ml at baseline to 5.9 ml at 6 month (reduction rate 62.7%, range 48.5–76.9; p < .05). No major immediate or late complications occurred. Minor complications occurred in two patients. QOL score significantly improved from 68 ± 36 at baseline to 97 ± 16 at six-months follow-up (p < .05).Conclusion: Transvaginal US-guided RFA assisted by a real-time VT system is a feasible, safe and effective technique for the treatment of uterine fibroids.

Improvement in health utility after transcervical radiofrequency ablation of uterine fibroids with the sonata system: Health utility after radiofrequency ablation

ObjectivesTo establish the improvement in patient health utilities following treatment of symptomatic uterine fibroids with the Sonata™ System. Study designA prospective, single-arm trial was conducted in which 49 women in the United Kingdom, Netherlands and Mexico with fibroids were treated with transcervical, intrauterine ultrasound- guided radiofrequency ablation. The EQ-5D-3L system was utilized to collect patient health status at baseline, 3, 6, and, 12 months post-procedure. Patient-reported health states at each time point were converted into a health utility value using time-trade off methodology. ResultsIn the overall cohort, patient health utility increased from a mean of 0.745 at baseline, to means of 0.838, 0.852, and 0.914 at 3 months, 6 months, and 12 months, respectively. The change from baseline at 12 months was significant. When stratified by country, the 12-month improvement in health utility remained significant for both the Mexican and Dutch cohorts. ConclusionsTranscervical radiofrequency ablation of uterine fibroids with the Sonata System resulted in statistically significant 12-month improvements in health utility for the overall patient cohort and for the Mexican and Dutch sub-populations.

489 - Investigational Treatment of Uterine Fibroids with Transcervical Radiofrequency Ablation in a Patient with Concomitant Adenomyosis

Study Objective: To describe a case in which radiofrequency ablation of uterine fibroids led to symptom relief in a patient with adenomyosis.

Radiofrequency Ablation of Uterine Fibroids Is Safe and Efficacious in Symptomatic Patients with Uteri of 15 Weeks Gestational Size and Larger

Radiofrequency Ablation of Uterine Fibroids Is Safe and Efficacious in Symptomatic Patients with Uteri of 15 Weeks Gestational Size and Larger

Improvement in Health Utility After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System

Improvement in Health Utility After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System

Normal Pregnancy Outcome After Transcervical Radiofrequency Ablation of Uterine Fibroids

Normal Pregnancy Outcome After Transcervical Radiofrequency Ablation of Uterine Fibroids

The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of 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.

Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System: three- and six-month endpoint results from the FAST-EU study.

This was a prospective, longitudinal, multicenter, single-arm controlled trial, using independent core laboratory validation of MRI results, to establish the effectiveness and confirm the safety of the VizAblate® System in the treatment of symptomatic uterine fibroids. The VizAblate System is a transcervical device that ablates fibroids with radiofrequency energy, guided by a built-in intrauterine ultrasound probe. Fifty consecutive women with symptomatic uterine fibroids received treatment with the VizAblate System. Patients had a minimum Menstrual Pictogram score of 120, no desire for fertility, and met additional inclusion and exclusion criteria. The VizAblate System was inserted transcervically and individual fibroids were ablated with radiofrequency energy. An integrated intrauterine ultrasound probe was used for fibroid imaging and targeting. Anesthesia was at the discretion of each investigator. The primary study endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months. Secondary endpoints, reached at 6 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 questionnaire (UFS-QOL), 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, medical reintervention for abnormal uterine bleeding, and procedure times. Fifty patients were treated, representing 92 fibroids. Perfused fibroid volumes were reduced at 3 months by an average of 68.8 ± 27.8 % (P < 0.0001; Wilcoxon signed-rank test). At 6 months, mean MP and SSS scores decreased by 60.8 ± 38.2 and 59.7 ± 30.4 %, respectively; the mean HRQOL score increased by 263 ± 468 %. There were two serious adverse events (overnight admissions for abdominal pain and bradycardia, respectively) and no surgical reinterventions. These 6-month results suggest that the VizAblate System is safe and effective in providing relief of abnormal uterine bleeding associated with fibroids, with appropriate safety and a low reintervention rate.

Fibroid Symptom Reduction, Health-Related Quality of Life Improvement and Patient Satisfaction after Radiofrequency Ablation of Uterine Fibroids with the VizAblate® System

Fibroid Symptom Reduction, Health-Related Quality of Life Improvement and Patient Satisfaction after Radiofrequency Ablation of Uterine Fibroids with the VizAblate® System

Transcervical, Intrauterine Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate® System: 12-Month Reduction of Fibroid Perfused and Total Volume

Transcervical, Intrauterine Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate® System: 12-Month Reduction of Fibroid Perfused and Total Volume

Combined Hysteroscopic Resection and Laparoscopic Radiofrequency Ablation of Uterine Fibroids

Combined Hysteroscopic Resection and Laparoscopic Radiofrequency Ablation of Uterine Fibroids

Menstrual Blood Loss Reduction at Twelve Months after Radiofrequency Ablation of Uterine Fibroids with the VizAblate® System

Menstrual Blood Loss Reduction at Twelve Months after Radiofrequency Ablation of Uterine Fibroids with the VizAblate® System

Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate® System: 12-Month Safety, Reintervention and Pregnancy Outcomes

Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate® System: 12-Month Safety, Reintervention and Pregnancy Outcomes

Transcervical, Intrauterine Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate™ System: Preliminary Analysis of the FAST-EU Trial

Transcervical, Intrauterine Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate™ System: Preliminary Analysis of the FAST-EU Trial

Transcervical, Intrauterine Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate™ System: Initial Three- and Six-Month Efficacy Results of the FAST-EU Trial

Transcervical, Intrauterine Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate™ System: Initial Three- and Six-Month Efficacy Results of the FAST-EU Trial

The VizAblate™ FAST Trial: Early Efficacy Results of Transcervical, Intrauterine Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate™ System

The VizAblate™ FAST Trial: Early Efficacy Results of Transcervical, Intrauterine Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate™ System

Erratum to: Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting

This was a single-site cohort study to evaluate the safety of a new transcervical device (VizAblate™) combining real-time intrauterine sonography with radiofrequency (RF) ablation for the treatment of fibroids. Nineteen women with uterine fibroids received treatment with the VizAblate System in a closed abdomen setting prior to hysterectomy. Twelve of these subjects underwent an immediate abdominal hysterectomy after radiofrequency ablation (acute group), while the remaining seven underwent hysterectomy on post-ablation days 16 and 17 (subacute group). Uteri were sectioned and stained with the viability stain triphenyltetrazolium chloride (TTC) to quantify fibroid ablation dimensions and assess the serosa for thermal injury. Subjects in the subacute group were treated with the VizAblate System under conscious sedation; they provided pain and tolerability data for the interval from ablation through hysterectomy, and indicated overall procedural satisfaction. Twenty-two ablations ranging from 1.8 to 36.2 cm3 were created among 19 subjects within 20 fibroids and one region of adenomyosis. There were no complications or thermal serosal injury. For subjects in the subacute group receiving one ablation, the mean total procedure time was 25.8 ± 6.0 min (range 18–32 min). All subjects in the subacute group were discharged within 2 h of the VizAblate procedure. For fibroids ≤ 5 cm, 67.2% ± 27.0% of the fibroid volume was ablated (range 15–100%; median 75%). Transcervical RF ablation of fibroids under intrauterine sonographic guidance with the VizAblate system can be accomplished with a high degree of reliability and without adverse events.

Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting

Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting

Ultrasound-Guided Transcervical Radiofrequency Ablation of Uterine Fibroids: Perihysterectomy Feasibility Study

Study Objective: To evaluate the current VizAblate™ System in a setting approximating its future clinical use for maximizing volumetric fibroid ablation with real-time, gynecologist-selected treatment parameters.

Laparoscopic, Radiofrequency Ablation of Uterine Fibroids

Study Objective: This video demonstrates a relatively new and unknown outpatient procedure, laparoscopic radiofrequency ablation of uterine fibroids, and introduces a mode of ultrasound new to gynecology, intra-abdominal ultrasound, as the optimal imaging tool for this procedure. Scientific and clinical aspects of radiofrequency thermal ablation are shown and discussed, including finite element analysis. The use of the unique radiofrequency probe and generator, currectly investigational, is demonstrated, as is the use of the laparoscopic ultrasound transducer for needle guidance and imaging in all directions and planes.