Radiofrequency Volumetric Thermal Ablation Research Articles

Changes in Pelvic Floor Symptoms After Procedural Interventions for Uterine Leiomyomas: A Systematic Review.

To conduct a systematic review to evaluate the effect of procedural interventions for leiomyomas on pelvic floor symptoms. PubMed, EMBASE, and ClinicalTrials.gov were searched from inception to January 12, 2023, searching for leiomyoma procedures and pelvic floor disorders and symptoms, restricted to primary study designs in humans. Double independent screening for studies of any study design in all languages that reported pelvic floor symptoms before and after surgical (hysterectomy, myomectomy, radiofrequency volumetric thermal ablation) or radiologic (uterine artery embolization, magnetic resonance-guided focused ultrasonography, high-intensity focused ultrasonography) procedures for management of uterine leiomyomas. Data were extracted, with risk-of-bias assessment and review by a second researcher. Random effects model meta-analyses were conducted, as feasible. Six randomized controlled trials, one nonrandomized comparative study, and 25 single-group studies met criteria. The overall quality of the studies was moderate. Only six studies, reporting various outcomes, directly compared two procedures for leiomyomas. Across studies, leiomyoma procedures were associated with decreased symptom distress per the UDI-6 (Urinary Distress Inventory, Short Form) (summary mean change -18.7, 95% CI -25.9 to -11.5; six studies) and improved quality of life per the IIQ-7 (Incontinence Impact Questionnaire, Short Form) (summary mean change -10.7, 95% CI -15.8 to -5.6; six studies). There was a wide range of resolution of urinary symptoms after procedural interventions (7.6-100%), and this varied over time. Urinary symptoms improved in 19.0-87.5% of patients, and the definitions for improvement varied between studies. Bowel symptoms were inconsistently reported in the literature. Urinary symptoms improved after procedural interventions for uterine leiomyomas, although there is high heterogeneity among studies and few data on long-term outcomes or comparing different procedures. PROSPERO, CRD42021272678.

Minimally invasive surgery for uterine fibroids.

The incidence of uterine fibroids, which comprise one of the most common female pelvic tumors, is almost 70-75% for women of reproductive age. With the development of surgical techniques and skills, more individuals prefer minimally invasive methods to treat uterine fibroids. There is no doubt that minimally invasive surgery has broad use for uterine fibroids. Since laparoscopic myomectomy was first performed in 1979, more methods have been used for uterine fibroids, such as laparoscopic hysterectomy, laparoscopic radiofrequency volumetric thermal ablation, and uterine artery embolization, and each has many variations. In this review, we compared these methods of minimally invasive surgery for uterine fibroids, analyzed their benefits and drawbacks, and discussed their future development.

Interventional Uterine-Sparing Therapies for Leiomyomas: A Commentary on Myolysis.

Uterine leiomyomas (myomas, fibroids) are very common in premenopausal women and frequently are associated with abnormal uterine bleeding, bulk effects, and reproductive issues. In women who wish to retain their uterus and/or to enhance or retain fertility, interventional therapies have been introduced, including radiofrequency, laser (chromo), cryotherapy, and magnetic resonance (MR)-guided high-intensity focused ultrasound (MRgHIFU) myolysis. In formulating this commentary, all modalities of myolysis from systematic reviews, randomized controlled clinical trials, and observational studies through December 2018 were reviewed. There are only two treatment modalities available in Canada: the laparoscopic radiofrequency volumetric thermal ablation of fibroids (RFVTA) and MRgHIFU systems. In women who wish to enhance or retain their fertility, the safety and efficacy of radiofrequency and HIFU myolysis have not been clearly established, and these treatments should be offered only after extensive counselling and informed consent. Given the recent concerns regarding the incidence of undiagnosed malignant tumours, the lack of histological confirmation before or after these therapies for symptomatic fibroids mandates a thorough process of informed patient consent before any such interventions.

Ultrasound guided core needle biopsy prior to thermo ablative treatment of uterine tumors: first results.

This study aimed at evaluating the diagnostic yield for core needle biopsies of uterine fibroids before laparoscopic radiofrequency volumetric thermal ablation (RFVTA) with the aim of sonographic imaging. This study was in the context of a randomized, prospective, single-center, longitudinal comparative study in which RFVTA and laparoscopic myomectomy for symptomatic uterine fibroids were compared. All patients of the RFVTA-arm received a core needle biopsy under the guidance of an intraoperative laparoscopic ultrasound system. The Tissue samples were observed histologically. 24 patients were included and received in the median 3.17 biopsies (range 2-7). 45.8% of the fibroids were intramural. In 92% uterine leiomyoma was detected, in 4% a cell rich leiomyoma and in 4% a smooth muscle tumor with uncertain malignant potential (STUMP). There were no complications caused by core needle biopsy. Ultrasound guided core needle biopsy can be used to receive a histological result before treating uterine fibroids with thermo surgical methods like RFVTA.

Uterine Fibroids in the Setting of Infertility: When to Treat, How to Treat?

We aim to provide insight on the treatment of fibroids in the infertile patient. Specifically, we discuss which fibroids, based on size and location within the uterine wall, have the most impact on fertility outcomes. In addition, we demonstrate which methods are best for treatment of fibroids in the infertile patient, focusing on minimally invasive techniques. Current research demonstrates that, in addition to submucosal fibroids, also intramural fibroids can have a negative impact on fertility via molecular and mechanical disruption of the endometrium and of normal uterine peristalsis. Certain intramural fibroids should be considered for removal or treatment in the infertile patient, depending on size and patient history. We also provide a large body of evidence demonstrating the safety and clinical advantages of minimally invasive techniques, such as hysteroscopy, laparoscopy, and robot-assisted laparoscopy in the treatment of uterine fibroids. All submucosal and many intramural fibroids interfere with uterine function. In the evaluation of the infertile patient, accurate fibroid mapping within the uterus is essential to identify those submucosal and intramural fibroids that are likely to have the most impact of fertility outcomes. The mainstay of treatment is surgery for those fibroids with the most detrimental impact. Nonsurgical alternatives such as magnetic resonance-guided focused ultrasound (MRgFUS) and radiofrequency volumetric thermal ablation (RFVTA) need further validation before their widespread adoption in infertile patients.

Surgeons' early experience with the Acessa™ procedure: gaining proficiency with new technology.

PurposeSuccessful adoption of a new surgical procedure varies among practicing surgeons, and skill acquisition depends on the surgeon’s innate ability, the complexity of the technique, and training. We report intraoperative and near-term postoperative outcomes from the Acessa procedure conducted by minimally invasive gynecologic surgeons new to Acessa, and report the surgeons’ experiences during the training period.Patients and methodsThe study was designed as a postmarket, prospective, single-arm, multicenter analysis of operative and early postoperative outcomes after proctored surgical training with the Acessa device and procedure (laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic fibroids) in premenopausal, menstruating women as conducted in community and university hospitals in the USA and Canada. Surgeons completed evaluation forms once they felt they could safely and comfortably conduct the operations.ResultsTen gynecologic surgeons without prior Acessa experience completed 40 Acessa procedures – all on an outpatient basis. Mean procedure time was 1.9±1.0 hours and was similar to that reported in the pivotal premarket study (2.1±1.0 hours). Two intraoperative complications occurred: a 1 cm uterine serosal laceration due to uterine manipulation and blood loss from both the probe insertion site and the lysis of uterine-omental adhesions. No postoperative complications or reinterventions for fibroid symptoms were reported. The surgeons completed the evaluation forms after two to five cases, and none found any factors affecting procedure efficiency to be inferior or needing improvement.ConclusionMinimally invasive gynecologic surgeons new to Acessa can perform the procedure and provide acceptable outcomes after two to five proctored cases.

Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Myomas and Laparoscopic Myomectomy (LM): Clinical Outcomes at Three Years from a Randomized Trial of Uterine-Sparing Techniques

Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Myomas and Laparoscopic Myomectomy (LM): Clinical Outcomes at Three Years from a Randomized Trial of Uterine-Sparing Techniques

Post-Market Evaluation of Intraoperative and Clinical Outcomes After Radiofrequency Volumetric Thermal Ablation of Symptomatic Myomas

Post-Market Evaluation of Intraoperative and Clinical Outcomes After Radiofrequency Volumetric Thermal Ablation of Symptomatic Myomas

Ultrasound Evaluations After Radiofrequency Volumetric Thermal Ablation of Symptomatic Myomas

Ultrasound Evaluations After Radiofrequency Volumetric Thermal Ablation of Symptomatic Myomas

Gaining Proficiency with New Technology: Ten Surgeons’ Early Experience with Laparoscopic Ultrasound-Guided Radiofrequency Volumetric Thermal Ablation of Uterine Myomas (RFVTA, the Acessa™ Procedure)

Gaining Proficiency with New Technology: Ten Surgeons’ Early Experience with Laparoscopic Ultrasound-Guided Radiofrequency Volumetric Thermal Ablation of Uterine Myomas (RFVTA, the Acessa™ Procedure)

Reproductive Outcomes in Subjects Following Radiofrequency Volumetric Thermal Ablation (RFVTA) of Their Symptomatic Myomas: A Retrospective Case Series

Reproductive Outcomes in Subjects Following Radiofrequency Volumetric Thermal Ablation (RFVTA) of Their Symptomatic Myomas: A Retrospective Case Series

Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial.

Aims: Laparoscopic myomectomy (LM) has been the gold standard treatment for uterine fibroids in women desiring uterine conservation. To evaluate a new fibroid treatment modality - radiofrequency volumetric thermal ablation (RFVTA) - we compare 12-month results in women who had symptomatic uterine fibroids and who were randomized to laparoscopic ultrasound-guided RFVTA or LM. Materials and Methods: Our study is a 1 : 1 parallel, randomized, prospective, single-center, longitudinal, comparative analysis of RFVTA to LM for fibroid treatment in women ≥ 18 years of age who desired uterine conservation. Fifty women were randomized intraoperatively to RFVTA (n = 25) or to LM (n = 25) after laparoscopic ultrasound mapping of the uterus. Results: Post surgery, ablation and myomectomy subjects took pain medications for 4 days (range: 1-46) and 7 days (range: 1-83 days) respectively (p = 0.60). Ablation and myomectomy subjects missed 10.0 workdays (range: 2-86 days) and 17.0 workdays (range: 7-30 days) (p = 0.28), resumed normal activities in 20.5 days (range: 5-103 days) versus 28.0 days (range: 10-42 days) (p = 0.86) respectively. Mean symptom severity scores decreased (improved) by - 7.8 for the ablation subjects and by - 17.9 for the myomectomy subjects (p = 0.16). Health-related quality of life improved (increased) by 7.5 and 13.1, respectively, for the two groups (p = 0.46). Two myomectomy subjects had pregnancies that ended in a Cesarean delivery and a vaginal delivery of healthy infants. Two pregnancies in the RFVTA group ended in full-term vaginal deliveries of healthy infants. Conclusions: Early postoperative recovery and twelve-month results attest to similar clinical benefits from RFVTA and LM.

Outpatient Treatment by Radiofrequency Volumetric Thermal Ablation (RFVTA) of a 15-cm Cervical Myoma in Close Proximity to the Bladder: A Case Study

To describe an unusual and difficult case of RFVTA of a 15-cm symptomatic cervical myoma extending anteriorly into the uterovesical peritoneum and in close proximity to the bladder.

Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Fibroids and Myomectomy: A Randomized Trial of Uterine-Sparing Techniques in Canada

Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Fibroids and Myomectomy: A Randomized Trial of Uterine-Sparing Techniques in Canada

Three Years’ Outcome from the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas

Three Years’ Outcome from the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas

Radiofrequency Volumetric Thermal Ablation of Fibroids

INTRODUCTION: Radiofrequency volumetric thermal ablation of fibroids has been reported in the literature, the procedure has been cleared by the U.S. Food and Drug Administration, but mid- to-long-term quality-of-life results in a heterogeneous population of premenopausal and symptomatic women are lacking. Our objective was to analyze the clinical success of radiofrequency volumetric thermal ablation through 3 years of study. METHODS: Prospective, multicenter, outpatient interventional clinical trial of radiofrequency volumetric thermal ablation fibroid treatment in 83 premenopausal women who were followed to 3 years and who had symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (160 mL or greater to 500 mL or less) at baseline. RESULTS: Eighty-three participants (mean age, 42.7±4.2 years) provided responses to validated questionnaires at 36 months of follow-up; four participants had surgical reinterventions and one participant became pregnant in the third year of analysis. Mean uterine fibroid symptom severity scores decreased (improved) from baseline (n=135) through 36 months (n=83) by 55.3% (61.35±18.39 to 25.98±22.10) and mean health-related quality-of-life scores likewise showed improvement (93.8%; 37.09±19.62 to 78.87±22.42). Health-related quality-of-life subscale scores demonstrated significant improvement over the same period (Table 1). Mean EQ-5D Health State scores also improved 22.7% from baseline through 36 months (70.7±19.1 to 86.7±11.2). Surgical reinterventions were 0.7% (1/135) at 12 months, 4.4% (6/129) between 12 and 24 months, and 4.5% (4/88) between 24 and 36 months.CONCLUSIONS: Radiofrequency volumetric thermal ablation of fibroids provides significant and sustained improvement in patient quality of life and significant reduction in symptom severity with low surgical reintervention rates through 36 months of follow-up.

Three-Year Outcome of the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas

Study ObjectiveTo analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas. DesignProspective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1). SettingUniversity hospitals and private surgical centers. PatientsOne hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥160 to ≤500 mL). InterventionsLaparoscopic ultrasound-guided RFVTA. Measurements and Main ResultsOne hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was –32.6 (95% confidence interval, –37.5 to –27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial. ConclusionRFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.

Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy

ObjectiveTo compare the mean hospital discharge times and perioperative outcomes for radiofrequency volumetric thermal ablation (RFVTA) of fibroids and laparoscopic myomectomy (LM). MethodsThe present postmarket, randomized, prospective, single-center, longitudinal, comparative study, conducted in Tübingen, Germany, evaluated the outcomes of RFVTA and the current standard of care (LM) for symptomatic uterine fibroids in women who desired uterine conservation. The surgeons were blinded to the treatment until all fibroids had been mapped by laparoscopic ultrasound. ResultsThe mean hospitalization times were 10.0±5.5 (median 7.8 [range 4.2–25.5]) hours for the RFVTA group and 29.9±14.2 (median 22.6 [range 16.1–68.1]) hours for the LM group (P<0.001, Wilcoxon test). Intraoperative blood loss was 16±9 (median 20 [range: 0–30]) mL for the RFVTA procedures and 51±57 (median 35 [range 10–300]) mL for the LM procedures. The percentage of fibroids imaged by laparoscopic ultrasound that were treated/excised was 98.6% for RFVTA and 80.3% for LM. Two complications were reported: vertigo (n=1; RFVTA) and port site hematoma (n=1; LM). ConclusionRadiofrequency volumetric thermal ablation resulted in the treatment of more fibroids, a significantly shorter hospital stay, and less intraoperative blood loss than laparoscopic myomectomy.ClinicalTrials.gov:NCT01750008

Laparoscopic radiofrequency fibroid ablation: phase II and phase III results.

Background and Objectives:To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA).Methods:We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasound-guided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied.Results:From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P < .001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P < .001) (n = 57), and mean uterine volume decreased from 204.4 cm3 to 151.4 cm3 (P = .008) (n = 58). Patients missed a median of 4 days of work (range, 2–10 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related quality-of-life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1–29 days). The rate of periprocedural device-related adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment.Conclusions:RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.

Laparoscopic Ultrasound-Guided Radiofrequency Volumetric Thermal Ablation (RFVTA) of Deep Intramural Fibroids

Current uterine-sparing fibroid treatment options commonly leave many untreated fibroids in the uterus and are associated with a high risk of fibroid recurrence and high re-intervention rates. Laparoscopic ultrasound-guided RFVTA is a uterine-sparing method for ablation of virtually all uterine fibroids, including deep intramurals which account for >50% of fibroids; the method is presented in this procedural video and is targeted at gynecologic surgeons. No uterine incisions or uterine suturing are required. Demonstration of both the use and advantages of laparoscopic ultrasound—as well as of the RFVTA technique—are shown.