Transcervical radiofrequency ablation is a potential minimally invasive alternative for the treatment of symptomatic uterine leiomyomas, also known as fibroids, new research suggests.
Results through 12 months of the Sonography Guided Transcervical Ablation of Uterine Fibroids pivotal trial were published in the January issue of Obstetrics & Gynecology by Scott Chudnoff, MD, of Stamford Hospital, Connecticut, and colleagues.
In the 22-site study of 147 women with heavy menstrual bleeding and uterine fibroids, use of the Sonata System (previously known as VizAblate, Gynesonics) for transcervical ablation was associated with a significant reduction in symptoms with no device-related adverse events and a low surgical reintervention rate.
"The findings from this study demonstrate the potential of the Sonata System to safely and effectively treat a variety of nonpedunculated leiomyoma types through a uterus-conserving, incisionless approach," Chudnoff and colleagues write.
The data were used to obtain US Food and Drug Administration (FDA) clearance of the system for the treatment of uterine fibroids in August 2018.
The results are important because women with uterine fibroids often delay or avoid treatment as a result of a perceived lack of acceptable options. Current therapeutic options include hormonal manipulation, uterine artery embolization, myomectomy, or definitive hysterectomy.
Recently, evidence has emerged demonstrating the efficacy of radiofrequency and other hyperthermal ablation methods in the management of uterine fibroids, and the transcervical approach may be more acceptable because it is less invasive and doesn't always require general anesthesia, the researchers note.
Significant Symptom Reduction, No Device-Related Complications
In the prospective, single-arm trial, transcervical ablation using the Sonata treatment device — which combines an intrauterine ultrasonography probe with a radiofrequency ablation handpiece — was performed on one to 10 nonpedunculated leiomyomas measuring 1 to 5 cm per patient.
All 147 patients were treated in the outpatient setting, including hospital-based operating rooms (59%), ambulatory care centers (25%), and physicians' offices (16%). Half were treated under general anesthesia and the other half under conscious sedation.
Patients returned to normal activities within an average of 2.2 days following the procedure.
Coprimary endpoints assessed at 12 months after the procedure were reduction in menstrual blood loss and absence of surgical reintervention.
The mean score for pictorial blood loss — a validated assessment tool to estimate menstrual blood loss using icons representing various degrees of saturation of sanitary products — dropped by 51% at 12 months, while 95% of patients experienced reduced menstrual bleeding by that point.
Only one patient required surgical reintervention for heavy menstrual bleeding. She underwent elective hysterectomy for bleeding just before her 12-month visit.
Nearly all (96%) of the 135 patients who completed the Overall Treatment Effect Scale questionnaire reported improvement of their leiomyoma symptoms, just 3% reported no change, and 0.7% (one patient) reported worsening symptoms.
On the Euro-Quality of Life questionnaire — for which scores ranged from less than 1.0 to a maximum of 1.0 — scores improved from 0.72 pre-ablation to 0.89 afterwards (P < .001).
Most patients (97%) reported satisfaction with the treatment (70% were "very" satisfied, 18% were "moderately" satisfied)and said they would recommend it to others.
There were no device-related adverse events. Nonserious procedure-related adverse events, reported in 50% of patients, included fibroid sloughing (30.6%), cramping or pain (7.5%), leukorrhea (6.1%), and uncomplicated genitourinary infections (4.8%).
System Used by Wide Variety of Practicing Ob/Gyns
The authors note that there were 24 treating investigators at the 22 sites, representing "a wide variety of practicing obstetrician/gynecologists, none of whom had prior experience with transcervical leiomyoma ablation."
Each investigator received the same training and support, consisting of didactic training followed by procedure simulation with a phantom model of a leiomyoma uterus.
The trial results suggest that "with appropriate training and support, transcervical radiofrequency ablation may be safely and effectively provided by obstetrician/gynecologists...[and they] demonstrate the potential of the Sonata System to safely and effectively treat a variety of nonpedunculated leiomyoma types through a uterus-conserving, incisionless approach," Chudnoff and colleagues conclude.
The study was funded by Gynesonics. Chudnoff and three other coauthors have served on the Gynesonics advisory board. Chudnoff has also received travel and lodging expenses for attendance at an investigator meeting and honoraria for speaking from Gynesonics.
Obstet Gynecol. 2019;133:13-22. Abstract
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Cite this: Transcervical Ablation Promising for Uterine Fibroids - Medscape - Jan 07, 2019.