Abstract
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.
Highlights
Uterine fibroids are the most prevalent benign uterine tumors and have an age-specific cumulative incidence in the United States that is nearly 70 % among white women and greater than 80 % among black women [1]
Fibroids were counted in this total if they had an edge within the inner half of the myometrium; these were termed “target fibroids,” as they are believed to be more likely associated with heavy menstrual bleeding than myomata that are distant from the endometrial cavity
The Menstrual Pictogram is a variant of the Pictorial Blood Loss Assessment Chart (PBAC) that patients complete to provide a visual assessment of menstrual blood loss during a single cycle [14, 15]
Summary
Uterine fibroids are the most prevalent benign uterine tumors and have an age-specific cumulative incidence in the United States that is nearly 70 % among white women and greater than 80 % among black women [1]. Despite the availability of several alternatives to hysterectomy, over 200,000. Gynecol Surg (2015) 12:61–70 hysterectomies are performed annually for fibroids in the United States [1, 2]. Effective minimally invasive alternatives to hysterectomy exist to accommodate the growing preference of many women for uterine preservation. Radiofrequency ablation (RFA) has been used as a fibroid treatment modality since the early 1990s, with multiple clinical studies confirming its safety and efficacy [4,5,6,7,8,9,10]. Recent studies have been performed using RFA in conjunction with simultaneous, real-time sonography to enable volumetric ablations, resulting in volume reduction and symptom improvement [8, 9, 12]
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