Milka Marinova

Ultrasound-guided high-intensity focused ultrasound for symptomatic uterine fibroids: clinical outcome of two European centers

Abstract Objectives The aim of this study is to assess the clinical outcome and mid-term efficacy of ultrasound-guided high-intensity focused ultrasound (USgHIFU) as a treatment for symptomatic uterine fibroids at two major European HIFU centers. Materials and methods This bi-center longitudinal clinical study involved the treatment of 100 patients with symptomatic uterine fibroids using USgHIFU (n = 59 in Germany, n = 41 in Bulgaria). Clinical outcomes were evaluated at 6 weeks, 6 months, and 1 year follow-up utilizing the uterine fibroid symptoms-quality of life questionnaire for fibroid-related symptoms and health-related quality of life as well as MRI imaging for determining the fibroid volume. Results The mean fibroid volume reduction rate was 33.2 ± 22.9%, 51.3 ± 24.2%, and 59.1 ± 28.0% at 6 weeks, 6 months, and 1 year, respectively (each p < 0.001). The mean symptom severity score decreased from 43.9 ± 18.8 at baseline to 35.4 ± 18.2 at 6 weeks, 31.1 ± 20.0 at 6 months, and 23.1 ± 14.0 at 1 year (each p < 0.001). The mean QOL score improved from 56.5 ± 23.4 at baseline to 65.4 ± 22.2 at 6 weeks, 72.5 ± 19.5 at 6 months, and 79.4 ± 15.3 at 1 year (each p < 0.001). No major complications were observed, though two patients experienced temporary sciatic nerve irritation following the procedure. Four patients had pregnancies and deliveries without any complications after USgHIFU therapy. Conclusion To our knowledge, this is the first longitudinal study conducted in two major European HIFU centers that reveals the clinical efficacy of USgHIFU ablation on symptomatic uterine fibroids. Our results confirm that USgHIFU is a non-invasive approach with a low risk of complications, offering an innovative treatment option for affected women. Key Points Question To evaluate mid-term clinical efficacy and safety of US-guided high-intensity focused ultrasound (HIFU) for treating symptomatic uterine fibroids and patient outcomes across two European centers. Findings US-guided HIFU treatment resulted in significant fibroid volume reduction (up to 59.1% after 1 year) improving symptoms and quality of life with no major complications. Clinical relevance This prospective longitudinal study provides preliminary data assessing mid-term efficacy and clinical outcomes of ultrasound-guided HIFU. It is shown to be a low-risk, non-invasive treatment option for symptomatic uterine fibroids that reduces fibroid size and improves patients’ quality of life.

Ablation of symptomatic uterine fibroids with the Mirabilis system for rapid noninvasive ultrasound-guided high-intensity focused ultrasound (HIFU): a prospective observational clinical study

Abstract Objectives Uterine fibroids often lead to symptoms that negatively impact health-related quality of life (HRQOL). High-intensity focused ultrasound (HIFU) has emerged as a promising noninvasive treatment for reducing fibroid size and symptoms. The Mirabilis system for ultrasound (US)-guided HIFU introduces a novel technique known as ‘shell ablation’. This study evaluates the feasibility and efficacy of Mirabilis in a clinical setting, focusing on clinical outcomes. Materials and methods Sixteen patients with 23 uterine fibroids were treated with the Mirabilis system. Follow-up assessments included US and MRI at baseline, 6 weeks, 3, 6 and 9 months, and 1 year after HIFU. Changes in symptoms and QOL were evaluated using the Uterine Fibroid Symptom and HRQOL Questionnaire. Results A significant reduction in fibroid volume was observed after HIFU (baseline 182.1 ± 49.3 ml; 1 year: 76.0 ± 37.9 ml, p < 0.001). The symptom severity score significantly declined (baseline 57.2 ± 3.8; 1 year: 30.2 ± 4.9, p < 0.001), correlating with a significant improvement in HRQOL (baseline 47.0 ± 3.9, 1 year: 71.8 ± 5.3, p < 0.001). Conclusion HIFU with the portable Mirabilis system is a feasible and safe noninvasive treatment for symptomatic uterine fibroids in an outpatient setting. This approach allows efficient and rapid ablation even for large fibroids, significantly reducing fibroid volume and symptoms.