Ultrasound-Guided High Intensity Focused Ultrasound Ablation for Symptomatic Uterine Fibroids: Preliminary Clinical Experience

Abstract

Objective To evaluate the middle-term efficacy and complications of ultrasound-guided high intensity focused ultrasound (USgHIFU) for the treatment of symptomatic uterine fibroids in an NHS population.

Methods A prospective observational single-center study at a single university hospital in Oxford, UK. Patients with symptomatic uterine fibroids who declined standard surgical/radiological intervention and were referred to the HIFU unit were considered for USgHIFU treatment. Clinical evaluation, adverse event monitoring, uterine fibroid symptoms and health-related quality of life questionnaire (UFS-QOL) and contrast-enhanced pelvic magnetic resonance imaging (MRI) were performed before and at regular intervals after treatment to assess patient outcome.

Results 12 of 22 referred patients underwent one session of USgHIFU ablation of 14 fibroids overall and received a two-year follow-up. No serious adverse events were reported, but a second-degree skin burn was observed in one patient who had a surgical scar from a previous caesarean section. Mean symptom severity scores (SSS-QOL) improved significantly from 56.5 ± 29.1 (SD) at baseline to 33.4 ± 23.3 (p < 0.01) at three months, 45.0 ± 35.4 (p < 0.05) at one year and 40.6 ± 32.7 (p < 0.01) at two years post-treatment. The mean non-perfused volume ratio was 67.7 ± 39.0 % (SD) in the treated fibroids (n = 14) within three months of treatment. The mean volume reduction rates of the treated fibroids were 23.3 ± 25.5 % (SD) at 3 months post-treatment (p < 0.01, n = 14), 49.3 ± 23.7 % at 12 months (p < 0.05, n = 8), and 51.9 ± 11.1 % at 24 months (p < 0.005, n = 8).

Conclusion This study demonstrates the clinical efficacy of USgHIFU ablation of uterine fibroids and the low risk of complications. We believe that this noninvasive approach may offer an alternative therapy for women with symptomatic uterine fibroids. While HIFU is fast becoming the standard of care for fibroid ablation in other countries, to our knowledge, this study is the first to present clinical experience of US-guided HIFU ablation of symptomatic uterine fibroids in an NHS population.

Plain Language Summary High intensity focused ultrasound (HIFU) can be used for the noninvasive ablation of symptomatic uterine fibroids, and MR-guided treatment has already gained FDA approval. Ultrasound-guided HIFU has the advantage of offering practicalities in anesthesia and considerable cost-savings over MR-guided treatments. In this prospective study we have demonstrated the middle-term efficacy and favorable safety profile of ultrasound-guided HIFU for the treatment of symptomatic uterine fibroids for the first time in an NHS population.

Zusammenfassung

Ziel Bewertung der mittelfristigen Wirksamkeit und der Komplikationen des ultraschallgesteuerten hochintensiven fokussierten Ultraschalls (USgHIFU) zur Behandlung von symptomatischen Uterusmyomen in einer NHS-Population.

Material und Methoden Prospektive Beobachtungsstudie an einem Universitätsklinikum in Oxford (Vereinigtes Königreich). Patienten mit symptomatischen Uterusmyomen, die eine chirurgische/radiologische Standardintervention ablehnten und an die HIFU-Einheit überwiesen wurden, wurden für eine Behandlung mit USgHIFU in Betracht gezogen. Zur Beurteilung des Patienten-Outcomes wurden vor und in regelmäßigen Abständen nach der Behandlung klinische Untersuchungen, die Überwachung von Nebenwirkungen, eine Befragung zur Symptomatik der Uterusmyome und zu der gesundheitsbezogenen Lebensqualität (UFS-QOL) sowie eine kontrastverstärkte Magnetresonanztomografie (MRT) des Beckens durchgeführt.

Ergebnisse 12 von 22 überwiesenen Patienten nahmen an einer Sitzung der USgHIFU-Ablation von insgesamt 14 Myomen teil und erhielten eine 2-jährige Nachbeobachtung. Es wurden keine schwerwiegenden unerwünschten Nebenwirkungen berichtet, bei einem Patienten mit einer Operationsnarbe aus einem früheren Kaiserschnitt wurde jedoch eine Hautverbrennung zweiten Grades beobachtet. Die mittleren Schweregrade der Symptome (SSS-QOL) verbesserten sich signifikant von 56,5 ± 29,1 (SD) zu Studienbeginn auf 33,4 ± 23,3 (p < 0,01) nach 3 Monaten, 45,0 ± 35,4 (p < 0,05) nach 1 Jahr und 40,6 ± 32,7 (p < 0,01) 2 Jahre nach der Behandlung. Das mittlere nicht perfundierte Volumenverhältnis der behandelten Myome (n = 14) lag innerhalb von 3 Monaten nach der Behandlung bei 67,7 ± 39,0 % (SD). Die mittleren Volumenreduktionsraten der behandelten Myome waren 3 Monate nach der Behandlung 23,3 ± 25,5 % (SD) (p < 0,01; n = 14), 49,3 ± 23,7 % nach 12 Monaten (p < 0,05; n = 8) und 51,9 ± 11,1 % nach 24 Monaten (p < 0,005; n = 8).

Schlussfolgerung Diese Studie zeigt die klinische Wirksamkeit der USgHIFU-Ablation von Uterusmyomen und das geringe Risiko von Komplikationen. Wir glauben, dass dieser nichtinvasive Ansatz eine alternative Therapie für Frauen mit symptomatischen Uterusmyomen bieten kann. Während in anderen Ländern die HIFU zur Myom-Ablation immer mehr zum Standard wird, ist diese Studie unseres Wissens die erste, die klinische Erfahrungen mit der US-gestützten HIFU-Ablation von symptomatischen Uterusmyomen in einer NHS-Population zeigt.

Key words

gynecology - high intensity focused ultrasound - HIFU - uterine fibroids - thermal ablation

Publication History

Received: 25 September 2018

Accepted: 19 March 2019

Article published online:
25 June 2019

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