Adverse effect analysis of high-intensity focused ultrasound in the treatment of benign uterine diseases

Abstract

Objective: To retrospectively analyze the adverse effects of high-intensity focused ultrasound (HIFU) in management of benign uterine diseases.

Materials and methods: From 2011 to 2017, 27,053 patients with benign uterine diseases were treated with HIFU in 19 centers in China. Among them, 17,402 patients had uterine fibroids, 8434 had adenomyosis, 876 had caesarean scar pregnancies, and 341 had placenta accreta.

Results: The median age, height, weight, BMI of the patients was 42 years, 158 mm, 56 kg, 22.5 kg/cm², respectively. After HIFU treatment, 13,170 adverse events were observed. Based on society of interventional radiology classification system, these adverse events were classified as Class A (47.5030%), Class B (0.7947%), Class C (0.3327%), and Class D (0.0518%). The rate of major adverse effects (Class C&D) was 0.3844%. Major adverse effects include skin burn, leg pain, vaginal discharge or bleeding, urinary retention, acute cystitis, intrauterine infection, bowel injury, acute renal failure, deep vein thrombosis, pubic symphysis injury, post-HIFU thrombocytopenia, sciatic nerve injury, and hydronephrosis. In 2011, the annual rate of major adverse effects was 0.9565%; the incidence decreased to 0.2852% in 2017. No significant difference was observed in the rates of major adverse effects between patients with uterine fibroids, adenomyosis and placenta accreta.

Conclusions: Based on the results with low rate of major adverse effects from multiple centers, we concluded that HIFU is safe in treating patients with benign uterine diseases. With development of this technique and more experience on the part of the physicians, the rates of the major adverse effects will be further lowered.

Keywords: High-intensity focused ultrasound (HIFU); adverse effects; uterine benign diseases.