A large multicenter survey of adverse events and complications of focused ultrasound ablation surgery in the treatment of benign uterine diseases
Objective To retrospectively analyze the ad-verse events and complications of focused ultrasound ab-lation surgery(FUAS)in the treatment of benign uterine diseases.Methods From January 2019 to December 2023,27 524 patients with benign uterine diseases were treated with FUAS in 24 centers nationwide.Among them,there were 17 519 patients with uterine fibroids,8676 patients with adenomyosis,1077 patients with cesarean scar pregnancy,and 252 patients with placental accreta spectrum.According to the classification system of the Society of Interventional Radi-ology(SIR),these adverse events were classified as Class A(no therapy,no consequences),Class B(nominal therapy,ob-servation,no consequences),Class C(required therapy,minor hospitalization),Class D(major therapy,unplanned in-crease in level of care,prolonged hospitalization),Class E(permanent adverse sequelae),Class F(Death).Results Af-ter FUAS,Class A adverse events were seen in 13.51％(3718)of patients,Class B adverse events were seen in 0.33％(91)of patients,Class C adverse events were seen in 0.19％(52)of patients,and Class D adverse events were seen in 0.07％(20)of patients,no Class E and F adverse events occurred.The incidence of severe adverse events(Class C&D)was 0.26％(72).Serious adverse events observed included lower limb sensory and motor abnormalities 0.19％(51),deep second and third degree of skin bums 0.04％(11),abnormal vaginal discharge and bleeding 0.02％(5),intestinal inju-ries 0.01％(3),and acute renal injury 0.01％(2).Between 2019 and 2023,the annual incidence rates of severe adverse events were 0.04％、0.50％、0.14％、0.33％and 0.24％,respectively.Conclusion Based on the results from real-word data of multiple centers with large subjects,we concluded that FUAS treatment is safe for the treatment of gynecological and obstetric diseases.
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