Safety of ultrasound-guided ultrasound ablation for uterine fibroids and adenomyosis: A review of 9988 cases

Objective: To evaluate the incidence and severity of adverse reactions to ultrasound-guided ultrasound ablation of uterine fibroids through a multicenter, large-scale retrospective study. Methods: Between July 2006 and June 2007, 9988 patients with uterine fibroids or adenomyosis were enrolled and received ultrasound ablation treatment under conscious sedation. Forty-two doctors administrated the treatment following a standardized clinical protocol. In-treatment and post-treatment side effects and complications were monitored and each patient was followed up for at least 6 months after the treatment. Complications were classified and graded according to the SIR classification system. The technical success and safety of the treatment were evaluated. Results: The mean age of the 9988 patients was 40.4 +/- 5.8 years (range, 20-56 years). Among them, 7438 had uterine fibroids and 2549 had adenomyosis. Specifically, 6545 patients had solitary uterine fibroid, 818 had multiple uterine fibroids, and 76 had fibroids complicated with adenomyosis. There were mainly three types of fibroids: submucous myoma in 89 patients (12.0%), intramural myoma in 5059 patients (68.0%) and subserosal myoma in 1478 patients (20.0%). In terms of fibroid location, 3496 fibroids were found in the anterior wall (47.0%), 2306 in the posterior wall (31.0%), 447 in the lateral wall (6.0%), and 1190 in fundus (16.0%). The length of treatment for uterine fibroids and adenomyosis averaged 84.2 38.8 min (range, 30.0-240.0 min) and 93.3 +/- 55.4 min (range, 15.0-240.0 min), respectively; and the lengths of sonication were 1243.8 +/- 725.2 s (range, 506.0-2658.0 s) and 1169.7 +/- 707.7 s (range, 185.0-3600.0 s), respectively. Of the uterine fibroids patients, 98.38% (7319/7439) underwent successful ablation with a mean volume ablation rate of 83.1% +/- 15.6% (range, 25-100%). Of the adenomyosis patients, 94.59% (2411/2549) underwent successful ablation with a mean volume ablation rate of 73.2% +/- 23.6% (range, 21-100%). A total of 1062 patients (10.6%) presented with 1305 events of adverse reactions. According to the SIR classification system, 1228 (94.1%) of these reactions fell under Class A; 45 (3.4%) fell under Class B; 24(1.8%) fell under Class C; and the rest 8 (0.6%) fell under Class D. Adverse reactions included 874 cases (8.67%) of vaginal secretion, 225 cases (2.23%) of lower abdominal pain 24 h after the treatment but requiring no painkillers, 76 cases (0.76%) of melosalgia or buttock pain, 52 cases (0.52%) of odynuria, 20 cases (0.20%) of menstruation-like vaginal bleeding, 2 cases (0.2%) of temporary blurred vision, 26 cases (0.26%) of blisters or tangerine pericarp-like burns in the abdominal skin, 16 cases (0.16%) of urinary retention, 4 cases (0.4%) of fever of 38.5 degrees C, 3 cases (0.3%) of acute renal insufficiency, 2 cases (0.2%) of intestinal perforation, and 1 case (0.01%) of long-term lateral ventral syndrome. No permanent injury or fatal complication occurred. Conclusions: Based on our observations from 9988 cases, ultrasound ablation treatment for uterine fibroid and adenomyosis is highly effective and safe. Adverse reactions to ultrasound ablation under conscious sedation are slight and temporary for both conditions. Hence, this clinically effective and safe treatment is an alternative treatment for women with uterine fibroids and adenomyosis. (C) 2015 Elsevier B.V. All rights reserved.