Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System.

Thirty-one women aged 28 to 51 years with symptomatic uterine leiomyomas who desired uterine preservation underwent outpatient laparoscopic, ultrasound-guided, radiofrequency volumetric thermal ablation using the Halt 2000 System. Postoperative follow-up occurred at 3, 6, and 12 months. The primary outcome measures were patient safety, frequency of adverse events, repeat intervention rate because of symptoms of myoma, symptom severity, and health-related quality-of-life scores from the validated Uterine Fibroid Symptom and Quality-of-Life Questionnaire. Secondary outcome measures were uterine volume changes over time. At 3, 6, and 12 months, respectively, mean symptom severity scores improved significantly compared with baseline, by 59.7% (95% confidence interval [CI], 44.8-74.7], 71.7% [95% CI, 55.7%-87.7%], and 82.0% (95% CI, 70.9%-93.1%). The increase in mean health-related quality-of-life scores over time reached statistical significance (p <.001): 60.15 (95% CI, 51.6%-68.7%) at baseline, 87.9 (95% CI, 82.1%-93.7%) at 3 months, 90.8 (95% CI, 82.1%-99.5%) at 6 months, and 97.8 (95% CI, 96.2-99.4) at 12 months. Mean (SD) uterine volume decreased from 194.4 (105.9 cm(3)) at baseline to 159.5 (66.8) at 3 months, 147.2 (73.0 cm(3)) at 6 months, and 113.2 (53.5 cm(3)) at 12 months (p = .006). There were no procedure-related repeat hospitalizations, repeat treatments, or any procedures related to symptoms of myoma after radiofrequency ablation. An anterior abdominal wall vascular injury was discovered in the early postoperative period and resolved after vessel ligation. Volumetric thermal ablation using the Halt 2000 System produced significant reduction in symptoms and improvement in quality of life at 1 year after treatment, with an excellent safety profile. Additional larger multicenter studies are needed to confirm these results.