Exhibit Hall | Forum 6
Purpose: The aim of this study was to assess the impact of the improved technology of the ExAblate 2100 system (Insightec Ltd, Haifa, Israel) for magnetic resonance-guided focused ultrasound (MRgFUS) surgery on treatment outcomes in patients with symptomatic uterine fibroids, as measured by the nonperfused volume ratio (NPV-ratio) and re-intervention rate.
Methods: This is a retrospective analysis of 73 women with symptomatic fibroids who consecutively underwent MRgFUS treatment in a single center with the ExAblate 2100 system. Mean±SD total fibroid volume were 269±199cm3. Based on the dominant tumor per patient, tumors were classified as follows: 54 (73.9%) dark and 19 (26.1%) bright on T2-weighted MR images. Baseline patient and fibroid characteristics were analyzed regarding their impact on the resulting NPV-ratio and number of sonications per target volume. Five-year follow-up was carried out through patient questionnaires on Uterine Fibroid Symptom quality of life (UFS-QOL) and re-interventions.
Results: MRgFUS treatment was technically successful in 71 of 73 patients (97%) where a significant confluent NPV-ratio was achieved. The mean (± 95 % Confidence Interval), NPV-ratio for dark and bright fibroids were significantly different (p< 0.05), 80±5% and 46±5 %, respectively, after treatment. No major complications occurred. The only minor complications included 4 cases of abdominal subcutaneous fat edema of which patient reported symptoms resolved within 1 month of the intervention. Five-year follow-up of secondary outcomes such as quality of life and reintervention was achieved with 55 patients; the mean tSSS decreased following intervention from 63 to 27±24 after 6 months and remained constant for 3 years; 18 out of 55 patients (33%) had additional interventions for their continued or recurring symptoms.
Conclusion: With technological advancement, MRgFUS treatment demonstrated outcomes exceeding previous clinical results for NPV-ratio, treatment completion rate, adverse events and re-intervention rate¹⁻² and sustained improvement in UFS-QOL up to 5-years following intervention.
Not Applicable / None Entered.