Abstract：
OBJECTIVE: To identify variables predictive of durable clinical success after MRI-guided focused ultrasound (MRgFUS) treatment of uterine fibroids.
METHODS: In this prospective, multicenter trial, 99 women with symptomatic uterine fibroids were treated using MRgFUS. Pelvic MRI was obtained at baseline and treatment day. The Uterine Fibroid Symptom-Quality of Life questionnaire was used to calculate a symptom severity score (SSS) at baseline and 6, 12, 24, and 36 months following treatment. Clinical, imaging, and treatment variables were correlated with symptom reduction sustained through the 12- and 24-month time points using univariable and multivariable logistic regression analyses. A novel parameter, the ratio of non-perfused volume to total fibroid load (NPV/TFL), was developed to determine association with durable outcomes.
RESULTS: Post-treatment, mean symptom severity decreased at the 6-, 12-, 24-, and 36-month follow-ups (p < 0.001, all time points). In univariable analysis, three variables predicted treatment success (defined by ≥ 30-point improvement in SSS) sustained at both the 12-month and 24-month time points: increasing ratio of NPV/TFL (p = 0.002), decreasing total fibroid load (p = 0.04), and the absence of T2-weighted Funaki type 2 fibroids (p = 0.02). In multivariable analysis, the NPV/TFL was the sole predictor of durable clinical success (p = 0.01). Patients with ratios below 30% had less improvement in SSS and lacked durable clinical response compared with those between 30-79 (p = 0.03) and ≥ 80% (p = 0.01).
CONCLUSIONS: Increased non-perfused volume relative to total fibroid volume was significantly associated with durable reduction of symptoms of abnormal uterine bleeding and bulk bother.
CONCLUSIONS: Patient selection for sustained clinical benefit should emphasize those with likelihood of achieving high ablation ratios, as determined by imaging (e.g., device access, Funaki type) and by considering the total fibroid load, not just the primary symptomatic fibroid.
BACKGROUND: Clinical trial ID: NCT01285960.
CONCLUSIONS: • Patient selection/treatment approach associated with durable symptom relief in MRI-guided focused ultrasound ablation of uterine fibroids remains unclear. • The ablation ratio, non-perfused volume/total fibroid volume, was positively associated with sustained symptom relief in both bleeding and bulk bother at 1- and 2-year follow-ups. • Selecting patients with imaging features that favor a high ratio of ablation to total fibroid load (including non-targeted fibroids) is the main factor in predicting durability of symptom relief after uterine fibroid treatment.
METHODS: In this prospective, multicenter trial, 99 women with symptomatic uterine fibroids were treated using MRgFUS. Pelvic MRI was obtained at baseline and treatment day. The Uterine Fibroid Symptom-Quality of Life questionnaire was used to calculate a symptom severity score (SSS) at baseline and 6, 12, 24, and 36 months following treatment. Clinical, imaging, and treatment variables were correlated with symptom reduction sustained through the 12- and 24-month time points using univariable and multivariable logistic regression analyses. A novel parameter, the ratio of non-perfused volume to total fibroid load (NPV/TFL), was developed to determine association with durable outcomes.
RESULTS: Post-treatment, mean symptom severity decreased at the 6-, 12-, 24-, and 36-month follow-ups (p < 0.001, all time points). In univariable analysis, three variables predicted treatment success (defined by ≥ 30-point improvement in SSS) sustained at both the 12-month and 24-month time points: increasing ratio of NPV/TFL (p = 0.002), decreasing total fibroid load (p = 0.04), and the absence of T2-weighted Funaki type 2 fibroids (p = 0.02). In multivariable analysis, the NPV/TFL was the sole predictor of durable clinical success (p = 0.01). Patients with ratios below 30% had less improvement in SSS and lacked durable clinical response compared with those between 30-79 (p = 0.03) and ≥ 80% (p = 0.01).
CONCLUSIONS: Increased non-perfused volume relative to total fibroid volume was significantly associated with durable reduction of symptoms of abnormal uterine bleeding and bulk bother.
CONCLUSIONS: Patient selection for sustained clinical benefit should emphasize those with likelihood of achieving high ablation ratios, as determined by imaging (e.g., device access, Funaki type) and by considering the total fibroid load, not just the primary symptomatic fibroid.
BACKGROUND: Clinical trial ID: NCT01285960.
CONCLUSIONS: • Patient selection/treatment approach associated with durable symptom relief in MRI-guided focused ultrasound ablation of uterine fibroids remains unclear. • The ablation ratio, non-perfused volume/total fibroid volume, was positively associated with sustained symptom relief in both bleeding and bulk bother at 1- and 2-year follow-ups. • Selecting patients with imaging features that favor a high ratio of ablation to total fibroid load (including non-targeted fibroids) is the main factor in predicting durability of symptom relief after uterine fibroid treatment.
摘要：
目的：确定预测MRI引导聚焦超声（MRgFUS）治疗子宫肌瘤后持续临床成功的变量。
方法：在此前瞻性中，多中心试验,99例有症状的子宫肌瘤患者使用MRgFUS治疗。在基线和治疗日获得盆腔MRI。使用子宫纤维状症状-生活质量问卷来计算基线和治疗后6、12、24和36个月的症状严重程度评分(SSS)。临床,成像,使用单变量和多变量逻辑回归分析,治疗变量与持续12个月和24个月时间点的症状减轻相关.一个新的参数，非灌注体积与总肌瘤负荷之比（NPV/TFL），是为了确定与持久结果的关联而开发的。
结果：治疗后，平均症状严重程度在6-，12-，24-,和36个月的随访（p<0.001，所有时间点）。在单变量分析中，三个变量预测治疗成功（定义为SSS改善≥30点）在12个月和24个月时间点持续：NPV/TFL比率增加（p=0.002），减少总肌瘤负荷（p=0.04），并且没有T2加权的Funaki2型肌瘤（p=0.02）。在多变量分析中，NPV/TFL是持久临床成功的唯一预测因子(p=0.01).与30-79（p=0.03）和≥80％（p=0.01）之间的患者相比，比率低于30％的患者SSS改善较少，并且缺乏持久的临床反应。
结论：非灌注体积相对于子宫肌瘤总体积的增加与异常子宫出血和体积紊乱症状的持续减少显著相关。
结论：选择可持续临床获益的患者应强调那些有可能实现高消融率的患者，如通过成像确定的(例如，设备访问,Funaki型)，并考虑到纤维瘤的总负荷，不仅仅是原发性有症状的纤维瘤.
背景：临床试验ID：NCT01285960。
结论：•MRI引导下聚焦超声消融子宫肌瘤的患者选择/治疗方法与持续症状缓解相关仍不清楚。•消融比,非灌注体积/总肌瘤体积，在1年和2年的随访中，出血和大量打扰的持续症状缓解呈正相关。•选择具有有利于高比例的消融与总肌瘤负荷（包括非靶向肌瘤）的影像学特征的患者是预测子宫肌瘤治疗后症状缓解的持久性的主要因素。
方法：在此前瞻性中，多中心试验,99例有症状的子宫肌瘤患者使用MRgFUS治疗。在基线和治疗日获得盆腔MRI。使用子宫纤维状症状-生活质量问卷来计算基线和治疗后6、12、24和36个月的症状严重程度评分(SSS)。临床,成像,使用单变量和多变量逻辑回归分析,治疗变量与持续12个月和24个月时间点的症状减轻相关.一个新的参数，非灌注体积与总肌瘤负荷之比（NPV/TFL），是为了确定与持久结果的关联而开发的。
结果：治疗后，平均症状严重程度在6-，12-，24-,和36个月的随访（p<0.001，所有时间点）。在单变量分析中，三个变量预测治疗成功（定义为SSS改善≥30点）在12个月和24个月时间点持续：NPV/TFL比率增加（p=0.002），减少总肌瘤负荷（p=0.04），并且没有T2加权的Funaki2型肌瘤（p=0.02）。在多变量分析中，NPV/TFL是持久临床成功的唯一预测因子(p=0.01).与30-79（p=0.03）和≥80％（p=0.01）之间的患者相比，比率低于30％的患者SSS改善较少，并且缺乏持久的临床反应。
结论：非灌注体积相对于子宫肌瘤总体积的增加与异常子宫出血和体积紊乱症状的持续减少显著相关。
结论：选择可持续临床获益的患者应强调那些有可能实现高消融率的患者，如通过成像确定的(例如，设备访问,Funaki型)，并考虑到纤维瘤的总负荷，不仅仅是原发性有症状的纤维瘤.
背景：临床试验ID：NCT01285960。
结论：•MRI引导下聚焦超声消融子宫肌瘤的患者选择/治疗方法与持续症状缓解相关仍不清楚。•消融比,非灌注体积/总肌瘤体积，在1年和2年的随访中，出血和大量打扰的持续症状缓解呈正相关。•选择具有有利于高比例的消融与总肌瘤负荷（包括非靶向肌瘤）的影像学特征的患者是预测子宫肌瘤治疗后症状缓解的持久性的主要因素。
