Department of Radiology, Stanford University, 1024 Welch Road, MC 5488, Stanford, CA, 94305, USA.
Department of Obstetrics and Gynecology, Stanford University, Stanford, CA, USA.
Eur Radiol. 2023 Nov;33(11):7360-7370. doi: 10.1007/s00330-023-09984-4. Epub 2023 Aug 9.
To identify variables predictive of durable clinical success after MRI-guided focused ultrasound (MRgFUS) treatment of uterine fibroids.
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.
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).
Increased non-perfused volume relative to total fibroid volume was significantly associated with durable reduction of symptoms of abnormal uterine bleeding and bulk bother.
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.
Clinical trial ID: NCT01285960.
• 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.
确定磁共振引导聚焦超声（MRgFUS）治疗子宫肌瘤后持久临床疗效的预测变量。
在这项前瞻性、多中心试验中，99 名有症状的子宫肌瘤患者接受了 MRgFUS 治疗。在基线和治疗日获得盆腔 MRI。使用子宫肌瘤症状质量生活问卷（UFS-QoL）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）。使用单变量和多变量逻辑回归分析，将临床、影像学和治疗变量与 12 个月和 24 个月时持续的症状缓解相关联。开发了一个新参数，即未灌注体积与总肌瘤负荷的比值（NPV/TFL），以确定与持久结局的关联。
治疗后，6、12、24 和 36 个月的随访时（p < 0.001，所有时间点），平均症状严重程度均降低。在单变量分析中，有三个变量可预测治疗成功（定义为 SSS 至少改善 30 分），并在 12 个月和 24 个月时均持续存在：NPV/TFL 比值增加（p = 0.002），总肌瘤负荷减少（p = 0.04），T2 加权 Funaki 2 型肌瘤不存在（p = 0.02）。在多变量分析中，NPV/TFL 是持久临床疗效的唯一预测因素（p = 0.01）。与 30-79（p = 0.03）和≥80%（p = 0.01）相比，比值低于 30%的患者 SSS 改善较少，缺乏持久的临床反应。
与总肌瘤体积相比，未灌注体积的增加与异常子宫出血和肿块不适症状的持久缓解显著相关。
为了获得持续的临床获益，患者选择应强调那些有可能实现高消融比的患者，这可以通过影像学（例如设备通道、Funaki 类型）来确定，并考虑到总肌瘤负荷，而不仅仅是主要的有症状的肌瘤。
临床试验注册号：NCT01285960。
磁共振引导聚焦超声消融子宫肌瘤后持久缓解症状的患者选择/治疗方法仍不清楚。
消融比（未灌注体积/总肌瘤体积）与出血和肿块不适的 1 年和 2 年随访时的持续症状缓解呈正相关。
选择具有有利于高消融比例的影像学特征（包括非靶向肌瘤）的患者是预测子宫肌瘤治疗后症状缓解持续时间的主要因素。
