American Hospital of Paris, Neuilly-sur-Seine, France.
Department of Endocrinology, Diabetology and Metabolism, Paris Saint-Joseph Hospital, GHPSJ, Paris, France.
Int J Hyperthermia. 2020;37(1):1301-1309. doi: 10.1080/02656736.2020.1846795.
Outcomes of high-intensity focused ultrasound (HIFU), as a non-surgical treatment option for benign symptomatic thyroid nodules, has mainly been based on single-center studies and short-term follow-up. Therefore, we assessed the safety, and long-term efficacy of HIFU in benign thyroid nodules among four centers with expertise in thyroid mini-invasive procedures.
Retrospective three year follow-up study in four European centers, treating solid benign thyroid nodules causing pressure symptoms and/or cosmetic concerns. Nodule volume reduction was assessed at 1, 3, 6, 12, 24, and 36 months post-treatment. Technical efficacy, defined as a volume reduction rate (VVR) >50% was evaluated at 6, 12, 24 and 36 months. Predictive factors of efficacy were assessed using logistic models. Complications and side effects were classified according to the Interventional Radiology Guidelines and changes in local symptoms were scored on a visual-analog scale.
Sixty-five patients (mean age 51.1 ± 14.0 years; 86.2% women) with a single thyroid nodule and a mean baseline nodule volume of 9.8 ± 10.3 mL were treated with a mean energy of 7.1 ± 3.1 kJ (range: 2.0 to 15.5 kJ). Median nodule volume reduction was 31.5% (IQR: -38.6% to -23.1%) at 12 months and 31.9% (IQR: -36.4% to -16.1%) at 36 months. Technical efficacy was obtained in 17.2% of cases at 6 months, 17.8% at 12 months, 3.4% at 24 months, and 7.4% at 36 months. The number of treated pixels and the mean energy delivered were positively correlated to VRR at 1, 6 and 12 months. The risk of treatment failure decreased by 4.3% for each additional unit of energy delivered. The procedure duration was inversely correlated with treatment failure (OR 1.043, 95% CI: 1.011-1.083; ). Improvement of cervical pressure symptoms or cosmetic complaints were observed in less than 15% of the cases at 12, 24 and 36 months. Horner's syndrome occurred in one case (1.5%) and minor complications, not requiring treatment, in three (4.6%) patients. No change in thyroid function was registered.
HIFU carried a low risk of complications. A single treatment resulted in a 30-35% thyroid nodule volume decrease within one year, reduction that remained stable for 2 years. Outcomes varied significantly between centers with different HIFU expertise. Focus on improved HIFU technology, adequate training, and appropriate selection of patients is needed to achieve efficacy comparable to other thermal ablation procedures.
高强度聚焦超声(HIFU)作为一种治疗良性有症状甲状腺结节的非手术治疗选择,主要基于单中心研究和短期随访。因此,我们评估了在 4 家具有甲状腺微创介入经验的中心,HIFU 治疗良性甲状腺结节的安全性和长期疗效。
这是一项在欧洲 4 家中心进行的回顾性三年随访研究,治疗因有压力症状和/或美容问题而导致的实性良性甲状腺结节。在治疗后 1、3、6、12、24 和 36 个月时评估结节体积缩小情况。在 6、12、24 和 36 个月时,评估技术疗效,定义为体积减少率(VVR)>50%。使用逻辑模型评估疗效的预测因素。根据介入放射学指南对并发症和副作用进行分类,并使用视觉模拟量表对局部症状的变化进行评分。
65 名患者(平均年龄 51.1±14.0 岁;86.2%为女性)患有单个甲状腺结节,基线结节体积为 9.8±10.3mL,平均能量为 7.1±3.1kJ(范围:2.0 至 15.5kJ)。在 12 个月时,中位数结节体积缩小 31.5%(IQR:-38.6%至-23.1%),在 36 个月时为 31.9%(IQR:-36.4%至-16.1%)。在 6 个月时,有 17.2%的病例达到技术疗效,在 12 个月时为 17.8%,在 24 个月时为 3.4%,在 36 个月时为 7.4%。在 1、6 和 12 个月时,治疗的像素数和平均能量与 VRR 呈正相关。每增加 1 单位能量,治疗失败的风险降低 4.3%。手术时间与治疗失败呈负相关(OR 1.043,95%CI:1.011-1.083)。在 12、24 和 36 个月时,不到 15%的患者出现颈椎压迫症状或美容投诉改善。一例(1.5%)出现霍纳综合征,三例(4.6%)出现无需治疗的轻微并发症。甲状腺功能无变化。
HIFU 并发症风险低。单次治疗可在一年内使甲状腺结节体积缩小 30-35%,2 年内缩小稳定。不同中心的疗效差异显著,与 HIFU 技术、适当的培训和患者的选择有关。