Department of Clinical Radiology, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München, Germany.
Invest Radiol. 2013 Jun;48(6):359-65. doi: 10.1097/RLI.0b013e3182806904.
The aim of this study was to assess the impact of the advanced technology of the new ExAblate 2100 system (Insightec Ltd, Haifa, Israel) for magnetic resonance imaging (MRI)-guided focused ultrasound surgery on treatment outcomes in patients with symptomatic uterine fibroids, as measured by the nonperfused volume ratio.
This is a retrospective analysis of 115 women (mean age, 42 years; range, 27-54 years) with symptomatic fibroids who consecutively underwent MRI-guided focused ultrasound treatment in a single center with the new generation ExAblate 2100 system from November 2010 to June 2011. Mean ± SD total volume and number of treated fibroids (per patient) were 89 ± 94 cm and 2.2 ± 1.7, respectively. Patient baseline characteristics were analyzed regarding their impact on the resulting nonperfused volume ratio.
Magnetic resonance imaging-guided focused ultrasound treatment was technically successful in 115 of 123 patients (93.5%). In 8 patients, treatment was not possible because of bowel loops in the beam pathway that could not be mitigated (n = 6), patient movement (n = 1), and system malfunction (n = 1). Mean nonperfused volume ratio was 88% ± 15% (range, 38%-100%). Mean applied energy level was 5400 ± 1200 J, and mean number of sonications was 74 ± 27. No major complications occurred. Two cases of first-degree skin burn resolved within 1 week after the intervention. Of the baseline characteristics analyzed, only the planned treatment volume had a statistically significant impact on nonperfused volume ratio.
With technological advancement, the outcome of MRI-guided focused ultrasound treatment in terms of the nonperfused volume ratio can be enhanced with a high safety profile, markedly exceeding results reported in previous clinical trials.
本研究旨在评估新型 ExAblate 2100 系统(以色列海法的 Insightec Ltd 公司)在磁共振成像(MRI)引导下聚焦超声手术治疗症状性子宫肌瘤患者中的应用,通过无灌注体积比来评估其治疗效果。
这是一项回顾性分析,纳入了 2010 年 11 月至 2011 年 6 月期间,在一家单中心应用新型 ExAblate 2100 系统对 115 例(平均年龄 42 岁,范围 27-54 岁)有症状的子宫肌瘤患者进行的 MRI 引导下聚焦超声治疗。患者的平均总体积和治疗肌瘤数量(每位患者)分别为 89 ± 94cm³和 2.2 ± 1.7。分析患者的基线特征,以探讨其对无灌注体积比的影响。
123 例患者中有 115 例(93.5%)治疗技术成功。8 例患者因治疗路径中的肠袢无法减轻(n=6)、患者移动(n=1)和系统故障(n=1)而无法进行治疗。平均无灌注体积比为 88%±15%(范围 38%-100%)。平均应用能量水平为 5400±1200J,平均超声次数为 74±27。无重大并发症发生。2 例一度皮肤烧伤在干预后 1 周内痊愈。在分析的基线特征中,只有计划的治疗体积对无灌注体积比有统计学显著影响。
随着技术的进步,MRI 引导下聚焦超声治疗的无灌注体积比的治疗效果可以得到显著提高,且具有较高的安全性,明显优于以前的临床试验结果。