Nomura Tadashi, Ozaki Mine, Osuga Keigo, Kurita Masakazu, Hayashi Ayato, Yuzuriha Shunsuke, Aramaki-Hattori Noriko, Hikosaka Makoto, Nozaki Taiki, Ozeki Michio, Ochi Junko, Akiyama Shimpei, Kakei Yasumasa, Miyakoda Keiko, Kashiwagi Naoko, Yasuda Takahiro, Iwashina Yuki, Kaneko Tsuyoshi, Terashi Hiroto, Harii Kiyonori
Department of Plastic Surgery, Kobe University Graduate School of Medicine, Kobe 655-0865, Japan.
Department of Plastic Surgery, Kyorin University Faculty of Medicine, Tokyo 181-8611, Japan.
J Clin Med. 2025 Jan 30;14(3):905. doi: 10.3390/jcm14030905.
The therapeutic efficacy of percutaneous sclerotherapy (PS) for venous malformations (VMs) based on volumetric magnetic resonance imaging (MRI) measurements and its association with early post-treatment coagulation markers remains unexplored. This study evaluates the therapeutic efficacy of 5% monoethanolamine oleate (EO)-based PS in treating difficult-to-resect VMs using volumetric MRI and investigates its association with early changes in coagulation markers. This post-hoc analysis utilized data from a prospective, open-label, multicenter clinical trial initiated on 1 January 2021. The correlation between MRI-determined volume reduction and post-sclerotherapy changes in coagulation markers was assessed. Between January 2021 and April 2023, 44 patients underwent EO-based PS. Based on a ≥ 20% VM volume reduction, patients were classified into "achieved" ( = 26; 59.1%) and "non-achieved" ( = 18; 40.9%) groups. D-dimer levels significantly increased on postoperative day 1 (POD1) compared with pretreatment screening ( < 0.001), whereas fibrinogen and prothrombin international normalized ratio levels remained unchanged. In the achieved group, a significant correlation was observed between the volume reduction rate and the administered EO dose per lesion volume (mL/cm; Spearman's ρ = 0.43, = 0.03). The non-achieved group showed significantly higher D-dimer elevation than the achieved group ( = 0.03). This is the first multicenter study to evaluate EO-based PS efficacy for VMs using volumetric MRI and explore its relationship with early post-treatment coagulation markers. Elevated D-dimer levels on POD1 were not predictive of treatment efficacy, highlighting their limited clinical utility in assessing therapeutic response.
基于容积磁共振成像（MRI）测量，经皮硬化治疗（PS）对静脉畸形（VMs）的治疗效果及其与治疗后早期凝血标志物的关系尚未得到探索。本研究使用容积MRI评估基于5%油酸单乙醇胺（EO）的PS治疗难以切除的VMs的疗效，并研究其与凝血标志物早期变化的关系。这项事后分析利用了2021年1月1日启动的一项前瞻性、开放标签、多中心临床试验的数据。评估了MRI确定的体积缩小与硬化治疗后凝血标志物变化之间的相关性。在2021年1月至2023年4月期间，44例患者接受了基于EO的PS治疗。根据VM体积减少≥20%，患者被分为“达到”组（n = 26；59.1%）和“未达到”组（n = 18；40.9%）。与治疗前筛查相比，术后第1天（POD1）D-二聚体水平显著升高（P < 0.001），而纤维蛋白原和凝血酶原国际标准化比值水平保持不变。在达到组中，观察到体积缩小率与每个病变体积（mL/cm）的EO给药剂量之间存在显著相关性（Spearman's ρ = 0.43，P = 0.03）。未达到组的D-二聚体升高显著高于达到组（P = 0.03）。这是第一项使用容积MRI评估基于EO的PS治疗VMs疗效并探索其与治疗后早期凝血标志物关系的多中心研究。POD1时D-二聚体水平升高并不能预测治疗效果，这突出了它们在评估治疗反应方面的临床效用有限。
