Interventional Radiololy Section, Department of Medical Imaging, University Hospital Timone, APHM, Marseille, France.
LiiE, Aix Marseille University, Marseille, France.
Cardiovasc Intervent Radiol. 2021 Apr;44(4):625-632. doi: 10.1007/s00270-020-02678-0. Epub 2020 Oct 25.
Microspheres are effective embolic agents, especially for the management of bleeding and oncologic lesions. The first FairEmbo study reported the effectiveness of embolization using suture fragments. The effectiveness and safety of arterial embolization with suture-based microparticles (SBM) were assessed in a swine model.
In this ethical-approved animal study, a polar artery in each kidney was embolized in four swine: one side with hand-cut non-absorbable SBM (Flexocrin 2®) and the contralateral side with Embozene® 900 for comparison. Swine were followed for 3 months (M3) to evaluate the effectiveness and the safety of SBM. Follow-up protocol included clinical monitoring, computed tomography (CT) control and digital subtraction angiography (DSA), followed by histological analyses. The SBM confection parameters were evaluated by automatic microscopic sizer. RStudio software and Mann-Whitney test (significance at P < 0.05) were used for statistics.
The average size of SBM was 1002 μm (SD = 258). All targets were effectively embolized by SBM with an angiogram defect estimated at 45.6% (95% CI [35.9-55.2]), compared to 40.5% (95% CI [30.6-55.5]) for Embozene® group (P = 0.342). The average duration of SBM embolization procedure was significantly increased compared to Embozene® embolization (1202 s versus 222 s, P = 0.029). There were no statistical differences in M3 DSA and CT for SBM and Embozene®, with persistence of partial arterial occlusion and atrophic embolized area. No postoperative complications were observed on clinical and CT controls.
This experimental study suggests that embolization with SBM is feasible, safe and effective in short- and medium-term follow-up as compared to microspheres.
微球是有效的栓塞剂，尤其适用于出血和肿瘤病变的治疗。首个 FairEmbo 研究报告了使用缝线碎片栓塞的有效性。本研究旨在通过猪模型评估基于缝线的微球（SBM）动脉栓塞的有效性和安全性。
在这项经过伦理批准的动物研究中，每只猪的每侧肾脏的极动脉均进行栓塞：一侧使用手工切割的不可吸收 SBM（Flexocrin 2®），对侧使用 Embozene® 900 进行对比。在 3 个月（M3）的随访中评估 SBM 的有效性和安全性。随访方案包括临床监测、计算机断层扫描（CT）控制和数字减影血管造影（DSA），随后进行组织学分析。使用自动显微镜测微仪评估 SBM 的制备参数。RStudio 软件和曼-惠特尼检验（P<0.05 为有统计学意义）用于统计学分析。
SBM 的平均直径为 1002μm（SD=258μm）。所有靶标均被 SBM 有效栓塞，血管造影缺损估计为 45.6%（95%CI [35.9-55.2]），而 Embozene® 组为 40.5%（95%CI [30.6-55.5]）（P=0.342）。与 Embozene® 栓塞相比，SBM 栓塞的平均时间显著增加（1202s 与 222s，P=0.029）。在 M3 DSA 和 CT 中，SBM 和 Embozene® 之间没有统计学差异，均存在部分动脉闭塞和萎缩性栓塞区域的持续存在。临床和 CT 监测未观察到术后并发症。
与微球相比，本实验研究表明 SBM 栓塞在短期和中期随访中是可行、安全且有效的。
