Won Dong-Sung, Seong Eunyeong, Kim Mi Hyeon, Hwang Sungbin, Park Jung-Hoon, Lee Hey-Jin, Won Chanhee, Lee Deok Hee
Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.
Department of Radiology, Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.
Sci Rep. 2025 Aug 26;15(1):31379. doi: 10.1038/s41598-025-15402-0.
This study aimed to evaluate the efficacy and safety of a novel flow-disruptor (NFD), designed to function as both a flow diverter and disruptor, in a rabbit aneurysm model. Elastase-induced aneurysms were created in 21 rabbits and treated with the NFD. Animals were randomly assigned to follow-up evaluations at 1 month (n = 7), 2 months (n = 7), and 3 months (n = 7). Angiographic and histological analyses were performed to assess aneurysm occlusion rates and neointimal formation. Immediate angiography demonstrated near-complete or complete flow disruption in 52% of aneurysms. Follow-up angiography revealed favorable aneurysm occlusion rates, reaching 76% (16 of 21 cases). Histologically, successful neointimal formation across the aneurysm neck was observed when the device was appropriately implanted in the aneurysmal sac. However, intentional device tip protrusion into the parent artery resulted in variable occlusion outcomes. The NFD demonstrated promising aneurysm occlusion rates and safety in a rabbit aneurysm model when appropriate wall apposition and tip embedding were achieved. Nevertheless, the intended protrusion design feature produced inconsistent effects due to anatomical limitations of the rabbit elastase-induced aneurysm model. Further studies with refined delivery systems, advanced imaging, and diverse aneurysm models are warranted to validate and optimize the clinical potential of the NFD.
本研究旨在评估一种新型血流干扰装置（NFD）在兔动脉瘤模型中的疗效和安全性，该装置设计兼具血流转向和干扰功能。在21只兔身上制造弹力酶诱导的动脉瘤，并用NFD进行治疗。将动物随机分为1个月（n = 7）、2个月（n = 7）和3个月（n = 7）进行随访评估。进行血管造影和组织学分析以评估动脉瘤闭塞率和新生内膜形成情况。即时血管造影显示52%的动脉瘤出现近乎完全或完全的血流中断。随访血管造影显示动脉瘤闭塞率良好，达到76%（21例中的16例）。组织学上，当装置适当植入动脉瘤囊时，观察到动脉瘤颈部有成功的新生内膜形成。然而，装置尖端有意突入母动脉会导致不同的闭塞结果。当实现适当的壁贴合和尖端嵌入时，NFD在兔动脉瘤模型中显示出有前景的动脉瘤闭塞率和安全性。尽管如此，由于兔弹力酶诱导的动脉瘤模型的解剖学局限性，预期的突出设计特征产生了不一致的效果。需要进一步开展研究，采用改进的输送系统、先进的成像技术和多种动脉瘤模型，以验证和优化NFD的临床潜力。
