Department of Neurosurgery, Ulsan University Hospital, University of Ulsan College of Medicine, Republic of Korea.
AJNR Am J Neuroradiol. 2011 Mar;32(3):602-6. doi: 10.3174/ajnr.A2314. Epub 2010 Dec 16.
Recent advances in endovascular devices have been aimed at providing high density, mesh-like metallic materials across the aneurysm neck, in place of coil technology. Therefore our aim was to report the in vivo preclinical performance of a self-expanding intrasaccular embolization device.
Elastase-induced aneurysms were created in 12 rabbits. Each aneurysm was embolized with a Luna AES. DSA was performed preimplantation; 5, 10, and 30 minutes postimplantation; and at 1 month in 12 rabbits and at 3 months in 8 rabbits. Early postimplantation intra-aneurysmal flow was graded as unchanged, moderately diminished, or completely absent. One- and 3-month DSAs were graded by using a 3-point scale (complete, near-complete, or incomplete occlusion). Aneurysms were harvested for gross and microscopic histologic evaluation at 1 month (n = 4) and at 3 months (n = 8). Tissues within the aneurysm dome and across the aneurysm neck were assessed by using HE staining.
Ten (83%) of 12 aneurysms demonstrated complete cessation of flow within 30 minutes of device implantation. At 1-month follow-up, 10 (83%) of 12 aneurysms were completely occluded. At 3 months, 7 of 8 (88%) aneurysms remained completely occluded. One-month gross examination in 4 rabbits demonstrated that membranous tissue completely covered the device in 3 subjects (75%). Microscopic examination showed that 3 aneurysms had loose connective tissue filling the aneurysm cavity. Three-month gross and microscopic examinations demonstrated membranous tissue completely covering the device, loose connective tissue filling the aneurysm cavity, and neointima formation crossing the aneurysm neck in 8 of 8 (100.0%) subjects.
The Luna AES achieved high rates of complete angiographic occlusion and showed promising histologic findings in the rabbit aneurysm model.
最近，血管内设备的进展旨在提供高密度、网状的金属材料穿过动脉瘤颈部，以替代线圈技术。因此，我们的目的是报告一种自膨式腔内栓塞装置的体内临床前性能。
在 12 只兔子中创建弹性蛋白酶诱导的动脉瘤。每个动脉瘤均采用 Luna AES 栓塞。在植入前、植入后 5、10 和 30 分钟以及 1 个月时对 12 只兔子进行 DSA 检查，在 3 个月时对 8 只兔子进行 DSA 检查。早期植入后动脉瘤内血流被评为无变化、中度减少或完全消失。1 个月和 3 个月的 DSA 检查采用 3 分制（完全、接近完全或不完全闭塞）进行评分。在 1 个月（n=4）和 3 个月（n=8）时，对动脉瘤进行大体和显微镜下组织学评估。通过 HE 染色评估动脉瘤穹顶内和动脉瘤颈部的组织。
12 个动脉瘤中有 10 个（83%）在植入后 30 分钟内完全停止血流。在 1 个月的随访中，12 个动脉瘤中有 10 个（83%）完全闭塞。在 3 个月时，8 个动脉瘤中有 7 个（88%）仍完全闭塞。4 只兔子的 1 个月大体检查显示，3 只（75%）兔子的膜状组织完全覆盖了装置。显微镜检查显示，3 个动脉瘤的动脉瘤腔内有疏松结缔组织填充。3 个月的大体和显微镜检查显示，8 只（100.0%）兔子的膜状组织完全覆盖了装置，疏松结缔组织填充了动脉瘤腔，新内膜形成跨越了动脉瘤颈部。
Luna AES 实现了高比例的完全血管造影闭塞，并在兔动脉瘤模型中显示出有前途的组织学发现。
