1Department of Neurosurgery, Odense University Hospital, Odense.
2Department of Clinical Research and BRIDGE (Brain Research Inter-Disciplinary Guided Excellence), University of Southern Denmark, Odense; and.
J Neurosurg. 2023 Apr 21;139(5):1412-1419. doi: 10.3171/2023.3.JNS222858. Print 2023 Nov 1.
Devices draining CSF to the intracranial venous sinus for the treatment of hydrocephalus have been tested in the past, and while clinically effective, have not shown efficacy in the long term. The majority of these devices become obstructed within 3 months due to endothelial overgrowth. In this study, the authors investigated a newly developed ventriculosinus (VS) shunt outlet device with the objective of showing it would remain patent for at least 6 months.
Twelve patients in need of shunting for hydrocephalus underwent an operation using the investigational device and were followed for 6 months to record patency of the shunt.
In 10 patients, the shunt was patent at 6 months, with the outlet device remaining unobstructed. In the remaining 2 patients, one died just before reaching the 6-month endpoint, and in the other the outlet was misplaced during surgery and therefore ceased to function after 3 months. No occlusion of the internal jugular vein or thrombus formation was noted in any of the 12 cases.
These findings indicate that the outlet device can remain patent and has the capability to mimic physiological drainage by diverting CSF to the intracranial sinus. Additional confirmation of its potential as part of a new VS shunt system and ultimately as a viable alternative for ventriculoperitoneal and ventriculoatrial shunting to reduce complication rates requires further clinical trials.
过去已经测试过将 CSF 引流到颅内静脉窦以治疗脑积水的设备,虽然在临床上有效,但在长期内没有显示出疗效。这些设备中的大多数由于内皮细胞过度生长而在 3 个月内发生阻塞。在这项研究中,作者研究了一种新开发的脑室 - 窦(VS)分流出口装置,目的是证明它至少能保持 6 个月的通畅。
12 名需要分流治疗脑积水的患者接受了使用该研究设备的手术,并在 6 个月内进行随访以记录分流的通畅情况。
在 10 名患者中,分流在 6 个月时是通畅的,出口装置没有阻塞。在其余 2 名患者中,1 名在达到 6 个月终点前死亡,另 1 名在手术中出口装置位置不当,因此在 3 个月后停止工作。在这 12 例患者中均未发现颈内静脉阻塞或血栓形成。
这些发现表明,出口装置可以保持通畅,并具有通过将 CSF 分流到颅内窦来模拟生理引流的能力。进一步确认其作为新的 VS 分流系统的一部分的潜在用途,并最终作为降低并发症发生率的脑室 - 腹腔和脑室 - 心房分流的可行替代方案,需要进一步的临床试验。