Section of Neuroplastic and Reconstructive Surgery, Departments of Plastic Surgery and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD.
Global Neuroscience Institute, Philadelphia, PA.
J Craniofac Surg. 2020 Oct;31(7):1998-2002. doi: 10.1097/SCS.0000000000006730.
Currently, the most effective treatment strategy for adults with hydrocephalus involves cerebrospinal fluid diversion by means of a shunt system, most commonly ventriculoperitoneal shunts (VPS). Ventriculoperitoneal shunting is associated with high complication and/or revision rates, in part due to the high-profile programmable valve designs. Thus, the valve-agnostic cranial implant (VACI) was designed and investigated as a safe and effective method of reducing the valve's high profile and is currently undergoing clinical trials. As such, the objective of this study was to collate preliminary, multi-institutional data of early outcomes using a VACI approach for patients requiring VPS by way of an Institutional Review Board approved registry.
A total of 25 adult patients across 4 institutions and 6 surgeons underwent VACI placement for VPS based on preoperative evaluation and perceived benefit. Patient demographics, operative details, and preliminary outcomes are presented here.
Valve-agnostic cranial implant placement via a limited size craniectomy at time of shunt revision was performed with no adverse events. Over an average follow-up period of 1 year (394 ± 178 days), 92% of patients experienced no major shunt-related or scalp-related complications. There were 2 cases with a major complication requiring reoperation: 1 shunt tubing extrusion and 1 case of meningitis. The most frequent postsurgical intervention seen in this study was related to adjustment of drainage: a non-invasively performed valve reprogramming after initial shunt placement when proper flow rate is being established. Of the 8 cases of drainage adjustment, all but 1 (88%) were receiving a VPS for the first time, with the exception undergoing a fourth shunt revision. All instances of improper flow were treated non-surgically and remediated effectively via shunt reprogramming in clinic. Removal of the VACI was not indicated in any treatment course. In this way, all complications as they relate to the shunt valve were minor and required nonsurgical intervention, and no complications reported were directly or indirectly caused by using the VACI.
Preliminary findings from this multicenter trial suggest promising outcomes with a low complication rate for patients with hydrocephalus undergoing VACI placement during VPS. Ongoing research will continue to provide a more robust clinical picture of VACI in hydrocephalus management as more data becomes available.
目前，成人脑积水最有效的治疗策略是通过分流系统进行脑脊液引流，最常见的是脑室-腹腔分流术（VPS）。脑室-腹腔分流术与高并发症和/或再手术率有关，部分原因是由于高调程控阀的设计。因此，设计并研究了无阀颅脑植入物（VACI）作为一种降低阀高调的安全有效的方法，目前正在进行临床试验。因此，本研究的目的是通过机构审查委员会批准的注册，收集使用 VACI 方法对需要 VPS 的患者进行初步的多机构早期结果数据。
共有 4 家机构的 6 名外科医生对 25 名成人患者进行了 VACI 放置，以进行 VPS，这是基于术前评估和预期获益。这里介绍了患者的人口统计学、手术细节和初步结果。
通过在分流器修订时进行有限大小的颅骨切除术进行无阀颅脑植入物放置，无不良事件发生。平均随访期为 1 年（394±178 天），92%的患者没有出现重大与分流器相关或头皮相关的并发症。有 2 例出现重大并发症需要再次手术：1 例分流器管脱出，1 例脑膜炎。本研究中最常见的术后干预是与引流调整有关：在最初放置分流器时，当建立适当的流速时，可进行非侵入性的阀门重新编程。在 8 例引流调整中，除 1 例（88%）首次接受 VPS 治疗外，其余均接受 VPS 治疗。所有流速异常均通过非手术治疗有效解决，通过在诊所进行分流器重新编程。在任何治疗过程中均未表明需要去除 VACI。通过这种方式，所有与分流器阀相关的并发症都是轻微的，需要非手术干预，并且没有报告的并发症直接或间接由使用 VACI 引起。
这项多中心试验的初步结果表明，对于接受 VPS 的脑积水患者，在 VACI 放置期间，具有低并发症发生率的患者有较好的结果。随着更多数据的出现，正在进行的研究将继续提供关于 VACI 在脑积水管理中的更全面的临床情况。
