The Neuroscience Centre, Department of Neurosurgery, Section NK 2092, Blegdamsvej 9, Copenhagen, DK-2100, Denmark.
Fluids Barriers CNS. 2012 Sep 20;9(1):21. doi: 10.1186/2045-8118-9-21.
A new adjustable valve, the Codman CertasTM valve for treatment of hydrocephalus was introduced into clinical practice in January 2011. It has 8 different settings with an opening pressure varying from 36 to over 400 mm H2O at a flow rate of 20 mL/h. The 8th setting is designed to provide a "virtual off" function. The objective of this report is to describe the initial clinical experience with the CertasTM valve and evaluate clinical usage with the main focus on the portable adjustment device - Therapeutic Management System (TMS), the "virtual off" setting and compatibility with magnetic resonance imaging (MRI).
Forty-two patients with hydrocephalus from different etiologies were treated with the CertasTM adjustable shunt system. Data regarding implantation procedures, the use of the TMS system, x-ray imaging, and MRI procedures were recorded prospectively. All patients had clinical follow-up at four weeks after implantation and every three months until a stable clinical condition was obtained.The mean time for follow-up was 8.6 months (1-16.6). Seventy-one adjustments were performed with the TMS, 12 were problematic. Twenty-nine MRI procedures were performed and did not cause accidental resetting. Five patients were treated with the "virtual off" function for a period.
We found the CertasTM valve valuable in the treatment of hydrocephalus, usability of the TMS was high because it is small and portable, but in some cases we experienced adjustment problems with the first procedures performed by a surgeon, indicating that there is a learning curve. The "virtual off" function provided a possibility of treating over-drainage without the need for shunt ligation or other invasive procedures.
一种新型可调节阀门——Codman CertasTM 脑积水治疗阀于 2011 年 1 月投入临床应用。它具有 8 种不同的设置,在流量为 20ml/h 时,其开启压力可在 36 至 400mmH2O 之间变化。第 8 种设置旨在提供“虚拟关闭”功能。本报告旨在描述 CertasTM 阀的初步临床经验,并评估其临床使用情况,主要关注便携式调节装置——治疗管理系统(TMS)、“虚拟关闭”设置以及与磁共振成像(MRI)的兼容性。
42 例不同病因的脑积水患者接受了 CertasTM 可调分流系统治疗。前瞻性记录了植入程序、TMS 系统使用、X 射线成像和 MRI 程序的数据。所有患者在植入后 4 周进行临床随访,直至获得稳定的临床状况,平均随访时间为 8.6 个月(1-16.6 个月)。使用 TMS 进行了 71 次调整,其中 12 次出现问题。进行了 29 次 MRI 检查,未导致意外重置。5 名患者使用“虚拟关闭”功能治疗一段时间。
我们发现 CertasTM 阀在脑积水治疗中具有价值,TMS 的可用性很高,因为它体积小且便于携带,但在一些情况下,我们在外科医生首次操作时遇到了调整问题,表明存在学习曲线。“虚拟关闭”功能提供了一种无需分流管结扎或其他侵入性操作即可治疗过度引流的可能性。