Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA)
Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA)
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DOI：
10.1136/jnnp-2012-303936
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发表时间：
2013-08-01
影响因子：
11
通讯作者：
Stenger, Dirk
中科院分区：
文献类型：
--
作者：
Lemcke, Johannes;Meier, Ullrich;Stenger, Dirk
目的探讨在特发性常压脑积水（iNPH）的脑室腹腔（VP）分流手术中，与可调压阀相比，重力阀是否能降低过度引流并发症的风险。背景iNPH患者可能受益于VP分流术，但在体位改变时容易发生过度引流并发症。钽球重力阀被认为是减少过度引流的风险，但其临床疗效尚不清楚。方法我们进行了一项务实的，随机的，多中心试验比较重力与非重力可调压阀与iNPH患者符合VP分流。主要终点是随机化后6个月过度引流的任何临床或放射学体征（头痛、恶心、呕吐、硬膜下积液或裂状脑室）。我们还评估了疾病的具体工具（黑色和基弗规模）和身体和精神成分评分的简表12（SF-12）generic health questionnaire.Results我们招募了145例患者（平均（SD）年龄71.9（6.9）岁），其中137人可用于终点分析。6个月后，标准组29例患者和重力分流组5例患者发生过度引流（风险差异-36%，95%CI-49%至-23%; p
Objectives To investigate whether gravitational valves reduce the risk of overdrainage complications compared with programmable valves in ventriculoperitoneal (VP) shunt surgery for idiopathic normal pressure hydrocephalus (iNPH).Background Patients with iNPH may benefit from VP shunting but are prone to overdrainage complications during posture changes. Gravitational valves with tantalum balls are considered to reduce the risk of overdrainage but their clinical effectiveness is unclear.Methods We conducted a pragmatic, randomised, multicentre trial comparing gravitational with nongravitational programmable valves in patients with iNPH eligible for VP shunting. The primary endpoint was any clinical or radiological sign (headache, nausea, vomiting, subdural effusion or slit ventricle) of overdrainage 6 months after randomisation. We also assessed disease specific instruments (Black and Kiefer Scale) and Physical and Mental Component Scores of the Short Form 12 (SF-12) generic health questionnaire.Results We enrolled 145 patients (mean (SD) age 71.9 (6.9) years), 137 of whom were available for endpoint analysis. After 6 months, 29 patients in the standard and five patients in the gravitational shunt group developed overdrainage (risk difference -36%, 95% Cl -49% to -23%; p