Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus
Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus
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DOI：
10.1097/00006123-199808000-00068
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发表时间：
1998-08-01
期刊：
影响因子：
4.8
通讯作者：
Mapstone, T
中科院分区：
文献类型：
--
作者：
Drake, JM;Kestle, JRW;Mapstone, T
目的：为治疗儿童脑积水而植入的标准脑脊液分流器中，有 40% 在第一年内失败。研究了两种旨在限制过量流量（特别是在直立位置时）的新型分流阀，以将治疗失败率与标准压差阀的治疗失败率进行比较。方法：在 12 个北美或欧洲儿科神经外科中心，对 344 名接受首次脑脊液分流插入的脑积水儿童（年龄，出生至 18 岁）进行随机分组。患者接受了三个阀门之一，即标准压差阀； Delta 阀（Medtronic PS Medical，戈利塔，加利福尼亚州），其中包含虹吸控制组件，旨在减少直立位置的虹吸；或 Orbis-Sigma 阀门（Cordis，迈阿密，佛罗里达州），带有可变阻力、限流组件。对患者进行至少一年的监测。终点定义为由于分流阻塞、引流过度、脑室形成或感染导致的分流失败。结果事件通过盲法独立病例审查进行评估。结果：150 名患者达到终点；分流阻塞 108 例（31.4%），引流过度 12 例（3.5%），室室 2 例（0.6%），感染 28 例（8.1%）。 61% 的患者在 1 年时未出现分流失败，47% 的患者在 2 年时未出现分流失败，中位分流失败持续时间为 656 天。三个瓣膜的无分流失败持续时间没有差异（P = 0.24）。结论：脑脊液分流失败（主要是由于分流阻塞和感染）仍然是小儿脑积水的一个持续存在的问题。两种新的阀门设计并未显着影响分流器故障率。
OBJECTIVE: Forty percent of standard cerebrospinal fluid shunts implanted for the treatment of pediatric hydrocephalus fail within the first year. Two new shunt valves designed to limit excess flow, particularly in upright positions, were studied to compare treatment failure rates with those for standard differential-pressure valves.METHODS: Three hundred-forty-four hydrocephalic children (age, birth to 18 yr) undergoing their first cerebrospinal fluid shunt insertion were randomized at 12 North American or European pediatric neurosurgical centers. Patients received one of three valves, i.e., a standard differential-pressure valve; a Delta valve (Medtronic PS Medical, Goleta, CA), which contains a siphon-control component designed to reduce siphoning in upright positions; or an Orbis-Sigma valve (Cordis, Miami, FL), with a variable-resistance, flow-limiting component. Patients were monitored for a minimum of 1 year. Endpoints were defined as shunt failure resulting from shunt obstruction, overdrainage, loculations of the cerebral ventricles, or infection. Outcome events were assessed by blinded independent case review.RESULTS: One hundred-fifty patients reached an endpoint; shunt obstruction occurred in 108 (31.4%), overdrainage in 12 (3.5%), loculated ventricles in 2 (0.6%), and infection in 28 (8.1%). Sixty-one percent were shunt failure-free at 1 year and 47% at 2 years, with a median shunt failure-free duration of 656 days. There was no difference in shunt failure-free duration among the three valves (P = 0.24).CONCLUSION: Cerebrospinal fluid shunt failure, predominantly from shunt obstruction and infection, remains a persistent problem in pediatric hydrocephalus. Two new valve designs did not significantly affect shunt failure rates.