Long-term follow-up data from the shunt design trial
Long-term follow-up data from the shunt design trial
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DOI：
10.1159/000055960
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发表时间：
2000-11-01
影响因子：
0.7
通讯作者：
MacNeil, N
中科院分区：
文献类型：
--
作者：
Kestle, J;Drake, J;MacNeil, N
背景资料：先前报告的一项多中心随机试验评估了与压差阀相比，2种新型分流阀设计是否会降低分流失败率。该研究未显示至首次分流失败的时间存在显著差异。患者在1993年10月1日至1995年10月31日期间进入试验。主要结果基于截至1996年10月31日的患者状态（至少随访1年）。本报告描述了基于患者最近随访的晚期并发症。研究方法：来自北美和欧洲12家临床试验机构的344例脑积水儿童被随机分配至3种瓣膜中的1种：标准压差阀、Delta阀（PS Medical-Medtronic）或Sigma阀（NMT Cordis）。随访患者直至首次分流失败。分流失败定义为因梗阻、过度引流、分室或感染而进行的分流手术。如果分流没有失败，则继续随访至1999年8月31日。结果：177例患者发生分流失败。分流道梗阻131例，引流过度13例，脑室闭锁2例，感染29例。术后1年、2是的、3是的、4年的总生存率分别为62%、52%、46%、41%。3种瓣膜的生存曲线与原始试验相似，未显示任何特定瓣膜的生存优势。结论：迄今为止的长期随访并未改变试验的主要结论：似乎没有一种瓣膜明显是小儿脑积水初始治疗的最佳选择。版权所有（C）2001 S. Karger AG.巴塞尔。
Background: A previously reported multicenter randomized trial assessed whether 2 new shunt valve designs would reduce shunt failure rates compared to differential pressure valves. The study did not show a significant difference in the time to first shunt failure. Patients entered the trial between October 1, 1993, and October 31, 1995. The primary results were based on the patients' status as of October 31, 1996 (a minimum follow-up of 1 year). This report describes the late complications based on the patients' most recent follow-up. Methods: Three hundred and forty-four hydrocephalic children at 12 North American and European centers were randomized to 1 of 3 valves: a standard differential pressure valve; a Delta valve (PS Medical-Medtronic) or a Sigma valve (NMT Cordis). Patients were followed until their first shunt failure. Shunt failure was defined as shunt surgery for obstruction, overdrainage, loculation or infection. If the shunt did not fail, follow-up was continued until August 31, 1999. Results: One hundred and seventy-seven patients had shunt failure. Shunt obstruction occurred in 131, overdrainage in 13, loculated ventricles in 2 and infection in 29. The overall shunt survival was 62% at 1 year, 52% at 2 yea rs, 46% at 3 yea rs, 41% at 4 years. The survival curves for the 3 valves were similar to those from the original trial and did not show a survival advantage for any particular va Ive. Conclusions: Prolonged follow-up to date does not alter the primary conclusions of the trial: there does not appear to be one valve that is clearly the best for the initial treatment of pediatric hydrocephalus. Copyright (C) 2001 S. Karger AG. Basel.