Eymann Regina, Steudel Wolf-Ingo, Kiefer Michael
Department of Neurosurgery, Saarland University Medical School, Saarland, Germany.
J Neurosurg. 2007 Mar;106(3 Suppl):179-84. doi: 10.3171/ped.2007.106.3.179.
The authors' goal in this paper was to evaluate prospectively the efficacy and safety of a new pediatric gravitational shunt to determine whether it warrants inclusion in a randomized, controlled trial with other shunts.
A total of 55 children between the ages of 0 and 6 years (median age 0.5 years, average age 4+/-6 years) underwent primary shunt implantation; all received the Miethke Paedi-GAV. The follow-up period ranged between 12 and 77 months (mean 47+/-21 months). The primary end point of the study was the first shunt failure necessitating revision. The 1- and 2-year shunt survival rates were 75 and 68%, respectively. The average failure-free shunt survival duration was 1423 +/- 641 days. Based on imaging findings, no slitlike ventricles occurred. The complication rate was 33%, and the median time to shunt failure was 45 days. Underdrainage occurred in one child (1.8%) and overdrainage in two children (3.6%).
These preliminary results prove the Miethke Paedi-GAV to be a safe and effective pediatric shunt worthy of inclusion in a randomized comparison with other shunts in the pediatric population.
本文作者的目标是前瞻性评估一种新型小儿重力分流器的疗效和安全性,以确定其是否值得纳入与其他分流器的随机对照试验。
共有55名年龄在0至6岁之间(中位年龄0.5岁,平均年龄4±6岁)的儿童接受了初次分流器植入;所有人均接受了米特克小儿重力分流器(Miethke Paedi-GAV)。随访期为12至77个月(平均47±21个月)。该研究的主要终点是首次因分流器故障而需要进行翻修。1年和2年分流器生存率分别为75%和68%。分流器无故障生存的平均持续时间为1423±641天。根据影像学检查结果,未出现裂隙样脑室。并发症发生率为33%,分流器故障的中位时间为45天。一名儿童(1.8%)出现引流不足,两名儿童(3.6%)出现引流过度。
这些初步结果证明米特克小儿重力分流器是一种安全有效的小儿分流器,值得在儿科人群中与其他分流器进行随机对照比较。