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回顾性单中心历史对照研究 proGAV 和 proGAV2.0 在手术翻修和种植体使用时间方面的差异。

Retrospective single-center historical comparative study between proGAV and proGAV2.0 for surgical revision and implant duration.

机构信息

Pediatric Neurosurgery, Charité Universitaetsmedizin Berlin, Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.

出版信息

Childs Nerv Syst. 2022 Jun;38(6):1155-1163. doi: 10.1007/s00381-022-05490-y. Epub 2022 Mar 30.

DOI:10.1007/s00381-022-05490-y
PMID:35353205
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9156487/
Abstract

OBJECTIVE

Cerebrospinal fluid (CSF) diversion shunt systems remain to be the most common treatment for pediatric hydrocephalus. Different valve systems are used to regulate CSF diversion. Preventing complications such as occlusions, ruptures, malpositioning, and over- or underdrainage are the focus for further developments. The proGAV and proGAV2.0 valve system are compared in this retrospective study for revision-free survival and isolated valve revision paradigms.

METHODS

In the first part of the study, the shunt and valve revision-free survival rates were investigated in a retrospective historical comparison design for a period of 2 years in which each valve was used as standard valve (proGAV: July 2012-June 2014; proGAV2.0: January 2015-December 2016) with subsequent 30-month follow-up period, respectively. In the second part of the study, the implant duration was calculated by detecting isolated valve (valve-only) revisions together with another valve explantation during the entire period of the first study and its follow-up period.

RESULTS

Two hundred sixty-two patients (145 male and 117 female, mean age 6.2 ± 6.1 years) were included in the cohort of revision-free survival. During the 30-month follow-up period, 41 shunt revisions, including 27 valve revisions (shunt survival rate: 72.1%, valve survival rate: 81.6%) were performed in the proGAV cohort and 37 shunt revisions, including 21 valve revisions (shunt survival rate: 74.8% and valve survival rate: 85.0%) were performed in the proGAV2.0 cohort without showing statistically significant differences. In the second part of the study, 38 cases (mean age 4.0 ± 3.9 years) met the inclusion criteria of receiving a valve-only-revision. In those patients, a total of 44 proGAV and 42 proGAV2.0 were implanted and explanted during the entire study time. In those, a significantly longer implant duration was observed for proGAV (mean valve duration 961.9 ± 650.8 days) compared to proGAV2.0 (mean length of implantation period 601.4 ± 487.8 days; p = 0.004).

CONCLUSION

The shunt and valve revision-free survival rates were found to be similar among the groups during 30 month follow-up. In patients who received "valve only" revisions and a subsequent explanation, the implant duration was significantly longer in the proGAV. Although the amount of patients with valve-only-revisions are small compared to the entire cohort certain patients seem to be at higher risk for repeated valve revisions.

摘要

目的

脑脊液(CSF)分流系统仍然是治疗小儿脑积水的最常见方法。不同的阀门系统用于调节 CSF 分流。防止堵塞、破裂、错位、过度或欠引流等并发症是进一步发展的重点。在这项回顾性研究中,对 proGAV 和 proGAV2.0 阀系统进行了比较,以评估无返修生存率和孤立阀返修范式。

方法

在研究的第一部分中,采用回顾性历史对照设计,对 2 年期间的分流和阀门无返修生存率进行了研究,分别使用每个阀门作为标准阀门(proGAV:2012 年 7 月至 2014 年 6 月;proGAV2.0:2015 年 1 月至 2016 年 12 月),随后进行了 30 个月的随访。在研究的第二部分中,通过在整个研究期间和随访期间检测孤立的阀门(仅阀门)返修以及另一次阀门摘除,计算植入物的持续时间。

结果

262 例患者(男性 145 例,女性 117 例,平均年龄 6.2±6.1 岁)被纳入无返修生存率队列。在 30 个月的随访期间,在 proGAV 队列中进行了 41 次分流器修订,包括 27 次阀门修订(分流器存活率:72.1%,阀门存活率:81.6%),在 proGAV2.0 队列中进行了 37 次分流器修订,包括 21 次阀门修订(分流器存活率:74.8%和阀门存活率:85.0%),但无统计学差异。在研究的第二部分中,有 38 例(平均年龄 4.0±3.9 岁)符合接受仅阀门返修的纳入标准。在这些患者中,总共植入和摘除了 44 个 proGAV 和 42 个 proGAV2.0。在这些患者中,proGAV 的植入持续时间明显更长(平均阀门持续时间为 961.9±650.8 天),而 proGAV2.0 的植入持续时间为 601.4±487.8 天(p=0.004)。

结论

在 30 个月的随访中,发现各组的分流器和阀门无返修生存率相似。在接受“仅阀门”修订和随后解释的患者中,proGAV 的植入持续时间明显更长。尽管与整个队列相比,仅阀门修订的患者数量较少,但某些患者似乎有更高的重复阀门修订风险。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/883a6689d684/381_2022_5490_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/880d1b96888b/381_2022_5490_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/c614ff446caf/381_2022_5490_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/969ce1fda941/381_2022_5490_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/4942e98bc7b9/381_2022_5490_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/883a6689d684/381_2022_5490_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/880d1b96888b/381_2022_5490_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/c614ff446caf/381_2022_5490_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/969ce1fda941/381_2022_5490_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/4942e98bc7b9/381_2022_5490_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e2/9156487/883a6689d684/381_2022_5490_Fig5_HTML.jpg

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