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分析Pipeline 栓塞装置在儿科动脉瘤中的安全性和疗效:多中心队列和汇总分析的见解。

Analyzing the safety and efficacy of pipeline embolization device in pediatric aneurysms: insight from a mul-ticenter cohort and pooled analysis.

机构信息

Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.

Department of Neurosurgery, Peking University International Hospital, Beijing, China.

出版信息

Acta Neurochir (Wien). 2024 Oct 15;166(1):412. doi: 10.1007/s00701-024-06306-5.

DOI:10.1007/s00701-024-06306-5
PMID:39404893
Abstract

BACKGROUND

Pediatric patients with intracranial aneurysms face high risks of spontaneous subarachnoid hemorrhages. Despite its approval for adults aged 22 and above, the Pipeline Embolization Device (PED, Covidien/Medtronic, Irvine, California, USA) is being considered for younger patients due to its efficacy. This study aims to assess the safety and effectiveness of using PEDs in pediatric aneurysm treatment.

METHODS

A retrospective study across 14 institutions identified 25 patients (age ≤ 18) treated with PED from November 2014 to October 2019. A literature review included all published pediatric aneurysm cases treated with PED from 2007 to 2023. Analyzed data included patient demographics, aneurysm characteristics, treatment, clinical outcomes, and complications.

RESULTS

We analyzed 81 pediatric patients, including 25 from the multi-center registry and 56 from 38 relevant literature. In the entire cohort of 81 patients, mean age of the patients was 11.9 ± 4.0 years (ranged from 9 months to 18 years), with 58.0% males. Ruptured aneurysms were observed in 7 patients (8.6%), whereas 43 patients (53.1%) harbored large/giant aneurysms. The aneurysm occlusion rate was 87.7% during the median 7 months follow-up. Complications occurred in 12.3% of patients, resulting in morbidity in 5 cases (6.1%) and mortality in 4 cases (4.9%). Patient age was not associated with the occurrence of aneurysm residual, complications, and mortality following PED treatment.

CONCLUSIONS

PED can be effective for pediatric aneurysms, but morbidity and mortality can be substantial compared to the adults. Surgical timing should depend on clinical judgment and patient factors, without age-related delays.

摘要

背景

颅内动脉瘤患儿有较高的自发性蛛网膜下腔出血风险。尽管 Pipeline 栓塞装置(PED,Covidien/Medtronic,加利福尼亚州欧文,美国)已批准用于 22 岁及以上的成人,但由于其疗效,也在考虑用于年龄较小的患者。本研究旨在评估 PED 在儿科动脉瘤治疗中的安全性和有效性。

方法

在 14 家机构进行的回顾性研究中,共纳入 25 例(年龄≤18 岁)自 2014 年 11 月至 2019 年 10 月接受 PED 治疗的患者。文献回顾包括自 2007 年至 2023 年期间所有用 PED 治疗的儿科动脉瘤病例。分析的数据包括患者人口统计学特征、动脉瘤特征、治疗、临床结局和并发症。

结果

我们分析了 81 例儿科患者,其中 25 例来自多中心登记研究,56 例来自 38 篇相关文献。在整个 81 例患者队列中,患者的平均年龄为 11.9±4.0 岁(范围为 9 个月至 18 岁),男性占 58.0%。7 例(8.6%)为破裂性动脉瘤,43 例(53.1%)为大/巨大动脉瘤。中位 7 个月的随访中,动脉瘤闭塞率为 87.7%。12.3%的患者发生并发症,导致 5 例(6.1%)患者出现病残,4 例(4.9%)患者死亡。患者年龄与 PED 治疗后动脉瘤残留、并发症和死亡率的发生无关。

结论

PED 对儿科动脉瘤有效,但与成人相比,发病率和死亡率可能较高。手术时机应根据临床判断和患者因素而定,不应因年龄相关而延迟。

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本文引用的文献

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Morphological features predicting in-stent stenosis after pipeline implantation for unruptured intracranial aneurysm.预测未破裂颅内动脉瘤 Pipeline 植入术后支架内狭窄的形态学特征
Front Neurol. 2023 May 12;14:1121134. doi: 10.3389/fneur.2023.1121134. eCollection 2023.
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Learning curve in pipeline embolization device: results from the pipeline embolization device in China post-market multicentre registry study.Pipeline 栓塞装置的学习曲线:来自 Pipeline 栓塞装置在中国上市后多中心注册研究的结果。
Int J Surg. 2023 Aug 1;109(8):2159-2167. doi: 10.1097/JS9.0000000000000467.
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Somatic mutation in intracranial extra-axial cavernous hemangiomas.
颅内轴外海绵状血管瘤中的体细胞突变。
Stroke Vasc Neurol. 2023 Dec 29;8(6):453-462. doi: 10.1136/svn-2022-002227.
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European Stroke Organisation (ESO) guidelines on management of unruptured intracranial aneurysms.欧洲卒中组织(ESO)关于未破裂颅内动脉瘤管理的指南。
Eur Stroke J. 2022 Sep;7(3):V. doi: 10.1177/23969873221099736. Epub 2022 Jun 3.
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Paediatric Intracranial Aneurysms: Long-term Angiographic and Clinical Outcomes in a Contemporary Series.儿童颅内动脉瘤:当代系列研究中的长期血管造影及临床结果
Front Neurol. 2022 Mar 11;13:684093. doi: 10.3389/fneur.2022.684093. eCollection 2022.
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Epidemiology and outcomes of pediatric intracranial aneurysms: comparison with an adult population in a 30-year, prospective database.儿童颅内动脉瘤的流行病学与转归:与一个30年前瞻性数据库中的成年人群的比较
J Neurosurg Pediatr. 2021 Sep 10;28(6):685-694. doi: 10.3171/2021.6.PEDS21268. Print 2021 Dec 1.
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Pipeline embolization of cerebral aneurysms in pediatric patients: combined systematic review of patient-level data and multicenter retrospective review.颅内动脉瘤的血管内栓塞治疗:患者水平数据的系统综述和多中心回顾性研究的综合分析。
J Neurosurg Pediatr. 2021 Apr 23;27(6):668-676. doi: 10.3171/2020.10.PEDS20324. Print 2021 Jun 1.
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CVIR Endovasc. 2020 Nov 22;3(1):60. doi: 10.1186/s42155-020-00153-y.
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Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results.颅内动脉瘤Pipeline 装置栓塞的前瞻性研究:PREMIER 研究 1 年结果。
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