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对使用Pipeline栓塞装置相关并发症的批判性评估。

Critical assessment of complications associated with use of the Pipeline Embolization Device.

作者信息

Park Min S, Albuquerque Felipe C, Nanaszko Michael, Sanborn Matthew R, Moon Karam, Abla Adib A, McDougall Cameron G

机构信息

Department of Neurological Surgery, Barrow Neurological Institute, St Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.

Department of Neurological Surgery, University of California San Francisco Medical Center, San Francisco, California, USA.

出版信息

J Neurointerv Surg. 2015 Sep;7(9):652-9. doi: 10.1136/neurintsurg-2014-011265. Epub 2014 Jun 26.

DOI:10.1136/neurintsurg-2014-011265
PMID:24968879
Abstract

BACKGROUND

The Pipeline Embolization Device (PED) has become an important tool in the treatment of complex cerebrovascular pathology since it was approved by the Food and Drug Administration in April 2011.

OBJECTIVE

To determine the overall complication rate (permanent and transient) associated with the use of this new device from a single institution.

METHODS

We retrospectively examined a prospectively maintained database of our patients treated with the PED since its availability to the current time. 126 patients (24 men, 102 women; age range 14-83 years, mean 59.8 years) were treated for a total of 137 intracranial aneurysms, one cervical internal carotid artery dissection, one cervical vertebral artery dissection, and one carotid-cavernous fistula with a total of 217 PEDs (1.72 PED/patient).

RESULTS

A total of 40 complications were experienced by 33 patients in our cohort. Four complications (4/126, 3.2%) in four patients were permanent, resulting in three deaths and one permanent disability. The other 36 complications (28.6%) occurred in 29 patients, all of whom went on to recover completely. The total complication rate associated with the use of the PED was 31.7% (40/126).

CONCLUSIONS

Despite a low rate of permanent complications associated with the PED in this series, the total complication rate was high. This finding supports the conclusion that this device should be reserved for the most challenging aneurysms. Patients should be advised of this higher rate of transient periprocedural complications.

TRIAL REGISTRATION NUMBER

IRB#:14BN027 Q7.

摘要

背景

自2011年4月获得美国食品药品监督管理局批准以来,Pipeline栓塞装置(PED)已成为治疗复杂脑血管疾病的重要工具。

目的

确定在单一机构中使用这种新装置的总体并发症发生率(永久性和暂时性)。

方法

我们回顾性研究了一个前瞻性维护的数据库,该数据库涵盖了自PED可用以来至当前时间接受治疗的患者。126例患者(24例男性,102例女性;年龄范围14 - 83岁,平均59.8岁)共接受了137例颅内动脉瘤、1例颈内动脉夹层、1例椎动脉夹层和1例颈动脉海绵窦瘘的治疗,共使用了217枚PED(每位患者1.72枚)。

结果

我们队列中的33例患者共经历了40例并发症。4例患者出现4例永久性并发症(4/126,3.2%),导致3例死亡和1例永久性残疾。另外36例并发症(28.6%)发生在29例患者中,所有这些患者均完全康复。使用PED的总体并发症发生率为31.7%(40/126)。

结论

尽管本系列中与PED相关的永久性并发症发生率较低,但总体并发症发生率较高。这一发现支持了该装置应仅用于最具挑战性动脉瘤的结论。应告知患者围手术期短暂并发症的发生率较高。

试验注册号

IRB#:14BN027 Q7。

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