Safety and efficacy of PED Shield in intracranial unruptured saccular aneurysms
10.3760/cma.j.cn115354-20250422-00239
- VernacularTitle:PED Shield治疗颅内未破裂囊性动脉瘤的安全性及有效性分析
- Author:
Runze GE
1
;
Xin FENG
;
Xueyan DENG
;
Zehui XIE
;
Can LI
;
Shuyin LIANG
;
Shixing SU
;
Xin ZHANG
;
Xifeng LI
;
Chuanzhi DUAN
Author Information
1. 南方医科大学珠江医院神经外科中心脑血管病外科，国家临床重点专科，脑血管病诊疗技术与器械教育部工程研究中心，广东省普通高校脑功能修复与再生重点实验室，脑科学与脑智能研究院，广州 510282
- Publication Type:Journal Article
- Keywords:
Intracranial aneurysm;
Flow diverter;
PED Shield;
Safety;
Efficacy
- From:
Chinese Journal of Neuromedicine
2025;24(7):649-655
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the safety and efficacy of Pipeline embolization device (PED) Shield in intracranial unruptured saccular aneurysms.Methods:This is a retrospective cohort study; 124 patients with intracranial unruptured saccular aneurysms treated with PED Shield at Department of Cerebrovascular Surgery, Neurosurgery Center, Zhujiang Hospital, Southern Medical University from July 2023 to October 2024 were enrolled. Intraoperative device-related complications and occurrence of hemorrhagic and ischemic complications within 30 days of the procedure were recorded. The clinical results and imaging results (degrees of stent patency and aneurysm occlusion rate) 6 months after follow-up were statistically analyzed. Modified Rankin scale (mRS) score>2 was defined as poor prognosis in clinical follow-up, and grade D according to O'Kelly Marotta (OKM) classification was considered as complete aneurysm occlusion in imaging follow-up.Results:Eighty-seven females and 37 males, aged (56.44±12.17) years (ranging from 27 to 80 years) were enrolled, with a maximum aneurysm diameter of 5.12 (3.73, 7.24) mm. Among the 124 patients, incidence of intraoperative instrument-related complications was 6.5% (8/124); and within 30 days of the procedure, incidence of ischemic complications was 4.8% (6/124) and that of hemorrhagic complications was 1.6% (2/124). Eighty-four patients had a 6-month clinical follow-up, with 1 patient (1.2%) having poor prognosis. Eighty-four patients (67.7%) completed a 6-month imaging follow-up: complete occlusion rate of aneurysms was 82.1% (69/84), incidence of in-stent stenosis (stenosis degree ≥25%) was 4.8% (4/84), and no symptomatic in-stent stenosis was found.Conclusion:Result of this study shows that PED Shield may be an effective and safe clinical option for intracranial unruptured saccular aneurysms.
