Related Experiment Video
Updated: Nov 21, 2025
Microsurgical Creation of Giant Bifurcation Aneurysms in Rabbits for the Evaluation of Endovascular Devices
Published on: September 8, 2023
Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis
Huibin Kang1, Yu Zhou2, Bin Luo1
1Department of Interventional Neuroradiology, Beijing Neurosurgical Institute and Beijing Tiantan Hospital, Capital Medical University, No. 119 South Fourth Ring West Road, Fengtai District, Beijing, 100050, China.
Insights
The PLUS study found predictors of complications in Chinese patients undergoing Pipeline embolization device (PED) treatment for intracranial aneurysms. Successful deployment and occlusion degree are novel predictors of ischemic stroke with PED use.
Area of Science:
- Neuroendovascular therapy
- Cerebrovascular disease management
- Medical device clinical research
Background:
- Pipeline Embolization Device (PED) use for intracranial aneurysms is associated with complications in Western populations.
- Real-world data on PED complications and outcomes in Chinese populations are limited.
Purpose of the Study:
- To assess real-world predictors of complications and functional outcomes in Chinese patients treated with PED.
- To identify risk factors for ischemic stroke, hemorrhage, and other adverse events following PED treatment.
Main Methods:
- Postmarket, multicenter registry study (PLUS study) including 1171 Chinese patients with 1322 intracranial aneurysms treated with PED (Nov 2014-Oct 2019).
- Evaluation of preoperative and postoperative functional outcomes (modified Rankin Scale) and PED-related complications up to 36 months.
- Multivariate analysis to identify independent predictors of complications.
Main Results:
- Hypertension, basilar artery aneurysms, and deployment issues predicted ischemic stroke; Flex PED use and incomplete occlusion were protective.
- Large aneurysm size (>10 mm), distal anterior circulation aneurysms, and adjunctive coiling predicted rupture, hemorrhage, and compression symptoms, respectively.
- PED-related complication rates were similar to Western populations; successful deployment and immediate occlusion degree are novel predictors of ischemic stroke.
Conclusions:
- The PLUS study provides valuable insights into PED treatment outcomes and complication predictors in a Chinese population.
- Successful deployment and immediate occlusion are identified as novel predictors for PED-related ischemic stroke.
- Findings support tailored treatment strategies and risk factor management for intracranial aneurysm embolization with PED in diverse populations.
Abstract:
During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative (< 30 days) functional outcomes (modified Rankin scale [mRS] scores) and complications related to PED treatment at early postoperative and follow-up time points (3-36 months). Multivariate analysis was performed to identify risk factors for complications. A total of 1171 consecutive patients (mean age, 53.9 ± 11.4; female, 69.6% [813/1171]) with 1322 aneurysms were included in the study. Hypertension, basilar artery aneurysms, and successful deployment after adjustment or unsuccessful device deployment were found to be independent predictors of ischemic stroke, while the use of the Flex PED and incomplete occlusion immediately after treatment were protective factors. An aneurysm size > 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population. ClinicalTrial.gov Identifier: NCT03831672.
