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Updated: Jun 11, 2025
00:09
Visualization of Flow Field Around a Vibrating Pipeline Within an Equilibrium Scour Hole
Published on: August 26, 2019
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Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data
Fernanda Rodriguez-Erazú1,2, Gustavo M Cortez1,3, Demetrius K Lopes4
1Lyerly Neurosurgery, Baptist Medical Center Downtown, Jacksonville, Florida, USA.
Journal of Neurointerventional Surgery
|October 2, 2024
Summary
The Pipeline Embolization Device (PED) showed excellent braid stability in early generations, with rare deformations not impacting safety or effectiveness for brain aneurysm treatment. Long-term follow-up confirmed device integrity.
Area of Science:
- Endovascular neurosurgery
- Medical device technology
- Cerebrovascular disease management
Background:
- Concerns exist regarding braid stability in newer Pipeline Embolization Device (PED) generations utilizing drawn filled tubing technology.
- The PED is increasingly adopted for treating intracranial aneurysms.
Purpose of the Study:
- To evaluate the braid stability of early-generation PED devices (Classic and Flex) within the PREMIER clinical trial.
- To assess the long-term safety and effectiveness of PED in aneurysm treatment.
Main Methods:
- Retrospective analysis of intracranial aneurysms treated with PED (Classic and Flex) in the PREMIER trial.
- Evaluation of braid stability (fish mouthing, foreshortening, braid bump, collapsing) using immediate postprocedure and 1- and 2-year follow-up imaging (cone-beam CT and angiography).
- Assessment of safety (modified Rankin Scale, vessel stenosis) and effectiveness (Raymond-Roy Scale, re-treatment rates).
Main Results:
- Complete datasets were available for 133/141 aneurysms; 6% (8/133) exhibited braid deformations.
- Braid deformations were significantly associated with in-stent stenosis >50% (P=0.029) but did not impact overall safety or effectiveness.
- Specific deformations included fish mouthing (0.75%), foreshortening (4.5%), and braid bump (0.75%), with one case of fish mouthing causing >50% stenosis.
- No new braid stability issues were observed at the 2-year follow-up; asymptomatic stenosis due to neointimal hyperplasia occurred in 3.0% without braid changes.
Conclusions:
- The Pipeline Embolization Device (Classic and Flex) demonstrated excellent braid stability in the PREMIER trial cohort.
- Observed braid changes were infrequent and did not compromise the safety or efficacy of the device for aneurysm treatment.
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