Particulates from hydrophilic-coated guiding sheaths embolise to the brain.
OBJECTIVE
We sought to evaluate the incidence of embolic material in porcine brains following vascular interventions using hydrophilic-coated sheaths.


RESULTS
A new self-expanding stent and delivery system (SDS) was deployed through a hydrophilic-coated (Flexor Ansel; Cook Medical, Bloomington, IN, USA) guiding sheath into the iliac and/or carotid arteries of 23 anaesthetised Yucatan mini swine. The animals were euthanised at three, 30, 90 and 180 days and their brains were removed for histological analysis. In an additional single control animal, the guiding sheath was advanced but no SDS was deployed. Advancement of the coated guiding sheath with or without the SDS was associated with frequent foreign material in the arterioles of the brain. The embolic material was amorphous, non-refractile, non-crystalline, non-birefringent and typically lightly basophilic with a slightly stippled appearance on haematoxylin and eosin (H&E) stain. Material was observed at all time points involving 54% of all study animals (i.e., test and control) and in vitro after incubation in 0.9% saline.


CONCLUSIONS
The hydrophilic coating on a clinically used guiding sheath readily avulses and embolises to the brain during deployment in a porcine model. Further documentation of this effect and monitoring in clinical scenarios are warranted.
CBSET, Inc., Lexington, MA, USA.
James R L
JR
Stanley
Abraham R
AR
Tzafriri
Kathryn
K
Regan
Alan
A
LaRochelle
Gee
G
Wong
Brett G
BG
Zani
Peter M
PM
Markham
Lynn
L
Bailey
Anna
A
Spognardi
Gregory A
GA
Kopia
Elazer R
ER
Edelman
D000818:Animals; D001921:Brain / Q000473:pathology; D002339:Carotid Arteries; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D004868:Equipment Failure; D005548:Foreign-Body Migration / Q000209:etiology* / Q000473:pathology; D057927:Hydrophobic and Hydrophilic Interactions; D007083:Iliac Artery; D020766:Intracranial Embolism / Q000209:etiology* / Q000473:pathology; D015607:Stents; D013552:Swine; D013556:Swine, Miniature; D013997:Time Factors; D062666:Vascular Access Devices
D020099:Coated Materials, Biocompatible