Abstract
Objectives
To evaluate a novel, ready-to-use, iodinated polyvinyl alcohol polymer embolic implant.
Methods
Under good laboratory practice conditions, 26 pigs were investigated. A complex arteriovenous malformation (AVM) model was created in 16 animals, and a simple rete model was used in the remaining 10 animals. The novel material was used for embolization in 22 animals, and a commercially available liquid embolic material in 4 animals as a control group. Animals were killed at 2 days, 3 months and 6 months. Feasibility, efficacy and safety were evaluated radiologically, clinically and histologically.
Results
Preparation was easy, without risk of catheter clogging or adhesiveness. Embolic delivery was well controlled under subtracted fluoroscopy. Visibility was homogeneous throughout the injection and the material behaved cohesively upon delivery. Best lesion penetration was obtained with the use of proximal microballoon occlusion. Unforeseen over-dilution of the test material by DMSO prefilled in the microballoon hub changed the material properties and caused inadvertent cerebral embolization leading to death in five animals. This phenomenon was avoided by practical measures. The casts produced no beam-hardening artefacts on CT scans. Histology showed excellent biocompatibility.
Conclusions
Embolization with this novel, iodinated, precipitating polymer was feasible and effective. Care should be taken during delivery to avoid over-dilution of the material by prefilled DMSO. The material is promising for embolization of AVMs and hypervascular lesions.
Key Points
• The intrinsically opaque precipitating polymer has adequate fluoroscopic visibility
• The polymer does not induce shading or beam-hardening artefacts on CT
• The novel liquid embolic material does not require lengthy preparation
• Lack of implant adherence reduces the risk of entrapment of the delivery catheter
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Abbreviations
- AVM:
-
Arteriovenous malformation
- CCA:
-
Ccommon carotid artery
- DMSO:
-
Dimethyl sulfoxide
- EVOH:
-
Ethylene vinyl alcohol copolymer
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Acknowledgements
We thank Nikola Cesarovic, DVM, and Flora Nicholls-Vuille, DVM, Division of Surgical Research, University Hospital of Zurich, Zurich, Switzerland, for their valuable contribution to the surgical procedures in the animals.
The scientific guarantor of this publication is I.W. O.J. is a shareholder of Antia Therapeutics AG. This study received funding from Antia Therapeutics AG. One of the authors (K.K.) has significant statistical expertise. Approval from the institutional animal care committee was obtained.
Methodology: Prospective/experimental study performed at one institution.
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Kulcsár, Z., Karol, A., Kronen, P.W. et al. A novel, non-adhesive, precipitating liquid embolic implant with intrinsic radiopacity: feasibility and safety animal study. Eur Radiol 27, 1248–1256 (2017). https://doi.org/10.1007/s00330-016-4463-7
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DOI: https://doi.org/10.1007/s00330-016-4463-7