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A novel, non-adhesive, precipitating liquid embolic implant with intrinsic radiopacity: feasibility and safety animal study

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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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Correspondence to Zsolt Kulcsár.

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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

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