Angiographic and Histopathological Characteristics of a Novel Polyacrylate Liquid Embolic Agent Compared to EVOH in a Large Animal Model.

Autores de IIS La Fe

• Fernando Gómez Muñoz

  Autor

Participantes ajenos a IIS La Fe

• de Garnica García MG
• Iglesias SV
• Pérez-Martínez C
• López-Rueda A
• Codina LD
• Crisol MM
• Castel AG
• Pérez de Prado A

Grupos

• Investigacion Biomédica en Imagen (GIBI 2-30)

  Investigador Principal

  Leonor Cerdá Alberich

Abstract

PURPOSE: To study the in vivo safety and efficacy of a novel radiopaque non-adhesive polyacrylate peripheral liquid embolic system (PA, AMBER SEL-P) relative to ethylene vinyl alcohol copolymer (EVOH, Onyx(TM)) in a healthy swine endovascular model. MATERIALS AND METHODS: Twenty-five swine underwent rete mirabile and bilateral kidney embolization with PA or EVOH and were followed up for 24 hours (n=5) and 30 days (n=10), and 3 (n=10) months. Angiographic features (penetrability, radiopacity, catheter entrapment, fragmentation, occlusion, and vasospasm) were evaluated. Necropsy and histology were used to evaluate the non-target embolization, safety, target-embolization effectiveness by recanalization and to analyze the vascular response. RESULTS: No adverse events occurred during the embolization process or study period. The angiographic performance confirmed a significant positive effect of PA compared to EVOH in terms of penetrability (p=0.007), catheter entrapment (p=0.007), fragmentation (p=0.007), vascular occlusion (p=0.038), vasospasm (p=0.038), and follow-up vascular occlusion (p=0.038). Pre-necropsy angiography found no vascular recanalization in the organs treated with PA, while it was detected at 3 months in two samples treated with EVOH. Histologically, PA was classified as non-irritant compared with EVOH under the study conditions according to ISO 10993-6:2016 as modified. No systemic effects during necropsy were detected in the animals treated with these agents. CONCLUSION: This in vivo study concludes that the angiographic behavior of PA has advantages compared to EVOH. The embolization and biocompatibility of PA are similar to those of EVOH. PA is safe and effective for transarterial embolization in an acute, subacute, and chronic endovascular embolization model.

Copyright © 2024 SIR. Published by Elsevier Inc. All rights reserved.

Keywords

• Liquid embolic agent; angiography; endovascular embolization; pathology; preclinical animal model