Experimental comparative study of a novel drug-eluting arteriovenous graft in a sheep model

• Published in: Frontiers in cardiovascular medicine 2024-02, Vol.11, p.1341154-1341154
• Main Authors: Riber, Sara Schødt, Clausen, Lene Langhoff, Dahl, Marie, Riber, Lars Peter Schødt, Andersen, Thomas Emil, Lindholt, Jes S
• Format: Article
• Language: English
• Subjects: Cardiovascular Medicine; expanded PTFE; experimental animal models; innovativeness; surgical; vascular surgical procedures
• ISSN: 2297-055X; 2297-055X
• DOI: 10.3389/fcvm.2024.1341154

Arteriovenous (AV) grafts often develop severe complications of stenosis due to neointimal proliferation that occurs either at the venous anastomosis site or at the outflow receiving vein. This study compares primary patency during 12 months of follow up for a new experimental Biomodics interpenetrating polymer network (IPN) drug-eluting graft prototype with state-of-the-art GORE® ACUSEAL (ACUSEAL) in an AV graft model in sheep. An end-to-end bypass from the common carotid artery to the jugularis vein was performed bilaterally in 12 sheep. The usage of ACUSEAL or the IPN, both 6.0 mm in diameter, was determined via randomization. The sheep were followed up every 4 weeks with ultrasonic duplex scanning to determine patency; the experienced observer was blinded to the randomization. One sheep died after 11 days, and the final sample accordingly consisted of 11 animals. When comparing neointimal hyperplasia after 12 months in the two grafts, Fisher's exact test showed a significant difference with none out of 11 in the IPN grafts and 9 out of 11 in the ACUSEAL graft (