In Vivo Feasibility of Arterial Embolization with a New Permanent Agar–agar-Based Agent
摘要
Evaluate the safety and efficacy of an eco-friendly permanent agar–agar-based embolization agent (ABEA) (EmboBio®) for intra-arterial use.
Materials and MethodsSix pigs embolized with one ABEA torpedo (6 lower polar renal and 6 lumbar arteries) and one coil (6 lower polar renal and 6 lumbar arteries).
Technical success was defined as a complete occlusion with no residual flow in DSA. Short-term endpoints included safety (non-targeted embolization), ease of use (embolization preparation time, occlusion time), and DSA controls at day 7, month 1, and month 3.
Tissue reaction was assessed via [18F]-FDG PET/CT at month 2 and histological study at month 3.
ResultsABEA torpedoes achieved immediate and persistent occlusion at month 3 for all kidney and lumbar embolizations (n = 12/12).
Control coils had technical success for 12/12, with a persistent occlusion at month 3 for 2/12.
No off-target embolization occurred.
ABEA torpedoes demonstrate faster occlusion (ABEA: 6 ± 4 s; coils: 427 ± 469 s; p = 0.0022, n = 12) and preparation times (ABEA: 96.9 1 ± 23 s; coils: 150.33 ± 58 s; p = 0.0432, n = 12) after device placement than coil.
No significant difference in inflammation between ABEA and coil groups at month 2 (ABEA: 3.35e−6 ± 1.7e−6%ID/mm3; coils: 2.24e−6 ± 8.5e−7%ID/mm3; p = 0.5) on PET imaging. These results were confirmed by histological analysis at month 3.
ConclusionPermanent dry foam torpedo comprising agar–agar is effective for arterial embolization. In animal model, one ABEA torpedo demonstrates a faster and more persistent occlusion than one fiber coil.
Levels of EvidenceNot applicable.
Graphical Abstract