Biodegradable Polydioxanone Microspheres for Transcatheter Arterial Embolization: Proof of Principle.

ABSTRACT

PURPOSE: To evaluate feasibility, embolization success, biodegradability, reperfusion, and biocompatibility of biodegradable microspheres (MS) made from polydioxanone (PDO) for transcatheter arterial embolization. MATERIALS AND METHODS: Unilateral selective renal embolization of a segmental artery was performed in 16 New Zealand White rabbits with PDO-MS (100-150 µm and 90-315 µm). Animals were randomly assigned to different observation periods and underwent control digital subtraction angiography (DSA) and MR imaging immediately (n = 3), 1 week (n = 2), 4 weeks (n = 2), 8 weeks (n = 2), 12 weeks (n = 5), and 16 weeks (n = 2) after embolization. Kidneys were harvested for macroscopic and histologic analysis of embolization success, biodegradability, and biocompatibility. RESULTS: Embolization was technically successful in 15 of 16 animals. One animal died of anesthesia-related circulatory failure. The 100-150 µm MS were injected easily through 3-F catheters; the 90-315 µm MS tended to clog with intermittent catheter obstruction. DSA and MR imaging showed successful target embolization in 13 of 15 animals. In 2 animals, the entire kidney was affected owing to catheter clogging, including a reflux of MS while flushing. Control DSA and MR imaging showed increasing vascular reperfusion with time. Macroscopic and histologic analysis revealed necrosis/infarction in areas in which embolization was achieved. MS were extensively degraded after 16 weeks, and overall inflammatory reaction was mild. CONCLUSIONS: Biodegradable PDO-MS induced effective embolization of target vessels while demonstrating good biocompatibility. MS increasingly dissolved at 16 weeks, partial reperfusion started at week 1, and complete reperfusion started at week 8, thus offering possible advantages as a temporary embolic agent.