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Development of novel drug-eluting biodegradable nano-fiber for prevention of postoperative pulmonary venous obstruction, ^,

^a Department of Cardiac Surgery, Nagoya University, Graduate School of Medicine, Nagoya, Aichi, Japan
^b Department of Clinical Cell Therapy and Tissue Engineering, Nagoya University School of Medicine, 65 Tsurumaicho Showa-ku, Nagoya, Aichi, 466-8550, Japan
^c Department of Tissue Engineering Development, Technology Innovation Center, Teijin Limited, Hino, Tokyo, Japan

*Corresponding author. Tel.: +81-52-744-2424; fax: +81-52-744-1978.

E-mail address: ynarita{at}med.nagoya-u.ac.jp (Y. Narita).

Pulmonary venous obstruction (PVO) after correction of total anomalous pulmonary venous connection (TAPVC) frequently occurs due to intimal-hyperplasia and the required re-operation. We have developed a novel sustained-release drug delivery system, using Tacrolimus-eluting biodegradable nano-fiber (TEBN). It consists of nano-scale fiber composed of biodegradable polymer and Tacrolimus. This study evaluated the effects of TEBN for prevention of venous anastomotic stricture in a rat model to apply to PVO operation. Tacrolimus was incorporated into poly (L-lactide-co-glycolide). The venous stricture model was made by rat inferior vena cava anastomosis. The IVC anastomosis was covered with TEBN with 1.0 wt% Tacrolimus (n=12) or without TEBN as a control (n=12), and evaluated histologically at 1, 2, and 4 weeks after operation. The ratio of intimal area was significantly reduced in the TEBN group compared with the control group (ratio; 1 week: 0.43±0.26 vs. 0.07±0.04, P=0.04, 2 weeks: 0.39±0.19 vs. 0.05±0.02, P=0.01, 4 weeks: 0.31±0.15 vs. 0.09±0.04, P=0.03, control vs. TEBN, respectively). Histological findings showed endothelialization along the inner surface of the vein even in TEBN. The TEBN reduced intimal hyperplasia and preserved endothelialization even in a venous stricture. These results suggested that this strategy might be useful for prevention of recurrent PVO after TAPVC correction.

Key Words: Pulmonary venous obstruction; Total anomalous pulmonary venous connection; Tacrolimus; Nano-fiber; Intimal hyperplasia