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J Thorac Cardiovasc Surg 2009;137:703-709
© 2009 The American Association for Thoracic Surgery

Evolving Technology

A new strategy for prevention of anastomotic stricture using tacrolimus-eluting biodegradable nanofiber

^a Nagoya University, Graduate School of Medicine, Department of Cardiothoracic Surgery, Nagoya, Aichi, Japan
^b Department of Clinical Cell Therapy and Tissue Engineering, Nagoya University School of Medicine, Nagoya, Aichi, Japan
^c Department of Tissue Engineering Development, Teijin Technology Innovation Center, Teijin Limited, Hino, Tokyo, Japan
^d Department of Cardiac Surgery, The University of Tokyo Graduate School of Medicine, Tokyo, Japan

Received for publication June 19, 2008; revisions received October 2, 2008; accepted for publication November 15, 2008.

^_* Address for reprints: Yuji Narita, MD, PhD, Department of Clinical Cell Therapy and Tissue Engineering, Nagoya University School of Medicine, 65 Tsurumaicho, Syowa-ku, Nagoya, Aichi 466-8550, Japan. (Email: ynarita{at}med.nagoya-u.ac.jp).

Objective: We developed a novel sustained drug-eluting device using tacrolimus-eluting biodegradable nanofiber to prevent anastomotic stricture and evaluated the effects in a rat abdominal aortic anastomosis model.

Methods: In vitro and in vivo tacrolimus release tests for tacrolimus-eluting biodegradable nanofiber were performed to confirm its sustained release. To verify the prevention of anastomotic stricture, tacrolimus-eluting biodegradable nanofiber was placed around the end-to-end anastomosis of abdominal aorta in rats. Five rats were allocated to the following 5 groups: (1) control without tacrolimus-eluting biodegradable nanofiber, (2) 5 mg of nanofiber only (0 wt% of tacrolimus), (3) 5 mg of tacrolimus-eluting biodegradable nanofiber containing 0.04 wt% of tacrolimus, (4) 5 mg of tacrolimus-eluting biodegradable nanofiber containing 0.1 wt% of tacrolimus, and (5) 5 mg of tacrolimus-eluting biodegradable nanofiber containing 1.0 wt% of tacrolimus. Morphometric and histologic analyses including immunohistochemistry were performed in each of the groups 2 weeks after the operation.

Results: The tacrolimus-eluting biodegradable nanofiber gradually released tacrolimus for at least 1 month in vitro and in vivo. The ratio of intimal area was significantly reduced in the 1.0 wt% tacrolimus-eluting biodegradable nanofiber group compared with the other groups (0.26, 0.24, 0.25, 0.21, and 0.08 in control, 0 wt%, 0.04 wt%, 0.1 wt%, and 1.0 wt%, respectively, P < .05). The cells, which constitute intimal hyperplasia, were positive for smooth muscle actin and SMemb, and factor VIII revealed that endothelial cells covered the surface of the aortic lumen even in the 1.0 wt% tacrolimus-eluting biodegradable nanofiber group in immunohistochemistry.

Conclusion: Tacrolimus-eluting biodegradable nanofiber reduced neointimal hyperplasia and preserved endothelialization. This device may be useful in the prevention of anastomotic stricture.