Development and long-term in vivo testing of a novel skin-button system for preventing driveline infection of an implantable VAD system.

Driveline infection is a serious complication in long-term therapy using a ventricular assist device (VAD). However, measures taken against this complication have not been sufficient. In this study, we evaluated our newly developed infection-resistant skin-button system against driveline infection of an implantable VAD in a chronic animal study. The skin button is made of two flanges using tissue-compatible segmented polyurethane. The exposed upper layer is made of a nonporous sheet with relative flexibility similar in texture to the skin. In addition, this shape was designed to defuse excessive stress at the edge of the skin caused by the external force put on the driveline. The lower layer, which is implanted subcutaneously, is made of a porous material with a three-dimensional reticular structure. The combination of these two flanges with different features enables the driveline to fix to the skin without epithelial downgrowth and peridriveline pocket formation and can prevent bacterial infection over a prolonged period. Results of 90 days of animal tests, the button maintained secure adhesion to the skin and did not exfoliate without special daily treatments, such as dressing or disinfection, and there were no infections or inflammations at the exit site. This study demonstrates that our newly developed skin-button system can be useful for preventing infections at the driveline exit site.