P101: Feasibility Study of the Percutaneous Access Device for Long-Term LVAS Application

Abstract

Background: Driveline infection (DLI) is a major chronic adverse event requiring re-hospitalization after durable left ventricular assist system (LVAS) implantation. The risk of DLI continues to rise over time and is associated with long-term mortality. Percutaneous access device (PAD) may be a potential technology to prevent DLI by the mechanical barrier interfaced with epidermal tissue. Methods: A prototype PAD was fabricated for the LVAS driveline and evaluated with two mini pigs for up to 69 days at the GLP facility. Test articles were implanted at the subcutaneous position on the left and right abdominal walls. After implant surgery, antibiotics were administered intravenously for three days for prophylactic purposes and discontinued unless there was any sign of infection. Skin and implanted PAD are showered weekly with warm water without any other disinfectant agent. Animals received humane care without restraints in the cage and were checked for general physical condition daily. The blood sample was collected at baseline, POD 7, 14, 28, and 69. Test Animals were euthanized, and articles and surrounding tissue samples were explanted en bloc for histopathology assessment. Results: Postoperative recovery was uneventful, and no remarkable organ dysfunction and no sign of infection were identified. A normal inflammatory response was observed on the skin a few days post-op but normalized within a week. Good tissue integrity was confirmed (no visible gap) around the interface between the test article and the skin without evidence of epidermal down growth and infection. Rich fibromatous tissue with keratin formation was confirmed. Conclusion: Initial feasibility of PAD for LVAS driveline was verified. Further design optimization will be required to finalize the clinical prototype before the pre-clinical GLP study.Figure 1. Upper left: Percutaneous access device tested (implanted to the test animal) Upper right: Close-up view of the skin interface Lower center: Histopathology of test article at subcutaneous tissue