Early Feasibility Testing and Engineering Development of a Sutureless Beating Heart (SBH) Connector for Left Ventricular Assist Devices (LVAD)

摘要

APK Advanced Medical Technologies (Atlanta, GA) is developing a sutureless beating heart (SBH) left ventricular assist device (LVAD) connector system consisting of anchoring titanium coil, titanium cannula with integrated silicone hemostatic valve, coring and delivery tool, and LVAD locking mechanism to facilitate LVAD inflow surgical procedures. Feasibility testing was completed in human cadavers (n=4) under simulated normal and hypertensive conditions using saline to observe seal quality in degraded human tissue and assess anatomic fit; acutely in ischemic heart failure (IHF) bovine model (n=2) to investigate short-term performance and ease of use; and chronically for 30-days in healthy calves (n=2) implanted with HeartWare HVAD to evaluate performance and biocompatibility. Complete hemostasis was achieved in human cadavers and animals at LV pressures up to 170 mmHg. In animals, off pump (no cardiopulmonary bypass) anchoring of the connector was accomplished in less than 1 minute with no residual bleeding after full delivery and locking of the LVAD; and implant of connector and LVAD were successfully completed in under 10 minutes with total procedure blood loss less than 100mL. In chronic animals prior to necropsy, no signs of leakage or disruption at the attachment site were observed at systolic LV pressures >200 mmHg.