Hemostasis Disturbances in Continuous-Flow Left Ventricular Assist Device (CF-LVAD) Patients-Rationale and Study Design.

Left ventricular assist devices are a treatment option for end-stage heart failure patients. Despite advancing technologies, bleeding and thromboembolic events strongly decrease the survival and the quality of life of these patients. Little is known about prognostic factors determining these adverse events in this group of patients. Therefore, we plan to investigate 90 consecutive left ventricular assist device (LVAD) patients and study in vitro fibrin clot properties (clot lysis time, clot permeability, fibrin ultrastructure using a scanning electron microscope) and the calibrated automated thrombogram in addition to the von Willebrand factor antigen, fibrinogen, D-dimer, prothrombin time/international normalized ratio (PT/INR), and activated partial thromboplastin time (APTT) to identify prognostic factors of adverse outcomes during the course of therapy. We plan to assess the hemostasis system at four different time points, i.e., before LVAD implantation, 3-4 months after LVAD implantation, 6-12 months after LVAD implantation, and at the end of the study (at 5 years or at the time of the adverse event). Adverse outcomes were defined as bleeding events (bleeding in general or in the following subtypes: severe bleeding, fatal bleeding, gastrointestinal bleeding, intracranial bleeding), thromboembolic events (stroke or transient ischemic attack, pump thrombosis, including thrombosis within the pump or its inflow or outflow conduits, arterial peripheral thromboembolism), and death.