Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices

Prior treatment

• Patients who are bridge to transplant and a current UNOS status 1-3
• Ongoing inotrope therapy after LVAD (e.g., milrinone, dobutamine, epinephrine)
• Permanent right ventricular assist device at the time of LVAD implant
• Thrombolysis within the previous 7 days
• Patients on antiplatelet therapy other than aspirin (e.g., clopidogrel, prasugrel, ticagrelor, dipyridamole, or pentoxifylline)
• Patients on combined P-glycoprotein and strong CPY3A4 inhibitors or inducers (e.g., fluconazole, posaconazole, rifampin)

Other illness

• History of post-LVAD device thrombosis, stroke, or gastrointestinal bleeding
• Patients with a mechanical heart valve
• Patients with end-stage renal disease on dialysis
• Known history of ischemic stroke, intracranial bleed, or neurosurgery within 3 months
• Known history of intracerebral arteriovenous malformation, cerebral aneurysm or mass lesions of the central nervous system.
• Patients with an allergy or contraindication to aspirin, warfarin, or apixaban
• Known bleeding within the last 30 days requiring emergency room presentation or hospitalization
• Known history of an inherited bleeding disorder (e.g., hemophilia, von Willebrand disease)

Lab values

• Prior history of known thrombophilia (e.g., factor V Leiden, prothrombin gene mutation, protein C or S deficiency, antithrombin 3 deficiency, hyperhomocysteinemia, antiphospholipid antibody syndrome) or indication for higher INR goal (\>2.5) with warfarin.
• Patients with active bleeding or a hemoglobin \< 8.0 g/dl
• Total bilirubin \> 2.0 mg/dl, shock liver, hepatic encephalopathy, or biopsy proven liver cirrhosis
• INR \> 2.0 not due to anticoagulation therapy
• Platelet count \<100,000 cells/mm3

Other

• Pregnant patients
• Recent (\<48 hours) or planned spinal or epidural anesthesia or puncture

• Patients implanted with a HeartMate 3 LVAD
• Age 18 or greater and able to provide written informed consent
• Females of childbearing age must agree to adequate contraception