Hemocompatibility in HeartMate III: Is Anticoagulation Alone a Safe Strategy?

Purpose Hemocompatibility represents the goal for left ventricular assist devices (LVADs). Currently, third generation-fully-magnetically-levitated LVAD (HeartMate 3, HM3) has shown high hemocompatibility. Aim of this retrospective study was to evaluate safety and effectiveness of anticoagulant therapy alone after HM3 implantation. Methods Patients were monitored by clinical evaluation, classical laboratory, thromboelastometry (ROTEM) and aggregometry (Multiplate) in the postoperative period and at follow-up. Based on therapeutic options, our population (=25 patients, from November 2015 to March 2018) was divided in: Group A (=15 patients, 60%) with antiplatelet+anticoagulant medications and Group B (=10 patients, 40%) with anticoagulant medication alone. Primary outcome was freedom from clinical thromboembolic and/or hemorrhagic events. For the assessment of asymptomatic neurologic events, patients were explored with MiniMental-State-Examination (MMSE) and Brief-Neuropsychological-Examination 2 (ENB2). Results Mean age was 61.5 ± 5.6 years and 4 patients (16%) were in INTERMACS profile 1, 15 (60%) in profile 2-3 and 6 (24%) in profile 4. Bleeding occurred in 10 patients (Group A=9, 40% vs Group B=1, 10%, p=0.0177). In particular, cerebral hemorrhage in 1 (Group A), gastrointestinal bleeding in 5 (Group A), late onset chest bleeding in 2 (Group A), minor bleeding in 6 (5 Group A, 1 Group B). No thromboembolic events were reported. At follow-up ENB2 showed significant improvement of patients’ neuropsychological performance (p=0.006), whereas MMSE results remained stable (p=0.1). Conclusion Heartmate 3 is a highly hemocompatible device. This study suggests that anticoagulation alone is a safe and effective therapy as it prevents both thrombotic and hemorrhagic events.