Abstract
Purpose The optimal antithrombosis regime for children on ventricular assist devices (VADs) is controversial and the neurologic event rate remains unacceptably high. Bivalirudin, a direct thrombin inhibitor (DTI), may confer advantages over unfractionated heparin but has not been well-studied in this population. The primary aim of this study was to describe the percent time in therapeutic range for activated partial thromboplastin time (aPTT) using bivalirudin in a cohort of children on VADs. Methods All children on VAD support and treated with bivalirudin at a tertiary care children's hospital from January 1, 2016 to September 31, 2018 were retrospectively studied. Demographics, lab, medication data, and PediMACS complications were collected for the first 2 weeks after VAD implantation. Basic statistical analyses were used to describe the cohort. Percent time in therapeutic range was calculated by dividing the time an aPTT was in therapeutic range by the total time the patient received bivalirudin during the study period. Results Among 11 VAD recipients (median age 2.75 years [IQR 0.6 - 6.2], median weight 12 kg [IQR 7.3 - 17.1]), the majority were supported with a Berlin EXCOR (9/11; 82%). 3 patients were on BiVAD support and 2 required dialysis. Goal ranges for aPTT were tailored to each patient. The mean percent time in therapeutic range was 68.7% (range 49.2-87.8%) for the entire cohort. Time in therapeutic range improved during the study period. Stroke occurred in 3/11 patients (28%), with major bleeding in 1/11. There were no mortalities. 7/11 (64%) received solid organ transplant, 1 underwent device explant, and 3 continued on VAD support. Conclusion These findings suggest bivalirudin is a reasonable alternative anticoagulant in this population. Time in therapeutic range at our center was better than published reports using DTIs in adult patients with heparin-induced thrombocytopenia. Time in range appears to have improved over the study period, suggesting an era effect as institutional experience was gained.
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