Economic Evaluation of Anticoagulation with Bivalirudin vs. Heparin during Pediatric Extracorporeal Membrane Oxygenation

Abstract

Extracorporeal membrane oxygenation (ECMO) is an invasive technology used to replace heart and/or lung function in critically ill patients with potential reversible causes of cardiac or respiratory failure. Anticoagulation is required during ECMO to prevent formation of blood clots as the body is exposed to foreign materials of the ECMO circuit. The delicate balance between bleeding and clotting can be difficult to achieve in pediatric patients who have developmentally immature clotting cascades. While heparin has traditionally been used for anticoagulation during ECMO, there is new interest in Bivalirudin, an alternate anticoagulant. Bivalirudin has a different mechanism of action with potential benefits of more consistent therapeutic effect and easier dosing. Costs are the most commonly cited disadvantage of using bivalirudin as the patent for the medication lasts until 2028. The purpose of this work was to evaluate the clinical and financial implications of using bivalirudin rather than heparin during pediatric ECMO. The PEDECOR dataset was queried for patients placed on ECMO from 2011-2020. Subjects were restricted to individuals who were age 0-18 years old, with only a single ECMO run. Exposure was defined based on the percentage of the ECMO run for which a patient received bivalirudin, using greater than 50% as the definition of bivalirudin exposure. Standardized costs were applied to various components of care in order to characterize the costs per hospitalization for each patient. Clinical outcomes, resource utilization, survival to discharge and costs were assessed for two groups: those who received bivalirudin for greater than 50% of the ECMO run and those who did not. Sensitivity analyses were conducted using different definitions of bivalirudin exposure. There were 1151 patients who met inclusion criteria from the dataset. Of these 48 received bivalirudin, with 22 receiving bivalirudin for greater than 50% of their ECMO run. Patients who received bivalirudin for greater than 50% of their ECMO run had a significantly decreased incidence rate of clinical complications per ECMO-day, and decreased utilization of laboratory assays and blood products per-ECMO day compared to the non-exposed group. However, there were no differences in survival or costs between the two groups. While further investigation is needed to justify switching to bivalirudin-based anticoagulation strategies based on financial implications, there are clear clinical benefits to using this approach in pediatric patients.