Bivalirudin use and Outcomes in Neonates With Congenital Diaphragmatic Hernia Managed With Extracorporeal Life Support

OBJECTIVE: To examine national trends in bivalirudin use among neonates with congenital diaphragmatic hernia (CDH) supported with extracorporeal membrane oxygenation (ECMO) and to evaluate its association with mortality and morbidity. SUMMARY BACKGROUND DATA: Preliminary data suggest that first-line anticoagulation of the ECMO circuit with bivalirudin, a direct thrombin inhibitor, may improve outcomes in neonates with CDH. METHODS: This multicenter retrospective cohort study used data from 48 United States children's hospitals from January 1, 2016, to December 31, 2023. The analytic cohort included neonates with CDH supported with ECMO. Patients were categorized by anticoagulant exposure: bivalirudin or unfractionated heparin. The primary outcome was in-hospital mortality. Secondary outcomes included anticoagulant utilization and anticoagulant-associated morbidity. Multivariable logistic regression models were constructed after exclusion of extreme high-volume center outliers. RESULTS: Among 1,049 neonates, bivalirudin use increased significantly over time, from 9.6% in 2016 to 48.0% in 2023. In the final cohort of 820 neonates, 398 died in hospital (48.5% mortality). Median hospital charges were higher among neonates receiving bivalirudin [$876,054 (IQR, $652,735 - $1,366,728)] compared with heparin [$577,326 (IQR, $384,468 - $871,769); P<0.0001]. Bivalirudin use was not associated with in-hospital mortality [adjusted odds ratio (aOR), 1.08, 95% CI, 0.42-2.82; P=0.87], bleeding (aOR, 1.43, 95% CI, 0.54-3.82; P=0.47), thrombosis (aOR, 1.88; 95% CI, 0.65-5.41; P=0.24), or neurologic complications (aOR, 2.00; 95% CI, 0.81-4.91; P=0.13). CONCLUSIONS: Among neonates with CDH supported with ECMO, bivalirudin use increased substantially over the study period and was associated with higher hospital charges but not with improved survival or reduced ECMO-related morbidity compared with unfractionated heparin.