Evaluation of Intraoperative Bivalirudin Anticoagulation in Neonates and Infants Undergoing Arterial Switch Operation on Integrated ECMO-CPB Circuit: A Prospective Study.

Objectives: To ascertain the dosage of bivalirudin in neonates and infants undergoing arterial switch operation on integrated extracorporeal membrane oxygenation-cardiopulmonary bypass (CPB) circuit.

Design: Pilot study.

Setting: A tertiary care hospital.

Participants: Ten neonates and infants with transposition of great arteries undergoing an arterial switch operation INTERVENTIONS: The patients received a bivalirudin bolus dose of 1 mg/kg followed by a maintenance dose of 2.5 mg/kg/h. The infusion dose was adjusted to maintain an activated clotting time (ACT) >480 s.

Measurements and main results: The mean age and weight were 92 ± 67 days and 4.1 ± 1.45 kg, respectively. There were more male children than female (8:2). The mean baseline ACT score was 207.6 ± 52.4 s. The bolus dose required was 1 mg/kg, and two children required an additional bolus dose of 0.5 mg/kg. The mean ACT of the priming solution was 999 s, and the mean ACT following the bolus dose was 575.9 ± 101 s. The maintenance dose required was 2.1 ± 0.3 mg/kg/h. The mean ACT on CPB after 30 min, 60 min, and 90 min was 956.2 ± 62.8 s, 936.8 ± 137 s, and 829.6 ± 232.5 s, respectively. There was no incidence of clot formation in the circuit or thromboembolic complications.

Conclusions: Bivalirudin can be effectively used for anticoagulation during CPB in neonates and infants with transposition of great arteries, at a bolus dose of 1 mg/kg and a maintenance dose of 2.1 ± 0.3 mg/kg/h, utilizing the integrated extracorporeal membrane oxygenation-CPB circuit.