Efficacy and safety of aprotinin in neonatal congenital heart operations.

BACKGROUND: Aprotinin has been associated with significant morbidity and mortality in adults, leading to its withdrawal from the market and clinical substitution with the lysine analogs, tranexamic acid and ε-aminocaproic acid. Neonates undergoing cardiopulmonary bypass are especially at risk for perioperative bleeding, yet little data exist comparing lysine analogs with aprotinin.

METHODS: Neonates undergoing cardiopulmonary bypass (January 2006 to December 2009) were included in this single-institution, retrospective cohort study. Preoperative, intraoperative, and postoperative data were analyzed. The relationship between demographic, surgical risk data, and outcomes were analyzed. Markers of effectiveness included transfusion requirement, duration of operation, duration of ventilation, and intensive care unit length of stay. Markers of safety included reexploration, renal dysfunction, neurologic complications, and death.

RESULTS: Of 423 included neonates, 271 (64%) received aprotinin and 152 (36%) a lysine analog. Infants who received aprotinin had a higher baseline creatinine and lower weight and gestational age. The aprotinin group experienced shorter time to surgical closure, lower blood product use, and lower rates of reexploration and postoperative renal dysfunction compared with the lysine-analog group. There was no difference in duration of ventilation or intensive care unit stay, neurologic outcomes, or death.

CONCLUSIONS: Neonates who received aprotinin had significantly lower intraoperative transfusion requirements and shorter surgical closure times. The aprotinin group was less likely to require surgical reexploration and had a lower rate of renal injury. These data illustrate the need for further research regarding safety and efficacy of aprotinin in a larger sample of children undergoing cardiac operations.