John P Scott1, Daniel J Costigan2, George M Hoffman2, Pippa M Simpson3, Mahua Dasgupta3, Rowena Punzalan4, Richard J Berens2, James S Tweddell5, Eckehard A E Stuth6. 1. Department of Anesthesiology, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA; Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA. Electronic address: scottjake@mcw.edu. 2. Department of Anesthesiology, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA; Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA. 3. Department of Biostatistics, Division of Quantitative Health Sciences, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA. 4. Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA. 5. Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA; Department of Cardiothoracic Surgery, Section of Pediatric Cardiothoracic Surgery, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA. 6. Department of Anesthesiology, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA.
Abstract
STUDY OBJECTIVE: To evaluate whether conversion from aprotinin to epsilon-aminocaproic acid (EACA) during infant cardiac surgery was associated with increased perioperative bleeding. DESIGN: Structured retrospective chart review. SETTING: University-affiliated large congenital cardiac surgery program. MEASUREMENTS: Records from 145 infants (age < 1 yr) receiving aprotinin as antifibrinolytic therapy for cardiac surgery between 6/1/2006 and 12/31/2006 were compared with a cohort of infants receiving EACA for cardiac surgery between 6/1/2008 and 12/31/2008. Sixty-eight infants received aprotinin and 77 infants received EACA. Measured indicators of perioperative bleeding included transfusion volumes, recombinant activated clotting factor VIIa (rFVIIa) administration, need for reexploration, and perioperative chest tube output. MAIN RESULTS: EACA treated patients received significantly more rFVIIa for uncontrolled bleeding (19/77 [25%] vs 3/68 [4%]; P < 0.001) and required surgical reexploration more frequently (21/77 [27%] vs 7/68 [10%]; P = 0.01]. Median (25th-75th percentiles) intraoperative platelet transfusion requirements were also increased after the switch to EACA (28 mL [0-58 mL] vs 0 mL [0 mL - 34.5 mL]), but this difference did not reach statistical significance (P = 0.06). CONCLUSIONS: Bleeding in infant cardiac surgery increased following the change in antifibrinolytic therapy from aprotinin to EACA. Given the potential for major harm, especially thrombotic complications, from rFVIIa use, prospective studies examining the safety of postcardiopulmonary bypass rFVIIa administration in infants are necessary before the routine off-label use may be recommended.
STUDY OBJECTIVE: To evaluate whether conversion from aprotinin to epsilon-aminocaproic acid (EACA) during infant cardiac surgery was associated with increased perioperative bleeding. DESIGN: Structured retrospective chart review. SETTING: University-affiliated large congenital cardiac surgery program. MEASUREMENTS: Records from 145 infants (age < 1 yr) receiving aprotinin as antifibrinolytic therapy for cardiac surgery between 6/1/2006 and 12/31/2006 were compared with a cohort of infants receiving EACA for cardiac surgery between 6/1/2008 and 12/31/2008. Sixty-eight infants received aprotinin and 77 infants received EACA. Measured indicators of perioperative bleeding included transfusion volumes, recombinant activated clotting factor VIIa (rFVIIa) administration, need for reexploration, and perioperative chest tube output. MAIN RESULTS:EACA treated patients received significantly more rFVIIa for uncontrolled bleeding (19/77 [25%] vs 3/68 [4%]; P < 0.001) and required surgical reexploration more frequently (21/77 [27%] vs 7/68 [10%]; P = 0.01]. Median (25th-75th percentiles) intraoperative platelet transfusion requirements were also increased after the switch to EACA (28 mL [0-58 mL] vs 0 mL [0 mL - 34.5 mL]), but this difference did not reach statistical significance (P = 0.06). CONCLUSIONS:Bleeding in infant cardiac surgery increased following the change in antifibrinolytic therapy from aprotinin to EACA. Given the potential for major harm, especially thrombotic complications, from rFVIIa use, prospective studies examining the safety of postcardiopulmonary bypass rFVIIa administration in infants are necessary before the routine off-label use may be recommended.