The Journal of Thoracic and Cardiovascular Surgery
Volume 134, Issue 6 , Pages 1421-1428 , December 2007

Aprotinin is safe in pediatric patients undergoing cardiac surgery

Read at the Eighty-seventh Annual Meeting of The American Association for Thoracic Surgery, Washington, DC, May 5-9, 2007.

  • Carl L. Backer, MD

      Affiliations

    • Division of Cardiovascular–Thoracic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Ill
    • Corresponding Author InformationAddress for reprints: Carl L. Backer, MD, Division of Cardiovascular-Thoracic Surgery, Children’s Memorial Hospital, 2300 Children’s Plaza, mc 22, Chicago, IL 60614.
    • ,
  • Angela M. Kelle, BS

      Affiliations

    • Division of Cardiovascular–Thoracic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Ill
    • ,
  • Robert D. Stewart, MD, MPH

      Affiliations

    • Division of Cardiovascular–Thoracic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Ill
    • ,
  • Sunitha C. Suresh

      Affiliations

    • Division of Cardiovascular–Thoracic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Ill
    • ,
  • Farah N. Ali, MD

      Affiliations

    • Division of Kidney Diseases, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Ill
    • ,
  • Richard A. Cohn, MD

      Affiliations

    • Division of Kidney Diseases, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Ill
    • ,
  • Roopa Seshadri, PhD

      Affiliations

    • Children’s Memorial Hospital, and the Department of Pediatrics and Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill. and Mary Ann and J. Milburn Smith Child Health Research Program, Children’s Memorial Research Center, Chicago, Ill.
    • ,
  • Constantine Mavroudis, MD

      Affiliations

    • Division of Cardiovascular–Thoracic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Ill

Received 16 May 2007 ,Revised 19 July 2007 ,Accepted 7 August 2007.

References 

  1. Approval of aprotinin [press release]. Washington (DC): US Food and Drug Administration; December 30, 1993. Available at: http://www.fda.gov/bbs/topics/NEWS/NEW00453.html.
  2. Levy JH, Pifarre R, Schaff HV, et al. A multicenter, double-blind, placebo-controlled trial of aprotinin for reducing blood loss and the requirement for donor-blood transfusion in patients undergoing repeat coronary artery bypass grafting. Circulation. 1995;92:2236–2244
  3. Cosgrove DM, Heric B, Lytle BW, et al. Aprotinin therapy for reoperative myocardial revascularization: a placebo-controlled study. Ann Thorac Surg. 1992;54:1031–1036
  4. Sedrakyan A, Treasure T, Elefteriades JA. Effect of aprotinin on clinical outcomes in coronary artery bypass graft surgery: a systematic review and meta-analysis of randomized clinical trials. J Thorac Cardiovasc Surg. 2004;128:442–448
  5. Kozik DJ, Tweddell JS. Characterizing the inflammatory response to cardiopulmonary bypass in children. Ann Thorac Surg. 2006;81(suppl):S2347–S2354
  6. Hill GE, Alonso A, Spurzem JR, Stammers AH, Robbins RA. Aprotinin and methylprednisolone equally blunt cardiopulmonary bypass-induced inflammation in humans. J Thorac Cardiovasc Surg. 1995;110:1658–1662
  7. Costello JM, Backer CL, de Hoyos A, Binns HJ, Mavroudis C. Aprotinin reduces operative closure time and blood product use after pediatric bypass. Ann Thorac Surg. 2003;75:1261–1266
  8. D’Errico CC, Shayevitz JR, Martindale SJ, Mosca RS, Bove EL. The efficacy and cost of aprotinin in children undergoing reoperative open heart surgery. Anesth Analg. 1996;83:1193–1199
  9. Miller BE, Tosone SR, Tam VK, et al. Hematologic and economic impact of aprotinin in reoperative pediatric cardiac operations. Ann Thorac Surg. 1998;66:535–540
  10. Mangano DT, Tudor IC, Dietzel C Multicenter Study of Perioperative Ischemia Research Group, Ischemia Research and Education Foundation. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006;354:353–365
  11. Mangano DT, Miao Y, Vuylstekc A, et al. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA. 2007;297:471–479
  12. Levy JH, Ramsay JG, Guyton RA. Aprotinin in cardiac surgery. [letter to the editor] N Engl J Med. 2006;354:1953–1957
  13. Royston D, van Haaften N, De Vooght P. Aprotinin; friend or foe?. Eur J Anesthesiol. 2007;24:6–14
  14. Ferguson TB. Aprotinin—are there lessons learned?. JAMA. 2007;297:471–479
  15. Jacobs JP, Mavroudis C, Jacobs ML Joint EACTS-STS Congenital Database Committee. What is operative mortality? (Defining death in a surgical registry database: a report of the STS Congenital Database Taskforce and the Joint EACTS-STS Congenital Database Committee). Ann Thorac Surg. 2006;81:1937–1941
  16. Kincaid EH, Ashburn DA, Hoyle JR, Reichert MG, Hammon JW, Kon ND. Does the combination of aprotinin and angiotensin-converting enzyme inhibitor cause renal failure after cardiac surgery?. Ann Thorac Surg. 2005;80:1388–1393
  17. Therneau TM, Grambsch PM. Modeling survival data: extending the Cox model. New York: Springer; 2000;
  18. Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73:13–22
  19. O’Brien SM, Clarke DP, Jacobs JP, et al. Accuracy of the Aristotle basic complexity score for classifying the mortality and morbidity potential of congenital heart surgery procedures. Paper presented at: 43rd Annual Meeting of the Society of Thoracic Surgeons; January 29, 2007; San Diego, Calif.
  20. Arnold DM, Fergusson DA, Chan AK, et al. Avoiding transfusions in children undergoing cardiac surgery: a meta-analysis of randomized trials of Aprotinin. Anesth Analg. 2006;102:731–737
  21. Skidmore KL, Azakie A. Aprotinin and Sevoflurane do not affect renal function during single-ventricle palliative surgery [letter to the editor]. Anesth Analg. 2006;103:1614–1615
  22. Jaquiss RD, Chanayem NS, Zacharisen MC, et al. Safety of aprotinin use and re-use in pediatric cardiothoracic surgery. Circulation. 2002;106(suppl I):I90–I94
  23. Tweddell JS, Berger S, Frommelt PC, et al. Aprotinin improves outcome of single-ventricle palliation. Ann Thorac Surg. 1996;62:1329–1336

PII: S0022-5223(07)01362-1

doi: 10.1016/j.jtcvs.2007.08.006

The Journal of Thoracic and Cardiovascular Surgery
Volume 134, Issue 6 , Pages 1421-1428 , December 2007

Article Tools