Safety and efficacy of tranexamic acid compared with aprotinin in thoracic aortic surgery with deep hypothermic circulatory arrest.

OBJECTIVES This study was conducted to evaluate the safety and efficacy of high-dose tranexamic acid (TA) compared with aprotinin in patients who underwent thoracic aortic surgery with deep hypothermic circulatory arrest (DHCA). DESIGN A retrospective study. PARTICIPANTS Eighty-four patients underwent thoracic aortic surgery with DHCA arrest between July 2006 and December 2007. Antifibrinolytic efficacy and perioperative outcomes were compared between the groups by appropriate statistical tests. MEASUREMENTS AND MAIN RESULTS Demographic data, comorbid conditions, aortic pathology, surgical procedures, and operative data were comparable between groups. The use of blood products tended to be more in the TA group, despite the fact that the aprotinin group had longer CPB duration. Thirty-day mortality was 5 of 48 (10.4%) in the aprotinin group versus 5 of 36 (13.9%) in the TA group (p = 0.44). Neurologic, cardiac, and respiratory dysfunctions were comparable as well as intensive care unit and hospital stay. Serum creatinine increased significantly postoperatively in both groups, with more patients in the aprotinin group developing stage 1 postoperative renal dysfunction based on Acute Kidney Insufficiency Network criteria. Multivariate logistic regression analysis identified risk factors for postoperative renal dysfunction including preoperative creatinine clearance, blood transfusion, and sepsis. Throughout the study, both drugs were available for use, allowing selective bias for providers. CONCLUSIONS Aprotinin appeared more effective in reducing blood product use after thoracic aortic surgery in this limited cohort. Aprotinin use also appeared to be associated with postoperative renal dysfunction. The choice of antifibrinolytic appeared to not be associated with cardiac, neurologic, or respiratory outcomes or survival after thoracic aortic surgery requiring DHCA.

[1]  R. Martineau,et al.  A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. , 2008, The New England journal of medicine.

[2]  W. White,et al.  The effect of aprotinin on outcome after coronary-artery bypass grafting. , 2008, The New England journal of medicine.

[3]  John D Seeger,et al.  Aprotinin during coronary-artery bypass grafting and risk of death. , 2008, The New England journal of medicine.

[4]  C. Umscheid,et al.  Antifibrinolytic use in adult cardiac surgery , 2007, Current opinion in hematology.

[5]  F. Pellegrini,et al.  Recombinant activated factor VII for refractory bleeding after acute aortic dissection surgery: A propensity score analysis* , 2007, Critical care medicine.

[6]  J. Apostolakis,et al.  Bleeding Following Deep Hypothermia and Circulatory Arrest in Children , 2007, Seminars in cardiothoracic and vascular anesthesia.

[7]  John A Kellum,et al.  Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury , 2007, Critical care.

[8]  Keyvan Karkouti,et al.  A propensity score case‐control comparison of aprotinin and tranexamic acid in high‐transfusion‐risk cardiac surgery , 2006, Transfusion.

[9]  I. C. Tudor,et al.  The risk associated with aprotinin in cardiac surgery. , 2006, The New England journal of medicine.

[10]  M. Braun,et al.  Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. , 2006, JAMA.

[11]  M. Borger,et al.  Renal dysfunction in high-risk patients after on-pump and off-pump coronary artery bypass surgery: a propensity score analysis. , 2005, The Annals of thoracic surgery.

[12]  John A Kellum,et al.  The first international consensus conference on continuous renal replacement therapy. , 2002, Kidney international.

[13]  J. Butterworth,et al.  Pharmacokinetics of Tranexamic Acid during Cardiopulmonary Bypass , 2002, Anesthesiology.

[14]  G. Calori,et al.  Hemostatic effects of tranexamic acid in elective thoracic aortic surgery: a prospective, randomized, double-blind, placebo-controlled study. , 2002, The Journal of thoracic and cardiovascular surgery.

[15]  Jennifer Y. King,et al.  Aprotinin, Blood Loss, and Renal Dysfunction in Deep Hypothermic Circulatory Arrest , 2001, Circulation.

[16]  G. Shorten,et al.  The effects of aprotinin on blood product transfusion associated with thoracic aortic surgery requiring deep hypothermic circulatory arrest. , 2000, Journal of cardiothoracic and vascular anesthesia.

[17]  K. Krause,et al.  Hypothermia-Induced Coagulopathy during Hemorrhagic Shock , 2000, The American surgeon.

[18]  S. Fremes,et al.  Aprotinin and tranexamic acid for high transfusion risk cardiac surgery. , 2000, The Annals of thoracic surgery.

[19]  A. Kirkpatrick,et al.  Hypothermia and the trauma patient. , 1999, Canadian journal of surgery. Journal canadien de chirurgie.

[20]  S. Westaby Anti-fibrinolytic therapy in thoracic aortic surgery. , 1999, The Annals of thoracic surgery.

[21]  G. Deeb,et al.  Aprotinin versus ϵ-aminocaproic acid for aortic surgery using deep hypothermic circulatory arrest☆ , 1998 .

[22]  H. Misumi,et al.  [The effect of intraoperative high-dose tranexamic acid on blood loss after operation for acute aortic dissection]. , 1998, The Japanese journal of thoracic and cardiovascular surgery : official publication of the Japanese Association for Thoracic Surgery = Nihon Kyobu Geka Gakkai zasshi.

[23]  G. Deeb,et al.  Aprotinin versus epsilon-aminocaproic acid for aortic surgery using deep hypothermic circulatory arrest. , 1998, Journal of Cardiothoracic and Vascular Anesthesia.

[24]  G. Laufer,et al.  Operations on the thoracic aorta and hypothermic circulatory arrest: is aprotinin safe? , 1998, The Journal of thoracic and cardiovascular surgery.

[25]  S. Westaby Coagulation disturbance in profound hypothermia: the influence of anti-fibrinolytic therapy. , 1997, Seminars in thoracic and cardiovascular surgery.

[26]  U. Mercati,et al.  Simple Method to Improve the Effectiveness of Brain Retrograde Perfusion During Total Circulatory Arrest , 1997, Journal of cardiac surgery.

[27]  J. T. Wilde Hematological consequences of profound hypothermic circulatory arrest and aortic dissection. , 1997, Journal of cardiac surgery.

[28]  P. Biglioli,et al.  Aprotinin and deep hypothermic circulatory arrest: there are no benefits even when appropriate amounts of heparin are given. , 1997, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[29]  M. Oz,et al.  Safety and efficacy of aprotinin under conditions of deep hypothermia and circulatory arrest. , 1995, The Journal of thoracic and cardiovascular surgery.

[30]  J. Dunning,et al.  Aprotinin and bleeding in profoundly hypothermic perfusion. , 1994, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[31]  T. Sundt,et al.  Renal dysfunction and intravascular coagulation with aprotinin and hypothermic circulatory arrest. , 1993, The Annals of thoracic surgery.

[32]  W. Zingg,et al.  PROLONGED SURVIVAL OF ORTHOTOPIC HOMOTRANSPLANTS OF THE HEART IN ANIMALS TREATED WITH METHOTREXATE. , 1963, The Journal of thoracic and cardiovascular surgery.