Original Article
Intraoperative tranexamic acid in pediatric bloodless cardiac surgery
Asian Cardiovascular & Thoracic Annals 2014, Vol. 22(9) 1039–1045 ß The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0218492314527991 aan.sagepub.com
Tomomi Hasegawa, Yoshihiro Oshima, Ayako Maruo, Hironori Matsuhisa, Akiko Tanaka, Rei Noda, Shinji Yokoyama and Kazutaka Iwasaki
Abstract Objective: The aim of this study was to evaluate the clinical effects of intraoperative tranexamic acid administration in cardiac surgery without blood transfusion (bloodless cardiac surgery) in children. Methods: Seventy-one consecutive patients weighing less than 20 kg, who underwent bloodless cardiac surgery for simple atrial or ventricular septal defects at Kobe Children’s Hospital from January 2011 to June 2013, were enrolled in this retrospective study. Tranexamic acid was administered during surgery from January 2012 (TXA group; n ¼ 31), whereas it was not administered before January 2012 (control group; n ¼ 40). Perioperative variables were compared between the TXA and control groups. Results: There were no significant differences in patient characteristics or preoperative data between the 2 groups. Serial changes in perioperative hemoglobin and hematocrit levels, mixed venous oxygen saturation, and regional cerebral oxygenation during cardiopulmonary bypass were significantly higher in the TXA group compared to the control group. There were significant reductions in operative time, dopamine dose, peak serum lactate level, intubation time, chest tube drainage and duration, and hospital stay in the TXA group. Conclusions: Intraoperative tranexamic acid administration was effective for blood conservation, and improved postoperative clinical outcomes in pediatric bloodless cardiac surgery.
Keywords Blood loss, surgical, blood transfusion, heart defects, congenital, tranexamic acid
Introduction Allogeneic blood transfusion is considered an effective and lifesaving therapy for perioperative anemia, but it is not completely without hazard to patients undergoing cardiac surgery. There are various transfusionrelated complications such as allergic reactions, transmission of viral infection, acute lung injury, and immunomodulation.1,2 The wide recognition of the drawbacks of allogeneic blood transfusion has attracted recent interest in cardiac surgery without blood transfusion, so-called ‘‘bloodless cardiac surgery’’. Pediatric cardiac surgery without allogeneic blood transfusion in patients with young age and low body weight is still challenging. The priming volume in the cardiopulmonary bypass (CPB) circuit is relatively large in relation to the patient’s size and circulating blood volume, easily leading to excessive hemodilution.
Even a small amount of perioperative blood loss may cause severe anemia which is associated with impaired oxygen delivery and coagulation abnormalities. Recent advances in techniques of blood conservation can minimize the need for blood products and allow bloodless management in limited pediatric cardiac surgeries. These techniques involve a low priming volume CPB by downsizing the bypass circuit with the help of iron and erythropoietin administration, autologous blood Department of Cardiovascular Surgery, Kobe Children’s Hospital, Kobe, Japan Corresponding author: Tomomi Hasegawa, MD, Department of Cardiovascular Surgery, Kobe Children’s Hospital, 1-1-1 Takakuradai, Suma-ku, Kobe, Hyogo 654-0081, Japan. Email: [email protected]
Downloaded from aan.sagepub.com at UNIV CALIFORNIA SANTA BARBARA on June 22, 2015
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Asian Cardiovascular & Thoracic Annals 22(9)
donation, cell salvaging, and ultrafiltration.3 The antifibrinolytic agent tranexamic acid (TXA) has been proved to substantially reduce perioperative blood loss and transfusion requirements in cardiac surgery.4 TXA is a lysine analogue that prevents degradation of fibrin and dissolution of clots by inhibiting the activation of plasminogen. After aprotinin was removed from the market in 2008,5 TXA became the mainstay of antifibrinolytic therapy for pharmacological blood conservation in cardiac surgery. In the field of pediatric cardiac surgery, perioperative blood loss and transfusion requirements have also been reduced by TXA.6 However, the benefits and risks associated with TXA use in pediatric cardiac surgery remain unclear. The objective of this study was to test the hypothesis that TXA can reduce perioperative blood loss to accomplish bloodless cardiac surgery, resulting in improved clinical outcomes in pediatric patients with congenital heart disease.
Patients and methods This study was approved by our institutional review board and the need for individual consent was waived. Medical records and databases were retrospectively reviewed. Between January 2011 and June 2013, 71 children weighing less than 20 kg underwent bloodless cardiac surgery for atrial septal defect (ASD) or ventricular septal defect (VSD) at Kobe Children’s Hospital. There were 42 males and 29 females. The median age at surgery was 2.1 years (range 0.4–7.5 years), and the median body weight was 10.4 kg (range 6.2–19.9 kg). This study was dichotomized with respect to intraoperative TXA use. From January 2012, TXA was routinely given in bloodless cardiac surgery as a bolus of 100 mgkg1 after induction of general anesthesia and before skin incision, followed by continuous infusion of 10 mgkg1h1 intraoperatively, as advocated in previous reports.6–8 The TXA group (n ¼ 31) included patients who underwent surgery with TXA (Transamin; Daiichi-Sankyo Co., Tokyo, Japan) between January 2012 and June 2013. The control group (n ¼ 40) included patients who underwent surgery without intraoperative TXA administration between January 2011 and December 2011. The patient characteristics and preoperative data are summarized in Table 1. Preoperative management was oral iron supplementation (sodium ferrous citrate; Eizai Co., Tokyo, Japan or ferric pyrophosphate; Alfresa Pharma Co., Osaka, Japan) and subcutaneous administration of recombinant human erythropoietin (epoetin alfa; Kyowa Hakko Kirin Co., Tokyo, Japan) for 1 week before the operation. To reduce the priming volume, OXIA IC06 (body weight
Intraoperative tranexamic acid in pediatric bloodless cardiac surgery
Asian Cardiovascular & Thoracic Annals 2014, Vol. 22(9) 1039–1045 ß The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0218492314527991 aan.sagepub.com
Tomomi Hasegawa, Yoshihiro Oshima, Ayako Maruo, Hironori Matsuhisa, Akiko Tanaka, Rei Noda, Shinji Yokoyama and Kazutaka Iwasaki
Abstract Objective: The aim of this study was to evaluate the clinical effects of intraoperative tranexamic acid administration in cardiac surgery without blood transfusion (bloodless cardiac surgery) in children. Methods: Seventy-one consecutive patients weighing less than 20 kg, who underwent bloodless cardiac surgery for simple atrial or ventricular septal defects at Kobe Children’s Hospital from January 2011 to June 2013, were enrolled in this retrospective study. Tranexamic acid was administered during surgery from January 2012 (TXA group; n ¼ 31), whereas it was not administered before January 2012 (control group; n ¼ 40). Perioperative variables were compared between the TXA and control groups. Results: There were no significant differences in patient characteristics or preoperative data between the 2 groups. Serial changes in perioperative hemoglobin and hematocrit levels, mixed venous oxygen saturation, and regional cerebral oxygenation during cardiopulmonary bypass were significantly higher in the TXA group compared to the control group. There were significant reductions in operative time, dopamine dose, peak serum lactate level, intubation time, chest tube drainage and duration, and hospital stay in the TXA group. Conclusions: Intraoperative tranexamic acid administration was effective for blood conservation, and improved postoperative clinical outcomes in pediatric bloodless cardiac surgery.
Keywords Blood loss, surgical, blood transfusion, heart defects, congenital, tranexamic acid
Introduction Allogeneic blood transfusion is considered an effective and lifesaving therapy for perioperative anemia, but it is not completely without hazard to patients undergoing cardiac surgery. There are various transfusionrelated complications such as allergic reactions, transmission of viral infection, acute lung injury, and immunomodulation.1,2 The wide recognition of the drawbacks of allogeneic blood transfusion has attracted recent interest in cardiac surgery without blood transfusion, so-called ‘‘bloodless cardiac surgery’’. Pediatric cardiac surgery without allogeneic blood transfusion in patients with young age and low body weight is still challenging. The priming volume in the cardiopulmonary bypass (CPB) circuit is relatively large in relation to the patient’s size and circulating blood volume, easily leading to excessive hemodilution.
Even a small amount of perioperative blood loss may cause severe anemia which is associated with impaired oxygen delivery and coagulation abnormalities. Recent advances in techniques of blood conservation can minimize the need for blood products and allow bloodless management in limited pediatric cardiac surgeries. These techniques involve a low priming volume CPB by downsizing the bypass circuit with the help of iron and erythropoietin administration, autologous blood Department of Cardiovascular Surgery, Kobe Children’s Hospital, Kobe, Japan Corresponding author: Tomomi Hasegawa, MD, Department of Cardiovascular Surgery, Kobe Children’s Hospital, 1-1-1 Takakuradai, Suma-ku, Kobe, Hyogo 654-0081, Japan. Email: [email protected]
Downloaded from aan.sagepub.com at UNIV CALIFORNIA SANTA BARBARA on June 22, 2015
1040
Asian Cardiovascular & Thoracic Annals 22(9)
donation, cell salvaging, and ultrafiltration.3 The antifibrinolytic agent tranexamic acid (TXA) has been proved to substantially reduce perioperative blood loss and transfusion requirements in cardiac surgery.4 TXA is a lysine analogue that prevents degradation of fibrin and dissolution of clots by inhibiting the activation of plasminogen. After aprotinin was removed from the market in 2008,5 TXA became the mainstay of antifibrinolytic therapy for pharmacological blood conservation in cardiac surgery. In the field of pediatric cardiac surgery, perioperative blood loss and transfusion requirements have also been reduced by TXA.6 However, the benefits and risks associated with TXA use in pediatric cardiac surgery remain unclear. The objective of this study was to test the hypothesis that TXA can reduce perioperative blood loss to accomplish bloodless cardiac surgery, resulting in improved clinical outcomes in pediatric patients with congenital heart disease.
Patients and methods This study was approved by our institutional review board and the need for individual consent was waived. Medical records and databases were retrospectively reviewed. Between January 2011 and June 2013, 71 children weighing less than 20 kg underwent bloodless cardiac surgery for atrial septal defect (ASD) or ventricular septal defect (VSD) at Kobe Children’s Hospital. There were 42 males and 29 females. The median age at surgery was 2.1 years (range 0.4–7.5 years), and the median body weight was 10.4 kg (range 6.2–19.9 kg). This study was dichotomized with respect to intraoperative TXA use. From January 2012, TXA was routinely given in bloodless cardiac surgery as a bolus of 100 mgkg1 after induction of general anesthesia and before skin incision, followed by continuous infusion of 10 mgkg1h1 intraoperatively, as advocated in previous reports.6–8 The TXA group (n ¼ 31) included patients who underwent surgery with TXA (Transamin; Daiichi-Sankyo Co., Tokyo, Japan) between January 2012 and June 2013. The control group (n ¼ 40) included patients who underwent surgery without intraoperative TXA administration between January 2011 and December 2011. The patient characteristics and preoperative data are summarized in Table 1. Preoperative management was oral iron supplementation (sodium ferrous citrate; Eizai Co., Tokyo, Japan or ferric pyrophosphate; Alfresa Pharma Co., Osaka, Japan) and subcutaneous administration of recombinant human erythropoietin (epoetin alfa; Kyowa Hakko Kirin Co., Tokyo, Japan) for 1 week before the operation. To reduce the priming volume, OXIA IC06 (body weight
