Role of Aprotinin in Paediatric Cardiac Surgery

Abstract

INTRODUCTION: The children undergoing open-heart surgery are likely to have major blood loss due to surgical interventions performing on major vascular structures as well as the coagulation abnormalities that accompany extracorporeal techniques. Certain characteristics are unique to paediatric patients with congenital heart disease undergoing heart surgery, that makes them prone to excessive bleeding and transfusion of blood and blood products. They are: • Decreased levels of coagulation factors compared with normal children of the same age group. • Hemodilution resulting from high priming volume relative to small blood volume. • Delayed hepatic maturation secondary to poor organ perfusion. • Complex operative procedures requiring long duration of cardiopulmonary bypass. • Multiple extra cardiac suture lines. • Deep hypothermic circulatory arrest. The use of aprotinin in children undergoing cardiopulmonary bypass attenuates the activation of the coagulation and fibrinolytic systems, preserves platelets function and reduces systemic inflammatory responses. Improved clinical outcomes have been consistently demonstrated in children undergoing primary and repeat sternotomies in aprotinin recipients. Many studies have demonstrated benefits in terms of; • Significant reduction in chest tube drainage, • Time to skin closure, • Postoperative transfusion requirements, • Decreased requirements of banked blood and donor, Exposures, • Substantial savings in cost. These clinical outcomes create a strong argument for the routine administration of aprotinin in paediatric cardiac operations undergoing cardiopulmonary bypass. Aprotinin is a potent part of an anesthesiologist arsenal when dealing with children undergoing cardiopulmonary bypass and its cost effective improvement of clinical outcomes justifies its consideration when planning the management strategy of these children. AIM OF THE STUDY: The purpose of the study was to assess the efficacy and use of aprotinin in paediatric open heart surgeries by comparing the time interval from protamine administration to skin closure, the volume of blood loss (ml/kg) in chest drain after 24 hours, and the volume of blood and blood products (ml/kg) transfused postoperatively with that of control group. MATERIALS AND METHODS: Study Design: This study was conducted in Paediatric Cardiothoracic Department at Institute of Child Health, an attached institution of Madras Medical College, Chennai between June 2008 and August 2008 on forty patients, posted for elective major cardiac surgery. This study was done after institutional approval and written informed consent was obtained from the parents of each child included in the study. This study was done in a prospective randomized manner. Forty patients of either sex posted for major elective cardiac surgeries satisfying the selection criteria were randomly allocated into the two groups (Group A and Group P) Group (A) - Patients in this group received aprotinin 20000 KIU/kg bolus after induction, 20000 KIU/kg in prime and maintenance infusion dose of 10000 KIU/kg/min till skin closure. Group (P) - Patients in this group received equal volume protocol of Ringer Lactate solution. SELECTION OF CASES: Inclusion criteria Child under any age of less than 12 years undergoing open heart surgery using cardiopulmonary bypass (CPB) is considered eligible for entry into the study. Exclusion criteria: • Patient refusal • Patients with known bleeding disorder; those taking aspirin, dipyridamole,or anticoagulants 7 days before surgery. • Patients with a known metabolic disorder, sepsis, or renal failure • Patients previously exposed to aprotinin or with a known allergy to aprotinin • Patients with a hemoglobin level of more than 19 g/dl. Preanaesthetic evaluation SUMMARY: In this study the efficacy and use of aprotinin in paediatric cardiac surgery was assessed based on following parameters: 1. The time interval (min) from protamine administration to skin closure. 2. The volume of blood loss (ml/kg) in chest drain after 24 hours. 3. The volume of blood and blood products (ml/kg) transfused postoperatively. 1. The mean time interval (min) from protamine administration to skin closure in Group A - 31.45 +/- 6.08 min, Group P - 52.05 +/- 8.71 min. There is significant reduction in duration of time from protamine administration to skin closure in group A. 2. The mean volume of blood loss (ml/kg) in chest drain after 24 hours in Group A- 7.01 +/- 3.13 ml/kg, Group P – 8.72 +/- 3.09 ml/kg. There is no significant reduction in volume of blood loss in chest drain in Group A. 3. The mean volume of blood and blood products (ml/kg) transfused postoperatively in Group A - 8.36 +/- 5.49 ml/kg, Group P - 11.76 +/- 4.62 ml/kg. There is significant reduction in volume of blood and blood products transfused postoperatively in Group A. CONCLUSION: From this study, it is observed that in children undergoing open heart surgery using cardiopulmonary bypass, aprotinin is effective in improving clinical outcomes of the patients, by reducing postoperative blood transfusion requirements and duration of the surgery. There is a decreased requirement of banked blood and donor exposures. Aprotinin recipients have a significantly dry operative field after protamine reversal, aiding in early hemostasis and skin closure, thereby it shortens the duration of surgical procedure. Hence it is concluded that aprotinin is useful in anaesthetic management of the children undergoing open heart surgery

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