The safety and efficacy of antifibrinolytic therapy in neonatal cardiac surgery.

BACKGROUND: Neonates undergoing open-heart surgery are particularly at risk of postoperative bleeding requiring blood transfusion. Aprotinin has attained high efficacy in reducing the requirement for a blood transfusion following a cardiopulmonary bypass, but is seldom studied in the neonatal age group. The aim of this study was to compare the efficacy and adverse effects of aprotinin and tranexamic acid in neonates undergoing open-heart surgery at a single centre. METHODS: Between October 2003 and March 2008, perioperative data of 552 consecutive neonatal patients undergoing open-heart surgery in Children's Hospital Boston were reviewed. Among them, 177 did not receive antifibrinolytic therapy (Group A); 100 were treated with tranexamic acid only (Group B); and 275 patients received aprotinin with or without tranexamic acid (Group C). Except for antifibrinolytic therapy, the anaesthesiological and surgical protocols remained identical. Postoperative complications and in-hospital mortality were the primary study endpoints. RESULTS: Body weight and Risk Adjustment for Congenital Heart Surgery (RACHS-1) scores were statistically comparable among the three groups. No statistically significant differences were observed between the duration of hospitalization, chest tube drainage, reexploration for bleeding, and kidney function impairment. In Group C, less blood was transfused within 24 hours than in GroupB. Operative mortality was similar among the three groups. CONCLUSION: No further risk and kidney injury were observed in the use of aprotinin in neonatal cardiac surgery, aprotinin demonstrated a reduced requirement for blood transfusion compared with tranexamic acid. Our data provide reasonable evidence that aprotinin and tranexamic acid are safe and efficacious as antifibrinolytic modalities in neonatal patients undergoing cardiac surgery.

Quality measurement of outcome in general surgery revisited: commentary and proposal.

Surgery has been trying to catch up to evidence-based medicine. Assessment of outcome in surgery is the child for quality assurance of patient care. We surgeons have our own set of mental variables that can predict good and poor outcomes. We value our experience and that of others, yet, are always inquisitive about which best predict morbidity and mortality. We all have our own functional equations for outcome that varies qualitatively and quantitatively. The main problem is lack of a uniform mathematical equation for individual patient risk factors that we refer to because of the limitations inherent in the equation or our understanding and awareness. Reviewing the literature in surgical outcome measurement, the impression is one of increasingly diverse messages with conclusions that are institution dependent. This can initiate confusion and controversy when comparing outcomes or extrapolating to one's own practice while hindering training surgeons to contribute to the evolving evidence of objective quality measurement early in a career. Overall, we are falling behind in recognizing this evolving problem. In this article, I address this controversy and attempt to offer new avenues in achieving a consensus among us in patient risk-adjusted outcomes by adopting and modifying well-recognized risk scoring systems from either side of the Atlantic Ocean. The millennium should see the birth of a new generation of surgeons charged with evidence-based ideas in quality outcome measurement and ready to improve current mathematical models.