Labatt Family Heart Centre, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
Ann Thorac Surg. 2012 Mar;93(3):878-82. doi: 10.1016/j.athoracsur.2011.09.048. Epub 2012 Jan 5.
We sought to determine whether the use of specific unfractionated heparin brands during cardiopulmonary bypass for pediatric cardiac surgery was associated with differences in postoperative outcomes, especially regarding the incidence of bleeding and thromboembolic complications.
We compared postoperative outcomes for pediatric cardiac surgeries performed with Hepalean (Organon Teknika) to those performed with PPC heparin (Pharmaceutical Partners of Canada). Differences in clinical outcomes were determined in multivariable logistic and linear regression models adjusted for patients and surgery characteristics.
In all, 903 operations were reviewed, 289 (32%) using Hepalean and 614 (68%) using PPC heparin. Patient demographics and surgical variables were comparable between groups. In multivariable regression models, adjusted for patients' characteristics, heparin use and choice of antifibrinolytic agents, the use of PPC heparin was associated with greater use of red blood cell transfusions in the first 48 postoperative hours (estimates +1.6 mL/kg, p<0.001), increased odds of bleeding complications (odds ratio 3.8, p=0.04), thromboembolic complications (odds ratio 4.7, p=0.01), early unplanned reoperation (odds ratio 6.9, p=0.03), longer postoperative intensive care unit stay (estimate +3.2 days, p<0.001), and longer hospital stay (estimate +3.6 days, p<0.001).
Brand of unfractionated heparin used during cardiopulmonary bypass for pediatric cardiac surgery was associated with bleeding complications and clinical outcomes. Different brands of unfractionated heparin should not be considered equivalent without proper validation in formal trials.
我们旨在确定在儿科心脏手术体外循环期间使用特定未分级肝素品牌是否与术后结果的差异相关，尤其是在出血和血栓栓塞并发症的发生率方面。
我们比较了使用 Hepalean（OrganonTeknika）和 PPC 肝素（Pharmaceutical Partners of Canada）进行的儿科心脏手术的术后结果。使用多变量逻辑和线性回归模型，根据患者和手术特征调整，确定临床结果的差异。
共回顾了 903 例手术，其中 289 例（32%）使用 Hepalean，614 例（68%）使用 PPC 肝素。两组患者的人口统计学和手术变量相似。在多变量回归模型中，根据患者特征、肝素使用和抗纤维蛋白溶解剂的选择进行调整，PPC 肝素的使用与术后前 48 小时内红细胞输注量增加相关（估计值为+1.6 毫升/公斤，p<0.001），出血并发症的风险增加（比值比 3.8，p=0.04），血栓栓塞并发症（比值比 4.7，p=0.01），早期计划外再次手术（比值比 6.9，p=0.03），术后重症监护病房停留时间延长（估计值+3.2 天，p<0.001），住院时间延长（估计值+3.6 天，p<0.001）。
在儿科心脏手术体外循环期间使用的未分级肝素品牌与出血并发症和临床结果相关。在没有经过正式试验的适当验证之前，不应将不同品牌的未分级肝素视为等效。
