Clancy R R, McGaurn S A, Wernovsky G, Spray T L, Norwood W I, Jacobs M L, Murphy J D, Gaynor J W, Goin J E
Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.
J Thorac Cardiovasc Surg. 2000 Feb;119(2):347-57. doi: 10.1016/S0022-5223(00)70191-7.
Our goal was to generate a preoperative risk-of-death prediction model in selected neonates with congenital heart disease undergoing surgery with deep hypothermic circulatory arrest.
We completed a single-center, prospective, randomized, double-blind, placebo- controlled neuroprotection trial in selected neonates with congenital heart disease requiring operations for which deep hypothermic circulatory arrest was used. An extensive database was generated that included preoperative, intraoperative, and postoperative variables. Variables (delivery, maternal, and infant related) were evaluated to produce a preoperative risk-of-death prediction model by means of logistic regression. An operative risk-of-death prediction model including duration of deep hypothermic circulatory arrest was also generated.
Between July 1992 and September 1997, 350 (74%) of 473 eligible infants were enrolled with 318 undergoing deep hypothermic circulatory arrest. The mortality was 52 of 318 (16.4%), unaffected by investigational drug. The resulting preoperative risk model contained 4 variables: (1) cardiac anatomy (two-ventricle vs single ventricle surgery, with/without arch obstruction), (2) 1-minute Apgar score (</=5 vs >5), (3) presence of genetic syndrome, and (4) age at hospital admission for surgery (</=5 or >5 days). Mortality for two-ventricle repair was 3.2% (4/130). Mortality for single ventricle palliation was 25.5% (48/188) and was significantly influenced by Apgar score, genetic diagnosis, and admission age. The preoperative model had a prediction accuracy of 80%. The operative risk model included duration of deep hypothermic circulatory arrest, which significantly (P =.03) increased risk of death, with a prediction accuracy of 82%.
In this selected population, postoperative mortality risk is significantly affected by preoperative conditions. Identification of infants with varying mortality risks may affect family counseling, therapeutic intervention, and risk stratification for future study designs.
我们的目标是为接受深低温循环停搏手术的特定先天性心脏病新生儿建立一个术前死亡风险预测模型。
我们在需要进行深低温循环停搏手术的特定先天性心脏病新生儿中完成了一项单中心、前瞻性、随机、双盲、安慰剂对照的神经保护试验。生成了一个包含术前、术中和术后变量的广泛数据库。通过逻辑回归评估变量（分娩、母亲和婴儿相关）以建立术前死亡风险预测模型。还建立了一个包括深低温循环停搏持续时间的手术死亡风险预测模型。
1992年7月至1997年9月，473名符合条件的婴儿中有350名（74%）入组，其中318名接受了深低温循环停搏。318名中有52名死亡（16.4%），不受研究药物影响。最终的术前风险模型包含4个变量：（1）心脏解剖结构（双心室与单心室手术，有无主动脉弓梗阻），（2）1分钟阿氏评分（≤5分与>5分），（3）遗传综合征的存在，（4）手术入院时的年龄（≤5天或>5天）。双心室修复的死亡率为3.2%（4/130）。单心室姑息治疗的死亡率为25.5%（48/188），并受到阿氏评分、基因诊断和入院年龄的显著影响。术前模型的预测准确率为80%。手术风险模型包括深低温循环停搏持续时间，其显著（P = 0.03）增加死亡风险，预测准确率为82%。
在这个特定人群中，术后死亡风险受术前状况的显著影响。识别具有不同死亡风险的婴儿可能会影响家庭咨询、治疗干预以及未来研究设计的风险分层。
