Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns.
Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns.
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DOI：
10.1136/bmj.a3037
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发表时间：
2009-01-08
影响因子：
105.7
通讯作者：
Ostman-Smith, Ingegerd
中科院分区：
文献类型：
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作者：
de-Wahl Granelli, Anne;Wennergren, Margareta;Sandberg, Kenneth;Mellander, Mats;Bejlum, Carina;Inganas, Leif;Eriksson, Monica;Segerdahl, Niklas;Agren, Annelie;Ekman-Joelsson, Britt-Marie;Sunnegardh, Jan;Verdicchio, Mario;Ostman-Smith, Ingegerd
目的评价脉搏血氧饱和度测定在早期筛查危及生命的先天性心脏病中的应用。设计：在西约塔兰的幼儿园出院前使用新一代脉搏血氧仪进行前瞻性筛查研究。比较西约塔兰与未使用脉搏血氧饱和度筛查的其他地区导管依赖性循环检出率的队列研究。包括在家中死亡的未检测到的导管依赖性循环。西约塔兰省的所有5个产科单位和新生儿心脏手术超区域转诊中心。参与者39 821筛选出生于2004年7月1日和2007年3月31日之间的婴儿。总导管依赖性循环队列：西哥塔兰n=60，其他参考区域n=100。主要结果测量脉搏血氧饱和度筛查和新生儿体格检查的敏感性、特异性、阳性和阴性预测值以及似然比。结果在西约塔兰州，29名婴儿在良好的托儿所有管道依赖性循环未被发现前新生儿出院检查。在13例病例中，脉搏血氧饱和度显示氧饱和度≤ 90%，并且（根据方案）立即告知临床工作人员结果。在其余16例中，仅体格检查发现10例（63%）。体格检查结合脉搏血氧饱和度筛查的敏感性为24/29（82.8%（95%CI 64.2%至95.2%）），检出100%的导管依赖性肺循环婴儿。漏诊5例（均为主动脉弓梗阻）。脉搏血氧饱和度测定的假阳性率明显低于单纯体格检查（69/39821（0.17%）vs 729/38413（1.90%），P<0.0001），其中31/69例脉搏血氧饱和度测定的“假阳性”病例有其他病理改变。因此，将所有血氧测定结果为阳性的病例转诊进行超声心动图检查，结果显示，对于每例导管依赖性循环的真正阳性病例，只有2.3例超声心动图显示正常心脏结果。在队列研究中，其他转诊地区因未确诊的导管依赖性循环而出院的风险为28/100（28%），而西约塔兰为5/60（8%）（P=0.0025，相对风险3.36（95%CI 1.37 - 8.24））。在其他转诊地区，11/25（44%）的大动脉转位婴儿未确诊而出院，而西约塔兰为0/18（P=0.0010），诊断时严重酸中毒更常见（33/100（33%）vs 7/60（12%），P=0.0025，相对风险2.8（1.3 - 6.0））。排除早产儿和诺伍德手术后，未确诊出院的婴儿死亡率高于住院诊断的婴儿（4/27（18%）v1/110（0.9%），P=0.0054）。在西约塔兰，没有婴儿死于未确诊的导管依赖性循环，而其他地区有5名婴儿死于导管依赖性循环。结论出院前引入脉搏血氧饱和度筛查可使导管依赖性循环的总检出率提高到92%。这种筛查在短期内似乎成本中性，但可能预防神经系统疾病和减少术前新生儿重症监护的需要表明，这种筛查将是具有成本效益的长期。
Objective To evaluate the use of pulse oximetry to screen for early detection of life threatening congenital heart disease. Design Prospective screening study with a new generation pulse oximeter before discharge from well baby nurseries in West Götaland. Cohort study comparing the detection rate of duct dependent circulation in West Götaland with that in other regions not using pulse oximetry screening. Deaths at home with undetected duct dependent circulation were included. Setting All 5 maternity units in West Götaland and the supraregional referral centre for neonatal cardiac surgery. Participants 39 821 screened babies born between 1 July 2004 and 31 March 2007. Total duct dependent circulation cohorts: West Götaland n=60, other referring regions n=100. Main outcome measures Sensitivity, specificity, positive and negative predictive values, and likelihood ratio for pulse oximetry screening and for neonatal physical examination alone. Results In West Götaland 29 babies in well baby nurseries had duct dependent circulation undetected before neonatal discharge examination. In 13 cases, pulse oximetry showed oxygen saturations ≤90%, and (in accordance with protocol) clinical staff were immediately told of the results. Of the remaining 16 cases, physical examination alone detected 10 (63%). Combining physical examination with pulse oximetry screening had a sensitivity of 24/29 (82.8% (95% CI 64.2% to 95.2%)) and detected 100% of the babies with duct dependent lung circulation. Five cases were missed (all with aortic arch obstruction). False positive rate with pulse oximetry was substantially lower than that with physical examination alone (69/39 821 (0.17%) v 729/38 413 (1.90%), P<0.0001), and 31/69 of the “false positive” cases with pulse oximetry had other pathology. Thus, referral of all cases with positive oximetry results for echocardiography resulted in only 2.3 echocardiograms with normal cardiac findings for every true positive case of duct dependent circulation. In the cohort study, the risk of leaving hospital with undiagnosed duct dependent circulation was 28/100 (28%) in other referring regions versus 5/60 (8%) in West Götaland (P=0.0025, relative risk 3.36 (95% CI 1.37 to 8.24)). In the other referring regions 11/25 (44%) of babies with transposition of the great arteries left hospital undiagnosed versus 0/18 in West Götaland (P=0.0010), and severe acidosis at diagnosis was more common (33/100 (33%) v 7/60 (12%), P=0.0025, relative risk 2.8 (1.3 to 6.0)). Excluding premature babies and Norwood surgery, babies discharged without diagnosis had higher mortality than those diagnosed in hospital (4/27 (18%) v 1/110 (0.9%), P=0.0054). No baby died from undiagnosed duct dependent circulation in West Götaland versus five babies from the other referring regions. Conclusion Introducing pulse oximetry screening before discharge improved total detection rate of duct dependent circulation to 92%. Such screening seems cost neutral in the short term, but the probable prevention of neurological morbidity and reduced need for preoperative neonatal intensive care suggest that such screening will be cost effective long term.