Lancet: Pulse oximetry may efficaciously diagnose infant heart defects
U.K. researchers have found pulse oximetry screening to be effective in early diagnosis of congenital heart defects in newborns, according to study findings published Aug. 5 in The Lancet. However, the accompanying editorialists argued that the evidence “still seems unsatisfying.”
Andrew K. Ewer, MD, University of Birmingham in Alabama, and colleagues prospectively recruited more than 20,000 newborn infants from six maternity units in U.K. hospitals to assess the accuracy of pulse oximetry within 24 hours for the screening of major congenital heart defects, according the study.
The researchers used the Radical-7 pulse oximeter with a reusable probe on newborn infants by securing the sensor around the palm of a baby’s hand or sole of the foot with a disposable wrap. A saturation of less than 95 percent in either limb or a difference of more than 2 percent between the two limb saturation readings—if both were above 95 percent—was judged to be abnormal, according to the study. If abnormalities were found, newborn babies were classified as test positive and echocardiography was undertaken.
Of the 20,055 infants in the study, 19,860 demonstrated normal results, while 195 were found to have abnormal results. Of those with abnormal results from the screening, 32 were found to have congenital heart defects—18 of which were critical, eight serious and six significant. Another 163 were found to have no congenital heart defects and three were followed up as having a normal result. Of the 18,860 infants that produced normal results using the pulse oximeter, 41 ultimately proved to have congenital heart defects—six of which were critical, 21 serious and 14 significant.
“If the results of this study were applied to a population of 100,000 babies, roughly 264 babies would have major congenital heart defects,” the authors wrote. “Of these, 130 would be identified by use of pulse oximetry. About 120 babies would have critical lesions and 90 of these would be detected by use of pulse oximetry. If an antenatal detection of 50 percent is assumed, pulse oximetry could detect an additional 35 cases of critical congenital heart defects.”
Additionally, the authors noted that pulse oximetry would also likely detect 30 cases of significant congenital heart defects and 199 cases of respiratory or infective illness that would require medical intervention, if the results were applied to a population of 100,000. Ewer and colleagues’ study was the largest U.K. accuracy investigation in the use of pulse oximetry, according to the researchers. They advocated the potential benefits of introducing predischarge pulse oximetry screening as a routine procedure in their conclusion.
“Pulse oximetry is a safe, non-invasive, feasible and reasonably accurate test, which has a sensitivity that is better than that of antenatal screening and clinical examination. The use of both preductal and postductal saturations compared with postductal saturation alone seems to be advantageous and in practice does not take much longer to do,” the authors concluded. “It adds value to existing screening procedures and is likely to be useful for identification of cases of critical congenital heart defects that would otherwise go undetected. The detection of other diseases such as significant congenital heart defects, and respiratory and infective illnesses is an additional advantage.”
In the accompanying editorial, authors William T. Mahle, MD, Children’s Healthcare of Atlanta, and Robert Koppel, MD, Cohen Children’s Medical Center of New York, recognized the importance of diagnosing critical congenital heart disease, however, they noted many health systems and governmental agencies have been hesitant to adopt the practice into routine care.
“There are several explanations for this ambivalence. The sensitivity of pulse oximetry for detection of potentially life-threatening congenital heart disease is 50 to 80 percent,” Mahle and Koppel wrote. “Moreover, the false-positive rate is high enough to present a burden to delivery centers.”
Nevertheless, the editorialists argued that implementation into routine care may be beneficial.
“The decision to introduce another screening assay for newborn babies is one that should be made after careful consideration. Healthcare systems in the developed world are already heavily burdened. Yet the compelling data provided by Ewer and colleagues support inclusion of pulse oximetry into the care of the newborn baby,” the authors wrote. “Occasionally, the results of one large randomized trial can abruptly change medical practice. More often, the decision to steer a new course is supported with results from a series of studies, all with some limitations.”
Andrew K. Ewer, MD, University of Birmingham in Alabama, and colleagues prospectively recruited more than 20,000 newborn infants from six maternity units in U.K. hospitals to assess the accuracy of pulse oximetry within 24 hours for the screening of major congenital heart defects, according the study.
The researchers used the Radical-7 pulse oximeter with a reusable probe on newborn infants by securing the sensor around the palm of a baby’s hand or sole of the foot with a disposable wrap. A saturation of less than 95 percent in either limb or a difference of more than 2 percent between the two limb saturation readings—if both were above 95 percent—was judged to be abnormal, according to the study. If abnormalities were found, newborn babies were classified as test positive and echocardiography was undertaken.
Of the 20,055 infants in the study, 19,860 demonstrated normal results, while 195 were found to have abnormal results. Of those with abnormal results from the screening, 32 were found to have congenital heart defects—18 of which were critical, eight serious and six significant. Another 163 were found to have no congenital heart defects and three were followed up as having a normal result. Of the 18,860 infants that produced normal results using the pulse oximeter, 41 ultimately proved to have congenital heart defects—six of which were critical, 21 serious and 14 significant.
“If the results of this study were applied to a population of 100,000 babies, roughly 264 babies would have major congenital heart defects,” the authors wrote. “Of these, 130 would be identified by use of pulse oximetry. About 120 babies would have critical lesions and 90 of these would be detected by use of pulse oximetry. If an antenatal detection of 50 percent is assumed, pulse oximetry could detect an additional 35 cases of critical congenital heart defects.”
Additionally, the authors noted that pulse oximetry would also likely detect 30 cases of significant congenital heart defects and 199 cases of respiratory or infective illness that would require medical intervention, if the results were applied to a population of 100,000. Ewer and colleagues’ study was the largest U.K. accuracy investigation in the use of pulse oximetry, according to the researchers. They advocated the potential benefits of introducing predischarge pulse oximetry screening as a routine procedure in their conclusion.
“Pulse oximetry is a safe, non-invasive, feasible and reasonably accurate test, which has a sensitivity that is better than that of antenatal screening and clinical examination. The use of both preductal and postductal saturations compared with postductal saturation alone seems to be advantageous and in practice does not take much longer to do,” the authors concluded. “It adds value to existing screening procedures and is likely to be useful for identification of cases of critical congenital heart defects that would otherwise go undetected. The detection of other diseases such as significant congenital heart defects, and respiratory and infective illnesses is an additional advantage.”
In the accompanying editorial, authors William T. Mahle, MD, Children’s Healthcare of Atlanta, and Robert Koppel, MD, Cohen Children’s Medical Center of New York, recognized the importance of diagnosing critical congenital heart disease, however, they noted many health systems and governmental agencies have been hesitant to adopt the practice into routine care.
“There are several explanations for this ambivalence. The sensitivity of pulse oximetry for detection of potentially life-threatening congenital heart disease is 50 to 80 percent,” Mahle and Koppel wrote. “Moreover, the false-positive rate is high enough to present a burden to delivery centers.”
Nevertheless, the editorialists argued that implementation into routine care may be beneficial.
“The decision to introduce another screening assay for newborn babies is one that should be made after careful consideration. Healthcare systems in the developed world are already heavily burdened. Yet the compelling data provided by Ewer and colleagues support inclusion of pulse oximetry into the care of the newborn baby,” the authors wrote. “Occasionally, the results of one large randomized trial can abruptly change medical practice. More often, the decision to steer a new course is supported with results from a series of studies, all with some limitations.”