HHS calls for newborn heart disease screening.
It's becoming clear that it's not a matter of whether universal pulse oximetry screening for congenital heart disease in newborns will become a reality, but when.
In late September, Health and Human Services (HSS) Secretary Kathleen Sebelius endorsed the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) recommendation that critical congenital heart disease (CCHD) screening be added to the newborn Recommended Uniform Screening Panel.
The endorsement caps off years of work, including a September 2010 recommendation by the SACHDNC to add pulse oximetry screening for CCHD to the uniform screening panel that the HSS secretary deemed not ready for adoption pending an implementation plan from HHS agencies. The SACHDNC had identified seven specific lesions as primary targets for screening: hypoplastic left heart syndrome, pulmonary atresia, tetralogy of Fallot, total anomalous pulmonary venous return, transposition of the great arteries, tricuspid atresia, and truncus arteriosus.
In a 2009 statement, the American Academy of Pediatrics (AAP) and American Heart Association (AHA) offered compelling reasons for adopting pulse oximetry CCHD screening, including two large-scale European screening studies in close to 80,000 newborns. The organizations stopped short of recommending universal screening, however, calling instead for further studies on implementation.
A work group was then convened in January 2011 to establish a standard approach to screening, follow-up, and strategies to fill in important knowledge gaps. A white paper outlining the outcomes of the work group has been endorsed by the AAP, AHA, and American College of Cardiology Foundation (ACCF) and appears in the November 2011 issue of Pediatrics.
"We might still have a way to go, but we are well on our way to universal screening," hospitalist Sandra Cuzzi, and Elizabeth Bradshaw, R.N., of Children's National Medical Center in Washington, wrote in an accompanying editorial.
Children's National has taken a leading role in the fight for universal screening and developed a community-based tool kit on implementing CCHD screening. As to why universal CCHD screening has taken so long to materialize, the tool kit cites a recent survey of 363 American pediatric cardiologists in which overall support for mandated pulse oximetry screening for all newborns was just 55%, despite only 58% of respondents reporting that current practice is adequate for detecting significant congenital heart disease (Pediatr. Cardiol. 2009;30:20-5). The same survey, however, notes that 26% of pediatric cardiologists reported "'too many false positives" with pulse oximetry, 21% said the technology is "prone to noise and artifact," and 30% viewed it as "very operator dependent."
In an effort to reduce false-positive results, the work group recommends screening not begin until 24 hours of life, or as late as possible if earlier discharge is planned, and that screening be completed on the second day of life.
"Earlier screening can lead to false-positive results because of the transition from fetal to neonatal circulation and stabilization of systemic oxygen saturation levels, and later screening can miss an opportunity for intervention before closing of the ductus arteriosus," wrote white paper lead author Dr. Alex R. Kemper of the departments of pediatrics and community and family medicine at Duke University, Durham, N.C., and his associates.
The work group recommends that screening be conducted using motion-tolerant pulse oximeters that report functional oxygen saturation, and that have been cleared by the Food and Drug Administration for use in newborns.
Other recommendations include the following:
* Screening should be based on the recommended screening algorithm and be performed by qualified personnel trained in the use of the algorithm and pulse oximetry monitoring of newborns.
* The algorithm cutoffs may need to be adjusted in high-altitude nurseries.
* Any abnormal pattern of low blood oxygen saturation requires a complete clinical evaluation by a licensed, independent practitioner. In the absence of other findings to explain hypoxemia, CCHD needs to be excluded on the basis of a comprehensive echocardiogram interpreted by a pediatric cardiologist before the newborn is discharged from the hospital.
* The results of newborn CCHD screening should be communicated to newborns' primary care providers. Primary care providers should ensure that newborns in their practice are appropriately screened.
Routine newborn pulse oximetry screening is a concept whose time has come, according to pediatric cardiologist Thomas Johnson of Children's Hospital at Dartmouth, Manchester, N.H.
"Past concerns about test reliability and the incidence of false-positive tests have been largely laid to rest," he said in an interview. "The AAP/AHA/ACC work group report specifies a protocol and management algorithm that appears to be practical, cost effective, and useful for detecting complex congenital heart lesions that may have a subtle presentation in the first 48 hours of life."
He noted that the New Hampshire legislature is considering similar legislation, known as Parker's Law, and expects that it will receive very strong support from the medical community. Three states--New Jersey, Maryland, and Indiana--have already passed legislation requiring pulse oximetry screening of all newborns. The Maryland law will not take effect until there are federal recommendations for such screenings.
The work group called on the AAP, AHA, and ACCF to work with the American Medical Association to develop appropriate CPT codes. Current codes for pulse oximetry are only appropriate when accompanied by a diagnostic code for a pulmonary disease associated with hypoxia.
Dr. Kemper and his associates, Dr. Cuzzi and Ms. Bradshaw, and Dr. Johnson reported no relevant financial disclosures.
The tool kit is available at www.childrensnational.org/ files/PDF/ForDoctors/cnhn/ pulse-oximetry-screening-of newborns.pdf
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|Title Annotation:||CLINICAL ROUNDS|
|Date:||Nov 1, 2011|
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