Pulse Oximetry Screening Hailed as the 'New Milestone' to Combat Critical Congenital Heart Disease

Date Announced: 17 Jul 2012

Signal Extraction Technology Leading the Way in Large, Independent Clinical Studies.

IRVINE, Calif., July 17, 2012 /PRNewswire/ -- Pulse oximetry screening is a "new milestone" in the war on critical congenital heart disease (CCHD), one of the most common causes of infant deaths worldwide, according to a recent editorial in The Lancet and accompanying meta-analysis of studies including 229,421 babies.

The meta-analysis by Drs. Andrew Ewer and Shakila Thangaratinam, and colleagues Kiritrea Brown, Javier Zamora, and Khalid S Khan, pooled the results of 13 separate studies and reported the sensitivity of pulse oximetry to detect babies with CCHD at 76.5% (67.7 – 83.5%) and specificity to identify babies without CCHD at 99.9% (99.7 – 99.9%), a significant improvement over existing approaches. The authors noted that three recent large studies (1,2,3) "used motion-tolerant sensors, which function in states of low perfusion", a reference to the use of Masimo Signal Extraction Technology (SET).

The Lancet editorial noted that each year in the United States, some 40,000 babies are born with congenital heart disease and about 4,800 have CCHD, requiring invasive procedures in the first 28 days of life. Fetal ultrasound often fails to adequately detect CCHD, discovering the ailment only 15%-50% of the time. The editorial concluded that "... surely the question now is not 'why should pulse oximetry screening be introduced?' but 'why should such screening not be introduced more widely?'" At the time of publication, The Lancet reported 16 states in the U.S. had either passed or introduced legislation for CCHD pulse oximetry screening.

CCHD screening gained wide exposure in a recent CNN news story, which describes the rationale for and benefits of pulse oximetry screening for CCHD detection. The piece includes clinical experts, product application examples using a SET pulse oximeter and sensor, and chronicles the devastating effect when a baby's CCHD is not detected at birth.

Joe Kiani, Founder and CEO of Masimo, stated: "It's time to screen every newborn. Screening with SET Pulse Oximetry has proven to not only save lives and families the unnecessary death due to CCHD, but it has been shown to be cost effective. Indeed, the best way to improve patient care and reduce cost of care is through medical innovations like these."

(1) de Wahl Granelli A, Wennergren M, Sandberg K, et al. Impact of pulse oximetry screening on detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ 2009; 338: a3037.

(2) Ewer AK, Middleton LJ, Furmston AT, et al. Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): a test accuracy study. Lancet 2011; 378: 785–94.

(3) Meberg A, Andreassen A, Brunvand L, et al. Pulse oximetry screening as a complementary strategy to detect critical congenital heart defects. Acta Pediatr 2009; 98: 682–86.

Source: Masimo Corporation

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