Masimo SET pulse oximetry screening effective for early diagnosis of critical CHD in newborns

Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that a new clinical study published online in the German pediatric journal, Klinische Padiatrie, showed that adding Masimo SET pulse oximetry screening to the physical examination of newborns was an effective method to achieve early diagnosis of critical congenital heart disease (CHD).

CHD affects five to ten of every 1,000 newborns, resulting in 3% of all infant mortalities.  Improving early detection and treatment is critical because up to 30% of all CHD-related deaths in the first year of life are due to failure to detect the condition.  However, critical duct-dependent CHD is often present without abnormal auscultation (listening to sounds within the body).  In total, fewer than 50% of cases are diagnosed with a clinical examination alone, so normal physical examination findings cannot exclude CHD.  Multiple previous studies have proven Masimo SET pulse oximetry, along with routine clinical examination, is an effective method capable of closing this diagnostic gap to reduce the morbidity and mortality associated with CHD.  In contrast, several studies using other pulse oximetry technologies have not shown effectiveness in reliably detecting CHD.

In the study, researchers from three obstetric departments in Mannheim, Germany, measured the postductal oxygen saturation of a total of 3,364 newborns between 6 and 36h of age over a year-long period.  Masimo SpO2 measurements were taken via noninvasive sensors placed on the right or left foot (using the VitaGuard VG 310 with integrated Masimo SET technology).  The length of the measurement procedure was 2-5min.  A standardized protocol was followed: In asymptomatic newborns with SpO2 =/+ 95%, no further steps were taken.  For newborns with values 90% - 94%, a check-up assessment was carried out 4-6h later and for persistent SpO2 < 90%, immediate echocardiography was ordered.  Following the standardized protocol, researchers found 18 babies that qualified for echocardiographic exam and 9 were diagnosed with CHD.  Five of the nine babies had normal auscultation finding in their physical exam, leading researchers to conclude: "These newborns were thus saved from potential cardiogenic shock and even sudden unexpected death."  On the basis of this data, a sensitivity of 82% and a specificity of 99.9% with a positive predictive value of 50% and negative predictive value of 99.9% were calculated for the group.  

The researchers concluded: "As the method is simple and reliable, has low cost, is not time consuming, creates no additional burden for the patient, and is available and usable anywhere, we would recommend that pulse oximetry screening, with its high sensitivity and specificity levels, should become established as a general screening method in the routine evaluation of the newborn."

Dr. Balaji Govindaswami, Chief of Neonatology and Director of the NICU at Santa Clara Valley Medical Center, stated, "There is overwhelming evidence that screening newborns with Masimo SET pulse oximetry improves our ability to recognize critical congenital heart disease in the first hours of life and that such early detection improves survival.  We have implemented pulse oximetry screening of all newborns with very positive results and believe that, based on the evidence and real-world success of CHD screening programs, physicians should advocate this approach as a standard of care in all nurseries."