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Determining the incidence of heart malformations in neonates: A novel and clinically approved solution
Arash Bordbar1, Mandana Kashaki1, Maryam Vafapour2
1Shahid Akbarabadi Clinical Research & Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, Iran.
Insights
Early screening for critical congenital heart defects (CCHD) in neonates is vital. A digital intelligent phonocardiogram accurately identified previously unrecognized heart defects in 45% of newborns, improving early detection and treatment.
Area of Science:
- Pediatrics
- Cardiology
- Medical Technology
Background:
- Congenital heart defects (CHDs) are often undetected at birth, leading to significant health issues in children and adults.
- Early screening is crucial for timely intervention and improved outcomes.
- Current screening methods miss a substantial percentage of CHDs in neonates.
Purpose of the Study:
- To assess the incidence of heart defects in neonates.
- To evaluate the effectiveness of a digital intelligent phonocardiogram for early detection of CHDs.
- To determine the rate of unrecognized heart malformations at birth.
Main Methods:
- A retrospective analysis of 840 neonates screened using a digital intelligent phonocardiogram and routine clinical examinations.
- Echocardiography performed by a pediatric cardiologist for neonates with abnormal heart sounds.
- Double-blind assessment to compare screening methods.
Main Results:
- The incidence of heart malformations was 5% in the study population.
- 45% of heart malformations, including one critical congenital heart defect, were unrecognized at birth.
- The intelligent phonocardiogram machine accurately identified CHDs missed by standard examinations.
Conclusions:
- Digital intelligent phonocardiography offers accurate and cost-effective screening for CHDs in neonates.
- This technology can detect critical congenital heart defects (CCHD) and other heart malformations not identified through standard medical evaluations.
- Potential for increased detection rates of unrecognized heart malformations with optimized study design.
Background:
Screening for critical congenital heart defects should be performed as early as possible and is essential for saving the lives of children and reducing the incidence of undetected adult congenital heart diseases. Heart malformations remain unrecognized at birth in more than 50% of neonates at maternity hospitals. Accurate screening for congenital heart malformations is possible using a certified and internationally patented digital intelligent phonocardiography machine. This study aimed to assess the actual incidence of heart defects in neonates. A pre-evaluation of the incidence of unrecognized severe and critical congenital heart defects at birth in our well-baby nursery was also performed.
Methods:
We conducted the Neonates Cardiac Monitoring Research Project (ethics approval number: IR-IUMS-FMD. REC.1398.098) at the Shahid Akbarabadi Maternity Hospital. This study was a retrospective analysis of congenital heart malformations observed after screening 840 neonates. Using a double-blind format, 840 neonates from the well-baby nursery were randomly chosen to undergo routine clinical examinations at birth and digital intelligent phonocardiogram examinations. A pediatric cardiologist performed echocardiography for each neonate classified as having abnormal heart sounds using an intelligent machine or during routine medical examinations. If the pediatric cardiologist requested a follow-up examination, then the neonate was considered to have a congenital heart malformation, and the cumulative incidence was calculated accordingly.
Results:
The incidence of heart malformations in our well-baby nursery was 5%. Furthermore, 45% of heart malformations were unrecognized in neonates at birth, including one critical congenital heart defect. The intelligent machine interpreted innocent murmurs as healthy heart sound.
Conclusion:
We accurately and cost-effectively screened for congenital heart malformations in all neonates in our hospital using a digital intelligent phonocardiogram. Using an intelligent machine, we successfully identified neonates with CCHD and congenital heart defects that could not be detected using standard medical examinations. The Pouya Heart machine can record and analyze sounds with a spectral power level lower than the minimum level of the human hearing threshold. Furthermore, by redesigning the study, the identification of previously unrecognized heart malformations could increase to 58%.
