One in ten congenital heart defects is a critical heart defect. Just a few decades ago, such a finding was a certain death sentence. This has changed thanks to the ongoing progress in diagnostic procedures and treatment methods since then.

Today, many children can develop well and lead happy lives even with severe congenital heart defects. The prerequisite for this is timely treatment of the heart malformation.  Early detection is therefore of great importance.

Closing Gaps in Early Detection

Despite major advances in diagnostics, such as prenatal ultrasound, not all critical heart defects are detected prior to birth. Even immediately after birth, during the first checkup, there may not be any clinical symptoms. A vulnerable gap: Critical heart defects require early surgical treatment or catheter intervention because of their life-threatening impairment of the postnatal interaction between the systemic and pulmonary circulation.

Since January 2017, pulse oximetry screening has therefore been one of the additional screening examinations paid for by the statutory health insurance. With the help of a cuff on the newborn's foot, a small light sensor measures the oxygen content in the blood 24 to 48 hours after birth. The non-invasive procedure is painless and takes only a few seconds. If the oxygen saturation is too low, this can be an indication of a critical heart defect.

Evaluation Commissioned by the Federal Joint Committee G-BA

Initial studies support the benefit of pulse oximetry screening. According to these studies, on average three out of 10,000 newborns were diagnosed with critical heart defects that had not been previously noticed. Therefore, there is justified hope that mortality and serious sequelae in those affected by critical congenital heart defects can be further reduced by widespread use of pulse oximetry screening. 

On behalf of the G-BA, we are therefore reviewing the quality and results of this procedure with a special focus on the early detection of critical congenital heart defects in newborns.

The project is divided into five parts, which together provide the evaluation results:

I. Evaluation of pulse oximetry screening in approximately 55,000 births in randomly selected birth facilities and midwives in out-of-hospital obstetric care throughout Germany.

II. Annual registration of all infants born in Germany after April 1, 2021, with a congenital heart defect requiring treatment.

III. Evaluation of the treatment of all patients registered in the "National Quality Assurance of Congenital Heart Defects" who are born in Germany and receive surgical or interventional treatment from April 1, 2021 onwards.

IV. Evaluation of health insurance and health care data of the Barmer Ersatzkasse.

V. Parent survey of registry participants among approximately 7,000 parents of children with congenital heart defects under the age of nine.

We would like to thank all parents who participate with their children in the evaluation of the pulse oximetry screening. We will of course keep you informed about the results.