Who was in the study?

People in the study were:

• Between 12-25 years of age
• Participants in the Fontan 1 (also called the Fontan Cross Sectional study)
• Not pregnant

What happened during the study?

Each qualified person completed the following study procedures:

• Medical Record Review: Medical charts were reviewed to obtain information about surgeries, tests or times in the hospital. Subjects were asked if they were taking medicine or getting services like physical or speech therapy.
• Questionnaires: Depending on age, parents and participants were asked to complete questionnaires about physical, emotional, and social aspects of health and about quality of life. The questionnaires asked about living situation, education, work outside the home, and other factors, such as health insurance coverage.

What were the results of the study?

Here are some things that we learned about Fontan patients as a group:

• Mean age of the patients was 18 years and mean time after Fontan surgery was 15 years.
• Patients were followed for an average of over 7 years after the Fontan Cross-Sectional study.
• An overall risk of death/transplant was at 5%; the risk was higher for patients with both an elevated brain natriuretic peptide and a low Child Health Questionnaire (CHQ) physical summary score measured during the Fontan Cross-Sectional study.
• The health surveys showed that, although the average score for the Fontan patient was lower than the average score in children without congenital heart disease, 78% of Fontan patients scored in the normal range for physical functioning and 88% were in the normal range for mental functioning.
• Over the follow-up period, a statistically significant but small and clinically unimportant decline was noted in CHQ Physical Functioning Summary Score, while change in CHQ Psychosocial Functioning Summary Score was not significant.

The things we learned may not apply to every child. The findings reflect those for all 427 people who participated; parents of only 245 children and adolescents completed the CHQ at two time points. Individual results varied quite a bit.

The PHN is grateful to all of the families who participated in this study. The results from this study will help us to design future studies to learn more about helping children who had Fontan surgery live healthier lives.