The Congenital Heart Initiative: Results from a Patient-Centered Registry for Adults with Congenital Heart Disease

Background In the United States, there are over 1.5 million adults living with congenital heart disease (CHD). The Congenital Heart Initiative (CHI) is a digital, online patient empowered registry that was created to advance multicenter research and improve clinical care by gathering patient-reported outcomes (PROs) in adults with CHD. Methods After a two year design process, the CHI was created and launched nationally on December 7, 2020 using a human centered design approach. Demographics and validated survey tools on quality of life, mental health, physical activity and health care utilization were collected at baseline and every 4 months. Data were collected virtually and stored on Health Insurance Portability and Accountability Act (HIPAA)–compliant cloud-based servers with restricted access. Results By December 31, 2023, the CHI had enrolled 4558 participants (56% female) with an average age of 39 years ± 14, representing all 50 states. Approximately 88% of participants have completed at least one e-Visit as of December 31, 2023. The most prevalent CHD anatomy included tetralogy of Fallot (883, 22%), transposition of great arteries (452, 11%), and coarctation of the aorta (429, 11%). Approximately 88% of participants reported at least one co-morbidity, with arrhythmia (1310, 29%) and mood disorder (1339, 29%) as the most common cardiac and non-cardiac co-morbidity, respectively. Among female participants, 45% (n=1147) reported having had a pregnancy with 38% (n=967) resulting in biological children. Participants with complex CHD were less likely to meet recommended physical activity guidelines (X 2 (2, n = 917) = 15.9, p < 0.001), a factor that was more pronounced amongst female participants. Overall health-related quality of life was rated as good or better by 84% of participants with no difference by CHD complexity. Conclusion CHI is the largest ongoing registry of adults living with congenital heart disease in the US and includes patients with a wide variety of CHD subtypes. Many patients report mood disorders, but most report good or very good health-reported quality of life. The CHI is poised to facilitate multicenter research with the goal of improving clinical outcomes for all adults with CHD.