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

BackgroundIn 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. MethodsAfter 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. ResultsBy 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 (X2 (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. ConclusionCHI 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.