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Observational Study
. 2024 Oct 1;7(10):e2439629.
doi: 10.1001/jamanetworkopen.2024.39629.

Patient-Reported Outcomes Among Adults With Congenital Heart Disease in the Congenital Heart Initiative Registry

Scott Leezer  1 , Rittal Mehta  2 , Anushree Agarwal  3 , Sneha Saraf  2 , Mindi Messmer  2 , Ruth Phillippi  2 , Jamie L Jackson  4 , Mark Roeder  5 , Aliza Marlin  5 , Noah D Peyser  3 , Mark J Pletcher  3 , Richard Krasuski  6 , Matthew Lewis  7 , Leigh Reardon  8 , Arwa Saidi  9 , Ronald Kanter  10 , Satinder Sandhu  11 , Thomas Young  12 , Roni Jacobsen  13 , Emily Ruckdeschel  14 , Adam Lubert  15 , Simran Singh  16 , Ali Zaidi  17 , Dan H Halpern  18 , Anita Mathews  2 , Thomas Carton  19 , Anitha S John  2
Affiliations
Observational Study

Patient-Reported Outcomes Among Adults With Congenital Heart Disease in the Congenital Heart Initiative Registry

Scott Leezer et al. JAMA Netw Open. .

Abstract

Importance: In the US, there are more than 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.

Objective: To report the initial findings of the PROs for adults with CHD from the first 3 years of the CHI.

Design, setting, and participants: The CHI was launched nationally on December 7, 2020, as an observational cohort (survey) study. Data were collected virtually through December 31, 2023, and stored on Health Insurance Portability and Accountability Act-compliant cloud-based servers with restricted access. Adults with CHD were recruited through email, social media, general advertising through advocacy organizations, and targeted outreach (telephone and in-clinic recruitment) by clinical centers.

Main outcomes and measures: 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. Descriptive statistics were used to understand the associations between various factors, including the complexity of heart defects, physical activity levels, mental health comorbidities, and socioeconomic and health care access variables. All categorical variables were analyzed using χ2 or Fischer exact test as appropriate.

Results: By December 31, 2023, the CHI had enrolled 4558 participants (2530 female [56%]) with a mean (SD) age of 38.5 (13.9) years, representing all 50 states. Approximately 88% of participants (3998 participants) completed at least 1 electronic visit as of December 31, 2023. The most prevalent CHD anatomy included tetralogy of Fallot (883 participants [22%]), transposition of great arteries (452 participants [11%]), and coarctation of the aorta (429 participants [11%]). Approximately 88% of participants (3998 participants) reported at least 1 comorbidity, with arrhythmia (1300 participants [33%]) as the most common cardiac comorbidity and mood disorder (1326 participants [35%]) as the most common noncardiac comorbidity. Among female participants, 45% (1147 participants) reported having had a pregnancy, with 38% (967 participants) resulting in biological children. Participants with complex CHD were less likely than those with moderate CHD to meet recommended physical activity guidelines (χ22 = 15.9; n = 3320; P < .001), a factor that was more pronounced among female participants. Overall health-related quality of life was rated as good or better by 84% of participants who completed the quality of life PROs (2882 participants), with no difference by CHD complexity.

Conclusions and relevance: In this cohort study of adults living with CHD, many patients reported mood disorders, but most reported good health-related quality of life. The CHI, the largest registry of adults with CHD, is poised to facilitate multicenter research with the goal of improving clinical outcomes for all adults with CHD.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Krasuski reported receiving personal fees from Actelion/Janssen, Bayer, Gore Medical, Medtronic, and Neptune; and grants from Actelion/Janssen and the Adult Congenital Heart Association outside the submitted work. Dr Halpern reported receiving personal fees from Medtronic outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Map of Participants in the Congenital Heart Initiative
Figure shows geographic distribution of 4558 participants as of December 31, 2023.
Figure 2.
Figure 2.. Congenital Heart Disease Subtype by Sex Assigned at Birth
Graph shows type of patient-reported congenital heart defect among 3998 Congenital Heart Initiative participants who joined by December 31, 2023, and completed an initial visit.
Figure 3.
Figure 3.. Comorbidity Burden
Graph shows number of patient-reported comorbidities per Congenital Heart Initiative participant (n = 3862).
Figure 4.
Figure 4.. Patient-Reported Outcomes by Congenital Heart Disease (CHD) Complexity
Graphs show participant physical activity (A; 3320 participants) and health-related quality of life (B; 3431 participants) by CHD complexity. Physical activity goals are considered met (Yes) if the participant achieves 75 minutes of vigorous activity per week or a combination of vigorous and moderate activity totaling 150 minutes per week.
See this image and copyright information in PMC

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