Health-Related Quality of Life After Neonatal Treatment of Symptomatic Tetralogy of Fallot: Insights from the Congenital Cardiac Research Collaborative

George T Nicholson^{1

2}, Jeffrey D Zampi³, Andrew C Glatz⁴, Bryan H Goldstein⁵, Christopher J Petit⁶, Yun Zhang⁶, Courtney E McCracken⁷, Athar M Qureshi⁸, Caren S Goldberg³, Jennifer C Romano⁹, Mark A Law¹⁰, Jeffery J Meadows¹¹, Shabana Shahanavaz¹², Sarosh P Batlivala¹², Shiraz A Maskatia¹³, Asaad Beshish¹⁴, Michael L O'Byrne¹⁵, R Allen Ligon¹⁴, Kathryn O Stack¹⁵, Hala Q Khan⁸, Shalin Parekh^{11

16}, Dawn L Ilardi¹⁷

Affiliations

¹ Division of Cardiology, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. george.t.nicholson@vumc.org.
² Thomas P. Graham Jr. Division of Pediatric Cardiology, Pediatric Heart Institute, Vanderbilt University Medical Center, 2200 Children's Way, 5230 Doctors' Office Tower, Nashville, TN, 37232, USA. george.t.nicholson@vumc.org.
³ Division of Cardiology, Department of Pediatrics, C.S. Mott Children's Hospital, University of Michigan School of Medicine, Ann Arbor, MI, USA.
⁴ Division of Cardiology, Department of Pediatrics, Washington University School of Medicine, St. Louis, MA, USA.
⁵ Department of Pediatrics, Heart Institute, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁶ Morgan Stanley Children's Hospital, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.
⁷ Center for Research and Evaluation, Kaiser Permanente Georgia, Atlanta, GA, USA.
⁸ Lillie Frank Abercrombie Division of Cardiology, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.
⁹ Section of Pediatric Cardiothoracic Surgery, Department of Cardiac Surgery, C.S. Mott Children's Hospital, University of Michigan School of Medicine, Ann Arbor, MI, USA.
¹⁰ Division of Pediatric Cardiology, Department of Pediatrics, Children's of Alabama, University of Alabama Birmingham School of Medicine, Birmingham, AL, USA.
¹¹ Division of Cardiology, Department of Pediatrics, University of California San Francisco School of Medicine, San Francisco, CA, USA.
¹² The Heart Institute, Cincinnati Children's Hospital Medical Center and Division of Pediatric Cardiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
¹³ Division of Pediatric Cardiology, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
¹⁴ Children's Heart Center Cardiology, Department of Pediatrics, Children's Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, USA.
¹⁵ The Cardiac Center at the Children's Hospital of Philadelphia, Philadelphia, PA, USA.
¹⁶ Connecticut Children's Hospital, Hartford, CT, USA.
¹⁷ Pediatric Neurodevelopmental Center, Atlanta, GA, USA.

PMID: 39305323
PMCID: PMC12583293
DOI: 10.1007/s00246-024-03650-2

Multicenter Study

Health-Related Quality of Life After Neonatal Treatment of Symptomatic Tetralogy of Fallot: Insights from the Congenital Cardiac Research Collaborative

George T Nicholson et al. Pediatr Cardiol. 2025 Dec.

. 2025 Dec;46(8):2303-2314.

doi: 10.1007/s00246-024-03650-2. Epub 2024 Sep 21.

Authors

Affiliations

¹ Division of Cardiology, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. george.t.nicholson@vumc.org.
² Thomas P. Graham Jr. Division of Pediatric Cardiology, Pediatric Heart Institute, Vanderbilt University Medical Center, 2200 Children's Way, 5230 Doctors' Office Tower, Nashville, TN, 37232, USA. george.t.nicholson@vumc.org.
³ Division of Cardiology, Department of Pediatrics, C.S. Mott Children's Hospital, University of Michigan School of Medicine, Ann Arbor, MI, USA.
⁴ Division of Cardiology, Department of Pediatrics, Washington University School of Medicine, St. Louis, MA, USA.
⁵ Department of Pediatrics, Heart Institute, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁶ Morgan Stanley Children's Hospital, Columbia University Vagelos College of Physicians & Surgeons, New York, NY, USA.
⁷ Center for Research and Evaluation, Kaiser Permanente Georgia, Atlanta, GA, USA.
⁸ Lillie Frank Abercrombie Division of Cardiology, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.
⁹ Section of Pediatric Cardiothoracic Surgery, Department of Cardiac Surgery, C.S. Mott Children's Hospital, University of Michigan School of Medicine, Ann Arbor, MI, USA.
¹⁰ Division of Pediatric Cardiology, Department of Pediatrics, Children's of Alabama, University of Alabama Birmingham School of Medicine, Birmingham, AL, USA.
¹¹ Division of Cardiology, Department of Pediatrics, University of California San Francisco School of Medicine, San Francisco, CA, USA.
¹² The Heart Institute, Cincinnati Children's Hospital Medical Center and Division of Pediatric Cardiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
¹³ Division of Pediatric Cardiology, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
¹⁴ Children's Heart Center Cardiology, Department of Pediatrics, Children's Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, USA.
¹⁵ The Cardiac Center at the Children's Hospital of Philadelphia, Philadelphia, PA, USA.
¹⁶ Connecticut Children's Hospital, Hartford, CT, USA.
¹⁷ Pediatric Neurodevelopmental Center, Atlanta, GA, USA.

PMID: 39305323
PMCID: PMC12583293
DOI: 10.1007/s00246-024-03650-2

Erratum in

Correction: Health-Related Quality of Life After Neonatal Treatment of Symptomatic Tetralogy of Fallot: Insights from the Congenital Cardiac Research Collaborative.
Nicholson GT, Zampi JD, Glatz AC, Goldstein BH, Petit CJ, Zhang Y, McCracken CE, Qureshi AM, Goldberg CS, Romano JC, Law MA, Meadows JJ, Shahanavaz S, Batlivala SP, Maskatia SA, Beshish A, O'Byrne ML, Ligon RA, Stack KO, Khan HQ, Parekh S, Ilardi DL. Nicholson GT, et al. Pediatr Cardiol. 2025 Jan;46(1):249-251. doi: 10.1007/s00246-024-03680-w. Pediatr Cardiol. 2025. PMID: 39432099 Free PMC article. No abstract available.

Abstract

To evaluate the association between initial management strategy of neonatal symptomatic Tetralogy of Fallot (sTOF) and later health-related quality of life (HRQOL) outcomes. We performed a multicenter, cross-sectional evaluation of a previously assembled cohort of infants with sTOF who underwent initial intervention at ≤ 30 days of age, between 2005 and 2017. Eligible patients' parents/guardians completed an age-appropriate Pediatric Quality of Life Inventory, a Pediatric Quality of Life Inventory Cardiac Module Heart Disease Symptoms Scale, and a parental survey. The association between treatment strategy and HRQOL was evaluated, and the entire sTOF cohort was compared to published values for the healthy pediatric population and to children with complex congenital heart disease and other chronic illness. The study cohort included 143 sTOF subjects, of which 59 underwent a primary repair, and 84 had a staged repair approach. There was no association between initial management strategy and lower HRQOL. For the entire cohort, in general, individual domain scores decreased as age sequentially increased. Across domain measurements, mean scores for the sTOF cohort were significantly lower than the healthy pediatric population and comparable to those with other forms of complex CHD and other chronic health conditions. The presence of a genetic syndrome was significantly associated with a poor HRQOL (p = 0.003). Initial treatment strategy for sTOF was not associated with differences in late HRQOL outcomes, though the overall HRQOL in this sTOF cohort was significantly lower than the general population, and comparable to others with chronic illness.

Keywords: Congenital heart disease; Quality of life; Tetralogy of fallot.

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Conflict of interest statement

Declarations. Conflict of interest: While none of the authors have any conflicts of interest related to this study, the following conflicts exist: Dr. Jeffrey Zampi is a Consultant for Medtronic, Inc. and Gore Medical. He also serves on the Data Safety Monitoring Board for Encore Medical. Dr. Athar Qureshi is a Consultant for Medtronic, Inc., Gore Medical, and B. Braun Medical, Inc. Dr. Bryan Goldstein is a Consultant for Medtronic, Inc. and Gore Medical. The authors declare no competing interests.

Figures

**Fig. 1**
a Mean PedsQL™ domain scores by age range. Mean value with standard deviation range displayed. b Mean PedsQL™ cardiac module domain scores by age range. Mean value with standard deviation range displayed

**Fig. 2**
Comparison of Quality-of-Life Scores to Healthy Children and Children with other Chronic Health Conditions

See this image and copyright information in PMC

References

1. Mandalenakis Z, Ging KW, Eriksson P, Liden H, Synnergen M, Wahlander H et al (2020) Survival in children with congenital heart disease: have we reached a peak at 97%? J Am Heart Assoc 9:e017704 - PMC - PubMed
1. Loffredo CA (2000) Epidemiology of cardiovascular malformations: prevalence and risk factors. Am J Med Genet 97:319–325 - PubMed
1. Goldstein BH, Petit CJ, Qureshi AM, McCracken CE, Kelleman MS, Nicholson GT et al (2021) Comparison of management strategies for neonates with symptomatic Tetralogy of Fallot. J Am Coll Cardiol 77(8):1093–1106 - PMC - PubMed
1. Rumsfeld JS, Alexander KP, Goff DC, Graham MM, Ho PM, Masoudi FA et al (2013) Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation 127:2233–2249 - PubMed
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Health-Related Quality of Life After Neonatal Treatment of Symptomatic Tetralogy of Fallot: Insights from the Congenital Cardiac Research Collaborative

Affiliations

Health-Related Quality of Life After Neonatal Treatment of Symptomatic Tetralogy of Fallot: Insights from the Congenital Cardiac Research Collaborative

Authors

Affiliations

Erratum in

Abstract

Conflict of interest statement

Figures

References

Publication types

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LinkOut - more resources

Full Text Sources

Medical