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J Heart Lung Transplant. 2019 Sep;38(9):972-981. doi: 10.1016/j.healun.2019.06.006. Epub 2019 Jun 20.

Early outcomes for low-risk pediatric heart transplant recipients and steroid avoidance: A multicenter cohort study (Clinical Trials in Organ Transplantation in Children - CTOTC-04).

Author information

Division of Pediatric Cardiology, Children's Hospital at Montefiore, Bronx, New York, New York. Electronic address:
Rho Federal Systems Division, Chapel Hill, North Carolina.
Division of Pediatric Cardiology, Children's Hospital at Montefiore, Bronx, New York, New York.
Departments of Pediatrics and Clinical and Translational Science, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Department of Pediatric Cardiology, Boston Children's Hospital, Boston, Massachusetts.
Division of Pediatric Cardiology, Washington University School of Medicine, St. Louis, Missouri.
Department of Paediatrics, Labatt Family Heart Center, Hospital for Sick Children, Toronto, Ontario, Canada.
Division of Pediatric Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Division of Pediatric Cardiology, Children's Healthcare of Atlanta, Atlanta, Georgia.
Division of Pediatric Cardiology, Columbia University Medical Center, New York, New York.
Transplantation Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee.



Immunosuppression strategies have changed over time in pediatric heart transplantation. Thus, comorbidity profiles may have evolved. Clinical Trials in Organ Transplantation in Children-04 is a multicenter, prospective, cohort study assessing the impact of pre-transplant sensitization on outcomes after pediatric heart transplantation. This sub-study reports 1-year outcomes among recipients without pre-transplant donor-specific antibodies (DSAs).


We recruited consecutive candidates (<21 years) at 8 centers. Sensitization status was determined by a core laboratory. Immunosuppression was standardized as follows: Thymoglobulin induction with tacrolimus and/or mycophenolate mofetil maintenance. Steroids were not used beyond 1 week. Rejection surveillance was by serial biopsy.


There were 240 transplants. Subjects for this sub-study (n = 186) were non-sensitized (n = 108) or had no DSAs (n = 78). Median age was 6 years, 48.4% were male, and 38.2% had congenital heart disease. Patient survival was 94.5% (95% confidence interval, 90.1-97.0%). Freedom from any type of rejection was 67.5%. Risk factors for rejection were older age at transplant and presence of non-DSAs pre-transplant. Freedom from infection requiring hospitalization/intravenous anti-microbials was 75.4%. Freedom from rehospitalization was 40.3%. New-onset diabetes mellitus and post-transplant lymphoproliferative disorder (PTLD) occurred in 1.6% and 1.1% of subjects, respectively. There was no decline in renal function over the first year. Corticosteroids were used in 14.5% at 1 year.


Pediatric heart transplantation recipients without DSAs at transplant and managed with a steroid avoidance regimen have excellent short-term survival and a low risk of first-year diabetes mellitus and PTLD. Rehospitalization remains common. These contemporary observations allow for improved caregiver and/or patient counseling and provide the necessary outcomes data to help design future randomized controlled trials.


immunosuppression; outcomes; pediatric heart transplant; rejection; steroid avoidance

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