Abstract
The Palivizumab Outcomes Registry prospectively collected data on 19,548 subjects who received respiratory syncytial virus (RSV) prophylaxis with palivizumab during the 2000–2004 RSV seasons. We evaluated the characteristics of enrolled registry subjects with congenital heart disease (CHD) over the four RSV seasons and examined additional information on these subjects collected in the 2002–2004 seasons. The percentage of registry subjects with CHD increased from 4.8% (102/2116) in the first season to 11.4% (688/6050) in the last season. Across all four seasons, 1500 subjects with CHD were enrolled, 71% of whom had acyanotic CHD. The proportion with cyanotic CHD increased from 19.6% (20/102) in the 2000–2001 season to 37.5% (258/688) in the 2003–2004 season, while the proportion of all CHD in the registry more than doubled during this time. The cumulative RSV hospitalization rate was 1.9% among patients with CHD who received prophylaxis. Among subjects with cyanotic and acyanotic CHD, hospitalization rates were 2.6% and 1.6%, respectively. Prospective data collected in the Palivizumab Outcomes Registry provide the largest published dataset available on infants with CHD receiving palivizumab and show low hospitalization rates and use consistent with prelicensure clinical trial data and revised American Academy of Pediatrics guidelines.
Similar content being viewed by others
References
Altman CA, Englund JA, Demmler G, et al. (2000) Respiratory syncytial virus in patients with congenital heart disease: a contemporary look at epidemiology and success of preoperative screening. Pediatr Cardiol 21:433–438
American Academy of Pediatrics (1998) Committee on Infectious Disease and Committee on Fetus and Newborn. Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IGIV. Pediatrics 102:1211–1216
American Academy of Pediatrics (2003) Committee on Infectious Disease and Committee on Fetus and Newborn. Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections. Pediatrics 112 (6 Pt 1):1442–1446
American Academy of Pediatrics (2006) Respiratory syncytial virus. In: Pickering LK (ed) RED BOOK®. 27th ed. American Academy of Pediatrics, Elk Grove Village, IL, pp 560–566
Boron M (2007) Case example 23: using registry data to study patterns of use and outcomes. In: Gliklich RE, Dreyer NA (eds) Registries for evaluating patient outcomes: a user’s guide. Agency for Healthcare Research and Quality, Rockville, MD. http://effectivehealthcare.ahrq.gov/repFiles/Registries.pdf, April 2007
Feltes TF, Cabalka AK, Meissner HC, et al., for the Cardiac Synagis Study Group (2003) Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr 143:532–540
Hoffman JI, Kaplan S (2002) The incidence of congenital heart disease. J Am Coll Cardiol 39:1890–1900
The IMpact-RSV Study Group (1998) Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics 102:530–537
Khongphatthanayothin A, Wong PC, Samara Y, et al. (1999) Impact of respiratory syncytial virus infection on surgery for congenital heart disease: postoperative course and outcome. Crit Care Med 27:1974–1981
Leader S, Kohlhase K (2003) Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr 143:S127–S132
MacDonald NE, Hall CB, Suffin SC, Alexson C, Harris PJ, Manning JA (1982) Respiratory syncytial viral infection in infants with congenital heart disease. N Engl J Med 307:397–400
Moler FW, Khan AS, Meliones JN, Custer JR, Palmisano J, Shope TC (1992) Respiratory syncytial virus morbidity and mortality estimates in congenital heart disease patients: a recent experience. Crit Care Med 20:1406–1413
Mullins JA, Lamonte AC, Bresee JS, Anderson LJ (2003) Substantial variability in community respiratory syncytial virus season timing. Pediatr Infect Dis J 22:857–862
Navas L, Wang E, de Carvalho V, Robinson J, the Pediatric Investigators Collaborative Network on Infections in Canada (1992) Improved outcome of respiratory syncytial virus infection in a high-risk hospitalized population of Canadian children. J Pediatr 121:348–354
Palivizumab Outcomes Registry Study Group (2003) Palivizumab prophylaxis of respiratory syncytial virus disease in 2000–2001: results from the palivizumab outcomes registry. Pediatr Pulmonol 35:484–489
Romero JR (2003) Palivizumab prophylaxis of respiratory syncytial virus disease from 1998–2002: results from four years of palivizumab usage. Pediatr Infect Dis J 22:S46–S54
Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Anderson LJ (1999) Bronchiolitis-associated hospitalizations among US children, 1980–1996. JAMA 282:1440–1446
Terletskaia-Ladwig E, Enders G, Schalasta G, Enders M (2005) Defining the timing of respiratory syncytial virus (RSV) outbreaks: an epidemiology study. BMC Infect Dis 5:20
Acknowledgments
The authors thank Lisa M. Klumpp, PhD, and Marissa Buttaro, MPH, of Scientific Connexions for their assistance in drafting the manuscript. Editorial support was provided by MedImmune, Inc. Data were captured and analyzed by The Synagis Outcomes Registry Coordinating Center, The EMMES Corporation, Rockville, MD.
Author information
Authors and Affiliations
Consortia
Corresponding author
Additional information
A. Cohen was formerly with MedImmune, Inc.
Rights and permissions
About this article
Cite this article
Cohen, S.A., Zanni, R., Cohen, A. et al. Palivizumab Use in Subjects with Congenital Heart Disease. Pediatr Cardiol 29, 382–387 (2008). https://doi.org/10.1007/s00246-007-9039-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00246-007-9039-5