Optimizing the delivery and use of a new monoclonal antibody in children with congenital heart disease: a successful provincial respiratory syncytial virus prophylaxis program.

OBJECTIVES

To describe a program for passive immunization against respiratory syncytial virus infection in infants with hemodynamically significant congenital heart disease (CHD) in accordance with the Canadian Paediatric Society recommendations.

METHODS

A provincial coordinating committee composed of specialists in pediatrics, cardiology, infectious diseases, neonatology and public health collaborated to develop and implement a program to identify children with hemodynamically significant heart disease and offer respiratory syncytial virus prophylaxis. Database records for all children younger than two years of age who were seen by the provincial pediatric cardiology referral service were reviewed. Children with hemodynamically significant heart disease, as determined by a clinical assessment and echocardiography, were considered to be eligible for monthly palivizumab prophylaxis for five winter months. All physicians in the province were notified that approval of the provincial cardiology service was required for prophylaxis to be administered. Immunization rates were compared with projected rates based on the expected population-based immunization rates in infants with CHD in other provinces.

RESULTS

401 children with any cardiac diagnoses were identified, representing 545 potential patient-seasons of prophylaxis over two years in a birth cohort of 20,173 and 19,227 children, in each respective season (13.8 patient-seasons per 1000 births). Of these, 21 children were eligible for palivizumab prophylaxis according to the Canadian Paediatric Society criteria. All eligible children were immunized, and no ineligible children received the immunization. A review of palivizumab use in other provinces revealed highly variable rates of prophylaxis.

CONCLUSIONS

The use of palivizumab for children with CHD can be optimized through a provincial model, in which children requiring prophylaxis are prospectively identified and reviewed by pediatric cardiologists -- and to whom evidence-based guidelines developed by a multidisciplinary team -- are applied. Such a model ensures that all patients requiring prophylaxis receive the appropriate immunization and avoids the immunization of low-risk children with CHD, in whom the benefits of palivizumab have not been proven.