119 Indications for Use of Palivizumab for RSV Prophylaxis in Infants and Children with Congenital Heart Disease: A Guide for Physicians

Abstract

Respiratory syncytial virus (RSV) is a major cause of morbidity among young infants and children. Recent data from a randomized trial have established the safety and efficacy of palivizumab in infants and children with cyanotic and acyanotic congenital heart disease. However, given that congenital heart disease (CHD) includes a wide range of conditions of different severity, there is a need to identify infants who are most in need of palivizumab based on the degree of cardiopulmonary compromise. A group of Canadian experts was assembled to examine the feasibility of defining specific criteria that could be used to identify infants and children with CHD who are at the greatest risk of severe RSV disease. The group included specialists in neonatology, cardiology and infectious diseases. The group participated in two concurrent workshops in June 2003. Prior to the workshops, background information on RSV prophylaxis, trends in congenital heart disease and the outcome of a CHD RSV study were presented and discussed. This facilitated the creation of statements based on available evidence. The recommendations that emanated from the workshops were summarized according to specific questions that the group addressed, based on 2 evidence statements as indicated below: Evidence Statement #1: Safety and efficacy data from a randomized trial support the use of palivizumab in infants and children <24 months of age who have haemodynamically significant (HS) congenital heart disease. Recommendations based on evidence statement #1 were centred on the following: Definition of haemodynamically significant heart disease; approach to patients who have undergone corrective procedures; special cardiac conditions Evidence Statement #2: There is currently no evidence to support the use of palivizumab in infants and children who have minor or haemodynami-cally non-significant congenital or acquired heart disease in the absence of other indications for the use of the drug. Recommendations based on evidence statement #2 were centred on the following: Patent ductus arteriosus; pulmonic stenosis; secundum atrial septal defects; minor ventricular septal defects; uncomplicated aortic stenosis and mild coarctation of the aorta The group concluded that it was possible to define criteria that will assist in facilitating the cost-effective use of palivizumab in children with congenital heart disease. These criteria will be presented.