Formal evidence-based and expert consensus on immuno-prophylaxis with palivizumab in patients with congenital heart disease

Introduction. Infants with congenital heart disease (CHD) constitute a patient cohort at risk of serious infections due to respiratory syncytial virus. The rate of respiratory infection complications in these patients is high compared with other groups. Given the high staff and economic burden of respiratory syncytial virus infection in high-risk groups, prevention of this infection is recommended. Method. The document was constructed in the following stages: A) defining the research questions; b) searching for, screening, evaluating and selecting the evidence; c) synthesizing the evidence to answer the research questions; d) conducting a GRADE evaluation; e) discussing in formal panels; f) establishing recommendations and expert opinion; and g) drafting, developing and reviewing the consensus document. Results. The 15 participants arrived at a consensus and framed 16 recommendations which, over the course of the consensus, were combined to ultimately leave 13. The certainty of the evidence ranged from low to moderate; the rating was lowered by the risk of bias and imprecision, and the recommendations were weakly in favor, indicating that the desirable consequences probably outweigh the undesirable consequences. The most important elements for this decision were the ratio of the effect size to damage, social availability and cost. Conclusion. The recommendations should serve as a guideline to facilitate immunoprophylaxis in infants with congenital heart disease. As new evidence emerges, these recommendations may need to be reconsidered and carefully reviewed.