Robert M R Tulloh1, Constancio Medrano-Lopez2, Paul A Checchia3, Claudia Stapper4, Naokata Sumitomo5, Matthias Gorenflo6, Eun Jung Bae7, Antonio Juanico8, Juan M Gil-Jaurena9, Mei-Hwan Wu10, Talal Farha11, Ali Dodge-Khatami12, Rocky Tsang13, Gerard Notario14, Colleen Wegzyn14. 1. 1Paediatric Cardiology,Bristol Royal Hospital for Children,Bristol,United Kingdom. 2. 2Pediatric Cardiology,Hospital General Universitario Gregorio Marañón,Madrid,Spain. 3. 3Cardiovascular Intensive Care Unit,Texas Children's Hospital and Sections of Pediatric Critical Care Medicine and Cardiology,Baylor College of Medicine,Houston Texas,United States of America. 4. 4Pediatric Cardiology,Congenital Heart Institute,Fundación Cardioinfantil,Bogotá,Colombia. 5. 5Pediatric Cardiology,Saitama Medical University International Medical Center,Saitama,Japan. 6. 6Pädiatrische Kardiologie und Angeborene Herzfehler,Zentrum für Kinder- und Jugendmedizin Universitätsklinikum Heidelberg,Heidelberg,Germany. 7. 7Pediatrics,Seoul National University College of Medicine,Seoul,South Korea. 8. 8Cardiología Pediátrica,Instituto Nacional de Cardiología Ignacio Chávez,Mexico City,Mexico. 9. 9Pediatric Cardiac Surgery,Hospital General Universitario Gregorio Marañón,Madrid,Spain. 10. 10Department of Pediatrics,National Taiwan University Hospital,Taipei,Taiwan. 11. 11Paediatrics,Paediatric Cardiology,Farha Children Clinics,Dubai,United Arab Emirates. 12. 12Division of Pediatric and Congenital Heart Surgery,University of Mississippi Medical Center,Jackson,Mississippi,United States of America. 13. 13Pediatric Cardiology,Children's Hospital of Philadelphia,Philadelphia,Pennsylvania,United States of America. 14. 14Neonatology,AbbVie Inc.,North Chicago,Illinois,United States of America.
Abstract
BACKGROUND: Palivizumab is the standard immunoprophylaxis against serious disease due to respiratory syncytial virus infection. Current evidence-based prophylaxis guidelines may not address certain children with CHD within specific high-risk groups or clinical/management settings. METHODS: An international steering committee of clinicians with expertise in paediatric heart disease identified key questions concerning palivizumab administration; in collaboration with an additional international expert faculty, evidence-based recommendations were formulated using a quasi-Delphi consensus methodology. RESULTS: Palivizumab prophylaxis was recommended for children with the following conditions: <2 years with unoperated haemodynamically significant CHD, who are cyanotic, who have pulmonary hypertension, or symptomatic airway abnormalities; <1 year with cardiomyopathies requiring treatment; in the 1st year of life with surgically operated CHD with haemodynamically significant residual problems or aged 1-2 years up to 6 months postoperatively; and on heart transplant waiting lists or in their 1st year after heart transplant. Unanimous consensus was not reached for use of immunoprophylaxis in children with asymptomatic CHD and other co-morbid factors such as arrhythmias, Down syndrome, or immunodeficiency, or during a nosocomial outbreak. Challenges to effective immunoprophylaxis included the following: multidisciplinary variations in identifying candidates with CHD and prophylaxis compliance; limited awareness of severe disease risks/burden; and limited knowledge of respiratory syncytial virus seasonal patterns in subtropical/tropical regions. CONCLUSION: Evidence-based immunoprophylaxis recommendations were formulated for subgroups of children with CHD, but more data are needed to guide use in tropical/subtropical countries and in children with certain co-morbidities.
BACKGROUND:Palivizumab is the standard immunoprophylaxis against serious disease due to respiratory syncytial virus infection. Current evidence-based prophylaxis guidelines may not address certain children with CHD within specific high-risk groups or clinical/management settings. METHODS: An international steering committee of clinicians with expertise in paediatric heart disease identified key questions concerning palivizumab administration; in collaboration with an additional international expert faculty, evidence-based recommendations were formulated using a quasi-Delphi consensus methodology. RESULTS:Palivizumab prophylaxis was recommended for children with the following conditions: <2 years with unoperated haemodynamically significant CHD, who are cyanotic, who have pulmonary hypertension, or symptomatic airway abnormalities; <1 year with cardiomyopathies requiring treatment; in the 1st year of life with surgically operated CHD with haemodynamically significant residual problems or aged 1-2 years up to 6 months postoperatively; and on heart transplant waiting lists or in their 1st year after heart transplant. Unanimous consensus was not reached for use of immunoprophylaxis in children with asymptomatic CHD and other co-morbid factors such as arrhythmias, Down syndrome, or immunodeficiency, or during a nosocomial outbreak. Challenges to effective immunoprophylaxis included the following: multidisciplinary variations in identifying candidates with CHD and prophylaxis compliance; limited awareness of severe disease risks/burden; and limited knowledge of respiratory syncytial virus seasonal patterns in subtropical/tropical regions. CONCLUSION: Evidence-based immunoprophylaxis recommendations were formulated for subgroups of children with CHD, but more data are needed to guide use in tropical/subtropical countries and in children with certain co-morbidities.