Prophylaxis protects infants with congenital heart disease from severe forms of RSV infection: an Italian observational retrospective study
Tóm tắt
In children with congenital heart disease (CHD) respiratory syncytial virus (RSV) infection may have a severe course, with increased risk of morbidity and mortality, requiring hospital admission and intensive care. The aim of the present study was to evaluate the effect of prophylaxis with palivizumab in preventing RSV-associated hospitalization in infants with CHD. We carried out an observational, retrospective study in a paediatric cardiology division at a secondary-care centre in Italy, extracting from the database children with CHD who, from November 2004 to March 2022, matched the criteria for palivizumab prophylaxis, to evaluate the hospitalization rate in CHD patients with and without palivizumab prophylaxis and their RSV-related hospitalization characteristics compared with a group of children without CHD and no other underlying clinical conditions (control group, CG), hospitalized for RSV infection. One hundred twenty-eight children with CHD were enrolled in the study, mainly (71.9%) with increased pulmonary flow, and received palivizumab prophylaxis. Twenty-seven received hospital care for bronchiolitis. Almost all CHD patients hospitalized for bronchiolitis (26 out of 27) received partial prophylaxis (≤ 3 doses). CHD patients with bronchiolitis stay longer in the hospital than control (14.4 ± 21.7 days vs 6.2 ± 2.3 days) some of which require intensive care (n = 4). Our study provides evidence of the efficacy of palivizumab in protecting patients with hemodynamically significant CHD under the age of 2 years from RSV disease and its life-threatening complications. Reducing hospitalisation rate, morbidity, and mortality in this category of patients, passive immune prophylaxis with palivizumab may impact healthcare resource availability and utilisation.
Tài liệu tham khảo
citation_journal_title=J Am Coll Cardiol; citation_title=Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis; citation_author=D Linde, EE Konings, MA Slager, M Witsenburg, WA Helbing, JJ Takkenberg, JW Roos-Hesselink; citation_volume=58; citation_issue=21; citation_publication_date=2011; citation_pages=2241-2247; citation_doi=10.1016/j.jacc.2011.08.025; citation_id=CR1
citation_journal_title=Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu; citation_title=The challenge of congenital heart disease worldwide: epidemiologic and demographic facts; citation_author=PL Bernier, A Stefanescu, G Samoukovic, CI Tchervenkov; citation_volume=13; citation_issue=1; citation_publication_date=2010; citation_pages=26-34; citation_doi=10.1053/j.pcsu.2010.02.005; citation_id=CR2
citation_journal_title=Int J Epidemiol; citation_title=Global birth prevalence of congenital heart defects 1970–2017: updated systematic review and meta-analysis of 260 studies; citation_author=Y Liu, S Chen, L Zuhlke, GC Black, MK Choy, N Li, BD Keavney; citation_volume=48; citation_issue=2; citation_publication_date=2019; citation_pages=455-463; citation_doi=10.1093/ije/dyz009; citation_id=CR3
citation_journal_title=J Am Coll Cardiol; citation_title=Changing mortality in congenital heart disease; citation_author=P Khairy, R Ionescu-Ittu, AS Mackie, M Abrahamowicz, L Pilote, AJ Marelli; citation_volume=56; citation_issue=14; citation_publication_date=2010; citation_pages=1149-1157; citation_doi=10.1016/j.jacc.2010.03.085; citation_id=CR4
citation_journal_title=Nat Rev Cardiol; citation_title=Prenatal screening for structural congenital heart disease; citation_author=LE Hunter, JM Simpson; citation_volume=11; citation_issue=6; citation_publication_date=2014; citation_pages=323-334; citation_doi=10.1038/nrcardio.2014.34; citation_id=CR5
citation_journal_title=Heart; citation_title=Survival with congenital heart disease and need for follow up in adult life; citation_author=C Wren, JJ O'Sullivan; citation_volume=85; citation_issue=4; citation_publication_date=2001; citation_pages=438-443; citation_doi=10.1136/heart.85.4.438; citation_id=CR6
Wienecke LM, Cohen S, Bauersachs J, Mebazaa A, Chousterman BG. Immunity and inflammation: the neglected key players in congenital heart disease? Heart Fail Rev. 2022;27(5):1957–71.
citation_journal_title=BMC Pediatr; citation_title=Impact of congenital heart disease on outcomes among pediatric patients hospitalized for influenza infection; citation_author=LV Ghimire, FS Chou, AJ Moon-Grady; citation_volume=20; citation_issue=1; citation_publication_date=2020; citation_pages=450; citation_doi=10.1186/s12887-020-02344-x; citation_id=CR8
citation_journal_title=J Clin Microbiol; citation_title=Global molecular epidemiology of respiratory syncytial virus from the 2017–2018 Inform-RSV study; citation_author=DE Tabor, F Fernandes, AC Langedijk, D Wilkins, RJ Lebbink, A Tovchigrechko, A Ruzin, L Kragten-Tabatabaie, H Jin, MT Esser; citation_volume=59; citation_issue=1; citation_publication_date=2020; citation_pages=e01828-20; citation_doi=10.1128/JCM.01828-20; citation_id=CR9
citation_journal_title=Int J Environ Res Public Health; citation_title=Respiratory syncytial virus resurgence in italy: the need to protect all neonates and young infants; citation_author=E Bozzola; citation_volume=19; citation_issue=1; citation_publication_date=2021; citation_pages=380; citation_doi=10.3390/ijerph19010380; citation_id=CR10
citation_journal_title=Infect Dis Ther; citation_title=Defining the risk and associated morbidity and mortality of severe respiratory syncytial virus infection among infants with congenital heart disease; citation_author=PA Checchia, B Paes, L Bont, P Manzoni, EA Simoes, B Fauroux, J Figueras-Aloy, X Carbonell-Estrany; citation_volume=6; citation_issue=1; citation_publication_date=2017; citation_pages=37-56; citation_doi=10.1007/s40121-016-0142-x; citation_id=CR11
citation_journal_title=Ital J Pediatr; citation_title=Inter-society consensus document on treatment and prevention of bronchiolitis in newborns and infants; citation_author=E Baraldi, M Lanari, P Manzoni, GA Rossi, S Vandini, A Rimini, C Romagnoli, P Colonna, A Biondi, P Biban; citation_volume=40; citation_publication_date=2014; citation_pages=65; citation_doi=10.1186/1824-7288-40-65; citation_id=CR12
citation_journal_title=PLoS ONE; citation_title=Modelling the seasonal epidemics of respiratory syncytial virus in young children; citation_author=HC Moore, P Jacoby, AB Hogan, CC Blyth, GN Mercer; citation_volume=9; citation_issue=6; citation_publication_date=2014; citation_doi=10.1371/journal.pone.0100422; citation_id=CR13
Synagis, INN-palivizumab [
https://www.ema.europa.eu/en/documents/product-information/synagis-epar-product-information_en.pdf
]
Riassunto delle caratteristiche del prodotto: Synagis [
https://farmaci.agenziafarmaco.gov.it/aifa/servlet/PdfDownloadServlet?pdfFileName=footer_004726_034529_RCP.pdf&sys=m0b1l3
]
citation_title=Prevenzione della malattia da virus respiratorio sinciziale nei bambini con cardiopatia congenita o acquisita; citation_publication_date=2019; citation_id=CR16; citation_author=M Lombardi; citation_author=M Carrozza; citation_author=C Morelli
R: A language and environment for statistical computing. [
https://www.r-project.org/
]
citation_journal_title=Pediatrics; citation_title=A controlled clinical trial of effects of water mist on obstructive respiratory signs, death rate and necropsy findings among premature infants; citation_author=WA Silverman, DH Andersen; citation_volume=17; citation_issue=1; citation_publication_date=1956; citation_pages=1-10; citation_id=CR18
American Academy of Pediatrics Subcommittee on D, Management of B: Diagnosis and management of bronchiolitis. Pediatrics 2006, 118(4):1774–1793.
citation_journal_title=Eur J Clin Microbiol Infect Dis; citation_title=Respiratory syncytial virus-associated hospitalizations over three consecutive seasons in children with congenital heart disease; citation_author=B Resch, S Kurath-Koller, J Hahn, W Raith, M Kostenberger, A Gamillscheg; citation_volume=35; citation_issue=7; citation_publication_date=2016; citation_pages=1165-1169; citation_doi=10.1007/s10096-016-2649-1; citation_id=CR20
citation_journal_title=Spain Epidemiol Infect; citation_title=Risk factors for hospitalization due to respiratory syncytial virus infection among infants in the Basque Country; citation_author=G Cilla, A Sarasua, M Montes, N Arostegui, D Vicente, E Perez-Yarza, E Perez-Trallero; citation_volume=134; citation_issue=3; citation_publication_date=2006; citation_pages=506-513; citation_doi=10.1017/S0950268805005571; citation_id=CR21
citation_journal_title=Arch Dis Child; citation_title=Risk factors for respiratory syncytial virus hospitalisation in children with heart disease; citation_author=K Kristensen, LG Stensballe, J Bjerre, D Roth, N Fisker, T Kongstad, AL Svendsen, BW Nielsen; citation_volume=94; citation_issue=10; citation_publication_date=2009; citation_pages=785-789; citation_doi=10.1136/adc.2008.143057; citation_id=CR22
citation_journal_title=PLoS ONE; citation_title=Predictors of RSV LRTI hospitalization in infants born at 33 to 35 weeks gestational age: a large multinational study (PONI); citation_author=Z Stranak, E Saliba, P Kosma, K Posfay-Barbe, K Yunis, T Farstad, K Unnebrink, J Wyk, C Wegzyn, G Notario; citation_volume=11; citation_issue=6; citation_publication_date=2016; citation_doi=10.1371/journal.pone.0157446; citation_id=CR23
citation_journal_title=J Pediatr; citation_title=Rates of hospitalization for respiratory syncytial virus infection among children in medicaid; citation_author=TG Boyce, BG Mellen, EF Mitchel, PF Wright, MR Griffin; citation_volume=137; citation_issue=6; citation_publication_date=2000; citation_pages=865-870; citation_doi=10.1067/mpd.2000.110531; citation_id=CR24
citation_journal_title=Arch Dis Child; citation_title=Low incidence of respiratory syncytial virus hospitalisations in haemodynamically significant congenital heart disease; citation_author=A Duppenthaler, RA Ammann, M Gorgievski-Hrisoho, JP Pfammatter, C Aebi; citation_volume=89; citation_issue=10; citation_publication_date=2004; citation_pages=961-965; citation_doi=10.1136/adc.2003.046714; citation_id=CR25
Wang EE, Law BJ, Robinson JL, Dobson S, al Jumaah S, Stephens D, Boucher FD, McDonald J, Mitchell I, MacDonald NE: PICNIC (Pediatric Investigators Collaborative Network on Infections in Canada) study of the role of age and respiratory syncytial virus neutralizing antibody on respiratory syncytial virus illness in patients with underlying heart or lung disease. Pediatrics 1997, 99(3):E9
citation_journal_title=Pediatr Infect Dis J; citation_title=Group CS: Community-acquired respiratory infections in young children with congenital heart diseases in the palivizumab era: the Spanish 4-season civic epidemiologic study; citation_author=C Medrano Lopez, L Garcia-Guereta; citation_volume=29; citation_issue=12; citation_publication_date=2010; citation_pages=1077-1082; citation_doi=10.1097/INF.0b013e3181efdac5; citation_id=CR27
citation_journal_title=J Paediatr Child Health; citation_title=Respiratory syncytial virus immunoprophylaxis in high-risk infants with heart disease; citation_author=PM Alexander, L Eastaugh, J Royle, AJ Daley, LS Shekerdemian, DJ Penny; citation_volume=48; citation_issue=5; citation_publication_date=2012; citation_pages=395-401; citation_doi=10.1111/j.1440-1754.2011.02219.x; citation_id=CR28
citation_journal_title=Pediatr Cardiol; citation_title=Respiratory syncytial virus in patients with congenital heart disease: a contemporary look at epidemiology and success of preoperative screening; citation_author=CA Altman, JA Englund, G Demmler, KL Drescher, MA Alexander, C Watrin, TF Feltes; citation_volume=21; citation_issue=5; citation_publication_date=2000; citation_pages=433-438; citation_doi=10.1007/s002460010103; citation_id=CR29
citation_journal_title=Arch Dis Child; citation_title=Does RSV infection cause pulmonary hypertension in children undergoing cardiac surgery?; citation_author=RFL Tulloh, J Henderson, R Thompson, T Feltes; citation_volume=96; citation_publication_date=2011; citation_pages=A37-A38; citation_doi=10.1136/adc.2011.212563.80; citation_id=CR30
citation_journal_title=J Pediatr; citation_title=Cardiac synagis study G: palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease; citation_author=TF Feltes, AK Cabalka, HC Meissner, FM Piazza, DA Carlin, FH Top, EM Connor, HM Sondheimer; citation_volume=143; citation_issue=4; citation_publication_date=2003; citation_pages=532-540; citation_doi=10.1067/S0022-3476(03)00454-2; citation_id=CR31
citation_journal_title=Pediatr Cardiol; citation_title=Impact of palivizumab on RSV hospitalizations for children with hemodynamically significant congenital heart disease; citation_author=RK Chang, AY Chen; citation_volume=31; citation_issue=1; citation_publication_date=2010; citation_pages=90-95; citation_doi=10.1007/s00246-009-9577-0; citation_id=CR32
citation_journal_title=Cardiol Young.; citation_title=Respiratory infection in congenital cardiac disease. hospitalizations in young children in Spain during 2004 and 2005: the CIVIC Epidemiologic Study; citation_author=C Medrano, L Garcia-Guereta, J Grueso, B Insa, F Ballesteros, J Casaldaliga, V Cuenca, F Escudero, null delaCalzada LG, Luis M, ; citation_volume=17; citation_issue=4; citation_publication_date=2007; citation_pages=360-371; citation_doi=10.1017/S104795110700042X; citation_id=CR33
citation_journal_title=Pediatr Cardiol; citation_title=Palivizumab outcomes registry G: palivizumab use in subjects with congenital heart disease: results from the 2000–2004 palivizumab outcomes registry; citation_author=SA Cohen, R Zanni, A Cohen, M Harrington, P VanVeldhuisen, ML Boron; citation_volume=29; citation_issue=2; citation_publication_date=2008; citation_pages=382-387; citation_doi=10.1007/s00246-007-9039-5; citation_id=CR34
citation_journal_title=Pediatr Infect Dis J; citation_title=investigators C: CARESS: the Canadian registry of palivizumab; citation_author=I Mitchell, BA Paes, A Li, KL Lanctot; citation_volume=30; citation_issue=8; citation_publication_date=2011; citation_pages=651-655; citation_doi=10.1097/INF.0b013e31821146f7; citation_id=CR35
citation_journal_title=Cochrane Database Syst Rev; citation_title=Bronchodilators for bronchiolitis; citation_author=AM Gadomski, MB Scribani; citation_volume=6; citation_publication_date=2014; citation_pages=CD001266; citation_id=CR36
citation_journal_title=Pediatrics; citation_title=Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis; citation_author=SL Ralston, AS Lieberthal, HC Meissner, BK Alverson, JE Baley, AM Gadomski, DW Johnson, MJ Light, NF Maraqa, EA Mendonca; citation_volume=134; citation_issue=5; citation_publication_date=2014; citation_pages=e1474-1502; citation_doi=10.1542/peds.2014-2742; citation_id=CR37
citation_journal_title=NPJ Prim Care Respir Med; citation_title=Impact of bronchiolitis guidelines publication on primary care prescriptions in the Italian pediatric population; citation_author=E Barbieri, A Cantarutti, S Cavagnis, L Cantarutti, E Baraldi, C Giaquinto, D Dona; citation_volume=31; citation_issue=1; citation_publication_date=2021; citation_pages=15; citation_doi=10.1038/s41533-021-00228-w; citation_id=CR38
citation_journal_title=Allergol Immunopathol (Madr); citation_title=Gonzalez de Dios J, Research Group of the a BP: Overuse of bronchodilators and steroids in bronchiolitis of different severity: bronchiolitis-study of variability, appropriateness, and adequacy; citation_author=C Ochoa Sangrador; citation_volume=42; citation_issue=4; citation_publication_date=2014; citation_pages=307-315; citation_doi=10.1016/j.aller.2013.02.010; citation_id=CR39
citation_journal_title=Ital J Pediatr; citation_title=Epidemiology and prevention of respiratory syncytial virus infections in children in Italy; citation_author=C Azzari, E Baraldi, P Bonanni, E Bozzola, A Coscia, M Lanari, P Manzoni, T Mazzone, F Sandri, G Checcucci Lisi; citation_volume=47; citation_issue=1; citation_publication_date=2021; citation_pages=198; citation_doi=10.1186/s13052-021-01148-8; citation_id=CR40
citation_journal_title=Pediatr Cardiol; citation_title=Incidence of respiratory disease during the first two years of life in children with hemodynamically significant congenital heart disease in Italy: a retrospective study; citation_author=G Pongiglione, A Possidoni, PU Luzio, AM Costanzo, G Gualberti, M Bonvicini, A Rimini, G Agnoletti, MP Calabro, M Pozzi; citation_volume=37; citation_issue=8; citation_publication_date=2016; citation_pages=1581-1589; citation_doi=10.1007/s00246-016-1473-9; citation_id=CR41