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Incidence of Respiratory Disease During the First Two Years of Life in Children with Hemodynamically Significant Congenital Heart Disease in Italy: A Retrospective Study

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Abstract

Children affected by hemodynamically significant congenital heart disease (HSCHD) experience severe respiratory complications that can increase the frequency of hospitalizations. The aim of the SINERGY study was to describe the incidence of respiratory diseases and to collect information on active and passive immunoprophylaxis in the first 2 years of life. In this retrospective, multicenter, and epidemiologic study, children with HSCHD were enrolled across 11 Italian sites. Children born between December 31, 2007, and December 31, 2012, were observed during their first 2 years of life. Data were collected through hospital database searches and parent interviews. Four hundred twenty children were enrolled: 51.7 % were female, 79.5 % were born full-term (≥37 weeks), and 77.6 % weighed >2500 g at birth. The most frequent heart defects were ventricular septal defect (23.1 %) and coarctation of the aorta (14.3 %). The incidence of respiratory diseases was 63.1 %. Frequent respiratory diseases not requiring hospitalization were upper respiratory tract infections (76.4 %), acute bronchitis (43.3 %), and influenza (22.1 %), while those requiring hospitalization were bronchitis and bronchiolitis (8.3 % each one). While active immunoprophylaxis was applied with wide compliance (diphtheria/pertussis/tetanus, 99.5 %; Haemophilus influenzae type b, 72.5 %; pneumococcus, 79.9 %; meningococcus, 77.4 %), only 54 % of children received respiratory syncytial virus (RSV) passive prophylaxis (palivizumab). Of the 35 hospitalizations due to bronchiolitis, 27 (77.1 %) did not receive prophylaxis against RSV, compared with 8 (22.9 %) who received prophylaxis (P < 0.0001). Children with HSCHD are at major risk of respiratory diseases. Passive immunoprophylaxis can help to prevent hospitalizations for bronchiolitis.

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Acknowledgments

AbbVie and the steering committee appreciate all the people who gave their support in the conduct of this study: Anna Ingargiola, Giulio Calcagni, Francesco De Luca, Concetta Ricci, Marianna Fabi, Lucia Manuri, Sabrina Montis, Monica Pelegrini, Eliana Franchi, Daniela Poli, Emanuela Portas, Carmen Privitera, Colin Gerard Egan, Lisa Serafini, and Lucia Trevisan. An abstract from the SINERGY study was published in Cardiology in the Young. A poster was presented at the 49th Annual Meeting of the Association for European Paediatric and Congenital Cardiology, May 20–23, 2015, Prague, Czech Republic.

Author contributions

ULP and AMC participated in the design of the study and interpretation of data. AP and GG participated in interpretation of data and writing of the manuscript. GP, MB, AR, GA, MPC, MP, RT, PS, PF, MGR, and OM were involved in the acquisition of data from the different clinical centers. All authors were involved in drafting the manuscript and read and approved the final manuscript.

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Authors and Affiliations

  1. Centro Cardiologico Paediatrico del Mediterraneo Taormina, Bambino Gesù Roma, Rome, Italy

    Giacomo Pongiglione

  2. AbbVie SrL Italy, Campoverde, Via Pontina km 52, Campoverde di Aprilia (LT), Latina, Italy

    Alessandro Possidoni, Umberto di Luzio Paparatti, Anna Maria Costanzo & Giuliana Gualberti

  3. Azienda Ospedaliero Universitaria di Bologna, Policlinico Sant’Orsola Malpighi, Bologna, Italy

    Marco Bonvicini

  4. Istituto “Giannina Gaslini” Genova, Genoa, Italy

    Alessandro Rimini

  5. A.O. Città della Salute e della Scienza di Torino, Ospedale Infantile Regina Margherita Torino, Turin, Italy

    Gabriella Agnoletti

  6. Azienda Ospedaliera Universitaria Policlinico “G. Martino” di Messina, Messina, Italy

    Maria Pia Calabrò

  7. Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona “Umberto I, G.M. Lancisi, G. Salesi”, Ancona, Italy

    Marco Pozzi

  8. Azienda Ospedaliera “G.Brotzu” Cagliari, Cagliari, Italy

    Roberto Tumbarello

  9. IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy

    Patrizia Salice

  10. Azienda Ospedaliero-Universitaria Meyer Firenze, Florence, Italy

    Patrizio Fiorini

  11. Ospedale Monaldi, Seconda Università di Napoli, Naples, Italy

    Maria Giovanna Russo

  12. Azienda Ospedaliera di Padova, Padua, Italy

    Ornella Milanesi

Authors
  1. Giacomo Pongiglione
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  2. Alessandro Possidoni
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  4. Anna Maria Costanzo
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  9. Maria Pia Calabrò
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  10. Marco Pozzi
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  11. Roberto Tumbarello
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  12. Patrizia Salice
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  13. Patrizio Fiorini
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  14. Maria Giovanna Russo
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  15. Ornella Milanesi
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Corresponding author

Correspondence to Anna Maria Costanzo.

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Conflict of interest

AbbVie was responsible for the design, conduct, analysis, and funding of the study. AbbVie participated in the interpretation of data, writing, review, and approval of this publication. Umberto di Luzio Paparatti, Anna Maria Costanzo, and Giuliana Gualberti are employees of AbbVie and may own AbbVie stock options. Alessandro Possidoni was an employee of AbbVie. Giacomo Pongiglione and Ornella Milanesi are consultants for Abbvie. Marco Bonvicini, Maria Pia Calabrò, Alessandro Rimini, Patrizia Salice, Maria Giovanna Russo, Marco Pozzi, Roberto Tumbarello, Patrizio Fiorini, and Gabriella Agnoletti declared no conflict of interest.

Ethical standard

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants, or their parents/legal guardians, included in the study.

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Pongiglione, G., Possidoni, A., di Luzio Paparatti, U. et al. Incidence of Respiratory Disease During the First Two Years of Life in Children with Hemodynamically Significant Congenital Heart Disease in Italy: A Retrospective Study. Pediatr Cardiol 37, 1581–1589 (2016). https://doi.org/10.1007/s00246-016-1473-9

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  • DOI: https://doi.org/10.1007/s00246-016-1473-9

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