Role of Multicenter Registries to Assess Outcomes of Fetal Interventions

  • Daud Lodin
  • Tara Karamlou
  • Anita J. Moon-GradyEmail author


Health registries are databases that are managed by an organized network of centers that contribute clinical data for research purposes. Within these registries, analysts, researchers, and physicians work together to generate new knowledge from pooled data that may improve treatments, outcomes, and systems of care. By combining cases from multiple sources, health registries create larger pools of study data without the added expense of clinical trials. They provide sample populations that have superior variability and therefore may have better representation of larger populations. Because registries utilize aggregate data, they are ideal for studying rare diseases, complications, or adverse effects. Registries also provide a unique source of collaboration for the research community, as the creation of these multicenter partnerships requires extensive participation from experts across many disciplines.


Congenital Heart Disease Hypoplastic Left Heart Syndrome Prenatal Intervention Fetal Intervention Pediatric Health Information System 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. 1.
    Grover FL, et al. The STS national database. Ann Thorac Surg. 2014;97(1):S48–54.CrossRefPubMedGoogle Scholar
  2. 2.
    Head SJ, et al. The European association for cardio-thoracic surgery (EACTS) database: an introduction. Eur J Cardiothorac Surg. 2013;44(3):e175–80.CrossRefPubMedGoogle Scholar
  3. 3.
    Murakami A, et al. The national clinical database as an initiative for quality improvement in Japan. Korean J Thorac Cardiovasc Surg. 2014;47(5):437–43.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Moon-Grady AJ, et al. Outcomes after in-utero cardiac interventions: a preliminary report of the collaborative international fetal cardiac intervention registry. Circulation. 2014;130 Suppl 2:A16469.Google Scholar
  5. 5.
    Moon-Grady AJ, et al. International fetal cardiac intervention registry: a worldwide collaborative description and preliminary outcomes. J Am Coll Cardiol. 2015;66(4):388–99.CrossRefPubMedGoogle Scholar
  6. 6.
    Jacobs JP, et al. Congenital heart surgery databases around the world: do we need a global database? In: Seminars in thoracic and cardiovascular surgery: pediatric cardiac surgery annual. 2010. Elsevier.Google Scholar
  7. 7.
    Makikallio K, et al. Fetal aortic valve stenosis and the evolution of hypoplastic left heart syndrome: patient selection for fetal intervention. Circulation. 2006;113(11):1401–5.CrossRefPubMedGoogle Scholar
  8. 8.
    Clarke DR, et al. Verification of data in congenital cardiac surgery. Cardiol Young. 2008;18 Suppl 2:177–87.CrossRefPubMedGoogle Scholar
  9. 9.
    Shahian DM, et al. The society of thoracic surgeons national database. Heart. 2013;99(20):1494–501.CrossRefPubMedGoogle Scholar
  10. 10.
    O’Brien SM, et al. The society of thoracic surgeons congenital heart surgery database mortality risk model: part 1-statistical methodology. Ann Thorac Surg. 2015;100(3):1054–62.CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Jacobs JP, et al. The society of thoracic surgeons congenital heart surgery database mortality risk model: part 2-clinical application. Ann Thorac Surg. 2015;100(3):1063–8.CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Welke KF, Diggs BS, Karamlou T. Chance, bias, and confounding: threats to valid measurement of quality in the context of pediatric cardiac surgery. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010;13(1):79–83.CrossRefPubMedGoogle Scholar
  13. 13.
    Mavroudis CD, et al. Ethical issues confronting outcomes analysis and quality assurance. In: Pediatric and congenital cardiac care. London: Springer; 2015. p. 295–303.Google Scholar
  14. 14.
    Pasquali SK, et al. Linking clinical registry data with administrative data using indirect identifiers: implementation and validation in the congenital heart surgery population. Am Heart J. 2010;160(6):1099–104.CrossRefPubMedPubMedCentralGoogle Scholar
  15. 15.
    Jacobs JP, et al. Linking the congenital heart surgery databases of the Society of Thoracic Surgeons and the Congenital Heart Surgeons’ Society: part 1 – rationale and methodology. World J Pediatr Congenit Heart Surg. 2014;5(2):256–71.CrossRefPubMedPubMedCentralGoogle Scholar
  16. 16.
    Jacobs JP, et al. Linking the congenital heart surgery databases of the Society of Thoracic Surgeons and the Congenital Heart Surgeons’ Society: part 2 – lessons learned and implications. World J Pediatr Congenit Heart Surg. 2014;5(2):272–82.CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Donofrio MT. The power is in the numbers: using collaboration and a data registry to answer our burning questions regarding fetal cardiac intervention. J Am Coll Cardiol. 2015;66(4):400–2.CrossRefPubMedGoogle Scholar
  18. 18.
    Representatives U.S.H.o. Patient protection and affordable care act. Public Law. 2010:111–48.Google Scholar
  19. 19.
    United Healthcare. In utero fetal surgery. Medical Policy, 2015;2015T0035N:16.Google Scholar
  20. 20.
    Nisbet MC, Brossard D, Kroepsch A. Framing science the stem cell controversy in an age of press/politics. Int J Press/Politics. 2003;8(2):36–70.CrossRefGoogle Scholar
  21. 21.
    Sciences C.f.I.O.o.M. International ethical guidelines for biomedical research involving human subjects. Bulletin of medical ethics. 2002(182):17.Google Scholar
  22. 22.
    Drane JF. Medical ethics and maternal-fetal conflicts. Pa Med. 1992;95(7):12–6.PubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Daud Lodin
    • 1
  • Tara Karamlou
    • 1
  • Anita J. Moon-Grady
    • 2
    • 3
    Email author
  1. 1.Division of Pediatric Cardiac Surgery, Department of SurgeryUniversity of CaliforniaSan FranciscoUSA
  2. 2.Fetal Cardiovascular Program and Fetal Treatment CenterUCSF Benioff Children’s Hospital, University of California San FranciscoSan FranciscoUSA
  3. 3.Division of Cardiology, Department of PediatricsUniversity of California San FranciscoSan FranciscoUSA

Personalised recommendations