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Safety and Short-Term Outcomes for Infants < 2.5 kg Undergoing PDA Device Closure: A C3PO Registry Study

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Abstract

To evaluate short-term procedural outcomes and safety for infants < 2.5 kg who underwent catheterization with intended patent ductus arteriosus (PDA) device closure in a multi-center registry, as performance of this procedure becomes widespread. A multi-center retrospective review was performed using data from the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry. Data were collected for all intended cases of PDA closure in infants < 2.5 kg from April 2019 to December 2020 at 13 participating sites. Successful device closure was defined as device placement at the conclusion of the catheterization. Procedural outcomes and adverse events (AE) were described, and associations between patient characteristics, procedural outcomes and AEs were analyzed. During the study period, 300 cases were performed with a median weight of 1.0 kg (range 0.7–2.4). Successful device closure was achieved in 98.7% of cases with a 1.7% incidence of level 4/5 AEs, including one periprocedural mortality. Neither failed device placement nor adverse events were significantly associated with patient age, weight or institutional volume. Higher incidence of adverse events associated with patients who had non-cardiac problems (p = 0.017) and cases with multiple devices attempted (p = 0.064). Transcatheter PDA closure in small infants can be performed with excellent short-term outcomes and safety across institutions with variable case volume.

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Abbreviations

AE:

Adverse event

C3PO:

Congenital Cardiac Catheterization Project on Outcomes

FDA:

Food and Drug Administration

IQR:

Inter-quartile range

PDA:

Patent ductus arteriosus

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Funding

No funding was received to support this study.

Author information

Authors and Affiliations

  1. Division of Pediatric Cardiology, New York-Presbyterian – Morgan Stanley Children’s Hospital, Columbia University Medical Center, 3959 Broadway, CHN-253, New York, NY, 10032, USA

    Oliver M. Barry & Mariel E. Turner

  2. Division of Pediatric Cardiology, Medical College of Wisconsin and Herma Heart Institute at Children’s Wisconsin, Milwaukee, WI, USA

    Todd M. Gudausky & Susan Foerster

  3. St. Louis Children’s Hospital, St. Louis, MO, USA

    David T. Balzer

  4. UH Rainbow Babies Hospital, Cleveland, OH, USA

    Martin L. Bocks

  5. Nationwide Children’s Hospital, Columbus, OH, USA

    Brian A. Boe

  6. Boston Children’s Hospital, Boston, MA, USA

    Ryan Callahan, Philip Levy & Grace Rahman

  7. Rady Children’s Hospital –San Diego, San Diego, CA, USA

    Howaida El-Said

  8. Arnold Palmer Children’s Hospital, Orlando, FL, USA

    Michael J. Farias

  9. Children’s Hospital of Pittsburgh, Pittsburgh, PA, USA

    Bryan H. Goldstein

  10. Weill Cornell, New York, NY, USA

    Ralf J. Holzer

  11. Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville, TN, USA

    Dana Janssen

  12. The Children’s Hospital of Philadelphia, Philadelphia, PA, USA

    Michael L. O’Byrne

  13. Le Bonheur Children’s Hospital, Memphis, TN, USA

    Shyam Sathanandam

  14. Cincinnati Children’s Hospital, Cincinnati, OH, USA

    Shabana Shahanavaz

  15. University of Michigan, Ann Arbor, MI, USA

    Wendy Whiteside

Authors
  1. Oliver M. Barry
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  2. Todd M. Gudausky
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Contributions

All authors contributed to the study conception and design. OB, TG, MT: responsible for the primary design of the study. DB, MB, BB, RC, HE, MF, SF, BG, RH, DJ, RL, MO, GR, SSa, SSh, WW: contributions to the study design and its completion. OB, GR: responsible for material preparation and data collection. GR: primarily responsible for the data analysis with contributions from OB, MT, TG. The first draft of the manuscript was written and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Oliver M. Barry.

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Competing interests

DB: Abbott (proctor); BG: Medtronic (consultant); TG: Abbott (proctor); SSa: Abbott (proctor, consultant and research grant); SSh: Abbott (proctor, consultant), Medtronic (proctor, consultant). No other authors have any relevant disclosures.

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Barry, O.M., Gudausky, T.M., Balzer, D.T. et al. Safety and Short-Term Outcomes for Infants < 2.5 kg Undergoing PDA Device Closure: A C3PO Registry Study. Pediatr Cardiol 44, 1406–1413 (2023). https://doi.org/10.1007/s00246-023-03147-4

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