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Interpreting Quality Improvement When Introducing New Technology: A Collaborative Experience in ASD Device Closures

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Abstract

The objective of this study was to evaluate the impact of the regular introduction of new technologies into interventional cardiac catheterization procedures, in this case new atrial septal defect (ASD) closure devices, while conducting a multi-center collaborative initiative to reduce radiation usage during all procedures. Data were collected prospectively by 8 C3PO institutions between January 1, 2014 and December 31, 2017 for ASD device closure procedures in the cardiac catheterization lab during a quality improvement (QI) initiative aimed at reducing patient radiation exposure. Radiation exposure was measured in dose area product per body weight (µGy*m2/kg). Use of proposed practice change strategies at the beginning and end of the QI intervention period was assessed. Radiation exposure was summarized by institution and by initial type of device used for closure. This study included 602 ASD device closures. Without changes in patient characteristics, total fluoroscopy duration, or number of digital acquisitions, median radiation exposure decreased from 37 DAP/kg to 14 DAP/kg from 2014 to 2017. While all individual centers decreased overall median DAP/kg, the use of novel devices for ASD closure correlated with a temporary period of worsening institutional radiation exposure and increased fluoroscopy time. The introduction of new ASD closure devices resulted in increased radiation exposure during a QI project designed to reduce radiation exposure. Therefore, outcome assessment must be contextualized in QI projects, hospital evaluation, and public reporting, to acknowledge the expected variation during innovation and introduction of novel therapies.

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Data Availability

The data that support the findings of this study are available from the corresponding author, LB, upon reasonable request.

Abbreviations

ASD:

Atrial septal defect

DAP:

Dose area product

QI:

Quality improvement

C3PO:

Congenital cardiac catheterization project on outcomes (C3PO)

PVR:

Pulmonary vascular resistance

AE:

Adverse event

GSO:

GORE® CARDIOFORM Septal Occluder

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Acknowledgements

None.

Funding

The research leading to these results received funding from the Children’s Heart Foundation (Northbrook, IL).

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Authors and Affiliations

  1. Department of Cardiology, Boston Children’s Hospital, Bader 2, Attn: Lisa Bergersen, 300 Longwood Avenue, Boston, MA, 02115, USA

    Mary J. Yeh, Lauren Shirley, Kimberlee Gauvreau, Nicola Maschietto, Brian P. Quinn & Lisa Bergersen

  2. Division of Cardiology, Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, USA

    David T. Balzer

  3. The Heart Center, Nationwide Children’s Hospital, Columbus, OH, USA

    Brian A. Boe

  4. Rady Children’s Hospital, San Diego, CA, USA

    Howaida El-Said

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

    Susan Foerster & Todd M. Gudausky

  6. Division of Pediatric Cardiology, University of Virginia Children’s Hospital, University of Virginia, Charlottesville, VA, USA

    Michael R. Hainstock

  7. Division of Pediatric Cardiology, Vanderbilt University Medical Center, Nashville, TN, USA

    George T. Nicholson

  8. The Heart Institute, Cincinnati Children’s Hospital and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA

    Shabana Shahanavaz

  9. Heart Institute, UPMC Children’s Hospital of Pittsburgh and Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA

    Sara Trucco

  10. Division of Pediatric Cardiology, University of Michigan C.S. Mott Children’s Hospital, Ann Arbor, MI, USA

    Wendy Whiteside

Authors
  1. Mary J. Yeh
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  2. Lauren Shirley
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  3. David T. Balzer
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  5. Howaida El-Said
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  6. Susan Foerster
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  7. Kimberlee Gauvreau
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  8. Todd M. Gudausky
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  9. Michael R. Hainstock
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  12. Brian P. Quinn
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  13. Shabana Shahanavaz
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  14. Sara Trucco
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  15. Wendy Whiteside
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  16. Lisa Bergersen
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Corresponding author

Correspondence to Lisa Bergersen.

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Conflict of interest

The authors have no other relevant financial or non-financial relationships to disclose.

Ethics Approval

IRB approval for this study was obtained at Boston Children’s Hospital and was sought at participating institutions in accordance with local requirements.

Consent to Participate and Publication

The Boston Children’s IRB determined that this study met regulatory requirements necessary to waive the need for informed consent.

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Yeh, M.J., Shirley, L., Balzer, D.T. et al. Interpreting Quality Improvement When Introducing New Technology: A Collaborative Experience in ASD Device Closures. Pediatr Cardiol 43, 596–604 (2022). https://doi.org/10.1007/s00246-021-02762-3

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  • DOI: https://doi.org/10.1007/s00246-021-02762-3

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