Skip to main content

Ethical Considerations in the Transcatheter Management of Congenital Heart Disease

  • Chapter
  • First Online:
Bioethical Controversies in Pediatric Cardiology and Cardiac Surgery
  • 355 Accesses

Abstract

Invasive treatment of congenital heart disease has seen remarkable advances over the past 80 years. With the advent of less invasive therapeutic strategic options, providers include interventional cardiologists as well as classically trained surgeons. The technological imperative for pursuing innovative therapy must be tempered by on-going observation. Outcomes research is problematic owing to the relative infrequency of like patients on the spectrum of any given condition. By necessity industry has also had a large influence on the development of surgical equipment and implantable devices thus creating the potential for real or perceived conflict of interest. A cooperative approach and transparency with respect to expected risks, benefits and alternatives are necessary to ensure informed consent central to the principles of autonomy, beneficence, non-maleficence, and justice.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 79.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 129.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Wendler D. The ethics of pediatric research. New York: Oxford University Press; 2010.

    Book  Google Scholar 

  2. Blalock A. The use of shunt or by-pass operations in the treatment of certain circulatory disorders, including portal hypertension and pulmonic stenosis. Ann Surg. 1947;125(2):129–41.

    Article  CAS  Google Scholar 

  3. Dodge-Khatami A, Mavroudis C, Mavroudis CD, Jacobs JP. Past, present, and future of the arterial switch operation: historical review. Cardiol Young. 2012;22(6):724–31.

    Article  Google Scholar 

  4. Ohye RG, Sleeper LA, Mahony L, Newburger JW, Pearson GD, Lu M, et al. Comparison of shunt types in the Norwood procedure for single-ventricle lesions. N Engl J Med. 2010;362(21):1980–92.

    Article  CAS  Google Scholar 

  5. McKneally MF. Ethical problems in surgery: innovation leading to unforeseen complications. World J Surg. 1999;23(8):786–8.

    Article  CAS  Google Scholar 

  6. Miller FG. Ethical issues in surgical research. Thorac Surg Clin. 2005;15(4):543–54.

    Article  Google Scholar 

  7. Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg. 2002;194(6):792–801.

    Article  Google Scholar 

  8. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283(20):2701–11.

    Article  CAS  Google Scholar 

  9. Rashkind WJ. Atrial septostomy in congenital heart disease. Adv Pediatr Infect Dis. 1969;16:211–32.

    CAS  Google Scholar 

  10. Mullins CE. History of pediatric interventional catheterization: pediatric therapeutic cardiac catheterizations. Pediatr Cardiol. 1998;19(1):3–7.

    Article  CAS  Google Scholar 

  11. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest: a systematic review. JAMA. 2003;297(5):480–8.

    Google Scholar 

  12. Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993;329(8):573–6.

    Article  CAS  Google Scholar 

  13. Burke RP, Hannan RL. Reducing the trauma of congenital heart surgery. Surg Clin N Am. 2000;80(5):1593–605.

    Article  CAS  Google Scholar 

  14. Podrid PJ, Graboys TB, Lown B. Prognosis of medically treated patients with coronary-artery disease with profound ST-segment depression during exercise testing. N Engl J Med. 1981;305(19):1111–6.

    Article  CAS  Google Scholar 

  15. Stergiopoulos K, Brown DL. Initial coronary stent implantation with medical therapy vs medical therapy alone for stable coronary artery disease: meta-analysis of randomized controlled trials. Arch Intern Med. 2012;172(4):312–9.

    Article  Google Scholar 

  16. Chan PS, Patel MR, Klein LW, Krone RJ, Dehmer GJ, Kennedy K, et al. Appropriateness of percutaneous coronary intervention. JAMA. 2011;306(1):53–61.

    Article  CAS  Google Scholar 

  17. Li JS, Eisenstein EL, Grabowski HG, Reid ED, Mangum B, Schulman KA, et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA. 2007;297(5):480–8.

    Article  CAS  Google Scholar 

  18. Thaler DE, Saver JL. Cryptogenic stroke and patent foramen ovale. Curr Opin Cardiol. 2008;23(6):537–44.

    Article  Google Scholar 

  19. Bergersen L, Gauvreau K, Foerster SR, Marshall AC, McElhinney DB, Beekman RH, et al. Catheterization for congenital heart disease adjustment for risk method (CHARM). JACC Cardiovasc Interv. 2011;4(9):1037–46.

    Article  Google Scholar 

  20. Cevallos PC, Rose MJ, Armsby LB, Armstrong AK, El-Said H, Foerster SR, et al. Implementation of methodology for quality improvement in pediatric cardiac catheterization: a multi-center initiative by the congenital cardiac catheterization project on outcomes-quality improvement (C3PO-QI). Pediatr Cardiol. 2016;37(8):1436–45.

    Article  Google Scholar 

  21. Holzer RJ, Gauvreau K, Kreutzer J, Moore JW, McElhinney DB, Bergersen L. Relationship between procedural adverse events associated with cardiac catheterization for congenital heart disease and operator factors: results of a multi-institutional registry (C3PO). Catheter Cardiovasc Interv. 2013;82(3):463–73.

    Article  Google Scholar 

  22. Hill KD, Du W, Fleming GA, Forbes TJ, Nykanen DG, Reeves J, et al. Validation and refinement of the catheterization RISk score for pediatrics (CRISP score): an analysis from the congenital cardiac interventional study consortium. Catheter Cardiovasc Interv. 2019;93(1):97–104.

    Article  Google Scholar 

  23. Nykanen DG, Forbes TJ, Du W, Divekar AA, Reeves JH, Hagler DJ, et al. CRISP: catheterization risk score for pediatrics: a report from the congenital cardiac interventional study consortium (CCISC). Catheter Cardiovasc Interv. 2016;87(2):302–9.

    Article  Google Scholar 

  24. Taggart NW, Du W, Forbes TJ, Nykanen DG, Wax DF, Cabalka AK, et al. A model for assessment of catheterization risk in adults with congenital heart disease. Am J Cardiol. 2019;149:172–9.

    Google Scholar 

  25. Welke KF, O’Brien SM, Peterson ED, Ungerleider RM, Jacobs ML, Jacobs JP. The complex relationship between pediatric cardiac surgical case volumes and mortality rates in a national clinical database. J Thorac Cardiovasc Surg. 2009;137(5):1133–40.

    Article  Google Scholar 

  26. Connors RC, Doty JR, Bull DA, May HT, Fullerton DA, Robbins RC. Effect of work-hour restriction on operative experience in cardiothoracic surgical residency training. J Thorac Cardiovasc Surg. 2009;137(3):710–3.

    Article  Google Scholar 

  27. Kan JS, White RI Jr, Mitchell SE, Gardner TJ. Percutaneous balloon valvuloplasty: a new method for treating congenital pulmonary-valve stenosis. N Engl J Med. 1982;307(9):540–2.

    Article  CAS  Google Scholar 

  28. Gross RE. Surgical management of the patent ductus arteriosus: with summary of four surgically treated cases. Ann Surg. 1939;110(3):321–56.

    Article  CAS  Google Scholar 

  29. Conrad C, Newberry D. Understanding the pathophysiology, implications, and treatment options of patent ductus arteriosus in the neonatal population. Adv Neonatal Care. 2019;19(3):179–87.

    Article  Google Scholar 

  30. Sathanandam S, Agrawal H, Chilakala S, Johnson J, Allen K, Knott-Craig C, et al. Can transcatheter PDA closure be performed in neonates ≤1000 grams? The memphis experience. Congenit Heart Dis. 2019;14(1):79–84.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to David Nykanen .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2020 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Nykanen, D. (2020). Ethical Considerations in the Transcatheter Management of Congenital Heart Disease. In: Mavroudis, C., Cook, J., Mavroudis, C. (eds) Bioethical Controversies in Pediatric Cardiology and Cardiac Surgery. Springer, Cham. https://doi.org/10.1007/978-3-030-35660-6_12

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-35660-6_12

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-35659-0

  • Online ISBN: 978-3-030-35660-6

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics