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.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Wendler D. The ethics of pediatric research. New York: Oxford University Press; 2010.
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.
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.
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.
McKneally MF. Ethical problems in surgery: innovation leading to unforeseen complications. World J Surg. 1999;23(8):786–8.
Miller FG. Ethical issues in surgical research. Thorac Surg Clin. 2005;15(4):543–54.
Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg. 2002;194(6):792–801.
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283(20):2701–11.
Rashkind WJ. Atrial septostomy in congenital heart disease. Adv Pediatr Infect Dis. 1969;16:211–32.
Mullins CE. History of pediatric interventional catheterization: pediatric therapeutic cardiac catheterizations. Pediatr Cardiol. 1998;19(1):3–7.
Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest: a systematic review. JAMA. 2003;297(5):480–8.
Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993;329(8):573–6.
Burke RP, Hannan RL. Reducing the trauma of congenital heart surgery. Surg Clin N Am. 2000;80(5):1593–605.
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.
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.
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.
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.
Thaler DE, Saver JL. Cryptogenic stroke and patent foramen ovale. Curr Opin Cardiol. 2008;23(6):537–44.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Gross RE. Surgical management of the patent ductus arteriosus: with summary of four surgically treated cases. Ann Surg. 1939;110(3):321–56.
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.
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.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2020 Springer Nature Switzerland AG
About this chapter
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)