Ethical considerations in the transcatheter management of congenital heart disease

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.