Navigating Ethical Challenges in the Use of Single Ventricle Assist Devices for Children

Jeremy Garrett, PhD – Professor of Pediatrics, Bioethics, Children's Mercy; Stephanie Kukora, MD – Associate Professor of Pediatrics, Neonatal/Perinatal Medicine, Bioethics, Children's Mercy; Christian Cintron, PhD, HECC – Senior Ethics Consultant, Ethics Program, Children's National Hospital; Vanessa Madrigal, MD, HECC – Associate Professor of Pediatrics; Ethics Program Director, Critical Care Medicine, Bioethics, Children's National Hospital; Roxanne Kirsch, MD, MBE, FRCPC, FAAP – Assistant Professor of Paediatrics, Division Head, Cardiac Critical Care Unit, Critical Care Medicine, The Hospital for Sick Children

Abstract: Single ventricle assist devices (sVADs) are a recent surgical treatment for children with failing single ventricle physiology. Currently, the outcomes remain sub-optimal for these patients with 50% survival at 3 months post-implantation in stage I and stage II patients, though experienced centers report improving outcomes (bridge to transplant, long-term support, and bridge to recovery). Despite this, the ethical challenges particular to sVADs have been largely ignored in discussions of ethical implications around innovations for congenital heart disease.
In this presentation, we will address the ethical concerns raised by sVADs at three distinct levels: (1) patient/family (e.g., informed consent and shared decision making, compassionate deactivation, end of life care), (2) provider/unit/institution (e.g., moral distress and the perception of suffering, anti-failure bias), and (3) national system (e.g., equity and access, allocation of limited resources, and competing incentives in care centers, future research and family perspectives). Since these ethical considerations impact the care of these patients and can conflict with the goals of the family, we propose a shared decision-making approach for sVADs that aligns with the thorough and sensitive communication used when informing and consenting patients and families in clinical trials. We also provide recommendations for clinicians to counsel and support their patients and staff and suggest future research directions that are inclusive of experiences and perspectives of families whose children have undergone this innovation.

Keywords: pediatric cardiology and critical care, Innovation, Shared decision making