Informed consent in the context of left ventricular assist device use as destination therapy (LVAD-DT): A systematic review and ethical analysis

Abstract

Background: The circumstances surrounding the informed consent process for accepting LVAD-DT are incredibly complex and discretely nuanced from individual to individual. Additionally, the population requiring this powerful technology continues to grow, and those receiving it are living much longer. The gaps between client experiences and expectations prior to LVAD-DT consideration and after LVAD-DT implantation, and the evolving legal and ethical underpinnings influencing clinicians and health care more generally indicate a critical need for review and assessment of the degree to which current practice conforms to the standard(s) of informed consent, and the level to which that application can be sustained. The primary aim of this proposed systematic review then is to identify and understand the standard(s) of informed consent applied in the context of LVAD-DT. A secondary aim is to determine the degree to which informed consent in this context conforms to the accepted standard(s). A third aim is to recommend guidelines for undertaking informed consent in a way that better addresses the needs and interests of individuals receiving LVAD-DT. Methods: This report is a systematic review of the LVAD-DT and ethics literature, and ethical analysis of the application of informed consent in the context of LVAD-DT. Two related but distinct literature reviews will be undertaken. Findings: Four important findings with regard to the practice of informed consent were identified: 1) the broadest perception of the purpose of informed consent is to inform the client, not foster and facilitate autonomy; 2) clinicians lack adequate understanding or insight about the amount and type of information required or preferred by the individual client, as well as how that information is preferred to be shared with them; 3) This lack of understanding or insight undermines the practice of informed consent and adversely affects care delivery and outcomes; 4) The quality of informed consent may be closely associated with the quality and depth of relationship between client and clinician. Conclusions: Although all centers offering LVAD-DT comply with the currently accepted practice of informed consent, there are significant concerns about the usefulness of that model in this context. Joan Tronto’s (2009) informed consent as a grant of authority is a model of empowered choice that is more conducive to the goal of fostering and facilitating client autonomy than the currently accepted practice of informed consent. Key words: standards of informed consent, left ventricular assist device-destination therapy, LVAD-DT, and LVAD