Elective inactivation of total artificial heart technology in non-futile situations: Inpatients, outpatients and research participants

Total artificial heart technology as a potential clinical therapy raises the issue of elective device inactivation in both futile and non-futile situations. This article explores elective device inactivation in non-futile situations. In reply to such requests for inactivation, the medical team should reflect on the individual's decision-making capacity, the clinical appropriateness of the therapy, and the setting of the request (clinical research vs. clinical practice). A decision-making flowchart is presented as a guide for managing inactivation requests. In the research setting, current U.S. federal regulations are murky as to the matter of study withdrawal made by participants who lack decision-making capacity. This compared with clear legal and ethical approaches in the non-research setting (clinical practice).