Preventive cardiovascular surgery: ethics, shared decision-making and informed consent

Preventive surgery aims either to prevent the occurrence of a disease or its progression to a point where it causes adverse outcomes for the patient. The ongoing Early valve replacement in severe ASYmptomatic Aortic Stenosis (Easy- AS) trial is an example: asymptomatic patients with severe aortic stenosis (a condition in which the heart’s main valve becomes narrowed and restricts blood flow out of the heart) are being randomised to early intervention, which may include surgical valve replacement (open- heart surgery) or transcatheter aortic valve replacement (a minimally invasive procedure to replace a narrowed heart valve without open- heart surgery), before the onset of symptoms, or standard care of waiting till symptoms before treatment. Data from our qualitative substudy of the trial around decision- making showed that patients’ decision- making is complicated by an increased role of time trade- offs in such asymptomatic conditions and non- health values such as caring responsibilities and satisfaction with current quality of life. In this paper, we argue that these are ethical concerns and suggest how they may be tackled. In particular, we suggest a process of shared decision- making using patient decision aids (PtDAs) which include elements to help, such as values clarification. PtDAs have been shown to improve outcomes such as reduced decision regret and increased involvement of patients in the decision. Treatments such as preventive surgery in cardiovascular diseases would benefit from development and use of PtDAs to ensure adequate and ethical shared decision- making.