Introduction Current guidelines recommend surgical or transcatheter aortic valve replacement (AVR) for severe aortic stenosis (AS) once symptoms or left ventricular dysfunction develop, whilst those with asymptomatic severe AS remain under active surveillance. The EASY-AS randomised control trial is testing the hypothesis that early surgery in this asymptomatic group will be beneficial, with participants being randomised to early AVR vs watchful waiting. It is unusual to offer treatment as invasive as AVR prophylactically. This makes the views of participants on the timing of treatment and factors influencing decision-making valuable in informing future guidelines and trials. Methods A sample of participants of EASY-AS trial, next of kin and those who declined to participate in the main trial, were invited to participate in this longitudinal qualitative sub-study. One-to-one semi-structured interviews were conducted by a qualitative researcher independent of the main trial, using an online platform or telephone. All interviews were digitally recorded, transcribed and identifiable data were removed, before thematic analysis was performed. Up to three semi-structured interviews with EASY-AS participants were conducted (see table 1 and figure 1). Results Data indicates a willingness for invasive treatment while remaining asymptomatic. The reasons varied: many believed the trajectory of illness would mean they required treatment soon anyway; others thought it best to have surgery while relatively healthy; others relied on clinicians. Next-of-kin views were consistent with the participants', although their importance to each decision varied. Reasons against wanting early intervention whilst asymptomatic included: My health is good enough at present My health is not good enough to risk surgery My life situation does not permit surgery at present Logistics of appointments and transport Reasons for early intervention Protect future health Have surgery while still healthy Future wait lists uncertain Trust in clinicians Decision making was complex given the serious nature of illness and intervention. Participants valued the right information. However, it was difficult given the uncertain trajectory of illness for all. There was also some discussion of importance of patient choice, for example, relating to TAVI and valve type. Conclusion This study confirms the complexity of decision-making and highlights the need for clear and accurate information for patients ahead of trial participation. Recruitment to the EASY-AS trial is therefore pivotal in providing accurate data for clinicians and patients in the future. Patients' attitudes to risk and their individual life situation is an important factor in decision-making. Decision aids for patients and clinicians might help. Conflict of Interest N/A
No takes yet. Share an insight, caveat, or question.
Singh et al. (2024) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: