Factors influencing the decision to accept or decline aortic valve replacement for asymptomatic aortic stenosis: a nested longitudinal qualitative substudy of the EASY-AS randomised trial

OBJECTIVE: To examine how patients and family members decide whether to accept a highly invasive intervention (aortic valve replacement (AVR)) when their condition (aortic stenosis (AS)) is asymptomatic and its course uncertain.

DESIGN: Nested, longitudinal, qualitative substudy of an ongoing randomised controlled trial (RCT) (NCT04204915) testing early intervention (EI) versus watchful waiting (WW) in patients with asymptomatic severe AS.

SETTING: Six select UK sites of the RCT.

PARTICIPANTS: Select participants of the RCT, their next-of-kin and some who declined RCT participation.

RESULTS: 73 interviews were conducted, with 41 participants. Few knew much about AS before diagnosis. Uncertainty and the need for reliable information regarding symptoms and progress was a significant problem. While some expressed unease at a major intervention for an asymptomatic condition, there were no outright objections to the idea. Those who declined participation in the RCT did so for personal reasons, for example, their home circumstances did not permit the required period of recovery or they felt too old to risk intervention. Reasons for accepting early intervention included the belief that the condition was serious and likely to deteriorate, and so better to have the intervention before such deterioration, as well as avoiding long waiting lists. Trusting clinicians' judgement played a part in some decisions. Patients also wanted choice in the type of intervention received. The longitudinal interviews (n=32) showed satisfaction in the early intervention group despite some problems in the the early recovery phase, especially for those undergoing surgical AVR.

CONCLUSIONS: Where evidence supports major intervention for an asymptomatic condition, patients are likely to accept the offer, although personal circumstances play an important role in decision-making. Where a condition is not well known to the public, such as AS, patients rely on clinicians and other resources to help decide. Liaison with patient groups in developing shared decision-making resources may help with complex decisions.

TRIAL REGISTRATION NUMBER: NCT04204915.