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Introduction
Background and rationale {6a}
The American College of Cardiology (ACC) and American Heart Association (AHA) recommend shared decision-making (SDM) for patients with severe aortic stenosis (AS) choosing between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). SAVR was historically the only treatment for severe AS until 2011 when TAVR was approved for use in patients at prohibitive risk for surgery. TAVR indications have since expanded, including symptomatic patients at intermediate or high surgical risk (in 2016) and low surgical risk over the age of 65 (in 2019) [1]. These types of decisions, where a new, disruptive technology rapidly alters the decision landscape, add complexity for patients and clinicians. While the coverage decision does not mandate the use of a decision aid for SDM, the US Centers for Medicare and Medicaid Services (CMS) does require evaluation by a multidisciplinary heart valve team, including both a cardiac surgeon and interventional cardiologist, as a condition for reimbursement for TAVR [1, 2]. However, a recent systematic review of decision-making in severe AS found very few elements of SDM in routine care, highlighting barriers to SDM from the patients’ perspective including lack of information, not being included in decision-making, and dealing with multiple serious co-morbidities [3]. A broad Cochrane systematic review has identified common barriers to SDM implementation including time constraints, perceived lack of applicability, and lack of clinician support [4, 5]. Common organizational and system level barriers include lack of team-based culture, limited leadership support, and misaligned financial incentives [6, 7–8]. Further, barriers specific to the context of severe AS include older patient age, limited patient activation, and severity of disease [3, 9]. Unfortunately, the guidelines recommending SDM have not provided any guidance for how to overcome these barriers to implementing SDM into routine care.
While the heart valve team approach mandated by CMS may address some of these known barriers to SDM in cardiology and cardiac surgery settings (e.g., financial incentives, leadership support, and clinician support), it is likely that other strategies will be needed to achieve fidelity to SDM in this setting. A recent survey of heart valve team physicians ranked clinician SDM skills training, leadership support, and patient decision aids as the top three priorities to effectively implement SDM [10, 11–12]. A...