The review emphasizes the importance of standardized heart failure event ascertainment and the use of recurrent event statistical analyses in severe aortic stenosis trials.
Standardized HF definitions and recurrent event analyses are needed in aortic stenosis trials; leaves open optimal ascertainment methods.
Aortic stenosis is a progressive disease that develops over decades, and once symptomatic and untreated, is associated with poor survival. Transcatheter aortic valve replacement has evolved significantly in the past decade and has expanded its indication from surgically inoperable and high-risk patients to patients with intermediate risk. Assessment of heart failure-related outcomes include the use of functional assessments, disease-specific quality of life surveys and standardised ascertainment of events, such as hospitalisations. Multiple statistical approaches are currently being tested to account for recurrent events such as hospitalisations for heart failure or to combine binary and continuous outcomes, both intended to assess the holistic burden of the disease, as opposed to the traditional analysis of time to first event.
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Spitzer et al. (2019) conducted a review in Severe aortic stenosis and heart failure. Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) or standard therapy was evaluated.
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