Why the study?
Multiple natural history studies showed worse outcomes with increasing TR severity, while surgery had high in-hospital mortality, prompting transcatheter options and the need to standardize definitions and clinical trial endpoints.
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Design
Consensus document
Promotes uniform tricuspid regurgitation trial reporting; leaves open effects on clinical practice until validated.
Interest in the pathophysiology, etiology, management, and outcomes of patients with tricuspid regurgitation (TR) has grown in the wake of multiple natural history studies showing progressively worse outcomes associated with increasing TR severity, even after adjusting for multiple comorbidities. Historically, isolated tricuspid valve surgery has been associated with high in-hospital mortality rates, leading to the development of transcatheter treatment options. The aim of this first Tricuspid Valve Academic Research Consortium document is to standardize definitions of disease etiology and severity, as well as endpoints for trials that aim to address the gaps in our knowledge related to identification and management of patients with TR. Standardizing endpoints for trials should provide consistency and enable meaningful comparisons between clinical trials. A second Tricuspid Valve Academic Research Consortium document will focus on further defining trial endpoints and will discuss trial design options.
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Hahn et al. (2023) studied this question.
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