Endpoints for tricuspid regurgitation trans-catheter therapy trials.

Abstract

Tricuspid regurgitation (TR), particularly functional or secondary TR, is increasingly recognized in clinical practice and when at least moderate in severity is associated with significant increase in mortality. In recent years multiple new trans-catheter devices have been developed to treat tricuspid regurgitation and are now undergoing clinical trial evaluations. The choice of appropriate endpoints in TR trials is particularly challenging as the disease is complex, often co-exists with left heart disease and pulmonary hypertension, and has not been extensively studied. Endpoints utilized in left heart disease trials have been applied with success to TR trials, and innovative trial designs will allow the initiation of pivotal randomized trials. Ultimately the development of TR specific endpoints may provide for more specific and robust assessment of these novel therapies.