Tricuspid Valve insufficiency (regurgitation) is a medical condition where the valve between the right ventricle (pumping chamber) and the right atrium does not close properly. This allows blood to reverse instead of moving towards the pulmonary artery for reoxygenation in the lungs. As this condition worsens, blood is backed up and creates edema of the lower extremities, damage to the kidneys, congestion of the liver and potentially fluid accumulation in the abdomen.
Current Treatment Options
Current treatments for clinically significant moderate or greater functional tricuspid regurgitation (FTR)/ tricuspid insufficiency are generally limited to medical management and/or tricuspid valve repair or replacement. While medical management may reduce symptoms and improve quality of life temporarily in some patients, it fails to address the underlying pathophysiology of the disease state (i.e., lack of coaptation of the tricuspid valve leaflets resulting in incompetence and FTR/tricuspid insufficiency). Surgical tricuspid valve replacement in some patients presenting with very advanced symptomatic FTR/tricuspid insufficiency are often at prohibitive risk for cardiac surgery as mortality is exceedingly high, most especially if performed in isolation and not as part of left-sided valve procedures. These patients have limited therapeutic options and potentially a life with a high rate of hospitalizations for heart failure, poor quality of life and impaired functional capacity.
To address the need of patients presenting with moderate to severe functional tricuspid valve regurgitation, NCSI is developing a bio-prosthetic transcatheter atrioventricular valved stent to replace function of the diseased native valve in a beating heart. Clinical use of the device under the early feasibility study is anticipated to begin at multiple centers under a common protocol in early 2020.