Transforming heart care
Heart failure remains a formidable challenge in modern medicine, claiming the lives of millions across Europe and the US annually. Among the various complexities of heart failure lies tricuspid valve regurgitation, a condition often overlooked due to the unique anatomical and functional intricacies of the tricuspid valve. The tricuspid valve is one of the four valves in the heart responsible for maintaining the proper flow of blood between the heart's chambers. In tricuspid valve regurgitation, the valve does not close properly during ventricular contraction and there is a backflow of blood into the right atrium. This reduces the heart's efficiency in pumping blood to the lungs and the rest of the body.
Groundbreaking device
Tricuspid valve regurgitation affects hundreds of thousands of individuals over 70 years of age each year, with disease severity depending on the degree of valve dysfunction. Although mild cases may be managed with medication to alleviate symptoms, treatment options for severe cases are limited to open-heart surgery. However, surgery is associated with significant risks, leaving patients who have other comorbidities untreated. To address this unmet clinical need, the EU-funded Duo project has developed an innovative device for the treatment of tricuspid valve disease. Unlike traditional methods that necessitate invasive surgeries, Duo offers a minimally invasive solution tailored specifically to the challenges of the tricuspid valve. “At the core of Duo's design, is its suitability to the variability in anatomy of the diseased tricuspid valve,” outlines Lucy O'Keeffe, project coordinator and CEO at CroiValve. Using an adjustable anchor, the device is positioned between the valve leaflets and anchored against the venous wall without interfering with delicate cardiac tissue. Importantly, this approach accommodates respiratory and cardiac motion.
Duo device advantages
The Duo device not only mitigates the risks associated with open-heart surgery but also enables delivery through a vein which minimises patient impact. Compared to existing solutions such as open-heart surgery or other minimally invasive approaches like repair and replacement, Duo offers unparalleled advantages. Its straightforward implantation procedure, coupled with its compatibility with diverse patient anatomies, sets it apart as a safer and more effective option for tricuspid valve disease. Early clinical trials have demonstrated remarkable improvements in symptoms and quality of life for those treated with Duo, underscoring its transformative potential in addressing this critical unmet medical need.
Future endeavours
“Our long-term goal is to establish Duo as the gold standard treatment for tricuspid regurgitation, potentially saving thousands of lives and alleviating the burden on healthcare systems,” emphasises O'Keeffe. Significant milestones have already been achieved, including FDA approval for early feasibility studies and advancements in manufacturing specifications to ensure scalability and efficacy. Moreover, health economic studies underscore the potential cost benefits of Duo, with reduced hospitalisations translating to substantial savings for healthcare systems. Looking ahead, the focus remains on expanding clinical studies and advancing Duo towards commercialisation. The Duo device has the potential to revolutionise treatment for tricuspid valve disease and offer hope to millions worldwide.
Keywords
Duo, tricuspid valve, tricuspid valve regurgitation, device, open-heart surgery