Biological Valve System Treats Tricuspid Valve Disease

A new tricuspid regurgitation (TR) therapy system treats patients at extreme risk or who are ineligible for open surgical therapy.

The Products+Features (P+F; Vienna, Austria) TricValve Transcatheter Bicval Valves system is comprised of two self-expanding biological valves made of bovine pericardium that are designed to treat patients with hemodynamically relevant TR insufficiency and caval reflux. The valves are implanted simultaneously via a percutaneous procedure into both the superior and inferior vena cava, without disturbing the native tricuspid valve. The valves come fully pre-mounted, facilitating the use of the system in clinical practice.

The superior vena cava valve is available in sizes of 25 mm and 29 mm; the 25 mm valve encompasses a treatment range of 22-31 mm, and the 29 mm valve is intended for veins 27-34 mm in diameter. Nitinol frame heights are 67 and 69 mm respectively in a relaxed state, with a long polyethylene terephthalate (PET) skirt to prevent para valvular leak (PVL). The inferior vena cava valve is available is 31 mm and 35 mm diameters; the treatment ranges are 24-31 mm and 28-35 mm, respectively. Frame height in both inferior vena cava valves is 65 mm, including a short PET skirt to prevent hepatic vein occlusion.

“The TricValve system represents a new technology offering a potentially simple, relatively low-risk, yet effective treatment for patients with symptomatic severe tricuspid regurgitation and heart failure, many of whom harbor anatomy unfavorable for edge-to-edge repair or direct annuloplasty,” said Professor Samir Kapadia, MD, of the Cleveland Clinic (OH, USA). “It allows for all future options as patients stabilize and improve.”

The tricuspid valve separates the right atrium from the right ventricle, preventing blood from flowing from the ventricle back into the atrium. Diseases of the tricuspid valve are much rarer than those of the mitral valve, its counterpart in the left half of the heart. Tricuspid insufficiency, leading to TR, leads to build-up of blood in the ventricle and the veins, resulting in water retention in the legs and abdomen, liver damage, and potential atrial fibrillation (AF). People with TR are typically older and suffer from multiple co-morbidities, making open-heart surgery a high-risk procedure.

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