New Tricuspid Valve Procedure Helps Patients Avoid Open-Heart Surgery

By HospiMedica International staff writers
Posted on 30 Sep 2024

Image: The TriClip Transcatheter Edge-to-Edge device (Photo courtesy of Abbott)

The tricuspid valve, one of the heart's four valves, opens and closes to regulate blood flow. In patients with tricuspid regurgitation (TR), the valve doesn't fully close, causing blood to flow backward, or regurgitate, rather than forward as it should. This backward flow makes the heart work harder and weakens it over time. Individuals with TR often suffer from fatigue, leg swelling, and congestion in the liver and kidneys. The tricuspid valve has historically been known as the "forgotten valve" due to the limited treatment options available for TR. Now, a new treatment breakthrough offers hope to TR patients who are too sick for open-heart surgery.

The first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system from Abbott (Chicago, IL, USA) is specifically designed to treat TR. This minimally invasive option provides a safe alternative for patients who are unable to undergo surgery. TriClip is delivered through a vein in the leg and works by clipping together part of the valve's leaflets, or tissue flaps, to help the tricuspid valve function properly and direct blood flow without the need for open-heart surgery. Patients who receive TriClip typically spend just one day in the hospital before recovering and returning home.

The TRILUMINATE Pivotal trial has shown that patients treated with TriClip experience significant improvements in both symptom severity and quality of life, with benefits lasting at least one year. This trial, the world's first randomized, controlled clinical study for TR, compared the safety and effectiveness of TriClip to medical therapy in patients with severe TR who are at intermediate or greater risk for open-heart surgery. Results showed that 90% of patients treated with TriClip saw their TR severity reduced from severe to moderate or less within 30 days, and these improvements were sustained over a year. The trial also demonstrated a strong safety profile, with 98% of patients experiencing no major adverse events at 30 days, along with significant quality-of-life improvements. Since its initial CE Mark approval in 2020, TriClip has been approved in over 50 countries, including the US, Europe, and Canada, and has already been used to treat more than 10,000 patients with TR.

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