TCT 2017 | The TRI-REPAIR and the FORMA Trials: New Devices for the “Forgotten Valve”

Courtesy of SBHCI.

Two new transcatheter treatments for severe or massive functional tricuspid regurgitation have showed good results at 30 days, according to their feasibility studies.

The long-forgotten tricuspid valve has been gaining more attention with research linking tricuspid regurgitation to an increase in mortality.

Early studies used devices originally designed for the mitral or aortic valves in patients who had no other treatment options. They were too frail and, of course, presented a high surgical risk.

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The TRI-REPAIR and the FORMA trials are the first studies on dedicated devices for the tricuspid valve.

The TRI-REPAIR study tested the Cardioband tricuspid repair system (Edwards Lifesciences), which performs annular reduction using the same concept as the Cardioband mitral system.

The study enrolled 30 symptomatic patients who were considered New York Heart Association (NYHA) class III or IV. The device achieved technical success in all patients, without procedural severe adverse events. At 30 days, two patients died for unrelated reasons.

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An echocardiography showed a 50% reduction in the regurgitant orifice area and a 31% reduction in the vena contracta area (p < 0.001).

The FORMA study tested its namesake device, which was especially designed for the tricuspid valve (Edwards Lifesciences). This device acts as a spacer positioned within the regurgitant orifice on which the native leaflets can coapt, and is anchored at the right ventricle apex and the subclavian vein.

This work included 30 patients and operators experienced device implantation problems due to subclavian vein disease or right ventricle perforation when trying to position the anchor. The next generation of this device should ensure more predictable anchor capture.

Courtesty of SBHCI.

Original titles:

-TRI-REPAIR: 30-Day outcomes of transcatheter TV repair in patients with severe secondary tricuspid regurgitation.

-The FORMA early feasibility study: 30-day outcomes of transcatheter tricuspid valve therapy in patients with severe secondary tricuspid regurgitation.

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