While minimally invasive repair devices have shown progress in stemming leaks of the heart’s notoriously tricky tricuspid valve, Edwards Lifesciences aims to show that replacing the valve entirely could be a strong alternative.
In a single-arm study, the company’s Evoque transcatheter tricuspid valve replacement system showed benefits in heart function and quality of life measures among patients with severe regurgitation, or the backflow of blood through the valve, within 30 days following the procedure.
Compared to the mitral valve—which separates the heart’s left atrium and ventricle and is commonly targeted for regurgitation treatment—the right-side tricuspid valve consists of three flaps instead of two, making it a greater technical challenge to get a tight seal.
Edwards’ investigational Evoque system is delivered to the heart by threading a catheter up through the veins from the thigh. Once in place, it unfolds and expands to take the place of the tricuspid with its own three-leaflet valve.
The study’s results, presented at the annual scientific sessions of the American College of Cardiology, showed significant reductions in regurgitation—after one month, two-thirds of 41 evaluated patients showed either no or trace amounts of leakage, while nearly all the rest showed only mild disease.
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received a breakthrough designation
from the FDA (Edwards)
Altogether, 98% of those participants saw the acuteness of their regurgitation downgraded from previously “torrential,” “massive” or “severe” categories and on average were able to walk 50 meters farther during a six-minute walking test.
Two deaths were reported, with one linked to cardiovascular disease, in addition to 12 cases of severe bleeding, none of which were life-threatening or fatal according to the trial’s investigators; 77% of patients had no major side effects after 30 days.
The study, named Triscend, will follow up with its participants at six months and annually for at least five years. Based on its positive results, Edwards recently began treating patients with Evoque in Triscend II, an open-label pivotal trial that aims to enroll at least 775 participants through 2024.
Together with mitral valve treatments—where Edwards launched a study for its minimally invasive Harpoon repair device last December—the company estimates the total transcatheter therapy market will reach $3 billion by 2025.
RELATED: Abbott customizes TriClip heart valve system with upgraded EU approval
Meanwhile, Abbott has received European approvals for two versions of its TriClip tricuspid valve repair device, modeled after its successful MitraClip system. It’s designed to fasten a clip to the valve’s leaflets and pinch them together to create a tighter seal. The system has also received approval in Canada, but it has not yet been approved in the U.S.