TriClip device gets FDA nod for leaky heart valve

The US Food and Drug Administration (FDA) has approved the TriClip device for transcatheter edge-to-edge repair (TEER) in patients with severe tricuspid regurgitation (TR) or a leaky heart valve who are not eligible for surgery.

The approval was based on findings from the randomized controlled TRILUMINATE trial, which enrolled 350 patients with symptomatic severe TR in the US and randomly assigned them to the TEER delivery system or medical therapy as a control.

The device reduced the severity of tricuspid regurgitation, leading to a substantial improvement in patients’ quality of life that persisted for up to 1 year.

TriClip TEER was safe, with 98.3 percent of the patients free from major adverse events at 30 days. [N Engl J Med 2023;388:1833-1842]

Approval a significant step

In patients with TR, the tricuspid valve fails to close completely, causing the blood to leak backwards into the atrium from the valve, causing the heart to pump harder to move blood through the valve.

Untreated severe TR is associated with substantial morbidity, and patients often have poor quality of life. Congestive right heart failure and impaired cardiac output are common manifestations in these patients, causing excessive fatigue and peripheral oedema.

Decreasing TR may reduce their symptoms and improve clinical outcomes.

Principal investigator Dr Paul Sorajja from Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, US said the approval is “a significant step” for patients with TR.

“With TriClip, physicians can offer patients a treatment option backed by excellent safety and effectiveness data to help restore tricuspid valve performance without the need for high-risk open-heart surgery, which may not be feasible for older and sicker patients,” he added.

New era of tricuspid valve intervention

Co-principal investigator Dr David Adams from the School of Medicine at Mount Sinai in New York, US said even when surgery is feasible in certain patients with TR, the mortality rate is about 10–15 percent.

“The findings usher in a new era of tricuspid valve intervention,” he said. “There will be a pendulum change now. Patients who may have failed medical therapy could be treated early, eventually showing us bigger gains in outcomes."

TriClip is indicated for improving QoL and functional status in patients with symptomatic severe TR despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom TEER is clinically appropriate and expected to reduce TR severity, as determined by a multidisciplinary heart team.

TriClip leverages the same clip-based technology as the MitraClip, also from Abbott.