Abbott's TriClip cuts heart valve leaks among patients with pacemakers

For the first time, Abbott showed that its transcatheter clip-based therapy for the heart’s tricuspid valve could help stem leaks and improve quality of life specifically among patients who have a pacemaker implant.

Typically, a pacemaker placed under the skin near the collarbone is connected to the cardiac muscles via a small wire that runs through a major vein and into the heart’s right atrium and ventricle, passing through the tricuspid valve separating both chambers. 

That electrical lead can end up interfering with the valve’s three leaflets, and keep them from closing properly. This allows blood to flow backward through the valve with each heartbeat, a condition known as tricuspid regurgitation.

To test if its tricuspid valve repair device could be of assistance, Abbott conducted two single-arm trials of its TriClip implant in people with a pacemaker lead—a group of patients previously deemed unlikely to see any benefits from a transcatheter approach and instead get directed toward open heart surgery.

After one month, the company found strong improvements in heart failure symptoms such as fatigue and discomfort. Some 69% of patients were categorized as Class I or II, indicating mild or no limitations during ordinary physical activity, compared to only 12% of participants at the start of the trial.

Abbott TriClip family
The TriClip implant (Abbott)

Additionally, 64% of patients saw their metrics of tricuspid regurgitation improve by at least two grades or more, while self-reported questionnaires on quality of life showed average gains of 19 points. 

The TriClip placement procedure itself delivered a 91% success rate, according to Abbott. The late-breaking results were presented at TVT: The Structural Heart Summit, the annual meeting from the Cardiovascular Research Foundation in Chicago. 

The TriClip—approved in Europe but awaiting the FDA’s green light in the U.S.—is based on the company’s successful MitraClip transcatheter implant, designed for leaks in the two-leafed valve connecting the heart’s left atrium and ventricle. It pinches and holds the valve’s flaps together in the middle of the opening, allowing blood to flow around it while helping create a tighter seal when closed.

Abbott also presented real-world data from MitraClip at TVT from a year-long study in patients with secondary mitral regurgitation, a condition caused after patients have a heart attack or an enlarged heart muscle causes the valve to change shape and not close properly. 

Among a broader group of patients compared to those enrolled in Abbott’s previous MitraClip trials, including people with advanced heart failure, the new study showed 89% of patients saw their regurgitation reduced to the least severe category, plus improvements in everyday symptoms and comparable safety rates.