Just weeks after Abbott launched a large, randomized trial of its TriClip device—a new iteration of its mainstay MitraClip system, designed for leaky tricuspid heart valves instead of mitral valve repair—the devicemaker presented new data from a smaller, single-arm analysis showing clinical improvements after six months.
While the catheter-based MitraClip is designed to treat mitral regurgitation by pinching together the two leaflets of the bicuspid valve, the TriClip is similarly meant to halt backflow through the three fragile leaflets separating the heart’s right ventricle and atrium. Previously, the MitraClip has been used off-label in this indication, and there are currently no minimally invasive tricuspid repair therapies approved.
If the tricuspid valve does not fully close, regurgitation can increase the volume and blood pressure in the heart as well as in the venous system, with severe cases contributing to heart failure, atrial fibrillation and swelling in the limbs.
In the feasibility study of 85 patients, 87% saw reductions in the severity of their tricuspid regurgitation after six months, alongside a reduction in symptoms. Patients also reported improvements in quality-of-life scores, with the study meeting its primary safety and performance endpoints. The late-breaking data were presented at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.
"We have seen the need for a safe and effective device to treat the tricuspid valve without open heart surgery, so we have focused efforts to support this patient population,” Neil Moat, chief medical officer of Abbott's structural heart business, said in a statement.
Earlier this year, Abbott posted similar positive data from the 30-day mark, where 86.6% of patients saw a reduction in regurgitation severity of at least one grade. The study plans to continue follow-up through one, two and three years. The larger study, launched earlier this month, aims to enroll 700 patients with severe regurgitation in spite of previous treatments, with preliminary data expected in August 2022.
"Treating a leaky tricuspid heart valve has long presented a significant challenge for cardiologists because it is an extremely complex and difficult heart valve to treat," lead study investigator Georg Nickenig, professor and chief of the department of cardiology at University Hospital in Bonn, Germany, said at the time.
"These data are extremely encouraging, and I am excited about the potential of transcatheter tricuspid valve repair as a minimally invasive treatment option for these very ill patients who have no other options," Nickenig said.
Elsewhere at the TCT conference, Abbott showed off data on the cost-effectiveness of its MitraClip device, one of the company’s best-performing products.
Across a period of three years, the implant was projected to lengthen life expectancy by 1.13 years, alongside a 0.82 increase in quality-adjusted life-years, compared to the guideline-recommended standard of care alone among heart failure patients with secondary mitral regurgitation.
Additionally, the MitraClip demonstrated an incremental cost-effectiveness ratio of $55,600 per quality-adjusted life-year. Scores lower than $100,000 are generally considered a cost-effective therapy, according to Abbott.
Currently, the Centers for Medicare & Medicaid Services are considering an expanded national coverage determination of the transcatheter mitral valve repair procedure, with a proposal and final decision expected by May 2020.