Trials Address New Options for Tricuspid Valve Defects

Tricuspid Valve

The tricuspid valve is often referred to as the “forgotten valve.” That’s because when it begins to malfunction, it usually doesn’t result in the same severity of symptoms as when there are problems with the aortic and mitral valves. Additionally, when it does stop working properly, fewer interventions are available for treatment.

Recently, however, that situation has begun to change. Experts from Brigham and Women’s Hospital are now participating in two multicenter clinical trials studying catheter-based treatments that could restore the function of the tricuspid valve. One trial is looking at valve repair, and the other is focused on valve replacement. Both approaches would provide new options for patients who don’t respond to medical treatment, but who are not good candidates for open-heart surgery, either because their disease is not severe enough to warrant the risks or due to comorbid conditions.

“We’ve seen tremendous success in the aortic space, to the point that now the majority of aortic valve replacements in the United States are done through a catheter-based treatment rather than by surgery,” said Pinak Bipin Shah, MD, director of the Interventional Cardiovascular Disease Training Program and director of the Cardiac Catheterization Laboratory at the Brigham. “There’s also one approved transcatheter device for the treatment of mitral valve regurgitation. Given what we’ve seen in these other areas, there’s now a lot of interest in looking at whether we can treat the tricuspid valves with catheter-based approaches.”

A Focus on Valve Repair and Replacement

One study being offered at the Brigham is the TRILUMINATE Pivotal Trial, which is a prospective, randomized trial that is evaluating an investigational clip device in patients who are experiencing symptoms from severe tricuspid regurgitation. The other study, the TRISCEND II Pivotal Trial, is looking at Evoque, a tricuspid valve replacement system that doesn’t require open-heart surgery. The control in both trials is medical therapy.

“There’s still much to be learned about the optimal time of treatment for these patients, but we probably ought to be intervening on these patients sooner rather than later,” said Tsuyoshi Kaneko, MD, a cardiac surgeon who specializes in endovascular approaches. “At the same time, the invasiveness of open-heart surgery is often more than we feel comfortable offering to patients who may otherwise feel well. Having transcatheter options for the management of these patients will be an important new option.”

“With tricuspid regurgitation, the patient typically doesn’t notice anything unusual. It’s often picked up on an echocardiogram looking for some other process,” Dr. Shah added. “But although it doesn’t cause symptoms right away, we are learning that this can be a very difficult illness to deal with if left untreated. It can result in dysfunction of the right side of the heart and lead to problems including severe fluid retention, shortness of breath and fatigue.”

Evaluating Less-Invasive Treatments for Tricuspid Valve Defects

Like other transcatheter procedures, tricuspid valve repairs and replacements are done under general anesthesia with echo guidance using a transesophageal echocardiogram. The procedures last no more than two hours, and the team thinks they will need even less time as they gain more experience. Patients who have these procedures require only an overnight stay and usually can go back to normal activities within a week.

For patients who have significant tricuspid regurgitation, especially those who are symptomatic, the comprehensive, multidisciplinary Cardiac Valve Center at the Brigham provides evaluations to determine the best course of action for managing disease. Having additional options for those with tricuspid valve defects adds to the scope of what can be offered to patients.

“This treatment is going to be really revolutionary because it is so much less invasive than open-heart surgery,” Dr. Kaneko said. “We will be able to offer treatment earlier in the disease process, allowing for a much more rapid recovery while preventing later complications.”