At a Glance
- Tricuspid and mitral valve disease can lead to serious complications like high blood pressure, arrhythmia, and heart failure and can produce debilitating symptoms that reduce quality of life.
- Because patients with tricuspid and mitral valve disease symptoms are often elderly and have other health concerns, they are typically not candidates for open heart surgery.
- New devices for valve repair and replacement that are implanted using minimally invasive transcatheter procedures are poised to offer safe and effective treatment options that could improve care for this neglected patient population and potentially change how we approach valve disease management.
While transcatheter aortic valve replacement (TAVR) has changed the landscape of cardiology by offering a minimally invasive alternative to open heart surgery, similar innovations for treating tricuspid and mitral valve disease have lagged behind. But thanks to a recent wave of clinical trials, that's about to change.
"This is an incredibly fast-moving space now," said Susheel Kodali, MD, Director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital. "These patients have new treatments for managing these diseases, and we're confident this is just the beginning."
Kodali is a co-director of Columbia's newly formed Mitral and Tricuspid Center. This research-focused effort is centered on the latest clinical trials for transcatheter and surgical innovations and making these advances part of standard management for these chronic conditions.
"The center is a natural extension of how active Columbia has been in this space," says Kodali. "Device development, innovation, clinical trials that change the landscape… These are all things that Columbia is known for. By the time patients hear about something, Columbia's already been working on it for years."
A Clinical Need
The tricuspid valve has long been an area of clinical need; often referred to as the "forgotten valve," tricuspid valve research was historically not an area of significant focus and growth-despite tricuspid valve disease causing debilitating symptoms and leading to high blood pressure, arrhythmia, and heart failure. Treatment was a choice between risky surgery and medications for symptom management that were often both ineffective and came with serious side effects.
By comparison, mitral valve disease has better surgical outcomes and is the most common surgically repaired valve. But as mitral valve disease is also the most common form of valve disease, there remains a need for expanding options for patients who are not candidates for surgery.
Because both tricuspid and mitral valve disease are chronic conditions that contribute to heart failure, they require long-term management as part of a comprehensive, team-driven approach. "That means working with heart failure specialists earlier," says Kodali. At the center, we're working with an integrated heart failure management program, led by Dr. Kelly Axsom," says Kodali.
Eventually, these devices may allow us to treat these conditions more aggressively, even before symptoms present. After all, waiting until symptoms affect quality of life may prove to be too late to slow the progression of heart failure. TAVR began as a treatment for the sickest patients who were not surgical candidates; now, clinical trials are exploring the use of TAVR to treat aortic stenosis in younger and healthier patients. Why not take the same approach with the tricuspid and mitral valves?
But first, these new technologies must be proven safe and effective. "These devices are new and not yet perfect," says Kodali. In the same way TAVR started and devices iterated, we learned, moved on, and improved. This is what we're trying to do with next-generation devices, different approaches."
A Wealth of New Treatment Options
The variety of new devices that have recently been approved or are currently the subject of clinical trials highlights the different approaches for treating tricuspid and mitral valve disease repair that may soon be available. "We want people to know that we're not just using this one approach, that we're expanding to all these different ideas," says Kodali.
Recently Approved Devices and Current Clinical Trials
- Evoque Transcatheter Valve Replacement: Evoque recently became the first transcatheter therapy approved by the U.S. Food and Drug Administration (FDA) to treat tricuspid regurgitation (TR). Columbia was a major center for TRISCEND II, a randomized controlled pivotal trial examining the EVOQUE tricuspid valve replacement system, and remains one of a handful of sites offering treatment with the Evoque device. Similar in design to the TAVR device, Evoque can be implanted within a tricuspid valve to permanently replace the diseased valve and restore healthy blood flow.
- MitraClip Transcatheter Edge-to-Edge Repair (TEER) System: The MitraClip device uses a pair of arms to capture the mitral valve's leaflets and hold them together, helping the valve open and close more efficiently and reducing mitral regurgitation (MR)..
- TriClip TEER System: The TriClip device was recently approved by the U.S. Food and Drug Administration (FDA), thanks to the randomized controlled TRILUMINATE trial results. Based on the same technology as the MitraClip, the TriClip helps close the valve's leaflets to limit regurgitation.
- PASCAL Transcatheter Valve Repair System: The PASCAL implant uses two broad paddles with clasps to capture and secure the tricuspid valve leaflets and reduce leakage. Approved for use to treat MR, the CLASP II TR is now underway to examine the PASCAL device for TR, as well.
- CardioBand Valve Reconstruction System: This annuloplasty device is being tested in clinical trials for use in tricuspid and mitral valves. It stabilizes the base (annulus) of the poorly functioning valve and can be adjusted during implantation to fit a wide range of valve anatomies.
- Intrepid Transcatheter Mitral Valve Replacement System: The Apollo trial is exploring the safety and effectiveness of the Intrepid, the first transcatheter device for mitral valve replacement.
One challenge is making sure potential patients know about these new treatments and clinical trials. "There are so many trials for new devices for treating tricuspid and mitral regurgitation," says Kodali. "We have treatments and clinical trial opportunities available here at Columbia that may not be available elsewhere."
New treatments have the potential for more than just better disease management. These new minimally invasive options may help with how we approach valve disease and heart failure as a whole. Combining these treatments with minimally invasive surgical approaches like robotic surgery and careful management that starts much earlier in the disease process could dramatically impact not just quality of life but also the incidence and progression of heart failure in a large portion of the patient population.
"Right now, we have these new treatments and managements available, and then coming down the road, this is where we see treatment going," says Kodali. "These really are the potential treatment strategies of tomorrow."
Interested in Learning More?
The Columbia Structural Heart and Valve Center offers unmatched access to the latest treatments and clinical trials for heart valve disease. Our team of world-renowned experts have the experience and procedural skill you deserve, and will work with you beyond the procedure to manage your disease and health.
