Last month, the U.S. Food and Drug Administration approved the first transcatheter therapy for the treatment of tricuspid regurgitation (TR) in patients with symptomatic severe TR. Susheel Kodali, MD, Director of the Structural Heart and Valve Center at NewYork-Presbyterian/Columbia, and Rebecca T. Hahn, MD, Director of Interventional Echocardiography at the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia, served as two of the global principal investigators of the pivotal TRISCEND II clinical trial, which proved the safety and efficacy of this new tricuspid valve replacement system. Successful six-month results from the trial were presented by Dr. Kodali at the Transcatheter Cardiovascular Therapeutics (TCT) conference in October 2023.
Below, Dr. Kodali shares background on the TRISCEND II Trial and his reaction to the FDA approval:
At New York-Presbyterian, we’re committed to advancing treatments for our patients living with tricuspid valve disease. We have been at the forefront of research looking at transcatheter tricuspid valve therapies for over 10 years and throughout this time we’ve studied 10 different devices with the goal of identifying the best approach to address TR.
Although historically underappreciated, TR is an issue that we, as physicians, see more of as people live longer. Treatment options for TR are limited, with medical therapy being suboptimal and surgery having high rates of morbidity and mortality. As a result, there has long been an unmet need for transcatheter solutions that provide treatment options at lower risk and result in improved outcomes. That need is what the TRISCEND II Trial stemmed from.
The TRISCEND II Trial aimed to address these issues by testing transcatheter tricuspid valve replacement (TTVR) with the EVOQUE system in 400 patients across two phases. The procedure is performed utilizing percutaneous access via the right or left femoral vein. A catheter containing the valve is advanced over a wire placed in the right ventricle, positioned across the diseased tricuspid valve under echocardiographic guidance and deployed. The valve consists of a nitinol frame with a tissue valve inside of it. In many ways, it's like transcatheter aortic valve replacement – the bioprosthesis anchors within the native tricuspid annulus, pushing aside the diseased leaflets and allowing the new valve inside to take over the function. Unlike repair techniques, treatment with TTVR eliminates TR.
In the first phase of TRISCEND II, which included 150 patients, we analyzed primarily the safety and feasibility of the procedure. Nearly all patients had successful valve implantations performed percutaneously and cardiovascular mortality was 3% at 30 days. These results showed us that it was feasible to do the procedure safely and that the transcatheter therapy led to elimination of TR along with significant improvements in both symptoms and quality of life, including not feeling short of breath and patients reporting improved functional status.
The second phase of TRISCEND II will look at one-year data for the entire cohort of patients treated and importantly evaluate outcomes such as mortality and heart failure hospitalization. Although the data for the entire cohort is not yet available, the FDA, after reviewing all available data including that for those patients in the second phase of the study, issued its approval of this new transcatheter therapy for patients with a poor long-term prognosis that currently have no treatment options available as part of its FDA breakthrough designation pathway.
It's been a journey over the past 10 years of looking at this disease state, testing different devices, and unfortunately experiencing a lot of failures. To finally get to this point where we finished a randomized trial and demonstrated benefit which led to an approved device is gratifying, it’s exciting, it’s all of it.
Now that this device is approved, we need to educate not only patients but the referring community and physicians about the disease process, when to treat, who to treat, and what treatment options are available. We must also work to disperse the technology responsibly and continue to critically analyze the data to ensure the right patients are benefiting from this device.
