In a clinical study, 90% of patients who received the FDA-approved device showed marked improvement that was sustained for at least one year.
On April 17, the interventional cardiology team at Providence Swedish successfully performed the first commercial procedure in the Pacific Northwest using the Abbott TriClip transcatheter edge-to-edge repair (TEER) system, the first-of-its-kind device to repair a leaky tricuspid valve condition known as tricuspid regurgitation (TR).
The Providence Swedish Structural Heart and Valve Team has been involved with minimally invasive catheter-based tricuspid valve regurgitation therapy since 2016 and with the TRILUMINATE Pivotal trial since 2020. The device has received FDA approval based on the data supplied by Swedish and other participating sites.
“Swedish has a long history of doing these types of procedures, and we were the first in the Northwest to perform this therapy,” said Sameer Gafoor, M.D., Medical Director of Structural Heart Disease at Swedish. “The trial showed the procedure was remarkably safe and associated with great improvements in quality of life, often more than just medications alone. This is a big deal because not only is it important to add years to life for people, but we often overlook how important it is to add life to those years.”
Abbott recently announced that the TriClip TEER system received approval from the U.S. Food and Drug Administration (FDA). As part of the approval process, the FDA reviewed findings from the TRILUMINATE Pivotal trial, the world's first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery. In the study, 90 percent of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction that was sustained at one year. The trial also demonstrated a highly favorable safety profile, with 98 percent of patients being free of major adverse events through 30 days, and a significant improvement in quality of life.
“The ease of this procedure is astounding. Many patients can go home the same or the next day and recovery is usually a week of activity restrictions,” said Sidakpal Panaich, M.D. “Overall, this procedure is revolutionary and really a great example of how Swedish research and Swedish clinical care has led the way to making patients feel better for longer periods of time.”
TriClip is delivered to the heart via a catheter inserted through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood. Designed specifically for the right side of the heart and the tricuspid valve’s complex anatomy, the innovative TriClip and steerable guiding catheter systems allow physicians to independently grasp and effectively clip leaflets of the tricuspid valve to reduce the regurgitation. This minimally invasive approach allows the heart to pump blood more efficiently and relieve symptoms of TR, which improves the quality of life for patients.
Tricuspid valve regurgitation is a condition in which the valve between the two right heart chambers, the right ventricle and the right atrium, don’t close properly, allowing blood to flow backward into the right atrium of the heart. The disease is often debilitating, causing symptoms such as shortness of breath and fatigue, and when left untreated, may progress into conditions such as atrial fibrillation, heart failure and ultimately death. Traditionally, the only treatment options for TR have been surgery, which is rarely performed due to the complexity of the procedure and high risks involved, and medical therapy, which is usually not successful in reducing TR. Abbott’s TriClip device provides a much-needed treatment option for people suffering from this condition.
“Swedish was one of the highest enrolling sites in Washington State and the Pacific Northwest for the trial, and we are amazingly grateful to the multiple patients that volunteered to be part of it,” said Santanu Biswas, M.D. “We now are able to provide an opportunity for patients, who previously did not have options, to have an ability to feel better and to make their medications work better.”
The Swedish Structural Heart and Valve Team has a long history of excellence in care of patients with complex valve disease. Through a multidisciplinary approach, they can address which patients are best suited for medical, surgical, or transcatheter therapy. Today, many patients can get transcatheter therapy, allowing them a shorter procedure time and a faster recovery with durable results. In addition, the program can access innovative research to treat patients who otherwise would have no commercially available options. Physicians at the Swedish Structural Heart Program speak nationally and internationally on these techniques and research, helping educate physicians and care providers to impact healthcare worldwide.
About Providence Swedish
Providence Swedish has served the Puget Sound region since the first Providence hospital opened in Seattle in 1877 and the first Swedish hospital opened in 1910. The two organizations affiliated in 2012 and today comprise the largest health care delivery system in Western Washington, with 22,000 caregivers, eight hospitals and 244 clinics. A not-for-profit family of organizations, Providence Swedish provides more than $406 million in community benefit in the Puget Sound Region each year. The health system offers a comprehensive range of services and specialty and subspecialty care in several clinical areas, including cancer, cardiovascular health, neurosciences, orthopedics, digestive health and women’s and children’s care.
