June 10, 2024 — Atrium Health Sanger Heart & Vascular Institute has successfully completed the first commercial tricuspid clip procedure in the Carolinas, performed in May at Atrium Health Carolinas Medical Center. This achievement marks a significant milestone in the treatment of tricuspid regurgitation (TR), offering new hope to patients who are not candidates for traditional open-heart surgery.
Tricuspid regurgitation is a condition where the tricuspid valve, located between the right atrium and right ventricle of the heart, fails to close properly, allowing blood to flow backward. This can lead to symptoms such as severe shortness of breath, swelling in the legs and abdomen and a significant reduction in quality of life. Until recently, treatment options for TR were limited to medical management or high-risk open-heart surgery.
"This is an exciting day for our team and our patients," said Dr. Michael Rinaldi, an interventional cardiologist and the medical director of the structural heart program at Atrium Health Sanger Heart & Vascular Institute. "We have been eagerly anticipating the opportunity to bring this innovative technology to our community. The tricuspid clip offers a lifechanging option for patients who previously had limited treatment choices.”
The tricuspid clip procedure is a minimally invasive technique designed to address this condition. Performed through a catheter inserted into the vein, the device is guided to the heart using advanced imaging technologies. Once in place, the clip grasps and pulls the leaflets of the tricuspid valve together, reducing the regurgitation and significantly improving the patient's symptoms and quality of life.
Rinaldi and Dr. Markus Scherer, director of cardiac CT and structural heart imaging at Atrium Health Sanger Heart & Vascular Institute, along with a team of cardiac imaging experts, successfully guided the tricuspid clip into place using the latest technology in cardiovascular care.
The recent approval of the tricuspid clip device by the U.S. Food and Drug Administration (FDA) was based on the positive results of the TRILUMINATE pivotal trial. Atrium Health Sanger Heart & Vascular Institute was a key participant in this landmark study, which has set a new standard for the management of severe tricuspid regurgitation.
The tricuspid clip procedure offers numerous benefits over traditional surgical methods. It is a same-day procedure, allowing patients to return home the next day. Recovery times are significantly shorter, with most patients resuming normal activities within one week. Additionally, the risks associated with the procedure are much lower compared to openheart surgery.
Sanger Heart & Vascular Institute has established itself as a global leader in pioneering innovative heart treatments. Nearly 20 years ago, the institute distinguished itself by becoming one of the first centers worldwide to perform the groundbreaking mitral clip procedure as part of an early feasibility study. This procedure has since become a cornerstone in the field of structural heart interventions. Today, Sanger remains a leader in structural heart interventions, training other institutions in these advanced techniques.
"This is an important project for our entire institution," said Rinaldi. "We were one of the first 10 centers in the world to perform mitral clip procedures, and now we are leading the way with the tricuspid clip. This is an addition to a number of regional firsts. We were the first to perform tricuspid clip in the Carolinas, the first to perform tricuspid clip and transcatheter tricuspid replacement in the Carolinas as part of clinical trials and we are authors on multiple publications on trans-catheter mitral and tricuspid therapies.”
“Sanger Heart & Vascular Institute remains committed to advancing heart care through cutting-edge technologies and multidisciplinary collaboration,” said Rinaldi. “As a leader in structural heart interventions, Atrium Health Sanger Heart & Vascular Institute will continue to pioneer new treatments and train other physicians ensuring that patients receive the best possible care.”
For more information: www.atriumhealth.org