MUSC Health first system in SC to use newly FDA-approved device for tricuspid regurgitation

In early October, surgeons at MUSC Health in Charleston and Columbia performed the first tricuspid transcatheter edge-to-edge repairs (TEER) in the state. 

The Abbott TriClip transcatheter tricuspid valve repair system was approved by the Federal Drug Administration earlier this year and became commercially available to patients in South Carolina on Oct. 1. 

Nicholas Amoroso, M.D., an interventional cardiologist at MUSC Health who specializes in catheter-based procedures, said this option can drastically change his patients’ quality of life. He is excited to have an alternative to open-heart surgery for his sicker or older patients who either can’t or shouldn’t undergo major surgery. 

“The tricuspid valve is the largest valve in the heart,” Amoroso said. “And its anatomy varies from patient to patient. So having flexible technology like the TriClip allows physicians to decide where to place the clip and how many clips to place for each of their patients.”

 

Its customizable nature appeals to physicians like Amoroso because he can reach more patients. Being commercially available also allows more patients access, as they no longer have to qualify for a trial to undergo the surgery. 

Daniel Steinberg, M.D., and Nicolas Pope, M.D., performed the surgery with Amoroso in Charleston on Oct. 1. Loren Garrison Morgan, M.D., and his team performed the procedure in Columbia on the same day. Not every hospital has the capability to perform the TEER, according to Amoroso, and a complex heart and vascular team like the one at MUSC Health is needed.

“As cardiologists, we're always looking for innovations that improve patient outcomes, Morgan said. “The TriClip represents a significant advancement in our ability to manage complex mitral valve disease, offering patients a minimally invasive option that can make a profound difference in their quality of life."

Tricuspid regurgitation occurs when blood is unable to flow properly from the heart’s right atrium to the right ventricle. The leaflets in the tricuspid valve don’t close properly, which results in a leak, and blood flows backward through the heart. Regurgitation like this can lead to swelling in the legs or stomach, fatigue and shortness of breath in patients as it forces the heart to work harder. Over time, it can lead to heart failure, atrial fibrillation and a debilitating quality of life.

Often referred to as the “forgotten valve,” the tricuspid valve’s size and anatomy variations lend it to being the last heart valve to receive FDA approval for new treatments. 

 

The TriClip TEER technology works by clipping leaflets in the heart together. By joining these flaps of tissue, the heart valve can function as it is designed – by allowing blood to flow forward through the heart without leaking backward. Sometimes, patients need two to three clips, and the unique design allows physicians to enter through the femoral vein in the leg and place the clip or multiple clips without incision or major surgery.

Patients are often in the hospital only one or two days before heading home. 

As tested in the TRILUMINATE trial in 2023, Abbott reported positive results for their TriClip technology. After 30 days, almost 90% of patients experienced great improvement in their tricuspid regurgitation. 

Amoroso expects MUSC Health to be performing this procedure regularly in the coming months, both with the TriClip and with a similar device from Edwards Lifesciences, which is expected to complete its clinical trial later this year. 

“With two landmark FDA approvals this year for minimally invasive procedures for the tricuspid valve, we are able to offer more treatments for our patients,” Amoroso said. “And we are thrilled to reach those patients who previously were without options.”