Momentum Continues for Transcatheter Edge-to-Edge Repair
By Jonathan Springston, Editor, Relias Media
In May, researchers released a flood of information about two types of systems to repair faulty heart valves, with promising news for patients.
During tricuspid valve regurgitation, the valve between the two right heart chambers does not close properly. Thus, blood leaks backward into the upper right chamber. Similarly, during mitral valve regurgitation, the valve between the left heart chambers does not close completely, also causing backward blood flow.
In recent decades, instead of risky open-heart surgery to repair the leak or replace the entire valve, an alternative has emerged. During a transcatheter edge-to-edge repair (TEER) procedure, surgeons insert a catheter through an artery to implant a tiny device on the malfunctioning valve to help restore normal blood flow. Because only a small incision is needed to insert the catheter, TEER is considered a minimally invasive procedure.
Researchers affiliated with Cedars-Sinai in Los Angeles published the results of their registry-based cohort study of TEER. Investigators examined data about such procedures conducted from 2014 through 2022 using the MitraClip. More than 19,000 patients underwent TEER for moderate-to-severe, isolated, degenerative mitral valve regurgitation. Such surgery resulted in successful repair for 88.9% of patients.
“For patients at elevated risk for surgery, TEER with the MitraClip device is a meaningful treatment option. The procedure is getting many patients back to a more energetic life, and back to activities some haven’t been able to do for years,” said Raj Makkar, MD, the study’s senior author and Cedars-Sinai’s vice president of cardiovascular innovation and intervention.
During the annual meeting of the European Association of the Percutaneous Cardiovascular Interventions (EuroPCR) in Paris, researchers presented 30-day outcomes from bRIGHT, a study of the TriClip for repairing tricuspid regurgitation. TriClip is similar to MitraClip, both of which are produced by the same company. Although it is approved for use in Europe and Canada, TriClip remains only an investigational device in the United States.
In the bRIGHT study, for hundreds of patients at more than two dozen sites across Europe, the TriClip system reduced the tricuspid regurgitation grade to moderate or less for 77% of patients. Participants also demonstrated quality of life improvements.
As EuroPCR was happening, U.S. researchers published the results of TRILUMINATE, a randomized, controlled study of tricuspid regurgitation in the right heart. They reported the TriClip system was efficacious. Although promising, in an analysis of TRILUMINATE by the American College of Cardiology, experts noted some limitations they argued prevent generalizability and leave open the question about the long-term efficacy of the TriClip for repairing tricuspid regurgitation in the right heart.