Treatment with the TriClip transcatheter tricuspid valve repair system for severe tricuspid regurgitation (TR) is associated with reduced TR and no major adverse events, according to new real-world data presented virtually at EuroPCR 2021.
TriClip, manufactured by Abbott, gained CE mark approval back in April. It is still only approved for investigational use in the United States.
The study’s authors tracked data from 75 patients treated in Europe. The average patient age was 78.2. years old, 51% of patients were female, 89.3% had atrial fibrillation and 88% had hypertension. In addition, 35.1% of the patients had already undergone a prior mitral intervention, and 13.5% had already undergone a prior aortic intervention.
The team reported an implant success rate and acute procedural rate of 100%. The procedure lasted an average of approximately 98 minutes. There were no major adverse events at discharge, though three patients did experience major bleeding events. TR was reduced to moderate levels or less for 84% of patients.
“The bRIGHT study is a real-world evaluation of Abbott’s TriClip device in patients with severe TR,” Barathi Sethuraman, Abbott’s divisional vice president of global clinical affairs, told Cardiovascular Business. “Importantly, the study allows us to observe the performance of the device outside of a controlled clinical trial setting. The bRIGHT study results further support TriClip’s ability to reduce TR and help patients get back to living their fullest possible lives.”
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