Novel Device Improves Severe Tricuspid Regurgitation
Treating severe tricuspid regurgitation with a transcatheter repair system may be both safe and feasible, according to the results of a study presented Oct. 11 at TCT 2015 and simultaneously published in the Journal of the American College of Cardiology.
In the study, Francisco Campelo-Parada, MD, et al., evaluated the efficacy and safety of Edwards Lifesciences’ Forma Repair System in seven high-risk patients with severe tricuspid regurgitation. The Forma Repair System “is designed to reduce severe tricuspid regurgitation by occupying the regurgitant orifice area and providing a surface for native leaflet coaptation.”
In addition to severe tricuspid regurgitation, the patients showed clinical signs of heart failure and were at prohibitive operative risk. At baseline, all patients had a normal left ejection fraction and a New York Heart Association functional class of III or IV.
The results of the study showed that all patients had a successful device implantation and had significant reduction in their tricuspid regurgitation severity, as assessed by transthoracic echocardiography (TTE). Further, patients showed substantial reductions in the presence and severity of peripheral edema at 30-day follow-up. TTE at 30 days showed that the tricuspid regurgitation in majority of patients improved to ‘moderate.’
The authors note that moving forward, long-term follow-up and “larger studies will need to be undertaken to further test the safety and efficacy of this novel device.”
“The current experience is preliminary and suggests feasibility, safety and short-term clinical benefits,” state Alec Vahanian, MD, and Jean Michael Juliard, MD, in an accompanying editorial comment. “We should now … carefully evaluate the results and refine the technology.”
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