TRI-REPAIR & FORMA: Transcatheter TV Repair in Patients With Severe Secondary Tricuspid Regurgitation
Both TRI-REPAIR and FORMA presented at TCT 2017 in Denver offer preliminary insights into 30-day outcomes following transcatheter tricuspid valve (TV) repair in patients with severe secondary tricuspid regurgitation (TR).
In TRI-REPAIR study investigators reported 100 percent (30/30) successful access, deployment and positioning of the Edwards Cardioband System, which allows for tricuspid annular reduction via transfemoral access and is a dedicated technology to treat TR.
Among the results, researchers noted significant annular reduction and improvements in functional status. At 30 days, a 50 percent reduction in PISA EROA, 31 percent reduction in vena contracta, and 7 percent improvement in stroke volume was observed. Additionally, reduced TR was shown to occur, despite a large proportion of patients needing treatment for "torrential" TR at baseline.
"Use of Edwards Cardioband System for tricuspid regurgitation is feasible and safe," said Georg Nickenig, MD, from the University of Bonn, Germany, who presented on the study. "However, further study needed to understand clinically important endpoints for patients with right-sided heart dysfunction."
In FORMA, researchers evaluated the safety, device performance and 30-day clinical outcomes in 29 patients with severe secondary TR and multiple comorbidities who were treated with the FORMA Tricuspid Transcatheter Therapy System.
Overall results suggest treatment with the FORMA tricuspid valve therapy system is feasible. Researchers observed significant reduction of TR, especially in those patients with the worst baseline TR. "The magnitude of TR reduction was proportional to the severity of baseline TR," they noted. "FORMA may be especially useful in patients with the most severe TR."
Significant improvement in NYHA functional class, six-minute walk tests and KCCQ scores at 30 days was also observed. However, researchers also highlighted infrequent distal anchor dislodgements and right ventricular (RV) perforations associated with the FORMA system.
"Next generation FORMA devices are being developed to ensure predictable anchor capture without dislodgement or RV perforations," said Martin B. Leon, MD, FACC, of Columbia University Medical Center, New York Presbyterian Hospital, who presented on the study. "Longer term follow-up is necessary to assess recurrence of TR, evidence of RV remodeling, and late clinical outcomes."
"While results from both trials are promising, the numbers are small," said ACC.org Editor-in-Chief Kim Eagle, MD, FACC. "We need to learn more about the complications including distal anchor dislodgements, RV perforation, and long term benefit vs hazards."
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