Transcatheter Tricuspid Valve Repair With a New Transcatheter Coaptation System for the Treatment of Severe Tricuspid Regurgitation: 1-Year Clinical and Echocardiographic Results.

Abstract Objectives This study sought to describe the 1-year experience with the transcatheter FORMA system for severe tricuspid regurgitation (TR). Background Severe TR is associated with significant morbidity and mortality. Novel transcatheter therapies have been recently developed. Methods Eighteen patients underwent device implantation at 3 centers in Canada and Switzerland. Baseline characteristics, procedural, 30-day, and 1-year outcomes were prospectively evaluated using multimodality imaging and hemodynamic and clinical assessments. Results Procedural success was achieved in 16 (89%) patients. Unsuccessful procedures were because of right ventricular perforation requiring open surgery and device dislocation. At 1 year there were no deaths, significant arrhythmias, device infections, or dislocations. Thrombus was observed on 1 device at 4 months and there was 1 rehospitalization for heart failure. Among the 14 patients with successful device implantation and 1-year follow-up, 79% were in New York Heart Association functional class I/II (p  Conclusions Implantation of the FORMA system in high-risk patients with severe TR shows feasibility with a good mid-term safety profile. At 1 year, despite variable success in reducing echocardiographic TR grade, there were significant clinical improvements and reductions in right ventricular dimensions.