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

Perlman, Gidon; Praz, Fabien; Puri, Rishi; Ofek, Hadass; Ye, Jian; Philippon, Francois; Carrel, Thierry; Pibarot, Philippe; Attinger, Adrian; Htun, Nay Min; Dvir, Danny; Moss, Robert; Campelo-Parada, Francisco; Bédard, Elisabeth; Reineke, David Christian; Moschovitis, Aris; Lauck, Sandra; Blanke, Philipp; Leipsic, Jonathon; Windecker, Stephan; ... (2017). Transcatheter Tricuspid Valve Repair With a New Transcatheter Coaptation System for the Treatment of Severe Tricuspid Regurgitation: 1-Year Clinical and Echocardiographic Results. JACC. Cardiovascular Interventions, 10(19), pp. 1994-2003. Elsevier 10.1016/j.jcin.2017.06.036

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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 < 0.001), the average 6-min-walk test increased by 84 m (p = 0.03), and the Kansas City Cardiomyopathy Questionaire heart failure score improved by 18 points (p = 0.02) compared with baseline. Echocardiography showed a reduction of TR from severe in 17 of 18 (94%) patients at baseline to moderate-severe or less in 11 of 16 patients (69%) by 30 days (p = 0.001) and 6 of 13 patients (46%) by 1 year (p = 0.01). The diameters of the tricuspid annulus and the right ventricle were reduced at 1 year (45.7 ± 4.8 mm to 42.1 ± 4.4 mm, p = 0.004; 54 ± 5.3 mm to 49.9 ± 4.3 mm, p = 0.02, respectively).

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.

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