Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System for the Treatment of Severe Tricuspid Regurgitation: Insights From the First-in-Human Experience.

Asmarats, Lluis; Perlman, Gidon; Praz, Fabien; Hensey, Mark; Chrissoheris, Michael P; Philippon, Francois; Ofek, Hadass; Ye, Jian; Puri, Rishi; Pibarot, Philippe; Attinger, Adrian; Moss, Robert; Bédard, Elisabeth; Moschovitis, Aris; Reineke, David; Lauck, Sandra; Blanke, Philipp; Leipsic, Jonathon; Spargias, Konstantinos; Windecker, Stephan; ... (2019). Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System for the Treatment of Severe Tricuspid Regurgitation: Insights From the First-in-Human Experience. JACC. Cardiovascular Interventions, 12(15), pp. 1438-1447. Elsevier 10.1016/j.jcin.2019.04.038

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OBJECTIVES

To evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California).

BACKGROUND

Scarce data exist on long-term outcomes following TTVr.

METHODS

This multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter.

RESULTS

Nineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline.

CONCLUSIONS

TTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years.

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