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
Lluis AsmaratsJosep Rodés-Cabau

Abstract

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). Scarce data exist on long-term outcomes following TTVr. 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. 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 ...Continue Reading

Citations

Sep 10, 2020·Frontiers in Cardiovascular Medicine·Guillem Muntané-CarolJosep Rodés-Cabau
Sep 23, 2020·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Rutao WangDarren Mylotte
Dec 15, 2020·Clinical Research in Cardiology : Official Journal of the German Cardiac Society·Atsushi SugiuraMarcel Weber
Mar 24, 2021·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Niklas F BoederHolger M Nef
May 18, 2020·The Journal of Thoracic and Cardiovascular Surgery·Guillem Muntané-Carol, Josep Rodés-Cabau
Apr 6, 2020·The Journal of Thoracic and Cardiovascular Surgery·Vinayak Bapat, Gilbert H L Tang

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