Transcatheter Tricuspid Valve Replacement With the EVOQUE System 1-Year Outcomes of a Multicenter, First-in-Human Experience

OBJECTIVES The aim of this study was to report the midterm outcomes at 1 year in the expanded first-in-human experience with the transfemoral EVOQUE system (Edwards Lifesciences) for tricuspid regurgitation (TR). BACKGROUND Untreated TR is associated with excess mortality and morbidity. The first-in-human experience with the EVOQUE tricuspid valve replacement system reported favorable 30-day outcomes with no mortality in a compassionate use population. METHODS Twenty-seven patients with severe TR were treated with the EVOQUE system in a compassionate use experience at 7 centers between May 2019 and July 2020. All patients had clinical right-sided heart failure (HF) and were deemed inoperable and unsuitable for transcatheter edge-to-edge repair by the institutional heart teams. The clinical outcomes collected included all-cause mortality, symptom status, TR severity, HF hospitalization, and major adverse cardiovascular events. RESULTS At baseline, all patients (age: 77 +/- 8 years, 89% female) were at high surgical risk (mean Society of Thoracic Surgeons score: 8.6% +/- 5.5%), with 89% New York Heart Association functional class III/IV. TR was predominantly functional in etiology (19/27, 70%). At 1 year, mortality was 7% (2/27), 70% of patients were New York Heart Association functional class I/II, and 96% and 87% of patients had a TR grade <= 2+ and <= 1+, respectively. Between 30 days and 1 year, 2 patients experienced HF hospitalizations, and 1 patient required a new pacemaker implantation. CONCLUSIONS In this early, compassionate use experience, the transfemoral transcatheter EVOQUE tricuspid valve replacement system demonstrated durable efficacy, persistent improvement in symptom status, and low rates of mortality and HF hospitalizations at a 1-year follow-up. Further studies are underway to validate its efficacy. (C) 2022 by the American College of Cardiology Foundation.