Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation A Multicenter, Observational, First-in-Human Experience

OBJECTIVES The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the PASCAL transcatheter valve repair system and its impact on short-term clinical outcomes in patients with severe tricuspid regurgitation (TR). BACKGROUND Transcatheter repair of severe TR is a promising treatment option for patients at prohibitive surgical risk. Large leaflet coaptation gaps and tethering represent common features that challenge the application of transcatheter repair techniques. METHODS Twenty-eight patients with severe TR were treated with the PASCAL system in a compassionate use experience at 6 sites. All patients had heart failure due to severe TR and were deemed at high surgical risk by institutional heart teams. The primary outcome was procedural success, defined as the implantation of at least 1 device with post-procedural TR grade <= 2+, without mortality or conversion to surgery. RESULTS All patients (mean age 78 +/- 6 years, 54% women) were at high surgical risk (mean European System for Cardiac Operative Risk Evaluation II score 6.2 +/- 5.2%). TR etiology was functional in 92%, with mean tricuspid annular diameter of 49.5 +/- 6 mm and mean coaptation gap of 6.9 +/- 3 mm. Procedural success was 86%, with 1.4 +/- 0.6 devices implanted per patient. There were no intraprocedural complications. At 30-day follow-up, mortality was 7.1%, 88% of patients were in New York Heart Association functional class I or II, with TR grade <= 2+ in 85%. There were 2 single-leaflet device attachments, which were managed conservatively. Six-min walk distance improved from 240 m (interquartile range: 172 to 337 m) to 335 m (interquartile range: 251 to 385 m) (p < 0.001). CONCLUSIONS This first-in-human experience evaluating transcatheter tricuspid repair with the PASCAL system demonstrated high procedural success, acceptable safety, and significant clinical improvement. Larger prospective studies with long-term follow-up are needed to confirm these initial promising results and further define the impact of PASCAL tricuspid repair on clinical outcomes. (C) 2019 by the American College of Cardiology Foundation.