Percutaneous tricuspid valve repair: A safer alternative to traditional approaches?

Tricuspid regurgitation (TR) is a common type of age‐related valve disease associated with a poor prognosis, even in patients who receive optimal medical therapy. In patients who undergo isolated tricuspid valve (TV) surgery, the operative mortality rate is 10%. Thus, additional approaches for managing TR are needed. The 2021 European Society of Cardiology/European Association for Cardio‐ Thoracic Surgery Guidelines for managing valvular heart disease suggested a potential role for the use of transcatheter TV intervention in patients with TR who are at high surgical risk. In this issue of Catheterization and Cardiovascular Interventions, Baldus et al. reported the 30‐day results of the TriCLASP study (Transcatheter Repair of Tricuspid Regurgitation with Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post‐Market Clinical Follow‐Up), which is a prospective, single‐arm, multicenter postmarket German study of the PASCAL transcatheter valve repair system for patients with symptomatic severe or greater TR who were deemed ineligible for surgery. The primary safety endpoint of major adverse events (MAEs) was adjudicated by the clinical events committee, and the primary effectiveness endpoint of echocardiographic TR severity was adjudicated by the core lab. The secondary endpoints were clinical, functional, and quality‐of‐life outcomes. Upon trial completion, the primary safety and performance endpoints of the PASCAL Ace implant (Edwards Lifesciences) at long‐term follow‐up (up to 5 years) will also be evaluated. The TRILUMINATE study (Mitraclip; Abbott Vascular‐Structural Heart) and bRIGHT registry (Triclip; Abbott Vascular) demonstrated a favorable safety profile for transcatheter edge‐to‐edge repair (TEER) devices. In addition, the CLASP TR trial recently showed that using the PASCAL Ace implant significantly reduced TR and improved quality of life at 1 year. In the TriCLASP study by Baldus et al., the PASCAL system had a high implant success rate of 97.2%. Furthermore, no embolization was reported, and only one (1.3%) patient had single‐ leaflet device attachment, compared with 5 (7.7%) reported in the TRILUMINATE study. The mean length of stay was 5 days, compared with 2 days reported in the CLASP TR study. Although only patients with greater than severe TR were initially enrolled in the TriCLASP study, the core lab reclassified the TR grade to moderate or less in 10 patients, leaving only 83% of study patients with severe TR. Nevertheless, procedural success, defined as a reduction by at least one grade of TR on transesophageal echocardiography at discharge, was observed in 77.8% of patients. At 30‐day follow‐up, 90% of patients had moderate TR on transthoracic echocardiography.