GROUNDBREAKING results presented at PCR London Valves 2024 demonstrated the safety and effectiveness of the PASCAL valve repair system at one year, in patients with severe tricuspid regurgitation (TR) who underwent tricuspid transcatheter edge-to-edge repair (T-TEER).
The TriCLASP study, a European single-arm post-market follow-up trial, assessed the safety and efficacy of the PASCAL transcatheter valve repair system in patients with severe or greater TR. This prospective study enrolled 300 participants, predominantly older adults with significant comorbidities. Most patients experienced severe TR and high symptom burden, with 78.0% classified as New York Heart Association (NYHA) class III/IV and 63.4% having a history of heart failure hospitalisation within the previous year.
Over one year, the procedure demonstrated a favourable safety profile, with a 12.7% rate of major adverse events (MAEs) at one year, including 7.3% cardiovascular mortality. Notably, 87.4% of patients achieved TR reduction to moderate or less immediately post-procedure, sustained in 87.7% at one year. Hospitalisations for heart failure declined significantly, with a 72.2% reduction in annualised rates, and functional capacity improved markedly, as reflected by NYHA class improvement in 74.4% of patients and a mean 6-minute walk distance increase of 29.4 metres. Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, also improved significantly, with a mean score increase of 8.3 points.
The results of the TriCLASP study highlight the clinical utility of the PASCAL system in managing severe TR, offering a minimally invasive alternative to surgical interventions. These findings suggest durable improvements in TR severity, reduced hospitalisations, and better patient-reported outcomes, aligning with the broader goals of patient-centred care in cardiology. Future research should explore long-term benefits beyond one year and identify optimal patient selection criteria to maximise therapeutic benefit.
Reference
Stephan B et al. TTVR: TriCLASP study one-year results. Abstract A55377HA. PCR London Valves, 24-26 November, 2024.
