Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results

Catheter Cardiovasc Interv. 2022 Dec;100(7):1291-1299. doi: 10.1002/ccd.30450. Epub 2022 Nov 15.

Abstract

Background: Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery.

Methods: TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated.

Results: Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001).

Conclusion: Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.

Keywords: PASCAL; TriClasp study; heart failure; transcatheter tricuspid valve repair; tricuspid regurgitation.

Publication types

  • Multicenter Study

MeSH terms

  • Aged, 80 and over
  • Cardiac Catheterization
  • Female
  • Follow-Up Studies
  • Heart Valve Prosthesis Implantation*
  • Humans
  • Male
  • Prospective Studies
  • Severity of Illness Index
  • Treatment Outcome
  • Tricuspid Valve Insufficiency* / diagnostic imaging
  • Tricuspid Valve Insufficiency* / surgery