Valvular & structural heart disease

1-Year Outcomes of Transcatheter Tricuspid Valve Repair

J Am Coll CardiolPublished Prospective single-arm early feasibility study

Authors' conclusion

The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year.

Study context

Population
Patients with severe or greater tricuspid regurgitation (TR) and persistent symptoms despite medical treatmentmean age 77.4 y
Participants
65 patients
Outcome
Primary safety and performance outcomes; 1-year all-cause mortality and HF hospitalization
Follow-up
1 year
Methodological detailsmulticentre, independent core laboratory, clinical events committee
  • Multicentre
  • Independent core laboratory
  • Clinical events committee

Main finding

As reported in the abstract

Freedom from all-cause mortality and HF hospitalisation (Kaplan-Meier)

Freedom from all-cause mortality (Kaplan-Meier)

87.9%

Freedom from HF hospitalisation (Kaplan-Meier)

78.5%

Observational data: associations, not effects.

Further findings

CV mortality, stroke and device-related reintervention · 30 days

CV mortality
3.1%
Stroke
1.5%
No device-related reinterventions

CV deaths, strokes and unplanned or emergency reintervention · Between 30 days and 1 year

Additional CV deaths: 3
4.8%
Strokes: 2
3.2%
Unplanned or emergency reintervention: 1
1.6%

TR severity · 1 year

TR severity significantly reduced
P < 0.001
Moderate or less TR: 31 of 36
86.0%
At least 1 TR grade reduction
100%

NYHA class, 6-minute walk distance, KCCQ · 1 year

NYHA class significantly improved
P < 0.001
NYHA class I or II
92%
6-minute walk distance increased by 94 m
P = 0.014
KCCQ overall score improved by 18 points
P < 0.001

Original publication

1-Year Outcomes of Transcatheter Tricuspid Valve Repair. J Am Coll Cardiol. Published 9 May 2023. doi:10.1016/j.jacc.2023.02.049

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