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Valvular & structural heart diseaseCohort study

Prospective Midterm Outcomes of the PULSTA Self-Expandable Transcatheter Pulmonary Valve: The PULSTA CE Approval Study

Circ Cardiovasc IntervPublished

  • premarket, multicenter, nonrandomized study
  • prospective
  • multinational
  • 11 centers in 6 countries
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Authors' conclusion

The PULSTA transcatheter pulmonary valve demonstrated high procedural success, durable valve function, and sustained hemodynamic benefits. Its adaptability to diverse right ventricular outflow tract anatomies and favorable safety profile supports its role as an effective therapeutic option for patients with right ventricular outflow tract dysfunction.

Study context

Population
Patients with congenital or acquired right ventricular outflow tract dysfunctionenrolled, successful PULSTA implantation in 57 patients (98.3%), including 4 valve-in-valve procedures
Participants
58 patients
Outcome
Procedural or device-related serious adverse events, hemodynamic improvement, and sustained valve function
Follow-up
Median 4.1 years

Main finding

As reported in the abstract

Significant reverse right ventricular remodeling at 6 months on cardiac magnetic resonance imaging, with marked reductions in right ventricular end-diastolic volume index, end-systolic volume index, and pulmonary regurgitation fraction

all P <0.001

Patients exhibiting mild or less pulmonary regurgitation at 4.1 years

93.8%

Freedom from reintervention at 5 years

98.2%

Observational data: associations, not effects.

Further findings

OutcomeValues
Successful PULSTA implantationPULSTA 98.3%
Successful PULSTA implantation — valve-in-valve procedures
4

Safety

Reintervention, infective endocarditis, stent fracture, structural valve deterioration

PULSTA-in-PULSTA implantation due to paravalvular leakage
One patient
Infective endocarditis, successfully managed with antibiotic therapy
one case
No stent fractures or structural valve deterioration were observed

Original publication

Prospective Midterm Outcomes of the PULSTA Self-Expandable Transcatheter Pulmonary Valve: The PULSTA CE Approval Study. Circ Cardiovasc Interv. Published 18 June 2026. doi:10.1161/circinterventions.126.016616
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Summarised from the published abstract; every number is checked against it