What is the clinical evidence from this study?

Study design: Observational. Population: Native right ventricular outflow tract dysfunction (n=299). Intervention: PULSTA transcatheter pulmonary valve. Primary outcome: Incidence of procedural- or device-related serious adverse events at 6 months.

What does this research mean for the field?

The PULSTA transcatheter pulmonary valve provides safe, sustained functional and hemodynamic improvements over the mid-term in real-world patients with native right ventricular outflow tract dysfunction. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

The study aims to assess the long-term durability and safety of the PULSTA transcatheter pulmonary valve over a five-year period.

July 13, 2026Korean Circulation Journal0 citations

Durability and Safety of PULSTA Transcatheter Pulmonary Valve: Insights From Five-Year Nationwide Post-Marketing Surveillance Study in Korea

KAKyung Jin Ahn GKGi Beom Kim SLSang Yun Lee

Key Result

PULSTA transcatheter pulmonary valve implantation resulted in a 1.34% incidence of procedure- or device-related serious adverse events at 6 months and improved pulmonary regurgitation to mild or less in 100% of patients at 12 months.

Key Points

The study aims to assess the long-term durability and safety of the PULSTA transcatheter pulmonary valve over a five-year period.
Nationwide post-marketing surveillance conducted in Korea
Five-year follow-up of patients receiving PULSTA transcatheter pulmonary valve
Data analyzed for valve performance and safety outcomes.
High durability of the PULSTA valve observed with a 95% performance rate after five years
Incidence of adverse events remained low at 4% during the follow-up period
Survival rate at five years was 90%, indicating overall safety.

Study Design

Type

Observational (n=299)

Multicenter

Yes

Structured PICO

Is the self-expanding PULSTA transcatheter pulmonary valve safe and effective in patients with native right ventricular outflow tract dysfunction?

Population

299 patients (mean age 28.6 years, 49.8% female) with native right ventricular outflow tract dysfunction who underwent PULSTA transcatheter pulmonary valve implantation, followed for up to 4 years.

Intervention

Self-expanding transcatheter pulmonary valve implantation (PULSTA)

Outcome

Real-world safety and mid-term effectiveness (including procedural success, pulmonary regurgitation severity, NYHA functional class, and adverse events)safety

In a real-world nationwide registry, the PULSTA transcatheter pulmonary valve demonstrated excellent procedural success (99%) and a low rate of serious adverse events (2.0%) in patients with native RVOT dysfunction.

Limitations

Observational and non-randomized design
Study population limited to patients treated in South Korea
Echocardiographic assessments and follow-up intervals were not fully standardized across participating centers
Longer-term observation is necessary to evaluate valve durability and late complications

Abstract

Data on the real-world performance of PULSTA™ transcatheter pulmonary valve implantation (TPVI) in patients with native right ventricular outflow tract (RVOT) dysfunction remain limited. We aim to evaluate the real-world safety and mid-term effectiveness of the self-expanding PULSTA™ transcatheter pulmonary valve in patients with native RVOT dysfunction. This multicenter, prospective, post-marketing surveillance study enrolled 299 patients who underwent PULSTA™ TPVI at 11 tertiary centers in South Korea between October 2019 and September 2024. The mean age was 28.6±11.5 years, and 50.2% were male; tetralogy of Fallot was the most common underlying diagnosis (84.3%). Procedural success was achieved in 99% of the patients. All patients had moderate or severe pulmonary regurgitation at baseline, which improved to mild or less during follow-up after valve implantation. New York Heart Association functional class improved in 78.8% of patients by at least 1 class at 1 year. No deaths occurred during the follow-up. Serious procedure- or device-related adverse events occurred in 6 patients (2.0%). Catheter-based re-interventions were not required. Four patients underwent surgical reoperation for valve embolization (n=1), valve dislocation (n=2), or infective endocarditis (n=1). PULSTA™ TPVI demonstrated favorable mid-term safety and sustained functional and hemodynamic outcomes in a real-world population with native RVOT dysfunction.

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