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Peer-reviewedCC BY-NC 4.0Korean Circulation Journal

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

  • Kyung-Jin Ahn1
  • Gi Beom Kim2
  • Sang Yun Lee2
  • Seong Ho Kim3
  • So-Ick Jang3
  • Jae Young Choi4
  • Chang Sin Kim4
  • I-Seok Kang5
  • Jinyoung Song5
  • Jeong Jin Yu6
  • Seul Gi Cha6
  • Myung Chul Hyun7
10 more authors
  • Young Tae Lim7
  • Hyoung Doo Lee8
  • Hoon Ko8
  • Tae-Jin Youn9
  • In Ho Chae9
  • Hong Ryang Kil10
  • Gee Na Kim10
  • Hwa Jin Cho11
  • Jae Young Lee12
  • Ju Ae Shin12
12 affiliations
  1. 1Department of Pediatrics, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea .
  2. 2Department of Pediatrics, Seoul National University Children’s Hospital, Seoul National University College of Medicine, Seoul, Korea .
  3. 3Department of Pediatrics, Sejong Hospital, Bucheon, Korea .
  4. 4Division of Pediatric Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea .
  5. 5Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Korea .
  6. 6Department of Pediatrics, Asan Medical Center Children’s Hospital, University of Ulsan College of Medicine, Seoul, Korea .
  7. 7Department of Pediatrics, Kyungpook National University Hospital, Daegu, Korea .
  8. 8Department of Pediatrics, Pusan National University Yangsan Hospital, Yangsan, Korea .
  9. 9Cardiovascular Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea .
  10. 10Department of Pediatrics, Chungnam National University Hospital, Daejeon, Korea .
  11. 11Department of Pediatrics, Chonnam National University Children’s Hospital, Chonnam National University Medical School, Gwangju, Korea .
  12. 12Department of Pediatrics, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea .
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Abstract

Background and Objectives: 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.

Methods: 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.

Results: 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).

Conclusions: 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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Cite

BibTeXRIS
BibTeX
@article{ahn2026durability,
  title = {{Durability and Safety of PULSTA Transcatheter Pulmonary Valve: Insights From Five-Year Nationwide Post-Marketing Surveillance Study in Korea}},
  author = {Kyung-Jin Ahn and Gi Beom Kim and Sang Yun Lee and Seong Ho Kim and So-Ick Jang and Jae Young Choi and Chang Sin Kim and I-Seok Kang and Jinyoung Song and Jeong Jin Yu and Seul Gi Cha and Myung Chul Hyun and Young Tae Lim and Hyoung Doo Lee and Hoon Ko and Tae-Jin Youn and In Ho Chae and Hong Ryang Kil and Gee Na Kim and Hwa Jin Cho and Jae Young Lee and Ju Ae Shin},
  journal = {Korean Circulation Journal},
  year = {2026},
  month = jul,
  doi = {10.4070/kcj.2026.0016},
  url = {https://doi.org/10.4070/kcj.2026.0016},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Durability and Safety of PULSTA Transcatheter Pulmonary Valve: Insights From Five-Year Nationwide Post-Marketing Surveillance Study in Korea
AU  - Kyung-Jin Ahn
AU  - Gi Beom Kim
AU  - Sang Yun Lee
AU  - Seong Ho Kim
AU  - So-Ick Jang
AU  - Jae Young Choi
AU  - Chang Sin Kim
AU  - I-Seok Kang
AU  - Jinyoung Song
AU  - Jeong Jin Yu
AU  - Seul Gi Cha
AU  - Myung Chul Hyun
AU  - Young Tae Lim
AU  - Hyoung Doo Lee
AU  - Hoon Ko
AU  - Tae-Jin Youn
AU  - In Ho Chae
AU  - Hong Ryang Kil
AU  - Gee Na Kim
AU  - Hwa Jin Cho
AU  - Jae Young Lee
AU  - Ju Ae Shin
PY  - 2026
DA  - 2026/07/08
JO  - Korean Circulation Journal
DO  - 10.4070/kcj.2026.0016
UR  - https://doi.org/10.4070/kcj.2026.0016
AB  - Background and Objectives: 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.  Methods: 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.  Results: 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).  Conclusions: PULSTA™ TPVI demonstrated favorable mid-term safety and sustained functional and hemodynamic outcomes in a real-world population with native RVOT dysfunction.
SN  - 1738-5520
SN  - 1738-5555
ER  -