Durability and Safety of PULSTA Transcatheter Pulmonary Valve: Insights From Five-Year Nationwide Post-Marketing Surveillance Study in Korea
Year: 2026
Type: article
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.
Source: Korean Circulation Journal
Authors: Kyung-Jin Ahn, Gi Beom Kim, Sang Yun Lee, Seong Ho Kim, So-Ick Jang, Jae Young Choi, Chang Sin Kim, I-Seok Kang, Jinyoung Song, Jeong Jin Yu, Seul Gi Cha, Myung Chul Hyun, Young Tae Lim, Hyoung Doo Lee, Hoon Ko, Tae-Jin Youn, In Ho Chae, Hong Ryang Kil, Gee Na Kim, Hwa Jin Cho, Jae Young Lee, Ju Ae Shin
Institutions: Gachon University, Gachon University Gil Medical Center, Seoul National University, Chungnam National University, Seoul National University Children's Hospital, Chungnam National University Hospital, Sejong General Hospital, Yonsei University, Severance Hospital, Yonsei University Health System, Samsung Medical Center, Sungkyunkwan University, Asan Medical Center, University of Ulsan, Kyungpook National University Hospital, Pusan National University Yangsan Hospital, Seoul National University Bundang Hospital, Chonnam National University, Chonnam National University Children's Hospital, The Catholic University of Korea Seoul St. Mary's Hospital, Catholic University of Korea
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7168082495