이달의 증례
| Durability and Safety of PULSTA Transcatheter Pulmonary Valve: Insights From Five-Year Nationwide Post-Marketing Surveillance Study in Korea | |||
|---|---|---|---|
| 년도 | 2026년 10월 | ||
| 카테고리 | 이달의 kcj Hot Article | ||
| 저자 | Kyung-Jin Ahn, MD,1 Gi Beom Kim, MD, PhD,2 Sang Yun Lee, MD, PhD,2 Seong Ho Kim, MD, PhD,3 So-Ick Jang, MD,3 Jae Young Choi, MD, PhD,4 Chang Sin Kim, MD,4 I-Seok Kang, MD,5 Jinyoung Song, MD, PhD,5 Jeong Jin Yu, MD, PhD,6 Seul Gi Cha, MD,6 Myung Chul Hyun, MD,7 Young Tae Lim, MD,7 Hyoung Doo Lee, MD, PhD,8 Hoon Ko, MD,8 Tae-Jin Youn, MD, PhD,9 In Ho Chae, MD, PhD,9 Hong Ryang Kil, MD, PhD,10 Gee Na Kim, MD,10 Hwa Jin Cho, MD, PhD,11 Jae Young Lee, MD, PhD,12 Ju Ae Shin, MD,12 | ||
| 소속 | 1Department of Pediatrics, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea. 2Department of Pediatrics, Seoul National University Children’s Hospital, Seoul National University College of Medicine, Seoul, Korea. 3Department of Pediatrics, Sejong Hospital, Bucheon, Korea. 4Division of Pediatric Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea. 5Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Korea. 6Department of Pediatrics, Asan Medical Center Children’s Hospital, University of Ulsan College of Medicine, Seoul, Korea. 7Department of Pediatrics, Kyungpook National University Hospital, Daegu, Korea. 8Department of Pediatrics, Pusan National University Yangsan Hospital, Yangsan, Korea. 9Cardiovascular Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea. 10Department of Pediatrics, Chungnam National University Hospital, Daejeon, Korea. 11Department of Pediatrics, Chonnam National University Children’s Hospital, Chonnam National University Medical School, Gwangju, Korea. 12Department of Pediatrics, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. | ||
| 첨부파일 1 | kcj-56-927-abf001.jpg | ||
- 관리자
- 등록일 : 2026.10.19
- Hit 81
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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