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이달의 kcj Hot Article / 2026년 10월 Durability and Safety of PULSTA Transcatheter Pulmonary Valve: Insights From Five-Year Nationwide Post-Marketing Surveillance Study in Korea
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.
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.
첨부파일1	kcj-56-927-abf001.jpg (다운 3회)

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