Presentation Information
[I-OR12-02]Impact of Self-Expanding Transcatheter Pulmonary Valve Implantation on Valve Function, Arrhythmias, and Hemodynamics: The PEARL-TPVI Registry
○Kazuto Fujimoto1, Tomohito Kogure2, Mizuhiko Ishigaki3, Sung-Hae Kim3, Kenji Baba4, Takanari Fujii5, Hiroaki Kise5, Yusuke Akazawa6, Naoto Kawamatsu7, Nakanishi Naohiko8 (1.Department of Pediatric Cardiology, National Cerebral and Cardiovascular Center, 2.Tokyo Women's Medical University Hospital, Department of Cardiology, 3.Shizuoka Children's Hospital, Department of Cardiology, 4.Okayama University Hospital, Department of Pediatrics, 5.Showa University, Pediatric Heart Disease and Adult Congenital Heart Disease Center, 6.Ehime University Hospital, Department of Pediatrics, 7.University of Tsukuba, Department of Cardiology, Faculty of Medicine, 8.Kyoto Prefectural University of Medicine, Department of Cardiovascular Medicine, Graduate School of Medical Science)
Keywords:
ファロー四徴症,肺動脈弁閉鎖不全,経カテーテル的肺動脈弁留置術
Background: Transcatheter pulmonary valve implantation (TPVI) using the self-expanding Harmony TPV has emerged as treatment for pulmonary regurgitation following right ventricular outflow tract (RVOT) reconstruction, predominantly in patients after tetralogy of Fallot repair. Since introduction in Japan (March 2023), over 400 procedures have been performed. Real-world data evaluating post-procedural outcomes about hemodynamics remain limited. Methods: This prospective multicenter study enrolled consecutive patients undergoing Harmony TPVI (March 2023-April 2025) at 8 Japanese centers with ≧6 procedures each. Serial echocardiography, cardiac MRI, and catheterization were performed at baseline, 3 months, and 1 year to evaluate valve function, ventricular remodeling, and hemodynamics. Results: Total 206 patients enrolled (mean age 39±15 years). One-year catheterization (n=89) demonstrated ≦mild pulmonary regurgitation in all. Adverse events: heart failure exacerbation (n=1), progressive aortic regurgitation from mild-moderate to moderate-severe (n=1, improved with ARB), RVOT valve thrombosis (n=5, resolved with anticoagulation modification from DAPT to DOAC in 1 and DOAC plus SAPT in 4), non-sustained ventricular tachycardia requiring ICD (n=1), and surgical reintervention for coronary compression (n=1).Conclusion: Harmony TPVI effectively controlled severe pulmonary regurgitation with favorable safety, demonstrating low rates of valve thrombosis, progressive semilunar regurgitation secondary to increased cardiac output, significant arrhythmias, and reintervention.