Circulation journal : official journal of the Japanese Circulation Society · 2026
Safety and Efficacy of HarmonyTM Transcatheter Pulmonary Valve Implantation - Clinical and Hemodynamic Assessment in a Single-Center Japanese Cohort.
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Kogure Tomohito, Yagishita Daigo, Kawamoto Takanori, Nokubo Arisa, Yoshikawa Masafumi, Shibahashi Eiji, Otsuki Hisao, Domoto Satoru, Asagai Seiji, Inai Kei, Shinkawa Takeshi, Niinami Hiroshi, Yamaguchi Junichi
Аннотация
BACKGROUND: HarmonyTMtranscatheter pulmonary valve implantation (TPVI) was developed to treat pulmonary regurgitation (PR) in patients with an enlarged native right ventricular outflow tract. Favorable outcomes have been reported in cohorts from the USA, but data from other regions are limited.
METHODS AND RESULTS: This prospective single-center study included 55 Japanese adults who underwent HarmonyTMTPVI between March 2023 and September 2024. Echocardiography and cardiac magnetic resonance imaging were performed at baseline and at 3 months. The median age was 45 years (interquartile range [IQR]: 29-54 years) and the median body mass index (BMI) was 20 kg/m2(IQR: 18-24). Procedural success was achieved in all patients. The PR fraction improved from 46% to 2.3% (P<0.01). Right ventricular end-diastolic and end-systolic volume indices decreased from 156 to 108 mL/m2and from 84 to 69 mL/m2, respectively (P<0.01). Stroke volume increased from 59 to 64 mL, and cardiac index from 2.4 to 2.6 L/min/m2(P<0.05). During a median follow-up of 17 months, all patients remained free from reintervention.
CONCLUSIONS: In Japanese patients characterized by older age and lower BMI, HarmonyTMTPVI achieved high procedural success and rapid right ventricular reverse remodeling, indicating it is a safe and effective treatment option.
METHODS AND RESULTS: This prospective single-center study included 55 Japanese adults who underwent HarmonyTMTPVI between March 2023 and September 2024. Echocardiography and cardiac magnetic resonance imaging were performed at baseline and at 3 months. The median age was 45 years (interquartile range [IQR]: 29-54 years) and the median body mass index (BMI) was 20 kg/m2(IQR: 18-24). Procedural success was achieved in all patients. The PR fraction improved from 46% to 2.3% (P<0.01). Right ventricular end-diastolic and end-systolic volume indices decreased from 156 to 108 mL/m2and from 84 to 69 mL/m2, respectively (P<0.01). Stroke volume increased from 59 to 64 mL, and cardiac index from 2.4 to 2.6 L/min/m2(P<0.05). During a median follow-up of 17 months, all patients remained free from reintervention.
CONCLUSIONS: In Japanese patients characterized by older age and lower BMI, HarmonyTMTPVI achieved high procedural success and rapid right ventricular reverse remodeling, indicating it is a safe and effective treatment option.