Background: Harmony TM transcatheter 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 Harmony TM TPVI 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/m 2 (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/m 2 and from 84 to 69 mL/m 2 , respectively (P<0.01). Stroke volume increased from 59 to 64 mL, and cardiac index from 2.4 to 2.6 L/min/m 2 (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, Harmony TM TPVI achieved high procedural success and rapid right ventricular reverse remodeling, indicating it is a safe and effective treatment option.
Horiuchi et al. (Fri,) studied this question.