Nordmeyer, JohannesEwert, PeterGewillig, MarcAlJufan, MansourCarminati, MarioKretschmar, OliverUebing, AnselmDähnert, IngoRöhle, RobertSchneider, HeikeWitsenburg, MaartenBenson, LeeGitter, RolandBökenkamp, ReginaMahadevan, VaikomBerger, Felix2025-01-072025-01-072019https://hdl.handle.net/10668/26359The post-approval MELODY Registry aimed to obtain multicentre registry data after transcatheter pulmonary valve implantation (TPVI) with the Melody™ valve (Medtronic plc.) in a large-scale cohort of patients with congenital heart disease (CHD). Retrospective analysis of multicentre registry data after TPVI with the Melody™ valve. Eight hundred and forty-five patients (mean age: 21.0 ± 11.1 years) underwent TPVI in 42 centres between December 2006 and September 2013 and were followed-up for a median of 5.9 years (range: 0-11.0 years). The composite endpoint of TPVI-related events during follow-up (i.e. death, reoperation, or reintervention >48 h after TPVI) showed an incidence rate of 4.2% per person per year [95% confidence interval (CI) 3.7-4.9]. Transcatheter pulmonary valve implantation infective endocarditis (I.E.) showed an incidence rate of 2.3% per person per year (95% CI 1.9-2.8) and resulted in significant morbidity and in nine deaths. In multivariable Cox proportional hazard models, the invasively measured residual right ventricle (RV)-to-pulmonary artery (PA) pressure gradient (per 5 mmHg) was associated with the risk of the composite endpoint (adjusted hazard ratio: 1.21, 95% CI 1.12-1.30; P 48 h after TPVI) showed an incidence rate of 4.2% per person per year [95% confidence interval (CI) 3.7-4.9]. Transcatheter pulmonary valve implantation infective endocarditis (I.E.) showed an incidence rate of 2.3% per person per year (95% CI 1.9-2.8) and resulted in significant morbidity and in nine deaths. In multivariable Cox proportional hazard models, the invasively measured residual right ventricle (RV)-to-pulmonary artery (PA) pressure gradient (per 5 mmHg) was associated with the risk of the composite endpoint (adjusted hazard ratio: 1.21, 95% CI 1.12-1.30; P 2 improved significantly from 36 [interquartile range (IQR) 24-47] to 12 (IQR 7-17) mmHg and 47 to 1%, respectively (P  The post-approval MELODY Registry confirms the efficacy of TPVI with the Melody™ valve in a large-scale cohort of CHD patients. The residual invasively measured RV-to-PA pressure gradient may serve as a target for further improvement in the composite endpoint and TPVI I.E. However, TPVI I.E. remains a significant concern causing significant morbidity and mortality.enCongenital heart diseaseRVOT dysfunctionTranscatheter pulmonary valve implantationAdolescentAdultCardiac CatheterizationChildFemaleFollow-Up StudiesHeart Valve DiseasesHeart Valve Prosthesis ImplantationHumansMalePulmonary ValveRegistriesRetrospective StudiesTime FactorsTreatment OutcomeYoung Adultresearch article31005985open access10.1093/eurheartj/ehz2011522-9645https://www.zora.uzh.ch/id/eprint/177407/9/EURHEARTJ-D-17-01733_R2-jnehj.pdf