Transcatheter pulmonary valve implantation with the Melody valve had a composite event incidence of 4.2% per person-year, with residual RV-to-PA gradient increasing this risk (HR 1.21; P<0.0001).
Cohort (n=845)
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TPVI with the Melody valve is effective in CHD patients, though residual RV-to-PA pressure gradient increases the risk of adverse events and infective endocarditis remains a significant concern.
AIMS: The 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). METHODS AND RESULTS: 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 2 improved significantly from 36 interquartile range (IQR) 24-47 to 12 (IQR 7-17) mmHg and 47 to 1%, respectively (P < 0.001 for each). CONCLUSION: 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.
“The positive results garnered in this real-world setting mirror those seen in other studies of the Melody valve. The one-year results show strong performance of the valve, which is intended to delay the time until open-heart surgery is needed. Decreasing the number of open-heart surgeries that our patients need has a significant impact on their lives and quality of life.”
Nordmeyer et al. (Wed,) conducted a cohort in congenital heart disease (CHD) (n=845). Transcatheter pulmonary valve implantation (TPVI) with the Melody valve was evaluated on Composite of TPVI-related events during follow-up (death, reoperation, or reintervention >48 h after TPVI) (95% CI 3.7-4.9). Transcatheter pulmonary valve implantation with the Melody valve had a composite event incidence of 4.2% per person-year, with residual RV-to-PA gradient increasing this risk (HR 1.21; P<0.0001).
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