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MELODY Registry Outcomes of Transcatheter Pulmonary Valve Implantation
Study Questions:
What are short- and mid-term clinical outcomes in patients undergoing transcatheter pulmonary valve implantation (TPVI) with the Melody valve for right ventricular outflow tract (RVOT) dysfunction?
Methods:
The post-approval MELODY Registry is an investigator-initiated, multicenter registry after TPVI with the Melody valve at 42 non-US centers. Data are collected retrospectively in this registry and self-reported by each site investigator.
Results:
Eight hundred and forty-five patients (mean age, 21.0 ± 11.1 years) underwent successful TPVI in the MELODY registry between December 2006 and September 2013, with low complication rates. Death and need for urgent surgery were 0.5% and 1.2%, respectively. In the short-term, median RV-to-pulmonary artery (PA) gradient improved significantly from 36 to 12 mm Hg, and only 1% had > grade 2 pulmonary regurgitation.
Tetralogy of Fallot (31%) and prior Ross procedure (20%) were the most common etiologies for RVOT dysfunction in this cohort. Valve implant was performed within a pre-existing homograft conduit in 68% of cases. At a median follow-up of 5.9 years, TPVI- related adverse event rate (i.e., death, reoperation, or reintervention) was 4.2% per person per year. Infective endocarditis was common (2.3% per person per year). Residual invasive RV-to-PA gradient (per 5 mm Hg) independently predicted TPVI-related adverse events (adjusted hazard ratio [aHR], 1.21; 95% confidence interval [CI], 1.12–1.30) and endocarditis occurrence (aHR, 1.19; 95% CI, 1.07–1.32).
Conclusions:
TPVI with a Melody valve implantation is a promising therapy for RVOT dysfunction in congenital heart disease (CHD) patients. Infective endocarditis is common and associated with high morbidity and mortality.
Perspective:
These findings show promising efficacy of TPVI with the Melody valve system in a large cohort of diverse patients. Infective endocarditis was common and associated with high morbidity and mortality. Patients and providers should be counseled on early detection and treatment of endocarditis as well as on general measures of endocarditis prevention (e.g., good dental hygiene). The residual invasively measured RV-to-PA pressure gradient is a key predictor of adverse events on follow-up. These data, combined with previously published reports, establish a role for TPVI in CHD patients with RVOT dysfunction. Future innovation should target minimizing the post-implant RV-to-PA gradient and infective endocarditis occurrence in such patients.
Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Interventions, Interventions and Structural Heart Disease
Keywords: Allografts, Cardiac Surgical Procedures, Cardiology Interventions, Endocarditis, Endocarditis, Bacterial, Heart Defects, Congenital, Heart Valve Diseases, Pulmonary Valve Insufficiency, Secondary Prevention, Tetralogy of Fallot, Ventricular Dysfunction, Right
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