Trial reportCirculation. Cardiovascular interventions2022
Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial.
Trial report in Circulation. Cardiovascular interventions, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00740870 (Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract), which is not on this map. Cited by 38 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study
Who cites it
38 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.
- Comparative effects of transcatheter versus surgical pulmonary valve replacement: A systematic review and meta-analysis.PloS one · 2025Pooled it
- Cardiovascular stent technologies for coronary and valvular heart disease: the potential of 3D printing for stent fabrication.Nature reviews. Cardiology · 2026Review
- Repaired tetralogy of Fallot across adulthood: from right ventricular remodelling to targeted intervention.Heart failure reviews · 2026Review
- Myval Beyond the Aortic Valve: Device-Anatomy Interaction, Procedural Strategy, and Clinical Evidence in Mitral, Tricuspid, and Pulmonary Positions.Bioengineering (Basel, Switzerland) · 2026Review
- Transcatheter Pulmonary Valve Replacement in Dysfunctional Valved Polytetrafluoroethylene (PTFE) Right Ventricular Outflow Tract Conduits.Pediatric cardiology · 2026Article
- Learning from Biodegradable Coronary Stents: Future Directions for TPVR Biodegradable Stents.International journal of molecular sciences · 2026Review
- Clinical and Experimental Studies of Structural Valve Degeneration of Bovine Jugular Vein Valves: Mitigation with Polyoxazoline Modification.Pediatric cardiology · 2026Article
- Early Outcomes and Mid-Term Follow-Up of Melody TPV Implantation: A Ten-Year Single-Center Retrospective Observational Study.Healthcare (Basel, Switzerland) · 2026Article
- Haemolytic anaemia due to severe melody pulmonary valve stenosis caused byEuropean heart journal. Case reports · 2026Article
- Article
- Lifelong Management of Right Ventricular Outflow Tract Dysfunction in Adults with Congenital Heart Disease.Methodist DeBakey cardiovascular journal · 2026Review
- Transcatheter Pulmonary Valve Outcomes and Mechanisms of Dysfunction.Journal of clinical medicine · 2025Review
- Serial Changes in Right Ventricular Outflow Tract Gradient and Endocarditis Risk After Transcatheter Pulmonary Valve Replacement.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Article
- Percutaneous implantation of self-expanding pulmonary valves: results from real-life experience of the Venus-P valve Registry of the Italian Society of Pediatric Cardiology (SICPED).International journal of cardiology. Congenital heart disease · 2025Article
- Updates in interventional cardiology in children with cardiac disease.European journal of pediatrics · 2025Review
- Predictors of Valve Failure Following Surgical Atrioventricular Valve Replacement with a Melody Valve in Infants and Children.Pediatric cardiology · 2025Article
- Transcatheter Pulmonary Valve Implantation in Congenital Heart Diseases: Current Advances and Future Prospectives.Children (Basel, Switzerland) · 2025Review
- Mid-term outcomes of percutaneous pulmonary valve replacement with Edwards-Sapien bioprosthesis in native right ventricular outflow tract.Scientific reports · 2025Article
- Experiencia de implante percutáneo de válvula pulmonar en un hospital de referencia cardiovascular en Colombia. Serie de casos.Archivos de cardiologia de Mexico · 2025Article
- Transcatheter Pulmonary Valve Replacement (TPVR): A Saudi Consensus Statement.Journal of the Saudi Heart Association · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 10 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Melody valve was developed to extend the useful life of previously implanted right ventricular outflow tract (RVOT) conduits or bioprosthetic pulmonary valves, while preserving RV function and reducing the lifetime burden of surgery for patients with complex congenital heart disease.
methodsEnrollment for the US Investigational Device Exemption study of the Melody valve began in 2007. Extended follow-up was completed in 2020. The primary outcome was freedom from transcatheter pulmonary valve (TPV) dysfunction (freedom from reoperation, reintervention, moderate or severe pulmonary regurgitation, and/or mean RVOT gradient >40 mm Hg). Secondary end points included stent fracture, catheter reintervention, surgical conduit replacement, and death.
resultsOne hundred seventy-one subjects with RVOT conduit or bioprosthetic pulmonary valve dysfunction were enrolled. One hundred fifty underwent Melody TPV replacement. Median age was 19 years (Q1-Q3: 15-26). Median discharge mean RVOT Doppler gradient was 17 mm Hg (Q1-Q3: 12-22). The 149 patients implanted >24 hours were followed for a median of 8.4 years (Q1-Q3: 5.4-10.1). At 10 years, estimated freedom from mortality was 90%, from reoperation 79%, and from any reintervention 60%. Ten-year freedom from TPV dysfunction was 53% and was significantly shorter in children than in adults. Estimated freedom from TPV-related endocarditis was 81% at 10 years (95% CI, 69%-89%), with an annualized rate of 2.0% per patient-year.
conclusionsTen-year outcomes from the Melody Investigational Device Exemption trial affirm the benefits of Melody TPV replacement in the lifetime management of patients with RVOT conduits and bioprosthetic pulmonary valves by providing sustained symptomatic and hemodynamic improvement in the majority of patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00740870.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.