Evidence map›Paper›PMID 20644013›Full record

Trial reportCirculation2010

Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial.

Doff B McElhinney, William E Hellenbrand, Evan M Zahn, Thomas K Jones, John P Cheatham, James E Lock, Julie A Vincent

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Circulation, 2010. 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 122 papers.

0numbers the graph read from it
0cells of the map it votes in
122citing papers in PubMed
29.0field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00740870 nacompletednot on this map

Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study

TypeinterventionalSponsorMedtronic CardiovascularRan2007 to 2020Enrolled171ConditionsCongenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract ConduitsArmsTranscatheter Pulmonary Valve replacement
3 · Its place in the literature

Who cites it

122 citing papers in PubMed, 570 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Prevalence of Aspirin Resistance in Patients with Transcatheter Pulmonary Valve Replacement.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
    Article
  14. A Novel Modification of the Melody Valve in a Short Right Ventricle-Pulmonary Artery Conduit: A Case Report.Journal of the Society for Cardiovascular Angiography & Interventions · 2025
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Percutaneous pulmonary valve implantation guided by three-dimensional rotational angiography.International journal of cardiology. Congenital heart disease · 2024
    Article
  20. Article

62 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Doff B McElhinneyDepartment of Cardiology, Children's Hospital Boston, Boston, Mass 10032, USA.
William E Hellenbrand
Evan M Zahn
Thomas K Jones
John P Cheatham
James E Lock
Julie A Vincent
Miami Children's Hospital · USBoston Children's Hospital · USHillenbrand (United States) · USSeattle Children's Hospital · US

Funding

RESEARCH METHODS IN PEDIATRICS HEART DISEASET32HL007572 · NHLBI · CHILDREN'S HOSPITAL BOSTON · PI Sarah D DE FERRANTI, Jane W. Newburger · 1985 to 2026
$13.0M
NHLBI NIH HHS T32 HL007572
6 · The paper itself

Abstract

backgroundTranscatheter pulmonary valve placement is an emerging therapy for pulmonary regurgitation and right ventricular outflow tract obstruction in selected patients. The Melody valve was recently approved in the United States for placement in dysfunctional right ventricular outflow tract conduits. METHODS AND

resultsFrom January 2007 to August 2009, 136 patients (median age, 19 years) underwent catheterization for intended Melody valve implantation at 5 centers. Implantation was attempted in 124 patients; in the other 12, transcatheter pulmonary valve placement was not attempted because of the risk of coronary artery compression (n=6) or other clinical or protocol contraindications. There was 1 death from intracranial hemorrhage after coronary artery dissection, and 1 valve was explanted after conduit rupture. The median peak right ventricular outflow tract gradient was 37 mm Hg before implantation and 12 mm Hg immediately after implantation. Before implantation, pulmonary regurgitation was moderate or severe in 92 patients (81% with data); no patient had more than mild pulmonary regurgitation early after implantation or during follow-up (>or=1 year in 65 patients). Freedom from diagnosis of stent fracture was 77.8+/-4.3% at 14 months. Freedom from Melody valve dysfunction or reintervention was 93.5+/-2.4% at 1 year. A higher right ventricular outflow tract gradient at discharge (P=0.003) and younger age (P=0.01) were associated with shorter freedom from dysfunction.

conclusionsIn this updated report from the multicenter US Melody valve trial, we demonstrated an ongoing high rate of procedural success and encouraging short-term valve function. All reinterventions in this series were for right ventricular outflow tract obstruction, highlighting the importance of patient selection, adequate relief of obstruction, and measures to prevent and manage stent fracture. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870.

Indexed as

Heart Valve ProsthesisAdolescentAdultCardiac CatheterizationChildEchocardiographyFemaleFollow-Up StudiesHeart Valve Prosthesis ImplantationHumansMagnetic Resonance ImagingMaleMiddle AgedProspective StudiesProsthesis FailurePulmonary Atresia

Identifiers

PMID20644013
PMCPMC4240270
OpenAlexW2001176850

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.