Document Detail


Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial.
MedLine Citation:
PMID:  20644013     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Transcatheter 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 RESULTS: From 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. CONCLUSIONS: In 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.
Authors:
Doff B McElhinney; William E Hellenbrand; Evan M Zahn; Thomas K Jones; John P Cheatham; James E Lock; Julie A Vincent
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2010-07-19
Journal Detail:
Title:  Circulation     Volume:  122     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2010 Aug 
Date Detail:
Created Date:  2010-08-03     Completed Date:  2010-09-08     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  507-16     Citation Subset:  AIM; IM    
Affiliation:
Department of Cardiology, Children's Hospital Boston, Boston, Mass 10032, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00740870
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Child
Echocardiography
Female
Follow-Up Studies
Heart Catheterization / methods
Heart Valve Prosthesis*
Heart Valve Prosthesis Implantation / methods*
Humans
Magnetic Resonance Imaging
Male
Middle Aged
Prospective Studies
Prosthesis Failure
Pulmonary Atresia / radiography,  surgery
Pulmonary Valve Insufficiency / radiography,  surgery*,  ultrasonography
Stents / statistics & numerical data
Tetralogy of Fallot / radiography,  surgery,  ultrasonography
Treatment Outcome
United States
Ventricular Outflow Obstruction / radiography,  surgery*,  ultrasonography
Young Adult

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