Document Detail

Transcatheter closure of perimembranous ventricular septal defects using the new Amplatzer membranous VSD occluder: results of the U.S. phase I trial.
MedLine Citation:
PMID:  16412854     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: This phase I study attempted to report the initial safety and efficacy results of transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using the new Amplatzer Membranous VSD Occluder (AGA Medical Corp., Golden Valley, Minnesota) in the U.S. BACKGROUND: The most common congenital heart disease is PmVSD. Surgical repair is widely accepted, but still carries a small but definite risk of morbidity and mortality. METHODS: Between October 2003 and August 2004, a total of 35 patients with PmVSD underwent an attempt of transcatheter closure under transesophageal and/or intracardiac echocardiographic guidance. The median age was 7.7 years (range, 1.2 to 54.4 years) and median weight was 25 kg (range, 8.3 to 110 kg). The median Qp/Qs ratio was 1.8 (range, 1 to 4), and the median VSD size as assessed by echocardiography was 7 mm (range, 4 to 15 mm). RESULTS: The attempt to place a device was successful in 32 patients (91%). The median device size used was 10 mm (range, 6 to 16 mm). The complete closure rates by echocardiography at 10 min (transesophageal/intracardiac), 24 h, 1 month, and 6 months (transthoracic) were 47% (15/32), 63% (20/32), 78% (25/32), and 96% (27/28), respectively. The median fluoroscopy time was 36 min (range, 14 to 191 min), and the median total procedure time was 121 min (range, 67 to 276 min). Three patients (8.6%) had serious adverse events of complete heart block, peri-hepatic bleeding, and rupture of tricuspid valve chordae tendineae. No other patient encountered serious adverse events during the follow-up. CONCLUSIONS: Transcatheter closure of a PmVSD is technically feasible and seems safe enough in children over 8 kg in weight to warrant continuation of clinical trials to assess the long-term safety and efficacy.
Yun-Ching Fu; John Bass; Zahid Amin; Wolfgang Radtke; John P Cheatham; William E Hellenbrand; David Balzer; Qi-Ling Cao; Ziyad M Hijazi
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Multicenter Study    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  47     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2006 Jan 
Date Detail:
Created Date:  2006-01-17     Completed Date:  2006-03-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  319-25     Citation Subset:  AIM; IM    
Section of Pediatric Cardiology, Department of Pediatrics, University of Chicago Comer Children's Hospital, Pritzker School of Medicine, Chicago, Illinois 60637, USA.
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MeSH Terms
Aortic Valve Insufficiency / epidemiology
Child, Preschool
Heart Aneurysm / epidemiology
Heart Catheterization
Heart Defects, Congenital / epidemiology
Heart Septal Defects, Ventricular / epidemiology,  therapy*
Middle Aged
Prospective Studies
Prostheses and Implants*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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