title: Evaluation of the AMPLATZER vascular plug for embolization of peripheral vascular malformations associated with congenital heart disease.
abstract: OBJECTIVE
  The purpose of this study is to evaluate the recently FDA-approved AMPLATZER Vascular Plug in the embolization of vascular lesions associated with congenital heart disease (CHD).
  
  
  BACKGROUND
  Fistulas and arteriovenous malformations have been occluded using various devices. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device, used for embolization in the peripheral vasculature.
  
  
  METHODS
  A total of 84 vessels in 52 patients with CHD from 11 centers were occluded with 89 AMPLATZER Vascular Plugs, delivered through a coronary guide catheter in various vascular sites, including collaterals, pulmonary arterio-venous and coronary artery fistulas, transhepatic tracts, central shunts, patent ductus arteriosus (PDA), and excluded hepatic vein. Complete vessel occlusion was demonstrated within 10 min in 94% of patients.
  
  
  RESULTS
  There was no device embolization, vascular disruption, or procedure-related complication. One vascular plug implanted in a large type C PDA required surgical removal followed by PDA ligation, after 5 weeks from successful implant because of significant residual flow through the device.
  
  
  CONCLUSIONS
  The AMPLATZER Vascular Plug is an effective transcatheter occlusion device in the embolization of a wide variety of vascular lesions associated with CHD. Based on our early experience, caution should be used when considering the Vascular Plug as a closure device for large PDA.
authors.affiliation: The Heart Center, Columbus Children's Hospital, Section of Cardiology, Department of Pediatrics, The Ohio State University, USA.
authors.forename: S L
authors.initials: SL
authors.lastname: Hill
authors.forename: Z M
authors.initials: ZM
authors.lastname: Hijazi
authors.forename: W E
authors.initials: WE
authors.lastname: Hellenbrand
authors.forename: J P
authors.initials: JP
authors.lastname: Cheatham
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006330:Heart Defects, Congenital / Q000453:epidemiology*; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000453:epidemiology* / Q000628:therapy*; D011651:Pulmonary Artery / Q000002:abnormalities; D011667:Pulmonary Veins / Q000002:abnormalities; D016896:Treatment Outcome; D016157:Vascular Fistula / Q000628:therapy