title: Device closure of muscular ventricular septal defects in infants less than one year of age using the Amplatzer devices: feasibility and outcome.
abstract: OBJECTIVE
  In this study, we evaluated the feasibility, safety, and outcome of device closure of muscular ventricular septal defects (mVSD) in infants less than 1 year of age using the Amplatzer devices.
  
  
  BACKGROUND
  Closure of mVSDs continues to represent a surgical challenge with significant morbidity. Hence, device closure is becoming an attractive and reliable alternative. However, little is known about the feasibility of this procedure in small infants.
  
  
  METHODS
  Between July 1999 and September 2006, device closure of mVSD was attempted in 20 infants ranging in age from 3 days to 12 months (median +/- SD; 4.6 +/- 3.8) and in weight from 3.2 to 8.9 kg (4.6 +/- 1.9) under TEE guidance by percutaneous or hybrid (perventricular) techniques. The size of the VSD as assessed by TEE ranged from 3 to 11 mm (6.0 +/- 2.2) and the Qp:Qs ratio ranged from 0.7 to 8.8 (2.8 +/- 2.3).
  
  
  RESULTS
  The device was successfully placed in 19/20 infants and it ranged in size from 4 to 14 mm (8.0 +/- 2.6). It was percutaneously deployed in 11/19 and by the hybrid approach in 8/19. There were 30 devices placed in 19 infants with multiple devices placed in 5/19 infants. Fluoroscopy times ranged from 11 to 136 min (41 +/- 28) and procedure times ranged from 57 to 291 min (178 +/- 68). The success rate as defined by complete closure or a trivial shunt was 84% immediately and 100% at 1-year follow-up. Major complications occurred in 4/20 patients: wire perforation and hemopericardium (n = 1), device migration (n = 1), transient electromechanical dissociation (n = 1), and mediastinitis (n = 1). At a median follow-up of 3.8 years, all patients improved and had no hemodynamically significant VSDs. No major complications were encountered in patients with multiple devices.
  
  
  CONCLUSIONS
  In infants less than 1 year of age, percutaneous and perventricular device closure of mVSDs is technically feasible and highly effective with low morbidity. Long term safety and efficacy needs to be assessed.
authors.affiliation: Department of Pediatrics, University of Chicago Comer Children's Hospital, Pritzker School of Medicine, Chicago, Illinois 60637, USA.
authors.forename: Karim A
authors.initials: KA
authors.lastname: Diab
authors.forename: Qi-Ling
authors.initials: QL
authors.lastname: Cao
authors.forename: Bassem N
authors.initials: BN
authors.lastname: Mora
authors.forename: Ziyad M
authors.initials: ZM
authors.lastname: Hijazi
mesh_terms: D006328:Cardiac Catheterization; D002932:Cineangiography; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D005471:Fluoroscopy; D005500:Follow-Up Studies; D006345:Heart Septal Defects, Ventricular / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D018579:Patient Selection; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D015641:Radiography, Interventional; D012107:Research Design; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional