title: Clinical practice, resource utilization, and outcomes of device closure of patent foramen ovale in pediatrics.
abstract: BACKGROUND
  There are few data on patent foramen ovale closure and its outcome in children. In this study, we evaluated the current clinical practice, resource utilization, and outcome of device closure of patent foramen ovale in children. We hypothesized that patent foramen ovale closure would not result in a demonstrated benefit in children.
  
  
  METHODS
  We undertook a prospective survey of all consecutive patients (<20 years) who underwent patent foramen ovale closure in our metropolitan area between 1995 and 2010. Differences in proportions were tested using the chi-square test or Fisher's exact test where appropriate. Differences in group medians were tested using Wilcoxon signed-rank test.
  
  
  RESULTS
  A total of 153 patients (104 girls), median age 16 years (range 7-19) were studied. Indications for patent foramen ovale closure included: (1) migraine headache (104; 68%), (2) nonmigraine headache (24; 16%), (3) visual symptoms (110; 72%), (4) transient ischemic attack symptoms (42; 28%), and (5) stroke-like symptom (24; 16%). Patent foramen ovale was closed with an Amplatzer septal occluder in 115 (75%) and a Helex septal occluder in 47 (30%). The mean length of hospital stay was 18 ± 11 hours; the mean hospital charge was $24,126 ± $5808. The median duration of follow-up was 12 months, and 80 patients responded to the study survey. On follow-up, symptoms improved in 143 (93%), of which 29 (19%) had a residual shunt. None of the patient or treatment parameters predicted lack of improvement on follow-up.
  
  
  CONCLUSIONS
  Despite the lack of proven benefit, children undergo closure of the patent foramen ovale for a variety of reasons, with the vast majority (92%) of patients reporting significant improvement in their symptoms. However, patent foramen ovale closure is an expensive procedure with serious potential complications. Symptomatic improvement even in the presence of a residual shunt suggests a strong placebo effect.
authors.affiliation: Division of Pediatric Cardiology, University of Utah, Salt Lake City, Utah. Electronic address: shaji.menon@utah.edu.
authors.forename: Shaji C
authors.initials: SC
authors.lastname: Menon
authors.affiliation: Division of Pediatric Cardiology, University of Utah, Salt Lake City, Utah.
authors.forename: Amanda
authors.initials: A
authors.lastname: Grove
authors.affiliation: Department of Pediatrics, University of Utah, Salt Lake City, Utah.
authors.forename: Molly
authors.initials: M
authors.lastname: McFadden
authors.affiliation: Department of Pediatrics, University of Utah, Salt Lake City, Utah.
authors.forename: Kent E
authors.initials: KE
authors.lastname: Korgenski
authors.affiliation: Division of Pediatric Cardiology, University of Utah, Salt Lake City, Utah.
authors.forename: Collin G
authors.initials: CG
authors.lastname: Cowley
mesh_terms: D000293:Adolescent; D013504:Cardiovascular Surgical Procedures / Q000009:adverse effects / Q000191:economics; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000150:complications / Q000188:drug therapy / Q000601:surgery*; D020773:Headache Disorders / Q000150:complications; D017048:Health Care Costs; D006801:Humans; D007902:Length of Stay; D008297:Male; D008881:Migraine Disorders / Q000150:complications; D010818:Practice Patterns, Physicians' / Q000191:economics; D011446:Prospective Studies; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
keywords: children; migraine; outcome; patent foramen ovale; resource utilization