title: CardioSEAL/STARflex versus Amplatzer devices for percutaneous closure of small to moderate (up to 18 mm) atrial septal defects.
abstract: BACKGROUND
  The Amplatzer septal occluder (ASO) allows the percutaneous closure of small to very large atrial septal defects (ASDs). The CardioSEAL/STARflex (CS/SF) can be used only for closure of small to moderate ASDs (stretch size up to 18 mm). These 2 devices are widely used in clinical practice. Therefore, a comparison of their use in the closure of small to moderate ASDs is needed.
  
  
  METHODS
  From December 1996 to September 2002, 274 consecutive patients (mean age 20.3 +/- 17 years) underwent percutaneous closure of small to moderate ostium secundum ASDs. The CS/SF device was used in 121 patients, and the ASO was used in 153.
  
  
  RESULTS
  There were no differences in age, sex ratio, or pulmonary/systemic flow ratio. Stretch size of the defect was higher in the ASO group (13.6 +/- 3.5 mm vs 15.5 +/- 3.2 mm, P <.001). Procedure time and fluoroscopy time were shorter in patients treated with the ASO (61 +/- 21 vs 75 +/- 32 min, P <.0003, and 11.6 +/- 9 vs 23.8 +/- 17.4 min, P <.0001, respectively). Residual shunt at procedure and discharge was significantly more frequent in the CS/SF group (P <.0001). There were no differences in the complication rate for the 2 groups (CS/SF 4/121 vs ASO 6/153). Length of follow-up was longer in the CS/SF group (24 +/- 14 vs 16 +/- 9 months, P =.0001). Residual shunting was significantly more frequent in the CS/SF group during follow-up, while closure rate reached 100% after 1 month in ASO group.
  
  
  CONCLUSIONS
  The 2 devices are clinically safe and effective in ASD closure. However, percutaneous closure of small to moderate ASDs with ASO is quicker and provides an higher rate of complete occlusion.
authors.affiliation: Department of Pediatric Cardiology, Istituto Policlinico San Donato, San Donato Milanese, Italy. gianfra.but@lycos.com
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Butera
authors.forename: Mario
authors.initials: M
authors.lastname: Carminati
authors.forename: Massimo
authors.initials: M
authors.lastname: Chessa
authors.forename: Angelica
authors.initials: A
authors.lastname: Delogu
authors.forename: Manuela
authors.initials: M
authors.lastname: Drago
authors.forename: Luciane
authors.initials: L
authors.lastname: Piazza
authors.forename: Alessandro
authors.initials: A
authors.lastname: Giamberti
authors.forename: Alessandro
authors.initials: A
authors.lastname: Frigiola
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006344:Heart Septal Defects, Atrial / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D019736:Prostheses and Implants; D011474:Prosthesis Design; D016896:Treatment Outcome