title: Transvenous closure of secundum atrial septal defects: preliminary results with a new self-expanding nitinol prosthesis in a swine model.
abstract: BACKGROUND
  Our purpose was to evaluate a new prosthesis for percutaneous closure of secundum atrial septal defects (ASDs).
  
  
  RESULTS
  Percutaneous closure of surgically created fossa ovalis ASD was attempted in 15 minipigs. The mean balloon-stretched ASD diameter was 12.3+/-2.3 mm (range, 10 to 16 mm). The self-expanding prosthesis was braided from 0.005-in Nitinol wires in the shape of two flat buttons with a short connecting waist with a diameter corresponding to that of the defect to be closed. Polyester filling was added to enhance thrombogenicity. Pulmonary arteriography with levo-phase was obtained before placement; immediately after placement; and at 1-week, 1-month, and 3-month follow-ups. Four animals were killed at 1 week, 1 month, and 3 months for histopathological correlation. Three deaths resulted from ventricular fibrillation (one during anesthesia and two during the placement procedure). Successful placement of the prosthesis was achieved in the remaining 12 animals. Overall immediate ASD closure on angiography occurred in 7 of 12 animals (all polyester-filled prostheses). Absent or trace shunt by angiography was present in 11 of 12 devices at 1 week, with the remaining one demonstrating a small shunt. All septal defects were completely closed at 1 month with the exception of one case in which delayed partial dislodgment of an undersized prosthesis into the right atrium had developed. Closure rate at 3 months was 100%. Neoendothelialization and fibrous incorporation of the prosthesis were completed within 1 to 3 months.
  
  
  CONCLUSIONS
  Effective and permanent occlusion of secundum ASDs is feasible with a device that offers the advantages of easy placement, self-centering, and repositionability.
authors.affiliation: Department of Radiology, University of Minnesota Hospital and Clinic (Minneapolis), 55455, USA. sharafuddinm@mirlink.wustl.edu
authors.forename: M J
authors.initials: MJ
authors.lastname: Sharafuddin
authors.forename: X
authors.initials: X
authors.lastname: Gu
authors.forename: J L
authors.initials: JL
authors.lastname: Titus
authors.forename: M
authors.initials: M
authors.lastname: Urness
authors.forename: J J
authors.initials: JJ
authors.lastname: Cervera-Ceballos
authors.forename: K
authors.initials: K
authors.lastname: Amplatz
mesh_terms: D000497:Alloys; D000818:Animals; D006328:Cardiac Catheterization; D004699:Endocardium / Q000473:pathology; D005268:Femoral Vein; D005548:Foreign-Body Migration; D006344:Heart Septal Defects, Atrial / Q000601:surgery*; D007601:Jugular Veins; D011183:Postoperative Complications / Q000209:etiology; D019736:Prostheses and Implants / Q000009:adverse effects; D011474:Prosthesis Design; D013552:Swine; D013556:Swine, Miniature; D014693:Ventricular Fibrillation / Q000209:etiology; D014945:Wound Healing
chemical_list: D000497:Alloys; C013616:nitinol