title: Transcatheter closure of large secundum atrial septal defects using the 40 mm Amplatzer septal occluder: results of an international registry.
abstract: Little is known about the efficacy and safety of the 40 mm Amplatzer septal occluder (ASO). Thirty-three patients (22 female, 11 male) with a large secundum atrial septal defect (ASD) underwent attempted device closure using the 40 mm ASO at a median age of 40 years (range, 14-81 years) and median weight of 65 kg (range, 48-98 kg). The median size of the ASD measured on 2D transesophageal echocardiography (27 patients) or intracardiac echocardiography (6 patients) was 30.5 mm (range, 24-39 mm) and the median balloon-stretched diameter was 37.7 mm (range, 32-43.7 mm). The median Qp:Qs ratio was 3.2:1 (range, 1.4-6.2). The attempt was unsuccessful in five patients; two had device embolization and one had left atrial wall perforation due to the sheath; all three required emergent surgery. The attempt was successful in the 28 remaining patients, resulting in complete immediate closure in 14 and a trivial residual shunt in 14. Fluoroscopy time ranged from 8.6 to 37.8 min (median, 12.2 min). At 24-hr follow-up, 2D transthoracic echocardiography with color flow Doppler revealed complete closure in 23 patients, and 5 had a trivial residual shunt. There were no complications encountered in patients who received the device. On follow-up, all patients are doing well. We conclude that the 40 mm ASO is safe and effective in most patients with a large ASD up to a diameter of 39 mm. However, the use of this device requires careful attention as the procedure may be unsuccessful or the device may embolize.
authors.affiliation: University of Chicago Comer Children's Hospital, Pritzker School of Medicine, Chicago, Illinois 60637, USA.
authors.forename: Keila
authors.initials: K
authors.lastname: Lopez
authors.forename: Bharat V
authors.initials: BV
authors.lastname: Dalvi
authors.forename: David
authors.initials: D
authors.lastname: Balzer
authors.forename: John L
authors.initials: JL
authors.lastname: Bass
authors.forename: Tarek
authors.initials: T
authors.lastname: Momenah
authors.forename: Qi-Ling
authors.initials: QL
authors.lastname: Cao
authors.forename: Ziyad M
authors.initials: ZM
authors.lastname: Hijazi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D004452:Echocardiography; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome