title: ASD and PFO closure with the Solysafe septal occluder - results of a prospective multicenter pilot study.
abstract: OBJECTIVE
  We report the results of a prospective multicenter pilot study performed in Germany, Sweden, and Switzerland with a new self-centering device for transcatheter closure of an atrial septal defect (ASD) or a patent foramen ovale (PFO) called the Solysafe Septal Occluder.
  
  
  METHODS
  The device was successfully implanted in 44 patients. In 15 patients with a median age of 40 years (range 6-76 years), a Solysafe device was successfully implanted in an ASD. The median size of the stretched defects was 17 mm (range 10-21 mm). Three 15-mm devices, eight 20-mm devices, and four 25-mm devices were used. Procedure time ranged from 40 to 107 min (median 66 min) and fluoroscopic time from 5.3 to 17.5 min (median 12 min). In 29 patients with a median age of 47 years (range 15-78 years), a Solysafe device was implanted in a PFO. The procedure time ranged from 21 to 155 min (median 51 min) and fluoroscopic time from 3.1 to 31.3 min (median 7.6 min).
  
  
  RESULTS
  At discharge, 1 of the 29 patients (3%) had a small shunt. No patient in either the ASD or the PFO group had any major complication. Six months after implantation, the overall closure rate with the Solysafe septal occluder in both groups was 100% (44/44).
  
  
  CONCLUSIONS
  With the self-centering Solysafe Septal Occluder, PFOs, and ASDs with a stretched diameter of up to 21 mm can be effectively closed with very high occlusion rates.
authors.affiliation: Abt. für angeborene Herzfehler, Deutsches Herzzentrum, Berlin, Germany. ewert@dhzb.de
authors.forename: Peter
authors.initials: P
authors.lastname: Ewert
authors.forename: Bjoern
authors.initials: B
authors.lastname: Söderberg
authors.forename: Ingo
authors.initials: I
authors.lastname: Dähnert
authors.forename: Otto
authors.initials: O
authors.lastname: Hess
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Christiane
authors.initials: C
authors.lastname: Bussmann
authors.forename: Jerome
authors.initials: J
authors.lastname: Bernhard
authors.forename: Peter
authors.initials: P
authors.lastname: Sick
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D021721:Balloon Occlusion / Q000295:instrumentation* / Q000379:methods; D006328:Cardiac Catheterization; D002648:Child; D015716:Electrocardiography, Ambulatory; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000175:diagnosis / Q000628:therapy; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods; D018570:Risk Assessment; D016896:Treatment Outcome