title: Closure of persistent foramen ovale with the BioSTAR biodegradable PFO closure device: feasibility and long-term outcome.
abstract: OBJECTIVE
  The presence of a patent foramen ovale (PFO) has been associated with recurrent cryptogenic cerebrovascular event (CVE). The BioSTAR is a partly biodegradeable atrial septal repair implant. We investigated the feasibility and efficacy of the BioSTAR PFO-occluder.
  
  
  METHODS
  From October 2007 to December 2008, 59 consecutive patients underwent PFO closure at our institution with a history of at least one cryptogenic CVE defined by a neurologist. During the study period, all patients, who fulfilled our institutional criteria for PFO closure, were included. No patients were lost to follow-up.
  
  
  RESULTS
  Of the 59 patients treated, a BioSTAR device could be implanted in 30 and in 29 patients another device, almost exclusively an Amplatzer, had to be used. No serious complications were observed during implantation of either. Four of 30 patients suffered a recurrent CVE after BioSTAR implantation as compared to 2/29 in the comparison group. At long-term follow-up 29/30 patients in the BioSTAR group had complete closure of their PFO as compared to 23 of 29 in the comparison group.
  
  
  CONCLUSIONS
  The BioSTAR device could be selected for use in small shunts less than 10 mm while the Amplatzer may be chosen for larger defects or more complicated anatomy.
authors: GUCH-Center, Department of Medicine/Östra, Sahlgrenska University Hospital, Gothenburg, Sweden. alexia.karagianni@vgregion.se
authors: Alexia
authors: A
authors: Karagianni
authors: Putte
authors: P
authors: Abrahamsson
authors: Eva
authors: E
authors: Furenäs
authors: Peter
authors: P
authors: Eriksson
authors: Mikael
authors: M
authors: Dellborg
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002561:Cerebrovascular Disorders / Q000209:etiology / Q000517:prevention & control*; D005240:Feasibility Studies; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012008:Recurrence; D012189:Retrospective Studies; D055989:Septal Occluder Device; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome